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Quality Management Systems: the ISO 9000 
Family of Standards 
Nicola Mezzetti, Ph.D. 
Department of Information Engineeri...
What is a Quality Management System? 
Quality Management System 
A set of coordinated activities to direct and control an ...
cation of customer requirements and ending with 
their satisfaction 
Nicola Mezzetti, Ph.D. Quality Management Systems: th...
The ISO 9000 case study 
Nicola Mezzetti, Ph.D. Quality Management Systems: the ISO 9000 Family of Standards
The ISO 9000 Family of Standards 
The ISO 9000 family addresses various aspects of quality 
management. 
It aims at provid...
nes basic concepts and language 
ISO 9001:2008 de
nes the requirement of a quality 
management system 
ISO 9004:2009 focuses on how to make a quality 
management system mor...
The Scope of ISO 9000:2005 
The ISO 9000 standard describes fundamentals of quality 
management systems and de
nes related terms. It applies to: 
organizations seeking advantage through the implementation 
of a quality management sys...
dence from their suppliers that 
their product requirements will be satis
ed; 
users of the products; 
those internal or external to the organization who assess the 
quality management system or a...
The Scope of ISO 9001:2008 
ISO 9001 speci
es requirements for a quality management system 
where an organization 
needs to demonstrate its ability to consistently p...
Rationale for QMSs (ISO 9000:2005) 
Customers require products with characteristics that satisfy their 
needs and expectat...
cations and 
collectively referred to as customer requirements. 
The QMS approach encourages organizations to analyze 
cus...
ne the processes that contribute to 
the achievement of a product which is acceptable to the customer, 
and keep these pro...
Requirements for QMSs  for products (ISO 9000:2005) 
The ISO 9000 family distinguishes between requirements for 
quality m...
ed by customers or by 
the organization in anticipation of customer requirements, or 
by regulation. 
1see ISO 9001:2008 
...
Quality Management System Approach (ISO 9000:2005) 
The quality management system approach encourages 
organizations to an...
ne the 
processes that contribute to the achievement of a product which 
is acceptable to the customer, and keep these pro...
dence to the organization and its customers that it 
is able to provide products that consistently ful
ll requirements. 
Nicola Mezzetti, Ph.D. Quality Management Systems: the ISO 9000 Family of Standards
What is a Quality Management System? (ISO 9000:2005) 
Quality Management System (ISO 9000:2005) 
Management systema to dir...
tability, the environment and occupational health and 
safety). 
Nicola Mezzetti, Ph.D. Quality Management Systems: the IS...
Implications of Adopting a QMS (ISO 9000:2005) 
Direction and control with regard to quality generally includes 
establish...
Quality Policies  Objectives (ISO 9000:2005) 
Quality Policy 
Overall intentions and direction of an organization related ...
Quality Planning (ISO 9000:2005) 
Quality Planning 
Part of quality management focused on setting quality objectives 
and ...
ll the quality objectives. 
Quality Plan 
Document specifying which proceduresa and associated resources 
shall be applied...
c project, product, 
process or contract. 
atypically those referring to quality management processes and to product 
real...
Quality Control, Assurance  Improvement 
Quality Control (ISO 9000:2005) 
Part of quality management focused on ful
lling quality 
requirements. 
Quality Assurance (ISO 9000:2005) 
Part of quality management focused on providing con
dence that 
quality requirements will be ful
lled. 
Quality Improvement (ISO 9000:2005) 
Part of quality management focused on increasing the ability to 
ful
ll quality requirements. 
Nicola Mezzetti, Ph.D. Quality Management Systems: the ISO 9000 Family of Standards
Quality Management's Principles 
Eight management principles that can be used by top management 
in order to lead the orga...
cial Supplier Relationships 
Nicola Mezzetti, Ph.D. Quality Management Systems: the ISO 9000 Family of Standards
Customer's Focus 
Customer's Focus (ISO 9000:2005) 
Organizations depend on their customers and therefore should 
understa...
Implications of Customer's Focus 
Researching and understanding customer needs and 
expectations 
Ensuring that the object...
nanciers, local communities and society as a whole) 
Nicola Mezzetti, Ph.D. Quality Management Systems: the ISO 9000 Famil...
Bene
ts of Customer's Focus 
Increased revenue and marked share 
Increased eectiveness in the use of organization's resources 
...
Leadership 
Leadership (ISO 9000:2005) 
Leaders establish unity of purpose and direction of the 
organization. They should...
Implications of Leadership 
Considering the needs of all interested parties including 
customers, owners, employees, suppl...
nanciers, local 
communities and society as a whole 
Establishing a clear vision of the organization's future 
Setting cha...
Bene
ts of Leadership 
People will understand and be motivated towards the 
organization's goal and objectives 
Activities are ...
ed 
way 
Miscommunication between levels of an organization will be 
minimized 
Nicola Mezzetti, Ph.D. Quality Management ...
Involvement of People 
Involvement of People (ISO 9000:2005) 
People at all levels are the essence of an organization and ...
t. 
Nicola Mezzetti, Ph.D. Quality Management Systems: the ISO 9000 Family of Standards
Implication of Involvement of People 
People understanding the importance of their contribution and 
role in the organizat...
Bene
ts of Involvement of People 
Motivated, committed and involved people within the 
organization 
Innovation and creativity ...
The Process Approach 
Process Approach (ISO 9000:2005) 
A desired result is achieved more eciently when activities and 
re...
cation and management of the processes 
employed within an organization and particularly the interactions 
between such pr...
Implications of the process approach 
Systematically de
ning the activities necessary to obtaining a 
desired result 
Establishing clear responsibility and accountability for 
ma...
The Process Approach 
The Process Approach (ISO 9000:2005) 
Monitoring the satisfaction of interested parties requires the...
Bene
ts of the process approach 
Lower costs and shorter cycle times through eective use of 
resources 
Improved, consistent an...
System Approach to Management 
System Approach to Management (ISO 9000:2005) 
Identifying, understanding and managing inte...
Implications of the system approach 
Structuring a system to achieve the organization's objectives 
in the most eective an...
ning how speci
c activities within a system 
should operate 
Continually improving the system thorough measurement and 
evaluation 
Nicol...
Bene
ts of the system approach 
Integration and alignment of the processes that will best 
achieve the desired results 
Ability...
dence to interested parties as to the 
consistency, eectiveness and eciency of the organization 
Nicola Mezzetti, Ph.D. Qu...
Continual Improvement 
Continual Improvement (ISO 9000:2005) 
Continual Improvement of the organization's overall performa...
Actions for Quality Improvement 
analyzing and evaluating the existing situation to identify 
areas for improvement; 
esta...
Implications of Continual Improvement 
Employing a consistent organization-wide approach to 
continual improvement of the ...
Bene
ts of Continual Improvement 
Performance advantage through improved organization 
capabilities 
Alignment of improvement a...
Factual Approach to Decision Making 
Factual Approach to Decision Making (ISO 9000:2005) 
Eective decisions are based on t...
Implications of Factual Approach to Decision Making 
Ensuring that data and information are suciently accurate 
and reliab...
Bene
ts of Factual Approach to Decision Making 
Informed decisions 
Increased ability to demonstrate the eectiveness of past 
d...
Mutually Bene
cial Supplier Relationship 
Mutually Bene
cial Supplier Relationship (ISO 9000:2005) 
An organization and its suppliers are interdependent and a mutually 
bene
cial relationship enhances the ability of both to create value. 
Nicola Mezzetti, Ph.D. Quality Management Systems: the IS...
Implications of Mutually Bene
cial Supplier Relationship 
Establishing relationships that balance short-term gains with 
long-term considerations 
Pooli...
Bene
ts of Mutually Bene
cial Supplier Relationship 
Increased ability to create value for both parties 
Flexibility and speed of joint responses t...
Steps in Developing a QMS (ISO 9000:2005) 
a) Determining the needs and expectations of customers and 
other interested pa...
Role of Top Management (ISO 9000:2005) 
The quality management principles can be used by top management as 
the basis of i...
lled and quality objectives to 
be achieved 
Ensuring that an eective and ecient QMS is established, 
implemented and main...
Value of Documentation (ISO 9000:2005) 
Documentation enables communication of intent and consistency 
of action. 
Its use...
Types of Documentation (ISO 9000:2005) 
The following types of document are used in QMSs: 
quality manuals, i.e. descripti...
c product, project or contract 
speci
cations, i.e. documents stating requirements 
guidelines, i.e. documents stating recommendations 
documents that provide i...
Evaluating Quality Management Systems (ISO 9000:2005) 
When evaluating QMSs, there are four basic questions that should 
b...
ed and appropriately de
ned? 
Are responsibilities assigned? 
Are the procedures implemented and maintained? 
Is the process eective in achieving ...
Auditing the Quality Management System (ISO 9000:2005) 
Audits are used to determine the extent to which the quality 
mana...
lled. 
Audit
ndings are used to assess the eectiveness of the QMS 
and to identify opportunities for improvement 
First-party audits ar...
Reviewing Quality Management Systems (ISO 9000:2005) 
One role of top management is to carry out regular systematic 
evalu...
Reviewing Quality Management Systems (ISO 9000:2005) 
An organization's self-assessment is a comprehensive and 
systematic...
ISO 9001: Requirements of a Quality 
Management System 
Nicola Mezzetti, Ph.D. Quality Management Systems: the ISO 9000 Fa...
General Requirements for a QMS (9001:2008) 
The organization shall establish, document, implement and 
maintain a quality ...
General Requirements: Outsourcing 
Where an organization chooses to outsource any process that 
aects product conformity t...
ned within the quality management system. 
Nicola Mezzetti, Ph.D. Quality Management Systems: the ISO 9000 Family of Stand...
Document Requirements (9001:2008) 
The quality management system documentation shall include 
documented statements of a q...
cation for any exclusions, 
the documented procedures established for the quality 
management system, or reference to them...
Control of Documents (ISO 9001:2008) 
Documents required by the QMS shall be controlled. A documented 
procedure shall be ...
ne the controls needed: 
to approve documents for adequacy prior to issue, 
to review and update as necessary and reapprov...
ed, 
to ensure that relevant versions of applicable documents are 
available at points of use, 
to ensure that documents r...
able, 
to ensure that documents of external origin determined by the 
organization to be necessary for the planning and op...
ed and their distribution controlled, and 
to prevent the unintended use of obsolete documents, and to apply 
suitable ide...
cation to them if they are retained for any purpose. 
Records are a special type of document and shall be controlled accor...
Control of Records (ISO 9001:2008) 
Records established to provide evidence of conformity to 
requirements and of the eect...
ne 
the controls needed for the identi
cation, storage, protection, 
retrieval, retention and disposition of records. 
Records shall remain legible, readily identi
able and retrievable. 
Nicola Mezzetti, Ph.D. Quality Management Systems: the ISO 9000 Family of Standards
ISO 9001: Management Responsibility 
Nicola Mezzetti, Ph.D. Quality Management Systems: the ISO 9000 Family of Standards
Management Commitment  Customer Focus 
Top management shall provide evidence of its commitment to the 
development and imp...
Management  Quality Policy 
Top management shall ensure that the quality policy 
is appropriate to the purpose of the orga...
Management Responsibility on Planning 
Quality Objectives 
Top management shall ensure that quality objectives, including ...
Responsibility, Authority and Communication 
Top management shall ensure that responsibilities and authorities 
are de
ned and communicated within the organization. 
Top management shall appoint a member of the organization's 
management who...
Management Review 
Top management shall review the organization's QMS, at planned 
intervals, to ensure its continuing sui...
ISO 9001: Resource Management 
Nicola Mezzetti, Ph.D. Quality Management Systems: the ISO 9000 Family of Standards
Resource Management 
The organization shall determine and provide the resources needed 
to implement and maintain the qual...
Competence, training and awareness 
The organization shall 
determine the necessary competence for personnel performing 
w...
ISO 9001: Product Realization 
Nicola Mezzetti, Ph.D. Quality Management Systems: the ISO 9000 Family of Standards
Planning of Product Realization 
The organization shall plan4 and develop the processes needed for 
product realization. 
...
c to the product 
required veri
cation, validation, monitoring, measurement, 
inspection and test activities speci
c to the product and the 
criteria for product acceptance 
records needed to provide evidence that the realization 
proces...
Determination of requirements related to the product 
The organization shall determine 
requirements speci
ed by the customer, including the 
requirements for delivery and post-delivery5 activities 
requirements not stated by the...
ed or intended use, where known 
statutory and regulatory requirements applicable to the 
product 
any additional requirem...
nal 
disposal 
Nicola Mezzetti, Ph.D. Quality Management Systems: the ISO 9000 Family of Standards
Determination of requirements related to the product (cont.) 
Prior to the organization's commitment to supply a product t...
ned 
contract or order requirements diering from those previously 
expressed are resolved 
the organization has the abilit...
e de
ned 
requirements. 
Records of the results of the review and actions arising from the 
review shall be maintained. 
It is ...
rmed by the 
organization before acceptance 
where product requirements are changed, the organization shall 
ensure that r...
Customer communication 
The organization shall determine and implement eective 
arrangements for communicating with custom...
Design and development planning 
The organization shall plan and control the design and 
development of product. During th...
cation and validation that are appropriate to 
each design and development stage 
the responsibilities and authorities for...
Design and Development Inputs 
Inputs relating to product requirements shall be determined and 
records maintained. These ...
Design and Development Outputs 
The outputs of design and development shall be in a form suitable 
for veri
cation against the design and development input and shall 
be approved prior to release. They shall 
meet the input requir...
Design and development review 
At suitable stages, systematic reviews of design and development 
shall be performed in acc...
Design and development veri
cation and validation 
In accordance with planned arrangements: 
Veri
cation shall be performed to ensure that the design and 
development outputs have met the design and development 
input re...
ed application or intended6 
Records of the results of veri
cation and validation, and any 
necessary actions, shall be maintained. 
6Wherever practicable, validation shall be comple...
Control of design and development changes 
Design and development changes shall be identi
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Quality Management Systems: the ISO 9000 Family of Standards

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Quality Management Systems: the ISO 9000 Family of Standards

  1. 1. Quality Management Systems: the ISO 9000 Family of Standards Nicola Mezzetti, Ph.D. Department of Information Engineering and Computer Science University of Trento nicola.mezzetti@gmail.com A.A. 2014/2015 Nicola Mezzetti, Ph.D. Quality Management Systems: the ISO 9000 Family of Standards
  2. 2. What is a Quality Management System? Quality Management System A set of coordinated activities to direct and control an organization in order to continually improve the eectiveness and eciency of its performance A Quality Management System (QMS): enables an organization to achieve the goals and objectives set out in its policy and strategy provides consistency and satisfaction in terms of methods, materials, equipment interacts with all activities of the organization, beginning with the identi
  3. 3. cation of customer requirements and ending with their satisfaction Nicola Mezzetti, Ph.D. Quality Management Systems: the ISO 9000 Family of Standards
  4. 4. The ISO 9000 case study Nicola Mezzetti, Ph.D. Quality Management Systems: the ISO 9000 Family of Standards
  5. 5. The ISO 9000 Family of Standards The ISO 9000 family addresses various aspects of quality management. It aims at providing companies and organizations with guidance and tools for ensuring that their product and services consistently meet customer's requirements, and that quality is consistently improved. ISO 9000:2005 de
  6. 6. nes basic concepts and language ISO 9001:2008 de
  7. 7. nes the requirement of a quality management system ISO 9004:2009 focuses on how to make a quality management system more ecient and eective ISO 19011:2011 sets out guidance on internal and external audits of quality management systems Nicola Mezzetti, Ph.D. Quality Management Systems: the ISO 9000 Family of Standards
  8. 8. The Scope of ISO 9000:2005 The ISO 9000 standard describes fundamentals of quality management systems and de
  9. 9. nes related terms. It applies to: organizations seeking advantage through the implementation of a quality management system; organizations seeking con
  10. 10. dence from their suppliers that their product requirements will be satis
  11. 11. ed; users of the products; those internal or external to the organization who assess the quality management system or audit it for conformity with the requirements of ISO 9001; those internal or external to the organization who give advice or training on the quality management system appropriate to that organization; developers of related standards. Nicola Mezzetti, Ph.D. Quality Management Systems: the ISO 9000 Family of Standards
  12. 12. The Scope of ISO 9001:2008 ISO 9001 speci
  13. 13. es requirements for a quality management system where an organization needs to demonstrate its ability to consistently provide product that meets customer and applicable statutory and regulatory requirements, and aims to enhance customer satisfaction through the eective application of the system, including processes for continual improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements. All requirements of this International Standard are generic and are intended to be applicable to all organizations, regardless of type, size and product provided. Where any requirement(s) of this International Standard cannot be applied due to the nature of an organization and its product, this can be considered for exclusion. Nicola Mezzetti, Ph.D. Quality Management Systems: the ISO 9000 Family of Standards
  14. 14. Rationale for QMSs (ISO 9000:2005) Customers require products with characteristics that satisfy their needs and expectations, expressed in product speci
  15. 15. cations and collectively referred to as customer requirements. The QMS approach encourages organizations to analyze customer requirements, de
  16. 16. ne the processes that contribute to the achievement of a product which is acceptable to the customer, and keep these processes under control. A QMS can provide the framework for continual improvement to increase the probability of enhancing customer satisfaction and the satisfaction of other interested parties. Nicola Mezzetti, Ph.D. Quality Management Systems: the ISO 9000 Family of Standards
  17. 17. Requirements for QMSs for products (ISO 9000:2005) The ISO 9000 family distinguishes between requirements for quality management systems and requirements for products. Requirements for QMSs1 are generic and applicable to organizations in any industry or economic sector regardless of the oered product category. Requirements for products can be speci
  18. 18. ed by customers or by the organization in anticipation of customer requirements, or by regulation. 1see ISO 9001:2008 Nicola Mezzetti, Ph.D. Quality Management Systems: the ISO 9000 Family of Standards
  19. 19. Quality Management System Approach (ISO 9000:2005) The quality management system approach encourages organizations to analyze customer requirements, de
  20. 20. ne the processes that contribute to the achievement of a product which is acceptable to the customer, and keep these processes under control. A quality management system can provide the framework for continual improvement to increase the probability of enhancing customer satisfaction and the satisfaction of other interested parties. It provides con
  21. 21. dence to the organization and its customers that it is able to provide products that consistently ful
  22. 22. ll requirements. Nicola Mezzetti, Ph.D. Quality Management Systems: the ISO 9000 Family of Standards
  23. 23. What is a Quality Management System? (ISO 9000:2005) Quality Management System (ISO 9000:2005) Management systema to direct and control an organization with regard to quality. aSystem to establish policy and objectives and to achieve those objectives. The QMS is that part of the organization's management system that focuses on the achievement of results, in relation to the quality objectives, to satisfy the needs, expectations and requirements of interested parties. Quality objectives complement other objectives of the organization (e.g., those related to growth, funding, pro
  24. 24. tability, the environment and occupational health and safety). Nicola Mezzetti, Ph.D. Quality Management Systems: the ISO 9000 Family of Standards
  25. 25. Implications of Adopting a QMS (ISO 9000:2005) Direction and control with regard to quality generally includes establishment of: quality policy, quality objectives, quality planning, quality control, quality assurance, and quality improvement. Nicola Mezzetti, Ph.D. Quality Management Systems: the ISO 9000 Family of Standards
  26. 26. Quality Policies Objectives (ISO 9000:2005) Quality Policy Overall intentions and direction of an organization related to quality as formally expressed by top management. Quality Objective Something sought, or aimed for, related to quality. Policy and objectives are established to provide a focus to direct the organization2: The quality policy provides a framework for establishing and reviewing quality objectives. The quality objectives need to be consistent with the quality policy and the commitment to continual improvement, and their achievement needs to be measurable. 2Both determine the desired results and assist the organization to apply its resources to achieve the results Nicola Mezzetti, Ph.D. Quality Management Systems: the ISO 9000 Family of Standards
  27. 27. Quality Planning (ISO 9000:2005) Quality Planning Part of quality management focused on setting quality objectives and specifying necessary operational processes and related resources to ful
  28. 28. ll the quality objectives. Quality Plan Document specifying which proceduresa and associated resources shall be applied by whom and when to a speci
  29. 29. c project, product, process or contract. atypically those referring to quality management processes and to product realization processes. Nicola Mezzetti, Ph.D. Quality Management Systems: the ISO 9000 Family of Standards
  30. 30. Quality Control, Assurance Improvement Quality Control (ISO 9000:2005) Part of quality management focused on ful
  31. 31. lling quality requirements. Quality Assurance (ISO 9000:2005) Part of quality management focused on providing con
  32. 32. dence that quality requirements will be ful
  33. 33. lled. Quality Improvement (ISO 9000:2005) Part of quality management focused on increasing the ability to ful
  34. 34. ll quality requirements. Nicola Mezzetti, Ph.D. Quality Management Systems: the ISO 9000 Family of Standards
  35. 35. Quality Management's Principles Eight management principles that can be used by top management in order to lead the organization towards improved performance: Customer Focus Leadership Involvement of People Process Approach System Approach to Management Continual Improvement Factual Approach to Decision Making Mutually Bene
  36. 36. cial Supplier Relationships Nicola Mezzetti, Ph.D. Quality Management Systems: the ISO 9000 Family of Standards
  37. 37. Customer's Focus Customer's Focus (ISO 9000:2005) Organizations depend on their customers and therefore should understand current and future customer needs, should meet customer requirements and strive to exceed customer expectations. Nicola Mezzetti, Ph.D. Quality Management Systems: the ISO 9000 Family of Standards
  38. 38. Implications of Customer's Focus Researching and understanding customer needs and expectations Ensuring that the objectives of the organization are linked to customer needs and expectations Communicating customer needs and expectations throughout the organization Measuring customer satisfaction and acting on the result Systematically managing customer relationships Ensuring a balanced approach between satisfying customers and other interested parties (i.e., owners, employees, suppliers,
  39. 39. nanciers, local communities and society as a whole) Nicola Mezzetti, Ph.D. Quality Management Systems: the ISO 9000 Family of Standards
  40. 40. Bene
  41. 41. ts of Customer's Focus Increased revenue and marked share Increased eectiveness in the use of organization's resources Improved customer loyalty Nicola Mezzetti, Ph.D. Quality Management Systems: the ISO 9000 Family of Standards
  42. 42. Leadership Leadership (ISO 9000:2005) Leaders establish unity of purpose and direction of the organization. They should create and maintain the internal environment in which people can become fully involved in achieving the organization's objectives. Nicola Mezzetti, Ph.D. Quality Management Systems: the ISO 9000 Family of Standards
  43. 43. Implications of Leadership Considering the needs of all interested parties including customers, owners, employees, suppliers,
  44. 44. nanciers, local communities and society as a whole Establishing a clear vision of the organization's future Setting challenging goals and targets Creating and sustaining shared values, fairness and ethical role models at all levels of the organization Proving people with the required resources, training and freedom to act with responsibility and accountability Inspiring, encouraging and recognizing people's contribution Nicola Mezzetti, Ph.D. Quality Management Systems: the ISO 9000 Family of Standards
  45. 45. Bene
  46. 46. ts of Leadership People will understand and be motivated towards the organization's goal and objectives Activities are evaluated, aligned and implemented in a uni
  47. 47. ed way Miscommunication between levels of an organization will be minimized Nicola Mezzetti, Ph.D. Quality Management Systems: the ISO 9000 Family of Standards
  48. 48. Involvement of People Involvement of People (ISO 9000:2005) People at all levels are the essence of an organization and their full involvement enables their abilities to be used for the organization's bene
  49. 49. t. Nicola Mezzetti, Ph.D. Quality Management Systems: the ISO 9000 Family of Standards
  50. 50. Implication of Involvement of People People understanding the importance of their contribution and role in the organization People identifying constraints to their performance People accepting ownership of problem and their responsibility for solving them People evaluating their performance against their personal goals and objectives People actively seeking opportunities to enhance their competence, knowledge and experience People freely sharing knowledge and experience People openly discussing problems and issues Nicola Mezzetti, Ph.D. Quality Management Systems: the ISO 9000 Family of Standards
  51. 51. Bene
  52. 52. ts of Involvement of People Motivated, committed and involved people within the organization Innovation and creativity in furthering the organization's objectives People being accountable for their own performance People eager to participate and contribute to continual improvement Nicola Mezzetti, Ph.D. Quality Management Systems: the ISO 9000 Family of Standards
  53. 53. The Process Approach Process Approach (ISO 9000:2005) A desired result is achieved more eciently when activities and related resources are managed as a process. Process (ISO 9000:2005) Set of interrelated or interacting activities which transforms inputs into outputs. The systematic identi
  54. 54. cation and management of the processes employed within an organization and particularly the interactions between such processes is referred to as the process approach. Nicola Mezzetti, Ph.D. Quality Management Systems: the ISO 9000 Family of Standards
  55. 55. Implications of the process approach Systematically de
  56. 56. ning the activities necessary to obtaining a desired result Establishing clear responsibility and accountability for managing key activities Analyzing and measuring of the capability of key activities Identifying the interfaces of key activities within and between the functions of the organization Focusing on the factors - such as resources, methods and materials - that will improve key activities in the organization Evaluating risks, consequences and impacts of activities on customers, suppliers and other interested parties Nicola Mezzetti, Ph.D. Quality Management Systems: the ISO 9000 Family of Standards
  57. 57. The Process Approach The Process Approach (ISO 9000:2005) Monitoring the satisfaction of interested parties requires the evaluation of information relating to the perception of interested parties as to the extent to which their needs and expectations have been met. Nicola Mezzetti, Ph.D. Quality Management Systems: the ISO 9000 Family of Standards
  58. 58. Bene
  59. 59. ts of the process approach Lower costs and shorter cycle times through eective use of resources Improved, consistent and predictable results Focused and prioritized improvement opportunities Nicola Mezzetti, Ph.D. Quality Management Systems: the ISO 9000 Family of Standards
  60. 60. System Approach to Management System Approach to Management (ISO 9000:2005) Identifying, understanding and managing interrelated processes as a system contributes to the organization's eectiveness and eciency in achieving its objectives. Nicola Mezzetti, Ph.D. Quality Management Systems: the ISO 9000 Family of Standards
  61. 61. Implications of the system approach Structuring a system to achieve the organization's objectives in the most eective and ecient way Understanding the interdependencies between the processes of the system Structured approaches that harmonize and integrate processes Providing a better understanding of the roles and responsibilities necessary for achieving common objectives and thereby reducing cross-functional barriers Understanding organizational capabilities and establishing resource constraints prior to action Targeting and de
  62. 62. ning how speci
  63. 63. c activities within a system should operate Continually improving the system thorough measurement and evaluation Nicola Mezzetti, Ph.D. Quality Management Systems: the ISO 9000 Family of Standards
  64. 64. Bene
  65. 65. ts of the system approach Integration and alignment of the processes that will best achieve the desired results Ability to focus eort on the key processes Providing con
  66. 66. dence to interested parties as to the consistency, eectiveness and eciency of the organization Nicola Mezzetti, Ph.D. Quality Management Systems: the ISO 9000 Family of Standards
  67. 67. Continual Improvement Continual Improvement (ISO 9000:2005) Continual Improvement of the organization's overall performance should be a permanent objective of the organization. Nicola Mezzetti, Ph.D. Quality Management Systems: the ISO 9000 Family of Standards
  68. 68. Actions for Quality Improvement analyzing and evaluating the existing situation to identify areas for improvement; establishing the objectives for improvement; searching for possible solutions to achieve the objectives; evaluating these solutions and making a selection; implementing the selected solution; measuring, verifying, analyzing and evaluating results of the implementation to determine that the objectives have been met; formalizing changes. Results are reviewed to determine further opportunities for improvement. Feedback from customers and other interested parties, audits and review of the quality management system can also be used to identify opportunities for improvement. Nicola Mezzetti, Ph.D. Quality Management Systems: the ISO 9000 Family of Standards
  69. 69. Implications of Continual Improvement Employing a consistent organization-wide approach to continual improvement of the organization's performance Providing people with training in the methods and tools of continual improvement Making continual improvement of products, processes and systems an objective for every individual in the organization Establishing goals to guide, and measures to track, continual improvement Recognizing and acknowledging improvements Nicola Mezzetti, Ph.D. Quality Management Systems: the ISO 9000 Family of Standards
  70. 70. Bene
  71. 71. ts of Continual Improvement Performance advantage through improved organization capabilities Alignment of improvement activities at all levels to an organization's strategic intent Flexibility to react quickly to opportunities Nicola Mezzetti, Ph.D. Quality Management Systems: the ISO 9000 Family of Standards
  72. 72. Factual Approach to Decision Making Factual Approach to Decision Making (ISO 9000:2005) Eective decisions are based on the analysis of data and information. Nicola Mezzetti, Ph.D. Quality Management Systems: the ISO 9000 Family of Standards
  73. 73. Implications of Factual Approach to Decision Making Ensuring that data and information are suciently accurate and reliable Making data accessible to those who need it Analyzing data and information using valid methods Making decisions and taking action based on factual analysis, balanced with experience and intuition Nicola Mezzetti, Ph.D. Quality Management Systems: the ISO 9000 Family of Standards
  74. 74. Bene
  75. 75. ts of Factual Approach to Decision Making Informed decisions Increased ability to demonstrate the eectiveness of past decisions through references to factual records Increased ability to review, challenge and change opinions and decisions Nicola Mezzetti, Ph.D. Quality Management Systems: the ISO 9000 Family of Standards
  76. 76. Mutually Bene
  77. 77. cial Supplier Relationship Mutually Bene
  78. 78. cial Supplier Relationship (ISO 9000:2005) An organization and its suppliers are interdependent and a mutually bene
  79. 79. cial relationship enhances the ability of both to create value. Nicola Mezzetti, Ph.D. Quality Management Systems: the ISO 9000 Family of Standards
  80. 80. Implications of Mutually Bene
  81. 81. cial Supplier Relationship Establishing relationships that balance short-term gains with long-term considerations Pooling of expertise and resources with partners Identifying and selecting key suppliers Clear and open communication Sharing information and future plans Establishing joint development and improvement activities Inspiring, encouraging and recognizing improvements and achievements by suppliers Nicola Mezzetti, Ph.D. Quality Management Systems: the ISO 9000 Family of Standards
  82. 82. Bene
  83. 83. ts of Mutually Bene
  84. 84. cial Supplier Relationship Increased ability to create value for both parties Flexibility and speed of joint responses to changing market or customer needs and expectations Optimization of costs and resources Nicola Mezzetti, Ph.D. Quality Management Systems: the ISO 9000 Family of Standards
  85. 85. Steps in Developing a QMS (ISO 9000:2005) a) Determining the needs and expectations of customers and other interested parties; b) Establishing the quality policy and quality objectives of the organization; c) Determining the processes and responsibilities necessary to attain the quality objectives; d) Determining and providing the resources necessary to attain the quality objectives; e) Establishing methods to measure the eectiveness and eciency of each process; f) Applying these measures to determine the eectiveness and eciency of each process; g) Determining means of preventing non-conformities and eliminating their causes; h) Establishing and applying a process for continual improvement of the quality management system. Nicola Mezzetti, Ph.D. Quality Management Systems: the ISO 9000 Family of Standards
  86. 86. Role of Top Management (ISO 9000:2005) The quality management principles can be used by top management as the basis of its role, which is as follows: Establishing and maintaining the quality policy and objectives Promoting the quality policy and objectives throughout the organization to increase awareness, motivation and involvement Ensuring focus on customer requirements throughout the organization Ensuring that appropriate processes are implemented to enable requirements of customers to be ful
  87. 87. lled and quality objectives to be achieved Ensuring that an eective and ecient QMS is established, implemented and maintained Ensuring the availability of necessary resources Reviewing the quality management system periodically Deciding on actions regarding the quality policy and objectives Deciding on actions for improvement of the QMS Nicola Mezzetti, Ph.D. Quality Management Systems: the ISO 9000 Family of Standards
  88. 88. Value of Documentation (ISO 9000:2005) Documentation enables communication of intent and consistency of action. Its use contributes to achievement of conformity to customer requirements and quality improvement provision of appropriate training repeatability and traceability provision of objective evidence evaluation of the eectiveness and continuing suitability of the quality management system Generation of documentation should not be an end in itself but should be a value-adding activity. Nicola Mezzetti, Ph.D. Quality Management Systems: the ISO 9000 Family of Standards
  89. 89. Types of Documentation (ISO 9000:2005) The following types of document are used in QMSs: quality manuals, i.e. descriptions of the organization's QMS quality plans, i.e. descriptions of how the QMS is applied to a speci
  90. 90. c product, project or contract speci
  91. 91. cations, i.e. documents stating requirements guidelines, i.e. documents stating recommendations documents that provide information about how to perform activities and processes consistently (e.g., procedures, work instructions) records, for providing objective evidence of activities performed or results achieved Each organization determines the extent of documentation required and the media to be used Nicola Mezzetti, Ph.D. Quality Management Systems: the ISO 9000 Family of Standards
  92. 92. Evaluating Quality Management Systems (ISO 9000:2005) When evaluating QMSs, there are four basic questions that should be asked in relation to every process being evaluated. Is the process identi
  93. 93. ed and appropriately de
  94. 94. ned? Are responsibilities assigned? Are the procedures implemented and maintained? Is the process eective in achieving the required results? The collective answers to the above questions can determine the result of the evaluation. Evaluation of a quality management system can vary in scope and encompass a range of activities, such as auditing and reviewing the quality management system, and self-assessments. Nicola Mezzetti, Ph.D. Quality Management Systems: the ISO 9000 Family of Standards
  95. 95. Auditing the Quality Management System (ISO 9000:2005) Audits are used to determine the extent to which the quality management system requirements (ISO 9001) are ful
  96. 96. lled. Audit
  97. 97. ndings are used to assess the eectiveness of the QMS and to identify opportunities for improvement First-party audits are conducted by, or on behalf of, the organization itself for internal purposes and can form the basis for an organization's self-declaration of conformity Second-party audits are conducted by customers of the organization or by other persons on behalf of the customer Third-party audits are conducted by external independent organizations ISO 19011 provides guidance on auditing. Nicola Mezzetti, Ph.D. Quality Management Systems: the ISO 9000 Family of Standards
  98. 98. Reviewing Quality Management Systems (ISO 9000:2005) One role of top management is to carry out regular systematic evaluations of the suitability, adequacy, eectiveness and eciency of the quality management system with respect to the quality policy and quality objectives. This review can include consideration of the need to adapt the quality policy and objectives in response to changing needs and expectations of interested parties The review includes determination of the need for actions Amongst other sources of information, audit reports are used for review of the quality management system. Nicola Mezzetti, Ph.D. Quality Management Systems: the ISO 9000 Family of Standards
  99. 99. Reviewing Quality Management Systems (ISO 9000:2005) An organization's self-assessment is a comprehensive and systematic review of the organization's activities and results referenced against the quality management system or a model of excellence. Self-assessment can provide an overall view of the performance of the organization and the degree of maturity of the quality management system. It can also help to identify areas requiring improvement in the organization and to determine priorities. Nicola Mezzetti, Ph.D. Quality Management Systems: the ISO 9000 Family of Standards
  100. 100. ISO 9001: Requirements of a Quality Management System Nicola Mezzetti, Ph.D. Quality Management Systems: the ISO 9000 Family of Standards
  101. 101. General Requirements for a QMS (9001:2008) The organization shall establish, document, implement and maintain a quality management system and continually improve its eectiveness in accordance with the requirements of this International Standard. The organization shall determine the processes needed for the quality management system and their application throughout the organization, determine the sequence and interaction of these processes, determine criteria and methods needed to ensure that both the operation and control of these processes are eective, ensure the availability of resources and information necessary to support the operation and monitoring of these processes, monitor, measure where applicable, and analyse these processes, and implement actions necessary to achieve planned results and continual improvement of these processes. Nicola Mezzetti, Ph.D. Quality Management Systems: the ISO 9000 Family of Standards
  102. 102. General Requirements: Outsourcing Where an organization chooses to outsource any process that aects product conformity to requirements, the organization shall ensure control over such processes. The type and extent of control to be applied to these outsourced processes shall be de
  103. 103. ned within the quality management system. Nicola Mezzetti, Ph.D. Quality Management Systems: the ISO 9000 Family of Standards
  104. 104. Document Requirements (9001:2008) The quality management system documentation shall include documented statements of a quality policy and quality objectives, a quality manual, documented procedures and records required by this International Standard, and documents, including records, determined by the organization to be necessary to ensure the eective planning, operation and control of its processes. The quality manual that includes: the scope of the quality management system, including details of and justi
  105. 105. cation for any exclusions, the documented procedures established for the quality management system, or reference to them, and a description of the interaction between the processes of the quality management system. Nicola Mezzetti, Ph.D. Quality Management Systems: the ISO 9000 Family of Standards
  106. 106. Control of Documents (ISO 9001:2008) Documents required by the QMS shall be controlled. A documented procedure shall be established to de
  107. 107. ne the controls needed: to approve documents for adequacy prior to issue, to review and update as necessary and reapprove documents, to ensure that changes and the current revision status of documents are identi
  108. 108. ed, to ensure that relevant versions of applicable documents are available at points of use, to ensure that documents remain legible and readily identi
  109. 109. able, to ensure that documents of external origin determined by the organization to be necessary for the planning and operation of the QMS are identi
  110. 110. ed and their distribution controlled, and to prevent the unintended use of obsolete documents, and to apply suitable identi
  111. 111. cation to them if they are retained for any purpose. Records are a special type of document and shall be controlled according to dierent requirements. Nicola Mezzetti, Ph.D. Quality Management Systems: the ISO 9000 Family of Standards
  112. 112. Control of Records (ISO 9001:2008) Records established to provide evidence of conformity to requirements and of the eective operation of the quality management system shall be controlled. The organization shall establish a documented procedure to de
  113. 113. ne the controls needed for the identi
  114. 114. cation, storage, protection, retrieval, retention and disposition of records. Records shall remain legible, readily identi
  115. 115. able and retrievable. Nicola Mezzetti, Ph.D. Quality Management Systems: the ISO 9000 Family of Standards
  116. 116. ISO 9001: Management Responsibility Nicola Mezzetti, Ph.D. Quality Management Systems: the ISO 9000 Family of Standards
  117. 117. Management Commitment Customer Focus Top management shall provide evidence of its commitment to the development and implementation of the quality management system and continually improving its eectiveness by communicating to the organization the importance of meeting customer as well as statutory and regulatory requirements establishing the quality policy ensuring that quality objectives are established conducting management reviews ensuring the availability of resources Top management shall ensure that customer requirements are determined and are met with the aim of enhancing customer satisfaction. Nicola Mezzetti, Ph.D. Quality Management Systems: the ISO 9000 Family of Standards
  118. 118. Management Quality Policy Top management shall ensure that the quality policy is appropriate to the purpose of the organization includes a commitment to comply with requirements and continually improve the eectiveness of the quality management system provides a framework for establishing and reviewing quality objectives is communicated and understood within the organization is reviewed for continuing suitability Nicola Mezzetti, Ph.D. Quality Management Systems: the ISO 9000 Family of Standards
  119. 119. Management Responsibility on Planning Quality Objectives Top management shall ensure that quality objectives, including those needed to meet requirements for product, are established at relevant functions and levels within the organization. The quality objectives shall be measurable and consistent with the quality policy. Quality Management System Planning Top management shall ensure that the planning of the quality management system is carried out in order to meet the general requirements, as well as the quality objectives the integrity of the quality management system is maintained when changes to the quality management system are planned and implemented. Nicola Mezzetti, Ph.D. Quality Management Systems: the ISO 9000 Family of Standards
  120. 120. Responsibility, Authority and Communication Top management shall ensure that responsibilities and authorities are de
  121. 121. ned and communicated within the organization. Top management shall appoint a member of the organization's management who, irrespective of other responsibilities, shall have responsibility and authority that includes ensuring that processes needed for the quality management system are established, implemented and maintained reporting to top management on the performance of the quality management system and any need for improvement ensuring the promotion of awareness of customer requirements throughout the organization Top management shall ensure that appropriate communication processes are established within the organization and that communication takes place regarding the eectiveness of the quality management system. Nicola Mezzetti, Ph.D. Quality Management Systems: the ISO 9000 Family of Standards
  122. 122. Management Review Top management shall review the organization's QMS, at planned intervals, to ensure its continuing suitability, adequacy and eectiveness. This review shall include assessing opportunities for improvement and the need for changes to the QMS, including the quality policy and quality objectives. Records from management reviews shall be maintained. Review Input: results of audits customer feedback process performance and product conformity status of preventive and corrective actions follow-up actions from previous management reviews changes that could aect the QMS recommendations for improvement Review Output: improvement of the eectiveness of the QMS and its processes improvement of product related to customer requirements resource needs Nicola Mezzetti, Ph.D. Quality Management Systems: the ISO 9000 Family of Standards
  123. 123. ISO 9001: Resource Management Nicola Mezzetti, Ph.D. Quality Management Systems: the ISO 9000 Family of Standards
  124. 124. Resource Management The organization shall determine and provide the resources needed to implement and maintain the quality management system and continually improve its eectiveness to enhance customer satisfaction by meeting customer requirements Three kinds of resources: Human resources: personnel performing work aecting conformity to product requirements shall be competent on the basis of appropriate education, training, skills and experience Infrastructure: the organization shall determine, provide and maintain the infrastructure3 needed to achieve conformity to product requirements Work Environment: the organization shall determine and manage the work environment needed to achieve conformity to product requirements 3e.g., buildings, workspace, process equipment, and supporting services Nicola Mezzetti, Ph.D. Quality Management Systems: the ISO 9000 Family of Standards
  125. 125. Competence, training and awareness The organization shall determine the necessary competence for personnel performing work aecting conformity to product requirements where applicable, provide training or take other actions to achieve the necessary competence evaluate the eectiveness of the actions taken ensure that its personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objectives maintain appropriate records of education, training, skills and experience Nicola Mezzetti, Ph.D. Quality Management Systems: the ISO 9000 Family of Standards
  126. 126. ISO 9001: Product Realization Nicola Mezzetti, Ph.D. Quality Management Systems: the ISO 9000 Family of Standards
  127. 127. Planning of Product Realization The organization shall plan4 and develop the processes needed for product realization. The organization shall determine: quality objectives and requirements for the product the need to establish processes and documents, and to provide resources speci
  128. 128. c to the product required veri
  129. 129. cation, validation, monitoring, measurement, inspection and test activities speci
  130. 130. c to the product and the criteria for product acceptance records needed to provide evidence that the realization processes and resulting product meet requirements The output of this planning shall be in a form suitable for the organization's method of operations. 4Planning of product realization shall be consistent with the requirements of the other processes of the QMS. Nicola Mezzetti, Ph.D. Quality Management Systems: the ISO 9000 Family of Standards
  131. 131. Determination of requirements related to the product The organization shall determine requirements speci
  132. 132. ed by the customer, including the requirements for delivery and post-delivery5 activities requirements not stated by the customer but necessary for speci
  133. 133. ed or intended use, where known statutory and regulatory requirements applicable to the product any additional requirements considered necessary by the organization 5e.g., actions under warranty provisions, contractual obligations such as maintenance services, and supplementary services such as recycling or
  134. 134. nal disposal Nicola Mezzetti, Ph.D. Quality Management Systems: the ISO 9000 Family of Standards
  135. 135. Determination of requirements related to the product (cont.) Prior to the organization's commitment to supply a product to the customer, the organization shall review the requirements related to the product. The review shall ensure that: product requirements are de
  136. 136. ned contract or order requirements diering from those previously expressed are resolved the organization has the ability to meet
  137. 137. e de
  138. 138. ned requirements. Records of the results of the review and actions arising from the review shall be maintained. It is worth noting that: where the customer provides no documented statement of requirement, the customer requirements shall be con
  139. 139. rmed by the organization before acceptance where product requirements are changed, the organization shall ensure that relevant documents are amended and that relevant personnel are made aware of the changed requirements. Nicola Mezzetti, Ph.D. Quality Management Systems: the ISO 9000 Family of Standards
  140. 140. Customer communication The organization shall determine and implement eective arrangements for communicating with customers in relation to product information enquiries, contracts or order handling, including amendments customer feedback, including customer complaints Nicola Mezzetti, Ph.D. Quality Management Systems: the ISO 9000 Family of Standards
  141. 141. Design and development planning The organization shall plan and control the design and development of product. During this activity the organization shall determine the design and development stages the review, veri
  142. 142. cation and validation that are appropriate to each design and development stage the responsibilities and authorities for design and development The organization shall manage the interfaces between dierent groups involved in design and development to ensure eective communication and clear assignment of responsibility. Planning output shall be updated, as appropriate, as the design and development progresses. Nicola Mezzetti, Ph.D. Quality Management Systems: the ISO 9000 Family of Standards
  143. 143. Design and Development Inputs Inputs relating to product requirements shall be determined and records maintained. These inputs shall include: functional and performance requirements applicable statutory and regulatory requirements where applicable, information derived from previous similar designs other requirements essential for design and development The inputs shall be reviewed for adequacy. Requirements shall be complete, unambiguous and not in con ict with each other. Nicola Mezzetti, Ph.D. Quality Management Systems: the ISO 9000 Family of Standards
  144. 144. Design and Development Outputs The outputs of design and development shall be in a form suitable for veri
  145. 145. cation against the design and development input and shall be approved prior to release. They shall meet the input requirements for design and development provide appropriate information for purchasing, production and service provision contain or reference product acceptance criteria specify the characteristics of the product that are essential for its safe and proper use Nicola Mezzetti, Ph.D. Quality Management Systems: the ISO 9000 Family of Standards
  146. 146. Design and development review At suitable stages, systematic reviews of design and development shall be performed in accordance with planned arrangements to evaluate the ability of the results of design and development to meet requirements to identify any problems and propose necessary actions.. Participants in such reviews shall include representatives of functions concerned with the design and development stage being reviewed. Records of the results of the reviews and any necessary actions shall be maintained. Nicola Mezzetti, Ph.D. Quality Management Systems: the ISO 9000 Family of Standards
  147. 147. Design and development veri
  148. 148. cation and validation In accordance with planned arrangements: Veri
  149. 149. cation shall be performed to ensure that the design and development outputs have met the design and development input requirements Validation shall be performed to ensure that the resulting product is capable of meeting the requirements for the speci
  150. 150. ed application or intended6 Records of the results of veri
  151. 151. cation and validation, and any necessary actions, shall be maintained. 6Wherever practicable, validation shall be completed prior to the delivery or implementation of the product. Nicola Mezzetti, Ph.D. Quality Management Systems: the ISO 9000 Family of Standards
  152. 152. Control of design and development changes Design and development changes shall be identi
  153. 153. ed and records maintained. The changes shall be reviewed, veri
  154. 154. ed and validated, as appropriate, and approved before implementation. The review of design and development changes shall include evaluation of the eect of the changes on constituent parts and product already delivered. Records of the results of the review of changes and any necessary actions shall be maintained. Nicola Mezzetti, Ph.D. Quality Management Systems: the ISO 9000 Family of Standards
  155. 155. Purchasing process The organization shall ensure that purchased product conforms to speci
  156. 156. ed purchase requirements. the type and extent of control applied to the supplier and the purchased product shall depend on the eect of the purchased product on subsequent product realization or the
  157. 157. nal product The organization shall evaluate and select suppliers based on their ability to supply product in accordance with the organization's requirements. Criteria for selection, evaluation and re-evaluation shall be established Records of the results of evaluations and any necessary actions arising from the evaluation shall be maintained. Nicola Mezzetti, Ph.D. Quality Management Systems: the ISO 9000 Family of Standards
  158. 158. Purchasing information Purchasing information shall describe the product to be purchased, including, where appropriate: requirements for approval of product, procedures, processes and equipment requirements for quali
  159. 159. cation of personnel quality management system requirements The organization shall ensure the adequacy of speci
  160. 160. ed purchase requirements prior to their communication to the supplier. Nicola Mezzetti, Ph.D. Quality Management Systems: the ISO 9000 Family of Standards
  161. 161. Veri
  162. 162. cation of purchased product The organization shall establish and implement the inspection or other activities necessary for ensuring that purchased product meets speci
  163. 163. ed purchase requirements. Where the organization or its customer intends to perform veri
  164. 164. cation at the supplier's premises, the organization shall state the intended veri
  165. 165. cation arrangements and method of product release in the purchasing information. Nicola Mezzetti, Ph.D. Quality Management Systems: the ISO 9000 Family of Standards
  166. 166. Control of production and service provision The organization shall plan and carry out production and service provision under controlled conditions which shall include, as applicable the availability of information that describes the characteristics of the product the availability of work instructions, as necessary the use of suitable equipment the availability and use of monitoring and measuring equipment the implementation of monitoring and measurement the implementation of product release, delivery and post-delivery activities Nicola Mezzetti, Ph.D. Quality Management Systems: the ISO 9000 Family of Standards
  167. 167. Validation of processes for production and service provision The organization shall validate any processes for production and service provision where the resulting output cannot be veri
  168. 168. ed by subsequent monitoring or measurement. Validation shall demonstrate the ability of these processes to achieve planned results. The organization shall establish arrangements for these processes including, as applicable, de
  169. 169. ned criteria for review and approval of the processes approval of equipment and quali
  170. 170. cation of personnel use of speci
  171. 171. c methods and procedures requirements for records revalidation Nicola Mezzetti, Ph.D. Quality Management Systems: the ISO 9000 Family of Standards
  172. 172. Identi
  173. 173. cation and traceability Where appropriate, the organization shall identify the product by suitable means throughout product realization. The organization shall identify the product status with respect to monitoring and measurement requirements throughout product realization. Where traceability is a requirement, the organization shall control the unique identi
  174. 174. cation of the product and maintain records. Nicola Mezzetti, Ph.D. Quality Management Systems: the ISO 9000 Family of Standards
  175. 175. Customer property The organization shall exercise care with customer property7 while it is under the organization's control or being used by the organization. The organization shall identify, verify, protect and safeguard customer property provided for use or incorporation into the product. If any customer property is lost, damaged or otherwise found to be unsuitable for use, the organization shall report this to the customer and maintain records. 7Customer property can include intellectual property and personal data. Nicola Mezzetti, Ph.D. Quality Management Systems: the ISO 9000 Family of Standards
  176. 176. Preservation of product The organization shall preserve the product during internal processing and delivery to the intended destination in order to maintain conformity to requirements. As applicable, preservation shall include: identi
  177. 177. cation handling packaging storage protection Preservation shall also apply to the constituent parts of a product. Nicola Mezzetti, Ph.D. Quality Management Systems: the ISO 9000 Family of Standards
  178. 178. Control of monitoring and measuring equipment The organization shall determine the monitoring and measurement to be undertaken and the monitoring and measuring equipment needed to provide evidence of conformity of product to determined requirements. The organization shall establish processes to ensure that monitoring and measurement can be carried out and are carried out in a manner that is consistent with the monitoring and measurement requirements. Nicola Mezzetti, Ph.D. Quality Management Systems: the ISO 9000 Family of Standards
  179. 179. Control of monitoring and measuring equipment (cont.) Where necessary to ensure valid results, measuring equipment shall be calibrated or veri
  180. 180. ed, or both, at speci
  181. 181. ed intervals, or prior to use, against measurement standards traceable to international or national measurement standards; where no such standards exist, the basis used for calibration or veri
  182. 182. cation shall be recorded be adjusted or re-adjusted as necessary have identi
  183. 183. cation in order to determine its calibration status be safeguarded from adjustments that would invalidate the measurement result be protected from damage and deterioration during handling, maintenance and storage Nicola Mezzetti, Ph.D. Quality Management Systems: the ISO 9000 Family of Standards
  184. 184. Control of monitoring and measuring equipment (cont.) In addition, the organization shall assess and record the validity of the previous measuring results when the equipment is found not to conform to requirements. The organization shall take appropriate action on the equipment and any product aected. Records of the results of calibration and veri
  185. 185. cation shall be maintained. When used in the monitoring and measurement of speci
  186. 186. ed requirements, the ability of computer software to satisfy the intended application shall be con
  187. 187. rmed. This shall be undertaken prior to initial use and recon
  188. 188. rmed as necessary. Nicola Mezzetti, Ph.D. Quality Management Systems: the ISO 9000 Family of Standards
  189. 189. ISO 9001: Measurement, analysis and improvement Nicola Mezzetti, Ph.D. Quality Management Systems: the ISO 9000 Family of Standards
  190. 190. Measurement, analysis and improvement The organization shall plan and implement the monitoring, measurement, analysis and improvement processes needed: to demonstrate conformity to product requirements to ensure conformity of the quality management system to continually improve the eectiveness of the quality management system. This shall include determination of applicable methods, including statistical techniques, and the extent of their use. Nicola Mezzetti, Ph.D. Quality Management Systems: the ISO 9000 Family of Standards
  191. 191. Monitoring and measurement: Customer Satisfaction As one of the measurements of the performance of the quality management system, the organization shall monitor information relating to customer perception as to whether the organization has met customer requirements. The methods for obtaining and using this information shall be determined. Nicola Mezzetti, Ph.D. Quality Management Systems: the ISO 9000 Family of Standards
  192. 192. Monitoring and measurement: Internal Audit The organization shall conduct internal audits at planned intervals to determine whether the QMS conforms to the planned arrangements, to the requirements of this International Standard and to the quality management system requirements established by the organization is eectively implemented and maintained. An audit programme shall be planned, taking into consideration the status and importance of the processes and areas to be audited, as well as the results of previous audits. The selection of auditors and conduct of audits shall ensure objectivity and impartiality of the audit process. Nicola Mezzetti, Ph.D. Quality Management Systems: the ISO 9000 Family of Standards
  193. 193. Monitoring and measurement: Internal Audit (cont.) A documented procedure shall be established to de
  194. 194. ne the responsibilities and requirements for planning and conducting audits, establishing records and reporting results. Records of the audits and their results shall be maintained. The management, responsible for the area being audited shall ensure that any necessary corrections and corrective actions are taken without undue delay to eliminate detected nonconformities and their causes. Follow-up activities shall include the veri
  195. 195. cation of the actions taken and the reporting of veri
  196. 196. cation results Nicola Mezzetti, Ph.D. Quality Management Systems: the ISO 9000 Family of Standards
  197. 197. Monitoring and measurement of processes The organization shall apply suitable methods for monitoring and, where applicable, measurement of the quality management system processes. These methods shall demonstrate the ability of the processes to achieve planned results. When planned results are not achieved, correction and corrective action shall be taken, as appropriate. When determining suitable methods, it is advisable that the organization consider the type and extent of monitoring or measurement appropriate to each of its processes in relation to their impact on the conformity to product requirements and on the eectiveness of the quality management system. Nicola Mezzetti, Ph.D. Quality Management Systems: the ISO 9000 Family of Standards
  198. 198. Monitoring and measurement of product The organization shall monitor and measure the characteristics of the product to verify that product requirements have been met. This shall be carried out at appropriate stages of the product realization process in accordance with the planned arrangements. Evidence of conformity with the acceptance criteria shall be maintained. Records shall indicate the person(s) authorizing release of product for delivery to the customer. The release of product and delivery of service to the customer shall not proceed until the planned arrangements have been satisfactorily completed, unless otherwise approved by a relevant authority and, where applicable, by the customer. Nicola Mezzetti, Ph.D. Quality Management Systems: the ISO 9000 Family of Standards
  199. 199. Control of nonconforming product The organization shall ensure that product which does not conform to product requirements is identi
  200. 200. ed and controlled to prevent its unintended use or delivery. A documented procedure shall be established to de
  201. 201. ne the controls and related responsibilities and authorities for dealing with nonconforming product. Nicola Mezzetti, Ph.D. Quality Management Systems: the ISO 9000 Family of Standards
  202. 202. Dealing with nonconforming product Where applicable, the organization shall deal with nonconforming product by one or more of the following ways: by taking action to eliminate the detected nonconformity by authorizing its use, release or acceptance under concession by a relevant authority and, where applicable, by the customer by taking action to preclude its original intended use or application by taking action appropriate to the eects, or potential eects, of the nonconformity when nonconforming product is detected after delivery or use has started When nonconforming product is corrected it shall be subject to re-veri
  203. 203. cation to demonstrate conformity to the requirements. Records of the nature of nonconformities and any subsequent actions taken, including concessions obtained, shall be maintained. Nicola Mezzetti, Ph.D. Quality Management Systems: the ISO 9000 Family of Standards
  204. 204. Analysis of data The organization shall determine, collect and analyze appropriate data to demonstrate the suitability and eectiveness of the quality management system and to evaluate where continual improvement of the eectiveness of the quality management system can be made. The analysis of data shall provide information relating to customer satisfaction conformity to product requirements characteristics and trends of processes and products, including opportunities for preventive action suppliers Nicola Mezzetti, Ph.D. Quality Management Systems: the ISO 9000 Family of Standards
  205. 205. Improvement The organization shall continually improve the eectiveness of the QMS through he use of the quality policy, quality objectives, audit results, analysis of data, corrective and preventive actions and management review. Corrective Actions The organization shall take appropriate action to eliminate the causes of nonconformities in order to prevent recurrence. A documented procedure shall be established to de
  206. 206. ne requirements for reviewing nonconformities (including customer complaints) determining the causes of nonconformities evaluating the need for action to ensure that nonconformities do not recur determining and implementing action needed records of the results of action taken reviewing the eectiveness of the corrective action taken Nicola Mezzetti, Ph.D. Quality Management Systems: the ISO 9000 Family of Standards
  207. 207. Improvement (cont.) Preventive Actions The organization shall determine action to eliminate the causes of potential nonconformities in order to prevent their occurrence. Preventive actions shall be appropriate to the eects of the potential problems. A documented procedure shall be established to de
  208. 208. ne requirements for determining potential nonconformities and their causes, evaluating the need for action to prevent occurrence of nonconformities determining and implementing action needed records of results of action taken reviewing the eectiveness of the preventive action taken Nicola Mezzetti, Ph.D. Quality Management Systems: the ISO 9000 Family of Standards
  209. 209. The Role of Statistical Techniques (ISO 9000:2005) The use of statistical techniques can help in understanding variability, and thereby can help organizations to solve problems and improve eectiveness and eciency. These techniques also facilitate better use of available data to assist in decision making. Statistical techniques can help to measure, describe, analyze, interpret and model such variability, even with a relatively limited amount of data. Statistical analysis of such data can help to provide a better understanding of the nature, extent and causes of variability, thus helping to solve and even prevent problems that may result from such variability, and to promote continual improvement. Guidance on statistical techniques in a quality management system is given in ISO/TR 10017. Nicola Mezzetti, Ph.D. Quality Management Systems: the ISO 9000 Family of Standards
  210. 210. ISO 9004: Managing for the sustained success of an organization - A quality management approach Nicola Mezzetti, Ph.D. Quality Management Systems: the ISO 9000 Family of Standards
  211. 211. Extended model of a process-based QMS Nicola Mezzetti, Ph.D. Quality Management Systems: the ISO 9000 Family of Standards
  212. 212. Sustained Success The organization can achieve sustained success by consistently meeting the needs and expectations of its interested parties, in a balanced way, over the long term. An organization's environment is ever-changing and uncertain, and to achieve sustained success its top management should: have a long-term planning perspective constantly monitor and regularly analyze the organization's environment identify relevant interested parties, assess their individual potential impacts on the organization's performance, as well as determining how to meet their needs and expectations in a balanced way continually engage interested parties and keep them informed of the organization's activities and plans Nicola Mezzetti, Ph.D. Quality Management Systems: the ISO 9000 Family of Standards
  213. 213. Sustained Success (cont.) establish mutually bene
  214. 214. cial relationships with suppliers, partners and other interested parties make use of a wide variety of approaches, including negotiation and mediation, to balance the often competing needs and expectations of interested parties identify associated short and long-term risks and deploy an overall strategy for the organization to mitigate them8 anticipate future resource needs (including competences) 8For more information on risk management, see ISO 31000 Nicola Mezzetti, Ph.D. Quality Management Systems: the ISO 9000 Family of Standards
  215. 215. Sustained Success (cont.) establish processes appropriate to achieving the organization's strategy, ensuring that they are capable of responding quickly to changing circumstances regularly assess compliance with current plans and procedures, and take appropriate corrective and preventive actions ensure that people in the organization have opportunities for learning for their own bene
  216. 216. t, as well as for maintaining the vitality of the organization establish and maintain processes for innovation and continual improvement Nicola Mezzetti, Ph.D. Quality Management Systems: the ISO 9000 Family of Standards
  217. 217. The Organization's Environment An organization's environment will be undergoing change continually, regardless of its size (large or small), its activities and products, or its type (for pro
  218. 218. t or not-for-pro
  219. 219. t); consequently this should be monitored constantly by the organization. Such monitoring should enable the organization to identify, assess and manage the risks related to interested parties, and their changing needs and expectations. Top management should make decisions for organizational change and innovation in a timely manner in order to maintain and improve the organization's performance. Nicola Mezzetti, Ph.D. Quality Management Systems: the ISO 9000 Family of Standards
  220. 220. Interested Parties, Needs and Expectations Interested parties are individuals and other entities that add value to the organization, or are otherwise interested in, or aected by, the activities of the organization. Meeting the needs and expectations of interested parties contributes to the achievement of sustained success by the organization. needs and expectations of individual interested parties are dierent, can be in con ict with those of other interested parties, or can change very quickly The means by which the needs and expectations of interested parties are expressed and met can take a wide variety of forms, including collaboration, cooperation, negotiation, outsourcing, or by terminating an activity. Nicola Mezzetti, Ph.D. Quality Management Systems: the ISO 9000 Family of Standards
  221. 221. Strategy and Policy To achieve sustained success, top management should establish and maintain a mission, a vision and values for the organization. a mission is a description of why the organization exists a vision describes its desired state, i.e. what the organization wants to be and how it wants to be seen by its interested parties These should be clearly understood, accepted and supported by people in the organization and, as appropriate, by other interested parties. Nicola Mezzetti, Ph.D. Quality Management Systems: the ISO 9000 Family of Standards
  222. 222. Strategy and Policy Formulation In order to establish, adopt and sustain an eective strategy and policy, the organization should have processes to continually monitor and regularly analyze the organization's environment, including its customers' needs and expectations, the competitive situation, new technologies, political changes, economic forecasts, or sociological factors identify and determine the needs and expectations of other interested parties assess its current process capabilities and resources identify future resource and technology needs update its strategy and policies identify the outputs necessary to meet the needs and expectations of the interested parties Nicola Mezzetti, Ph.D. Quality Management Systems: the ISO 9000 Family of Standards
  223. 223. Strategy and Policy Formulation (cont.) These processes should be established in a timely manner, with any necessary plans and resources being provided to support them. The formulation of an organization's strategy should also consider activities such as analyses of customer or regulatory demands, its products, its strengths, weaknesses, opportunities, and threats. A de
  224. 224. ned process should exist for the formulation and review of the organization's strategy. Nicola Mezzetti, Ph.D. Quality Management Systems: the ISO 9000 Family of Standards
  225. 225. Strategy and Policy Deployment To implement a strategy and policies for sustained success, the organization should establish and maintain processes and practices that translate its strategy and policies into measurable objectives for all relevant levels of the organization appropriate establish timelines for each objective and assign responsibility and authority for achieving the objective evaluate strategic risks and de
  226. 226. ne adequate counter measures provide the resources required to deploy needed activities execute the activities needed to achieve these objectives Nicola Mezzetti, Ph.D. Quality Management Systems: the ISO 9000 Family of Standards
  227. 227. Strategy and Policy Deployment: Processes Practices In order to ensure that its processes and practices are eective and ecient, the organization should perform activities for anticipating any potential con icts arising from the dierent needs and expectations of its interested parties assessing and understanding the organization's current performance and the root-causes of problems in the past keeping interested parties informed, gaining their commitment, keeping them aware of progress against plans, and obtaining feedback and ideas for improvement from them reviewing the management system and its processes, and updating them as necessary monitoring, measuring, analyzing, reviewing and reporting providing any required resources, including those for improvement, innovation and learning the development, updating and accomplishment of objectives ensuring that the results are consistent with the strategy Nicola Mezzetti, Ph.D. Quality Management Systems: the ISO 9000 Family of Standards
  228. 228. Strategy and Policy Deployment: Deployment To deploy its strategy and policies, the organization should identify the relationships between its processes. A description of the sequence and interaction of the processes can assist review activities by showing the relationship between organizational structures, systems and processes identifying potential problems in the interactions between processes providing a means for prioritizing improvement and other change initiatives providing a framework for setting, aligning and deploying objectives to all relevant levels of the organization Nicola Mezzetti, Ph.D. Quality Management Systems: the ISO 9000 Family of Standards
  229. 229. Strategy and Policy Communication The eective communication of the strategy and policies is essential to the sustained success of the organization. Such communication should be meaningful, timely and continual. Communication should also include a feedback mechanism, a review cycle and should incorporate provisions to proactively address changes in the organization's environment. The organization's communication process should operate both vertically and horizontally and should be tailored to the diering needs of its recipients. Nicola Mezzetti, Ph.D. Quality Management Systems: the ISO 9000 Family of Standards
  230. 230. Resource Management The organization should identify the internal and external resources that are needed for the achievement of the organization's objectives in the short and long term. the organization's policies and methods for resource management should be consistent with its strategy. To ensure that resources are used eectively and eciently, it is necessary to have processes in place to provide, allocate, monitor, evaluate, optimize, maintain and protect those resources. In parallel, research for new resources, optimized processes and new technologies should take place. The organization should periodically review the availability and suitability of the identi
  231. 231. ed resources, including outsourced resources, and take action as necessary. The results of these reviews should also be used as inputs into the organization's reviews of its strategy, objectives and plans. Nicola Mezzetti, Ph.D. Quality Management Systems: the ISO 9000 Family of Standards
  232. 232. Financial Resources Top management should determine the organization's
  233. 233. nancial needs and establish the necessary
  234. 234. nancial resources for current and future operations. The organization should establish and maintain processes for monitoring, controlling and reporting the eective allocation and ecient usage of
  235. 235. nancial resources related to the organization's objectives. Improving the eectiveness and eciency of the management system can positively in uence the
  236. 236. nancial results of the organization in many ways. Examples include internally, by reducing process and product failures and eliminating the waste of materials or time, and externally, by reducing product failures, costs of compensation under guarantees and warranties, product liabilities and other legal exposure, costs of lost customers and markets. Nicola Mezzetti, Ph.D. Quality Management Systems: the ISO 9000 Family of Standards
  237. 237. People in the Organization People are a signi
  238. 238. cant resource of an organization and their full involvement enhances their ability to create value for interested parties. Top management should, through its leadership, create and maintain a shared vision, shared values and an internal environment in which people can become fully involved in achieving the organization's objectives. As people are a most valuable and critical resource, it is necessary to ensure that their work environment encourages personal growth, learning, knowledge transfer and teamwork. People management should be performed through a planned, transparent, ethical and socially responsible approach. The organization should ensure that the people understand the importance of their contribution and roles. Nicola Mezzetti, Ph.D. Quality Management Systems: the ISO 9000 Family of Standards
  239. 239. People in the Organization: Management The organization should establish processes that empower people to: translate the organization's strategic and process objectives into individual job objectives, and to establish plans for their achievement identify constraints to their performance take ownership and responsibility to solve problems assess personal performance against individual job objectives actively seek opportunities to enhance their competence and experience promote teamwork and encourage synergy between people share information, knowledge and experience within the organization Nicola Mezzetti, Ph.D. Quality Management Systems: the ISO 9000 Family of Standards
  240. 240. People in the Organization: Competences The organization should establish and maintain a people development plan and associated processes, to assist the organization in identifying, developing and improving the competence of its people. Identifying the professional and personal competences the organization could need in the short and long term, in accordance with its mission, vision, strategy, policies, and objectives Identifying the competences currently available in the organization and the gaps between what is available and what is currently needed and could be needed in the future Implementing actions to improve and or acquire competences to close the gaps Reviewing and evaluating the eectiveness of actions taken to ensure that the necessary competences have been acquired Maintaining competences that have been acquired Nicola Mezzetti, Ph.D. Quality Management Systems: the ISO 9000 Family of Standards
  241. 241. People in the Organization: Involvement Motivation To enhance the involvement and motivation of its people, the organization should consider activities such as: developing a process to share knowledge and use the competence of people, e.g. a scheme for collecting ideas for improvement introducing an appropriate recognition and reward system, that is based on individual evaluations of the accomplishments of the people establishing a skills quali
  242. 242. cation system and career planning, to promote personal development continually reviewing the level of satisfaction and needs and expectations of people providing opportunities for mentoring and coaching Nicola Mezzetti, Ph.D. Quality Management Systems: the ISO 9000 Family of Standards
  243. 243. Suppliers and Partners Partners can be suppliers of products, service providers, technological and
  244. 244. nancial institutions, governmental and non-governmental organizations or other interested parties. Partners can contribute with any type of resource, as agreed and de
  245. 245. ned in a partnership agreement. The organization and its partners are interdependent and a mutually bene
  246. 246. cial relationship enhances their capabilities to create value. Nicola Mezzetti, Ph.D. Quality Management Systems: the ISO 9000 Family of Standards
  247. 247. Suppliers and Partners (cont.) When an organization is developing partnerships, the organization should give consideration to issues such as: the provision of information to partners, as appropriate, to maximize their contributions supporting partners, in terms of providing them with resources (e.g. information, knowledge, expertise, technology, processes, and shared training) the sharing of pro
  248. 248. ts and losses with partners improving the performance of partners Nicola Mezzetti, Ph.D. Quality Management Systems: the ISO 9000 Family of Standards
  249. 249. Suppliers and Partners: Selection Evaluation The organization should establish and maintain processes to identify, select, and evaluate its suppliers and partners, in order to continually improve their capabilities and to ensure that the products or other resources they provide meet the needs and expectations of the organization. In selecting and evaluating suppliers and partners, the organization should consider: their contribution to the organization's activities and ability to create value for the organization and its interested parties the potential for continually improving their capabilities the enhancement of its own capabilities that can be achieved through co-operation with the suppliers and partners the risks associated in the relationships with the suppliers and partners Nicola Mezzetti, Ph.D. Quality Management Systems: the ISO 9000 Family of Standards
  250. 250. Suppliers and Partners: Performance Improvement Together with its suppliers and partners, the organization should seek to continually improve the quality, price and delivery of products provided by the suppliers and partners, and the eectiveness of their management systems, based on periodic evaluation and feedback of their performance. The organization should continually review and strengthen its relationships with its suppliers and partners, while considering the balance between its short and long term objectives. Nicola Mezzetti, Ph.D. Quality Management Systems: the ISO 9000 Family of Standards
  251. 251. Infrastructure The organization should plan, provide and manage its infrastructure eectively and eciently. It should periodically assess the suitability of the infrastructure to meet organizational objectives. Appropriate consideration should be given to: the dependability of the infrastructure (including consideration of availability, reliability, maintainability, and maintenance support) safety and security infrastructure elements related to products and processes the eciency, cost, capacity and work environment the impact of the infrastructure on the work environment The organization should identify and assess the risks associated with the infrastructure and take action to mitigate the risks, including the establishment of adequate contingency plans. Nicola Mezzetti, Ph.D. Quality Management Systems: the ISO 9000 Family of Standards
  252. 252. Work Environment The organization should provide and manage a suitable work environment to achieve and maintain the sustained success of the organization and the competitiveness of its products. A suitable work environment, as a combination of human and physical factors, should include consideration of creative work methods and opportunities for greater involvement to realize the potential of people in the organization safety rules and guidance and the use of protective equipment ergonomics psychological factors, including workload and stress workplace location facilities for people in the organization maximization of eciency and minimization of waste heat, humidity, light, air ow hygiene, cleanliness, noise, vibration and pollution Nicola Mezzetti, Ph.D. Quality Management Systems: the ISO 9000 Family of Standards
  253. 253. Knowledge Top management should assess how the organization's current knowledge base is identi
  254. 254. ed and protected consider how to obtain the knowledge required to meet the present and future needs of the organization . There are many issues to consider when de
  255. 255. ning how to identify, maintain and protect knowledge: learning from failures, near miss situations and successes capturing the knowledge and experience of people in the organization gathering knowledge from customers, suppliers and partners capturing undocumented knowledge that exists within the organization ensuring the eective communication of important information content managing data and records Nicola Mezzetti, Ph.D. Quality Management Systems: the ISO 9000 Family of Standards
  256. 256. Information The organization should establish and maintain processes to gather reliable and useful data and for converting such data into the information necessary for decision making. This includes the processes needed for the storage, security, protection, communication and distribution of data and information to all relevant parties. The organization's information and communication systems need to be robust and accessible, to ensure their capabilities. The organization should ensure the integrity, con
  257. 257. dentiality and availability of information relating to its performance, process improvements, and on progress towards the achievement of sustained success. Nicola Mezzetti, Ph.D. Quality Management Systems: the ISO 9000 Family of Standards
  258. 258. Technology Top management should consider technological options to enhance the organization's performance in areas such as product realization, marketing, benchmarking, customer interaction, supplier relations and outsourced processes. The organization should establish processes for the assessment of the current levels of technology inside and outside the organization, including emerging trends economic costs and bene
  259. 259. ts the evaluation of risks related to changes in technology the competitive environment its speed and ability to react to customer requirements promptly, to ensure that it remains competitive Nicola Mezzetti, Ph.D. Quality Management Systems: the ISO 9000 Family of Standards
  260. 260. Natural Resources The availability of natural resources is one of the factors that can in uence an organization's sustained success and ability to meet the requirements of its customers and other interested parties. The organization should consider the risks and opportunities related to the availability and use of energy and natural resources in the short and long term give appropriate consideration to the integration of environmental protection aspects into product design and development, as well as to the development of its processes to mitigate identi
  261. 261. ed risks seek to minimize environmental impacts over the full life cycle of its products and its infrastructure, from design, through manufacturing or service delivery, to product distribution, use and disposal Nicola Mezzetti, Ph.D. Quality Management Systems: the ISO 9000 Family of Standards
  262. 262. Process Management Processes are speci
  263. 263. c to an organization and vary depending on the type, size and level of maturity of the organization. The organization should ensure the proactive management of all processes, including outsourced processes, to ensure that they are eective and ecient, in order to achieve its objectives. This can be facilitated by adopting a process approach that includes establishing processes, interdependencies, constraints and shared resources. Processes and their interrelationships should be reviewed on a regular basis and suitable actions should be taken for their improvement. Processes should be managed as a system by creating and understanding the networks of processes, their sequences and interactions. The consistent operation of this system is often referred to as the systems approach to management. Nicola Mezzetti, Ph.D. Quality Management Systems: the ISO 9000 Family of Standards
  264. 264. Process Planning and Control The organization should determine and plan its processes and de
  265. 265. ne the functions that are necessary for providing products that can continue to meet the needs and expectations of customers and other interested parties, on an ongoing basis. Processes should be planned and controlled to be in accordance with the organization's strategy and should address management activities, provision of resources, product realization, monitoring, measurement and reviewing activities. Nicola Mezzetti, Ph.D. Quality Management Systems: the ISO 9000 Family of Standards
  266. 266. Process Planning and Control (cont.) In the planning and control of processes, consideration should be given to analyses of the organization's environment short and long term forecasts of market developments the needs and expectations of the interested parties objectives to be achieved statutory and regulatory requirements potential
  267. 267. nancial and other risks process inputs and outputs interactions with other processes resources and information activities and methods records that are required or desired measurement, monitoring and analysis corrective and preventive actions improvement and/or innovation activities Nicola Mezzetti, Ph.D. Quality Management Systems: the ISO 9000 Family of Standards
  268. 268. Process Responsibility and Authority For each process, the organization should appoint a process manager (often referred to as the process owner) with de
  269. 269. ned responsibilities and authorities to establish, maintain, control and improve the process and its interaction with other processes. The process manager could be a person or a team, depending on the nature of the process and the organization's culture. The organization should ensure that the responsibilities, authorities and roles of process managers are recognized throughout the organization, and that the people associated with the individual processes have the competences needed for the tasks and activities involved. Nicola Mezzetti, Ph.D. Quality Management Systems: the ISO 9000 Family of Standards
  270. 270. Monitoring Top management should establish and maintain processes for monitoring the organization's environment, and for collecting and managing the information that is necessary for identifying and understanding the present and future needs and expectations of all relevant interested parties assessing strengths, weaknesses, opportunities and threats determining the need for alternative, competitive or new product oerings evaluating current and emerging markets and technologies anticipating current and expected changes in statutory and regulatory requirements Nicola Mezzetti, Ph.D. Quality Management Systems: the ISO 9000 Family of Standards
  271. 271. Monitoring (cont.) understanding the labor market and its eect on the loyalty of people in the organization understanding the social, economic, ecological trends and local cultural aspects relevant to the organization's activities determining the need for natural resources, and their protection over the long term assessing current organizational and process capabilities Nicola Mezzetti, Ph.D. Quality Management Systems: the ISO 9000 Family of Standards
  272. 272. Measurement Top management should assess progress in achieving planned results against the mission, vision, policies strategies and objectives, at all levels and in all relevant processes and functions in the organization. A measurement and analysis process should be used to monitor this progress, to gather and provide the information necessary for performance evaluations and eective decision making. The selection of appropriate key performance indicators and monitoring methodology is critical for success of the measurement and analysis process. The methods used for collecting information regarding key performance indicators should be practicable and appropriate to the organization. Nicola Mezzetti, Ph.D. Quality Management Systems: the ISO 9000 Family of Standards
  273. 273. Measurement: Key Performance Indicators Factors that are within the control of the organization and critical to its sustained success should be subject to performance measurement and identi
  274. 274. ed as key performance indicators (KPIs). KPIs should be quanti
  275. 275. able and should enable the organization to set measurable objectives, identify, monitor and predict trends and take corrective, preventive and improvement actions when necessary. Top management should select KPIs as a basis for making strategic and tactical decisions. KPIs should be suitably cascaded as performance indicators at relevant functions and levels within the organization to support the achievement of top level objectives. KPIs should be appropriate to the nature and size of the organization and to its products, processes and activities. KPIs need to be consistent with the objectives of the organization. Nicola Mezzetti, Ph.D. Quality Management Systems: the ISO 9000 Family of Standards
  276. 276. Measurement: Key Performance Indicators (cont.) In selecting the KPIs, the organization should ensure that they provide information that is measurable, accurate and reliable, and usable to implement corrective actions when performance is not in conformity with objectives or to improve process eciency and eectiveness. Such information should take into account the needs and expectations of customers and other interested parties, the importance of individual products to the organization, both at the present time and in the future, the eectiveness and eciency of processes, the eective and ecient use of resources, pro
  277. 277. tability and
  278. 278. nancial performance, and statutory and regulatory requirements, where applicable. Nicola Mezzetti, Ph.D. Quality Management Systems: the ISO 9000 Family of Standards
  279. 279. Measurement: Internal Audit Internal auditing is an eective tool for identifying problems, risks and nonconformities, as well as for monitoring progress in closing previously identi
  280. 280. ed nonconformities. Internal audits should assess the implementation and eectiveness of the management system. To be eective, internal audits should be conducted in a consistent manner, by competent personnel, in accordance with an audit plan. The outputs of internal audits provide a useful source of information for addressing problems and nonconformities benchmarking promoting good practices within the organization increasing understanding of the interactions between processes The results of internal audits are usually presented in the form of reports. Nicola Mezzetti, Ph.D. Quality Management Systems: the ISO 9000 Family of Standards
  281. 281. Measurement: Self-Assessment Self-assessment is a comprehensive and systematic review of the organization's activities and its performance in relation to its degree of maturity. should be used to determine the strengths and weaknesses of the organization in terms of its performance as well as its best practices. The results of self-assessments support continual improvement of the organization's overall performance progress towards achieving and maintaining sustained success for the organization innovation in the organization's processes, products and structure, when appropriate recognition of best practices the identi
  282. 282. cation of further opportunities for improvement The results of self-assessments should be communicated to relevant people in the organization. Nicola Mezzetti, Ph.D. Quality Management Systems: the ISO 9000 Family of Standards
  283. 283. Measurement: Benchmarking Benchmarking is a measurement and analysis methodology that an organization can use to search for the best practices inside and outside the organization, with the aim of improving its own performance. There are several types of benchmarking, such as internal benchmarking, competitive benchmarking, and generic benchmarking Successful benchmarking depends on factors such as support by top management, the employed methodology, estimation of bene
  284. 284. ts vs. costs, understanding of the subject being investigated The organization should establish and maintain a methodology for benchmarking that de
  285. 285. nes rules for items such as, for instance the de
  286. 286. nition of the scope of the subject, the determination of indicators, the collection and analysis of data Nicola Mezzetti, Ph.D. Quality Management Systems: the ISO 9000 Family of Standards
  287. 287. Analysis Top management should analyze information gathered from monitoring the organization's environment, identify risks and opportunities, and establish plans to manage them. The analysis of the information gathered should enable factual decisions to be made on strategy and policy issues such as potential changes in needs and expectations of interested parties products and activities providing the most value for its interested parties new products and processes needed to meet the changing needs and expectations of its interested parties the evolving demands for the organizations' products in the long term the in uence of emerging technologies on the organization new competences that could be needed changes that can be expected in statutory and regulatory requirements which would aect the organization. Nicola Mezzetti, Ph.D. Quality Management Systems: the ISO 9000 Family of Standards
  288. 288. Review of Information Top management should use a systematic approach to reviewing available information and for ensuring that the information is used for decision making. Data can be collected from many sources, such as monitoring of the organization's environment measurements of the organization's performance, including key performance indicators assessments of the integrity and validity of the measurement processes results of internal audit, self-assessment and benchmarking activities risk assessment feedback from customers and other interested parties The reviews should be used to evaluate the results achieved against applicable objectives such as, for instance, opportunities for improvement, innovation and learning. Nicola Mezzetti, Ph.D. Quality Management Systems: the ISO 9000 Family of Standards
  289. 289. Improvement, Innovation Learning Improvement and innovation could be necessary for sustained success. Learning provides the basis for eective and ecient improvement and innovation. Improvement, innovation and learning can be applied to products, processes and their interfaces, organizational structures, management systems, human aspects and culture, infrastructure, work environment and technology, and relations with relevant interested parties. Fundamental to eective and ecient improvement, innovation and learning is the ability and enablement of the people in the organization to make informed judgments on the basis of data analyses and the incorporation of lessons learned. Nicola Mezzetti, Ph.D. Quality Management Systems: the ISO 9000 Family of Standards
  290. 290. Improvement The organization should de
  291. 291. ne objectives for the improvement of its products, processes, organizational structures and its management system through the analysis of data. The improvement processes should follow a structured approach, such as the Plan-Do-Check-Act (PDCA) methodology. The organization should ensure that continual improvement becomes established as a part of the organizational culture by providing the opportunities for people in the organization to participate in improvement activities, through their empowerment providing the necessary resources establishing recognition and reward systems for improvement continual improvement of the eectiveness and eciency of the improvement process itself Nicola Mezzetti, Ph.D. Quality Management Systems: the ISO 9000 Family of Standards
  292. 292. Innovation Innovation could be required in order to meet the needs and expectations of interested parties. The organization should identify the need for innovation establish and maintain an eective and ecient innovation process provide the related resources Innovation can be applied to issues at all levels, through changes in technology or products, in processes, in the organization, or in the organization management system. The timing for innovation is usually a balance between urgency versus resources available for its development. Nicola Mezzetti, Ph.D. Quality Management Systems: the ISO 9000 Family of Standards

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