2. Key requirements of ISO
9001:2000
The requirements of the standard are specified in following clauses of
the standard:
4. Quality Management System
5. Management responsibility
6. Resource management
7. Product realization
8. Measurement, analysis and improvement
Key requirements of the standard are shown in subsequent slides.
3. Clause 4 :
General requirements
The organization shall establish, document, implement, maintain and
continually improve the effectiveness of a QMS.
To implement the quality management system, the organization shall:
a) Identify the processes needed for the QMS;
b) determine the sequence and interaction of these processes;
c) Implement actions necessary to achieve planned results and continual
improvement.
Ensure control over outsourced processes
5. Clause 4 requirements (Contd….)
Documentation requirements
QMS documentation must include:
a) documented quality policy & objectives
b) Quality Manual
c) documented procedures required in this standard
d) documents required by the organization to ensure the effective
planning, operation and control of its processes
e) quality records
6. Clause 4 requirements (Contd….)
Quality Manual
The quality manual must include:
- Scope of QMS, with justification for any exclusions
- Documented procedures, or reference to them
- Description of interaction between the QMS processes
7. Clause 4 requirements (Contd….)
Control of Documents and
Records
• Documents required by the quality management system shall be
controlled for ensuring availability of authentic and updated
documents for all concerned.
• Records shall be established and maintained to provide
evidence of conformity to requirements and effective operation
of Quality Management System.
9. Clause 5 : Management Responsibility
Requirements
Customer Focus
Top management shall ensure that customer requirements are
determined and fulfilled with the aim of enhancing customer
satisfaction.
10. Clause 5 requirements (Contd….)
Quality policy
Top management shall ensure that the quality policy:
a) is appropriate to the purpose of the organization;
b) includes a commitment to meeting requirements and to continually improve
effectiveness
c) provides a framework for establishing and reviewing quality objectives;
d) is communicated and understood within the
organization
e) is reviewed for continuing suitability.
11. Clause 5 requirements (Contd….)
Quality objectives
Top management shall ensure that quality objectives,
including those needed to meet requirements for product (see
7.1a) are established at relevant functions and levels within the
organization..
The quality objectives shall be measurable and consistent with
the quality policy.
12. Clause 5 requirements (Contd….)
Quality management system
planning
Top management shall ensure that:
a. Planning of the QMS is carried out in order to meet
requirements of 4.1. As well as the quality objectives
b. The integrity of the QMS is maintained when changes
to the QMS are planned and implemented
13. Clause 5 requirements (Contd….)
Management representative
Top management shall appoint a member of the management
who, irrespective of other responsibilities, shall have
responsibility and authority that includes:
Ensuring the promotion of awareness of customer
requirements throughout the organization.
14. Clause 5 requirements (Contd….)
Internal communication
Top management shall ensure that appropriate communication
processes are established within the organization and that
communication takes place regarding the effectiveness of the
QMS.
15. Clause 5 requirements (Contd….)
Internal Communications
Since most planning activities are carried by multifunctional teams, effective
internal communication should be established by documenting decisions
taken during meetings and responsibilities assigned.
Systems should be established in various departments so that information of
activities of QMS is passed on to persons concerned. Proper distribution of
procedures and instructions is an important means of internal communication
16. Clause 5 requirements (Contd….)
Internal Communications
Employees should be encouraged to give feedback about
effectiveness of QMS and corrective action and problems if any.
One way to improve internal communication is to designate a
QMS nodal officer in each department who could receive
feedback and pass on to appropriate authority and Management
Representative for necessary action.
17. Clause 5 requirements (Contd….)
Management review input
Inputs to management review shall include current performance
and improvement opportunities related to the following:
a) results of audits;
b) customer feedback;
c) process performance and product conformity;
d) status of preventive and corrective actions;
e) follow-up actions from previous management reviews;
f) changes that could affect the QMS
g) recommendations for improvement
18. Clause 5 requirements (Contd….)
Management review output
The outputs from the management review shall include any decisions and actions related
to:
a) Improvement of the effectiveness of the QMS and its processes;
b) Improvement of product related to customer requirements;
c) Resource needs.
20. Clause 6 : Resource Management Requirements
Competence, awareness and
training
The organization shall:
a) determine the necessary competence for personnel performing work affecting
product quality;
b) provide training or take other actions to satisfy these needs;
c) evaluate the effectiveness of actions taken;
d) 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.
21. Clause 6 requirements (Contd….)
Infrastructure
The organization shall determine, provide and maintain the infrastructure
needed to achieve the conformity to product requirements. Includes:
a) buildings, workspace and associated facilities;
b) process equipment (hardware and software);
c) supporting services (transport, communication)
22. Clause 6 requirements (Contd….)
Work Environment
The organization shall determine and manage the work environment
needed to achieve conformity to product requirements.
24. Clause 7 :
Product Realization
Requirements
Planning of product realization
In planning product realization, the organization shall determine the
following, as appropriate:
a) quality objectives and requirements for the product
b) Need to establish processes, documents and provide resources specific
to the product
c) Required verification, validation, monitoring, inspection and test activities
specific to the product and criteria for product acceptance
d)Records needed
25. Clause 7 requirements (Contd….)
Customer-related processes
Determination of requirements related to product shall include:
a) Requirements specified by the customer, including the requirements for
delivery and post-delivery activities;
b) Requirements not stated by the customer but necessary for specified or
intended use, where known;
c) Statutory and regulatory requirements related to product
d) Any additional requirements determined by the organization
26. Clause 7 requirements (Contd….)
Review of requirements related to product
Where customer provides no documented statement of requirement,
requirements shall be confirmed before acceptance.
Note: In some situations, such as internet sales, a formal review is
impractical for each order. Instead the review can cover relevant product
information such as catalogues or advertising material.
27. Clause 7 requirements (Contd….)
Customer communication
Customer organization shall determine and implement effective arrangements
for communicating with customers in relation to:
a) product information;
b) enquiries, contracts or order handling, including amendments;
c) customer feedback, including customer complaints
28. Customer Communications
ISO 9001: 1994 specifies communication only for contract
review. The new standard with its focus on customer
satisfaction goes much further. It requires that communication
channel be established with the customer for general enquiries
and for providing information about products, contract, order
program and customer feedback/complaints.
29. Customer Communications
Marketing, Sales and customer service departments should be
given clear responsibility for providing requisite information
concerning their field of activity.
Customer contact groups such as telephone operators and
reception should be informed of the responsibilities so that
customers are directed to the right person. Customers may also
be informed about departments handling different aspects.
30. Clause 7 requirements (Contd….)
Other Requirements of
Production Realization Clause
There is no significant change in other requirements of product
realization processes which were earlier given in clause .of ISO
9001:1994.
32. Clause 8 :
Measurement, Analysis and
Improvement Requirements
General Requirements
The organization shall plan and implement the monitoring, measurement,
analysis and improvement processes needed.
This shall include the determination of applicable methods, including
statistical techniques, and the extent of their use.
33. Clause 8 requirements (Contd….)
Monitoring and measurement
• Customer satisfaction:
The organization shall monitor information relating to customer
perception as to whether the organization has fulfilled customer
requirements. The methods for obtaining and using this
information shall be determined.
34. Clause 8 requirements (Contd….)
Monitoring and
measurement
• Internal audit:
The audit criteria, scope, frequency and methods shall be defined. Selection of
auditors and conduct of audits shall ensure objectivity and impartiality of the audit
process. Auditors shall not audit their own work.
The management responsible for the area being audited shall ensure that
actions are taken without undue delay to eliminate detected non-conformities and
their causes.
Follow up actions shall include the verification of the actions taken, and the reporting
of verification results.
35. Clause 8 requirements (Contd….)
Analysis of data
The organization shall determine, collect and analyze appropriate data to
determine the suitability and effectiveness of the quality management
system and to evaluate where continual improvement of effectiveness of
the QMS can be made.
The organization shall analyze this data to provide information on:
a) customer satisfaction;
b) conformance to product requirements;
c) characteristics and trends of processes and products
including opportunities for preventive action
d) suppliers
36. Clause 8 requirements (Contd….)
Continual improvement
The organization shall continually improve the effectiveness of the QMS
through the use of the quality policy, quality objectives, audit results,
analysis of data, corrective and preventive actions and management
review.
38. Documentation
What is a document ?
It is information and its supporting medium.
Examples: Specification, drawing, procedure and records
The medium of document could be papers, magnetic,
electronic,optical disc, photograph or a sample.
(ISO 9000:2000, 3.7.2)
39. Need for Documentation
In managing an organization, documentation is used:
• As a tool for information transmission and communication
• Evidence of conformity that what is planned has been done.
• Preservation of knowledge of the organization such as design
data, studies conducted and documented experience.
40. Documentation Objectives
of the New Standards
Two of the major objectives in the revision of ISO 9000 series of
standards were:
• To identify simplified standards that will be equally applicable to
different types of organizations including small scale industries.
• For the amount and detail of documentation required to be more
relevant to the desired results of organization’s activities.
41. Extent of Documentation
ISO 9000:2000 has significantly reduced the documentation requirements and is
much less prescriptive than the 1994 version of the standard. It allows an
organization more flexibility in the way it chooses to document its quality
management system (QMS). This enables each individual organization to
develop the minimum amount of documentation needed in order to demonstrate
the effective planning, operation and control of its processes and the
implementation and continual improvement of the effectiveness of its QMS.
It is stressed that ISO 9001 requires a “Documented quality management
system”, and not a “system of documents”.
42. Documentation Requirements
ISO 9001:2000 clause 4.2.1 states that the quality management system
documentation shall include:
• Documented statements of a quality policy and quality objectives;
• a quality manual
• documented procedures required by this International Standard
• documents needed by the organization to ensure the effective planning,
operation and control of its processes, and
• records required by this International Standard.
43. Flexibility in Documentation
The new standard is less prescriptive than 1994 version and
allows flexibility to the organization in developing QMS
documentation which may differ from one organization to other
due to:
• Size of the organization and type of its activities
• Complexity of processes and their interactions, and
• Training and competence of personnel
44. Existing Documentation in the
Organization
Most organizations in the organized sector would already be having
considerable documentation for successful management of their
business. This documentation may include:
• Company rules & procedures
• departmental and operating manuals
• Product specifications / product drawings
• Process plans/instructions
• Production schedules
• Approved supplier lists
• Test and inspection plans, etc.
45. Adoption of Existing Documents in
QMS Documentation
There is a need to analyze existing documentation for their
usefulness in effective control over important processes for
assuring customer satisfaction. It has also to be verified whether
these documents are being followed. If so, these documents
must be given unique identity and brought under document
control for integration into QMS documentation
46. Determination of Need for New
Documents
• In addition to adaptation of existing documents for implementation of
quality management system, the organization may need certain
additional documents to comply with ISO 9001:2000.
• The type of documents and records which may possibly be required by
the companies in the organized sector is given in the succeeding slides.
• List of clause-wise documents and records is suggestive in nature. The
management decision to have these documents will depend on the
complexity of the processes and the training/competence of staff.
47. ISO 9001:2000 Clause 4
Documents
• Quality manual
• Flow chart of major processes and their interaction
• Document control procedure
• Record control procedure.
• Description of out sourced services and their control procedure.
Records
• Document updating records
• Disposal of quality records
48. ISO 9001:2000 Clause 5
Documents
• Quality objectives at organizational and functional level.
• Organization structure and responsibilities of
management representative and key functionaries
whose job affects product quality.
• Description of internal communication channel. ( This
could be specified in quality manual. Also see slide
96,97 & 98 )
• Procedure for management review Records
• Evidence of quality planning
• Record of management review
49. ISO 9001:2000 Clause 6
Documents
• Specific requirement of qualification and competence of personnel
• Procedure for identifying training needs and yearly training plan
• List of special facilities or work environments affecting quality
• Procedure for maintenance of buildings equipment and facilities
Record
• Record of training and experience of personnel
• Maintenance record
50. ISO 9001:2000 Clause 7
Documents
• Quality plan or other documents showing how quality is planned in
products/projects
• Method of capturing customer requirements
• Review of orders or contracts to assess capability to meet customer’s
requirements
• Specifications for company’s products
• Procedure for design and development
• Specifications for purchased materials
51. ISO 9001:2000 Clause 7 (contd….)
• Procedure for selection and approval of suppliers
• Procedure for review of suppliers performance
• Procedure for verification of purchased products and dealing with non
conforming supplies.
• Procedures or work instruction for critical processes.
• Procedure for assessing process capability and approval of processes.
• Qualification of operators and processes where quality cannot be
verified after work is finished.
• Procedure for maintenance of critical equipment.
• Procedure for identification and traceability of materials (where
required).
52. ISO 9001:2000 Clause 7 (contd….)
• Inspection and testing plans/instructions.
• Procedure for showing inspection/test status of materials/equipment.
• Procedure for calibration measuring devices.
• Procedure for handling customer property.
• Procedure for preservation, packaging and storage of product.
53. ISO 9001:2000 Clause 7 (contd….)
Records
• Contract review of major contracts
• Design review record
• Results of design verification/validation
• Inspection results of purchased materials.
• Record of qualification of operators and processes where output cannot
be assessed for non conformity.
• Inspection and testing records
• Record of rework and rejection
• Calibration record of measuring devices.
• Record of damaged or lost customer property (where applicable).
54. Formulation of Quality Policy
Quality policy is the first step in the development of quality
management system
• The quality policy emanates from the vision and mission of the
organization. It should describe what quality means to your business
and customers.
• Quality policy should reflect top management’s commitment to quality.
• To make the policy meaningful it must include overall quality goals for
your business.
• Quality policy must be brief for ease of understanding by employees.
• Quality Policy is normally included in quality management manual.
55. Quality Manual
Quality manual is the basic document which describes the QMS
• ISO 9001 standard does not prescribe any specific format or a model
for the quality manual. It could either be structured in the order of
process flow in the organization or according to the applicable elements
of the standard. In case of process flow model it may be useful to
provide cross reference with the standard clauses for ease of internal
and external audit.
• Quality manual should contain an overview of the different processes of
organization and how various requirements of the standard are met.
56. Quality Manual (contd….)
Quality manual is high level document as such it contains very
little detail of the processes. However, it provides reference to
departmental manuals and other documents which give further
information of processes.
As quality manual can also be used as promotional material, it
should not contain anything that is confidential.
57. Contents of Quality Manual
Quality manual should normally include the following though not
necessarily in the same order:
• Brief background of the company
• Scope of the QMS with justification for exclusions if any.
• Quality policy
• QMS documentation containing list of documents such as departmental
manuals, procedures and other documents required to operate QMS.
• Quality records and their control
• Organizational structure
58. Contents of Quality Manual (contd….)
• Quality related responsibilities of main functionaries including
management representative.
• Document control
• Management commitment for QMS
• Method of internal communication
• Human resource management
• Infrastructure and work environment
• Production or service planning
• Product development (where applicable)
• Purchase control
• Control of production and/or service
59. Contents of Quality Manual (contd….)
• Identification and traceability
• Preservation of product
• Care of customer property
• Measurement of products and processes
• Control of non conforming products
• Corrective and preventive action
• Monitoring and measurement of customer satisfaction
• Internal audit of QMS
• Continual improvement
