Risk elimination and safety committee

1. Welcome
ISO 9001:2015 Quality management system
Training program 2018
Version 1.0 dated 21-05-20

2. Chapter 1 : Introduction
This international system is based upon the quality
management principles and process approach.

3. Chapter 01 : Introduction (cont.)
History:-
First time introduced in 1987
First revision in 1994
Second revision in 2000
Third revision in 2008
Fourth revision in 2015 (23rd sep 2015)

4. Chapter 01 : Introduction (cont.)
ISO draft:-
National
ISO
member
body
National
ISO
member
body
National
ISO
member
body
National
ISO
member
body
International organization for standardization

5. Chapter 01 : Introduction (cont.)
ISO draft:- Preparing international standard is carried
out through ISO/TC (technical committee).
ISO closely collaborate with international electro-
technical commission (IEC) on all matters of electro-
technical standardization.
Committee responsible for this document is technical
committee ISO/TC 176, Quality management and
Quality Assurance.

6. Chapter 01 : Introduction (cont.)
Based upon 07 QMP (Quality management principles)
1. Customer focus
2. Leadership
3. Engagement of people
4. Process Approach
5. Improvement
6. Evidence-based decision making
7. Relationship management

7. Chapter 02 : Process Approach
•Understanding and managing interrelated processes as a
system.
•Contributes effectiveness and efficiency in achieving intended
results.
•Overall performance of the org. can be enhanced using PDCA
cycle.
•Focuses on the Risk based thinking.
•Aimed at taking advantages of the opportunities.
•Preventing undesirable results.

8. Chapter 02 : Process Approach (cont.)
Input
Source of Input
Output
Receivers of Output
Activities
Possible controls
and check point
to monitor and
measure
performance

9. Chapter 03 : PDCA cycle
Planning (6)
Leadership
(5)
Improvement
(10)
Performance
Evaluation (9)
Support (7),
Operation
(8)

10. Chapter 03 : PDCA cycle (cont.)
Plan:- Establish the objectives of the system and its processes,
resources needed, customers requirements, Org. policies and identify
and address risks and opportunities.
Do:- Implement what was planned.
Check:- Monitor and measure processes, product and services and
report the results.
Act:- Take actions to improve performance .

11. Chapter 04 : Risk Based Thinking
•Essential to achieve an effective Quality management system.
•Organization needs to plan and implement actions to address risk
and opportunities.
•Risk is effect of the an uncertainty.
•A positive deviation arising form a risk can provide an opportunity.

12. Chapter 05 : Quality Management Systems-
Requirements 9001:2015
•Clause 01 : Scope
•Clause 02 : Normative References
•Clause 03 :Terms and definitions
•Clause 04 : Context of the organization.
•Clause 05 : Leadership
•Clause 06 : Planning
•Clause 07 : Support
•Clause 08 : Operation
•Clause 09 : Performance evaluation
•Clause 10 : Improvement

13. Clause 1 Scope of the QMS 9001:2015
•This international standard specifies
requirements for a QMS when an Organization:
•Needs to demonstrate its ability to consistently
provide products and services and applicable
statutory and regulatory requirements.
•Aims to enhance customer satisfaction.

14. Clause 2 Normative references
•Latest edition to the reference document
(including any amendment) applies.
•ISO 9000:2015 Fundamental and vocabulary.

15. Clause 3 terms and Definitions
•Management System:- Set of Interrelated or interacting elements of and
organization to establish Policies and objectives and processes to achieve those objectives.
•Organization:- Person or group of people that has its own functions with
responsibilities, authorities and relationships to achieve its objectives.
•Top management:- person or group of people who directs and control the
organization at highest level.
•Objective:- results to be achieved.
•Requirement:- need or expectation that is stated generally implied or obligatory.

16. Clause 3 terms and Definitions cont.
•Compliance obligation:- legal requirements and other requirements.
•Legal requirement:- are the requirements that org. has to comply with.
•Other requirement:- Organization has to or choose to comply with.
•Risk:- effect of uncertainty.
•Competence:- ability to apply knowledge and skills to achieve intended results.

17. Clause 3 terms and Definitions cont.
•Documented information:- information required to be controlled and maintained
by the organization and the media in which it is contained.
•Process:- set of interrelated or interacting activities which transforms inputs into
outputs.
•Audit:- Systematic, independent and documented process for obtaining audit evidence
and evaluating it objectively to determine the extent to which the audit criteria is fulfilled.
•Conformity:- fulfillment of a requirement.
•Non- conformity:- non-fulfillment of a requirement.

18. Clause 4 Context of the Organization (planning)
4.1 Understanding the organization and its context
Org. shall determine the external and internal issues
•Relevant to its purpose,
•Relevant to its strategic direction
•Affect its ability to achieve proposed results of QMS.

19. Clause 4 Context of the Organization (planning)
4.1 Understanding the organization and its context
Org. shall determine the external and internal issues
•Relevant to its purpose,
•Relevant to its strategic direction
•Affect its ability to achieve proposed results of QMS.

20. Clause 4 Context of the Organization (planning)
cont.
4.2 Understanding the needs and expectation of
interested parties.
Org. shall determine:
•Interested parties relevant to QMS
•Requirements of these interested parties relevant to QMS
Org. shall monitor and review above information.

21. Clause 4 Context of the Organization (planning)
cont.
4.3 Scope of Quality Management System:-
Org. shall consider:
•External and internal issues
•Requirements of relevant interested parties
•Products and services of the organization.
Scope shall be available and maintained as
documented information.

22. Clause 4 Context of the Organization (planning)
cont.
4.4 Scope of Quality Management System:-
Org. shall establish implement, maintain and continually
improve QMS:
•Determine the inputs and outputs from processes
•Determine the sequence of the processes
•Determine and apply the criteria
•Determine and apply the criteria to measure and monitors the
effectiveness of these processes
•Determine the resources needed for processes
•Assign responsibilities and authorities for these processes
•Address the risk and opportunity
•Evaluation of these processes
•Improve these processes an QMS
•Maintain and retain the required documented information.

23. Clause 5 Leadership
5.1 Leadership and commitment :-
Top management shall
•Take accountability for the effectiveness of the QMS
•Quality policy and quality objectives are established
•Ensure the integration of QMS into org. Business process.
•Process approach and risk based thinking
•Ensure the resources needed are available
•Communication of the QMS
•Promoting improvement
•Commitment with respect to customer focus

24. Clause 5 Leadership
5.2 Policy :-
Establishing the Quality policy
•Top mgt. Shall establish, implement and maintain a
policy which is compatible with the context of the
organisation,
•Provide framework for quality objectives,
•Includes a commitment to satisfy applicable requirements
•Includes a commitment to continual improvements
•Communicating the quality policy, maintain as
documented information understood within the
organisation and be available to the interested parties.

25. Clause 5 Leadership
5.2 Policy :-
DMB quality policy says that;-
Achieving total customer satisfaction by manufacturing tailor-made master batches, additives
and engineering compounds with incomparable quality; consistently meeting every customer’s
individual requirements/specifications;thereby providing a benchmark for our line of
products.
Meeting all statutory and regulatory requirements and complying with all International
standards like RoHS, ELV, IMDS and FDA in all our products.
Continual improvement of quality by research and development, upgrading technology
of plant, process, persons and product and delivering value for money to the customer.
•Integrating “Quality, Environmental, Health & Safety” in all our processes and
improving the quality of life of our employees both within and outside its plants and
offices.

26. Clause 5 Leadership
5.3 Organisational roles and responsibility and authorities :-
Top management shall assign the responsibilities and
authorities for
•Ensuring that QMS confirms the requirement of international
standard
•Ensure that processes are delivering the intended results
•Reporting on the performance of QMS and on opportunities for
improvement
•Ensuring the performance of customer focus
•Ensuring the integrity of the QMS is maintained when
changes occurs

27. Clause 6 Planning
6.1 Actions to address risk and opportunities :-
6.1.1 Organisation shall considers the issues of 4.1
(internal and external issues) requirements and risk
and opportunities.
6.1.2 actions to address these risk and opportunities
•6.2 quality objectives and planning to achieve them
•6.2.1 establish quality objectives at relevant function,
levels and processes
•6.2.2 plan how to achieve its quality objectives
•6.3 planning of the changes

28. Clause 7 Support
7.1 Resources :-
•People
•Infrastructure
•Environment for the operation of the processes
•Monitoring and measuring resources
•Organisational knowledge
7.2 Competence (determine, hiring , train/educate and evaluate)
7.3 Awareness (quality policy, objectives, benefits of QMS)
7.4 Communication (what, when, to whom, how and who)
7.5 Documented information (creating & updating and control of the
documented information)

29. Clause 8 Operation
8.1 Operational planning and control :-
•A.) determining the requirements for the products and
services
•B.) establishing the criteria for the processes, the
acceptance of the products and services
•C.) determining the resources needed
•D.) implementing the controls of the processes
•E.) determining, maintaining and retaining documented
information to the extent necessary

30. Clause 8 Operation
8.2 Requirements for products and services:-
•8.2.1 customer communication shall include :
•Providing information relating to the products and services,
•Handling inquiries, contracts and order including changes,
•Obtaining customer feedback including customer complaints
•Handling and controlling customer properties
•8.2.2 Determining the requirements for the products and services
•Any applicable statutory or regulatory requirement
•Requirement considered necessary by organisation
•Ensure org. Can meet the claims for the products and services it offers

31. Clause 8 Operation
8.2 Requirements for products and services:-
•8.2.3 Review of the requirements for products and services
8.2.3.1 Organisation shall conduct a review before committing to supply products
and services to include
Specified by the customer including requirements for delivery and post delivery
activities
•Requirement not stated by the customer, but specified or intended use, when
known
•Requirement specified by the organization
•Statutory and regulatory requirements contract or order requirements
•8.2.3.2. Organization shall retain documented information on the results of the
review and any new requirement for the products and services

32. Clause 8 Operation
8.4 Control for externally provided processes, products
and services.
•8.4.1 General
Organization shall
•Ensure EPS confirms to requirements
•Determine the controls to be applied to EPS
•Determine and apply criteria for evaluation ,
selection and monitoring and evaluation of EPS .

33. Clause 8 Operation
8.4 Control for externally provided processes, products
and services.
•8.4.2 Type and Extent of control
•Organization shall
•Ensure EPS do not adversely affects org. ability
•Remains within the applied control
•Consider effectiveness of the controls applied
•Determine the verification that EPS meets requirements

34. Clause 8 Operation
8.4 Control for externally provided processes, products
and services.
•8.4.3 Information for external providers
•Org. Shall communicate its requirements,
approval, competence required, control and
monitoring and verification of the
effectiveness of the EPS

35. Clause 8 Operation
8.5 Production and service provision.
•8.5.1 Control of production and service provision
•8.5.2 Identification and traceability
•8.5.3 Property belonging to customer or external
providers
•8.5.4 Preservation
•8.5.5 Post delivery activities
•8.5.6 Control of changes

36. Clause 8 Operation
8.6 Release of product and services.
Organization shall implement, verify that products and
services requirements have been met.
After ensuring the products and services conformity martial
to be release
Organization shall maintain an retain documented
information on the release of product and services
Documented information shall include the evidence of
conformity and traceability of the person authorizing the
release.

37. Clause 8 Operation
8.7 Control of non confirming output.
8.7.1 Org. Shall ensure that output that do not conform to
their requirements are identified and controlled to prevent
their unintended use.
Take appropriate action to deals with the no conformity
8.7.2 Org shall retain and maintain documented
information that describes non conformity, caption taken,
any concession obtained and authority deciding the actions
in respect of the conformity.

38. Clause 9 Performance evaluation
9.1 Monitoring, measurement, analysis and evaluation.
9.2 Internal Audit
9.2.1 Org. Shall conduct internal audits at a planned
intervals to provide information that QMS conforms to
own /standard requirements , QMS effectively
implemented and maintained
9.2.2 Org shall plan audit program, criteria and scope,
select auditors, conduct audits, results are informed to
relevant management
Take appropriate CAPA without undue delay, retain
documented information of the audit program.

39. Clause 9 Performance evaluation
9.3 Management review.
9.3.1 General:- Review QMS at planned intervals to ensure suitability,
adequacy and effectiveness and alignment with strategic directions of
organization
9.3.2 Management review inputs includes audit findings monitoring
and measuring results customer satisfaction feedback, risk and opportunities
etc.
9.3.2 Management review outputs shall include decisions and
action related to opportunities for improvements, any need for the change in
the QMS, resource required
Org. Shall retain documented information as evidence of the results of the
management reviews

40. Clause 10 Improvement
10.1 General
Org. Shall determine and select opportunities for improvements and
implement to meet customer requirements and satisfaction
10.2 Non conformity and corrective action org. Shall react to
non conformity and take action to control and correct it, evaluate the need for
action to eliminate the cause of NC, implement action, review the effectiveness
of corrective actions, update risk and opportunities determined etc.
Org. Shall retain documented information as evidence
10.3 Continual improvement shall include continually improve the
suitability, adequacy and effectiveness of the QMS