This slide show gives a bird's eye view of those who wish to transit from 2008 version to 2015 version. It is useful to conduct internal programmes.

1. ISO 9001:2015
One day workshop for organisations
which want to upgrade to the new
standard from 2008 version

2. Quality Management Principles
• Customer Focus
• Leadership
• Engagement of people
• Process Approach
• Improvement
• Evidence based decision making
• Relationship management

3. Process Approach
• Standard advocates a process approach. This
approach enables the organisation to control
the interrelationships and interdependence
among the processes.

4. A Single Process in a system

5. PDCA Cycle and the standard
Is this
possibl
e?

6. Risk Based thinking
• This is a new requirement in the standard.
• Organisation needs to plan and implement
actions to address risks and opportunities.
• Opportunities arise due to change in external
circumstances like the new technology.
• Risk is effect of uncertainty. It is due to
possible consequences of certain actions.
Risks can be positive or negative.

7. Main clauses (changes)
• 4. context of the organisation
• 5. Leadership
• 6. Planning
• 7. Support
• 8. Operation
• 9. Performance evaluation
• 10. Improvement

8. 4. Context of Organisation
• 4.1 Understanding the organisation
– Determine external and internal issues that are relevant
for the purpose of the organisation (P/D/R/A)
• 4.2Understanding the needs and expectations of
customers and interested parties
– The Interested parties are key for survival of the
organisation and their requirements are important
(P/D/R/A)
• 4.3 Determining the scope of the QMS
– Boundaries, products and services etc (P/D/R/A)
– Note P=Procedure D=Document R= Record A=only action
Extent of
documentation at
this clause

9. 4.4 QMS and its processes
• What are the processes needed to achieve the
objectives in the system?
• Inputs, outputs, interactions, measures for these
processes need to be defined. D
• Resources roles and responsibilities to be defined. D
• Risks and opportunities need to be determined. A
• Evaluate and improve the processes A
• Create and maintain documented information related
to these processes D
• Retain documented information to have confidence R
• (P/D/R/A )

10. 5. Leadership
• 5.1 Leadership and commitment
• 5.2 Policy
• 5.3 Organisational roles and responsibilities

11. 5.1 Leadership and Commitment
• 5.1.1 General
– Quality Policy, Objectives, Ensuring the resources required
are provided, Promoting Risk based thinking, promoting
Improvement, supporting other management roles
relevant for QMS A
– Policy and objectives (P/D/R/A)
• 5.1.2 Customer Focus
– Customer requirements are determined. Statutory
requirements are determined. Risks and opportunities
related to the products and services determined. Focus on
enhancing customer satisfaction is maintained.
– Statutory requirements (P/D/R/A)

12. 5.2 Policy
• 5.2.1 Establishing the Quality Policy
– Establish, maintain a quality policy
– (P/D/R/A)
• 5.2.2 Communicating the Quality Policy
– Policy should be available and should be
communicated
– (P/D/R/A)

13. 5.3 Organisational roles and
responsibilities (P/D/R/A)
• Ensuring that the QMS conforms to the
requirements of the standard.
• Ensuring that the processes are delivering
their intended inputs
• Reporting on the performance of QMS
• Ensuring the promotion of customer focus
• Ensuring the integrity of the QMS when
changes are implemented

14. 6 Planning
• 6.1 Actions to address risks and opportunities
– While planning consider the issues and requirements and
determine the risks and opportunities
– Plan the actions to address the risks and opportunities
– How to integrate these actions in QMS
– P/D/R/A
• 6.2 Quality objectives and planning
– Measurable, monitored, communicated updated P/D/R/A
– Determine how to achieve quality objectives P/D/R/A
• 6.3 Planning of changes
– Changes should be carried out in a phased manner P/D/R/A

15. 7 Support
• 7.1 Resources
– 7.1.1 capabilities of and constraints on existing internal
resources and what needs to be done on external service
providers P/D/R/A
– 7.1.2 People- Determine and provide the persons
necessary for implementation of QMS P/D/R/A
– 7.1.3 Infrastructure-Provide and maintain the
infrastructure necessary for operation of processes
P/D/R/A
– 7.1.4 Environment for operation of processes- social,
psychological and physical aspects P/D/R/A

16. 7.1.5 Monitoring and measuring
resources
– 7.1.5.1 provide resources required for measuring
and monitoring activities and maintain them for
continuing fitness.
– P/D/R/A
– 7.1.5.2 Measurement traceability: where
traceability is a requirement, calibration shall be
done and records will be maintained
– P/D/R/A

17. 7.1.6 Organisational Knowledge
• Knowledge shall be maintained for the
operation of its processes and will be made
available. P/D/R/A
• Current knowledge available and acquisition
of additional knowledge. P/D/R/A

18. 7.2 Competence
• Determine the competence required to
perform tasks-P/D/R/A
• Ensure that the persons doing the tasks are
competent -P/D/R/A
• Where applicable, take actions to acquire the
competence-P/D/R/A
• Retain appropriate documented information
regarding the actions taken as evidences.
P/D/R/A

19. 7.3 Awareness
• Ensure that people are aware of
– Quality policy
– Quality Objectives
– Their contribution to the effectiveness of QMS
– Implications of not conforming to the QMS
– P/D/R/A

20. 7.4 Communication
• Determine internal and external
communications relevant to the QMS
– What to communicate, when to communicate
with whom, how and who will communicate
– P/D/R/A

21. 7.5 Documented Information
• 7.5.1-Documented QMS will include
documented information required by the
standard and documented information
required as necessary by the organisation
• 7.5.2 Creating , updating and control of
documented information is to be ensured.
• Documents of external origin should be
identified. P/D/R/A

22. 8 Operation
• 8.1 Operation Planning and Control
– Determining requirements for products and services
Establishing criteria for products, services and
processes P/D/R/A
– Determining resources required to achieve the
conformity to requirements P/D/R/A
– Implementing control of processes P/D/R/A
– Determining , retaining documented information to
have the confidence that the processes have been
carried out as planned and products and services
meet the requirements. P/D/R/A

23. 8.2 Requirements for products and
services
• 8.2.1 Customer communication
– Providing information (related to products and
services) P/D/R/A
– Handling enquiries P/D/R/A
– Obtaining feedback P/D/R/A
– Handling customer property P/D/R/A
– Establishing specific requirements for contingency
actions P/D/R/A

24. 8.2.2 Determining requirements for
products and services
• Requirements for products and services
should be defined including statutory
requirements and its own requirements.
• P/D/R/A
• It should ensure that it meets the claims to
meet the requirements. P/D/R/A

25. 8.2.3 Review of the requirements for
products and services
• Organisation should conduct a review of
requirements and its ability to meet them
before committing to supply products and
services. P/D/R/A . These include stated ,
unstated, legal, and own requirements.
• Organisation should retain the documented
information and manage changes. P/D/R/A

26. 8.3 Design and Development of
products and services
• 8.3.2 Design and Development planning
– While doing the planning the organisation should
consider the complexity of the design, the
required stages, the need for reviews and
verifications, responsibilities , internal and
external resources, interfaces, involvement of
customers, requirements for the products being
designed, nature of control of customers in the
design process and the documented information
needed to demonstrate that the requirements
have been met. P/D/R/A

27. 8.3.3. Design and development Inputs
• Functional and performance requirements
P/D/R/A
• Information from previous design activities
• P/D/R/A
• Statutory and regulatory requirements P/D/R/A
• Standards and codes of practice P/D/R/A
• Potential causes of failure due to the nature of
products P/D/R/A
• Conflicting inputs should be resolved. P/D/R/A

28. 8.3.4 Design and Development
controls
• Controls applicable
– The results to be achieved should be defined D
– Reviews to be conducted to evaluate the ability of
design to satisfy the requirements A
– Verification to be done to evaluate whether design
outputs meet the input requirements A
– Validation to be done to evaluate whether the
product meets the requirements of the specific
application A
– Needed actions should be taken on problems noticed
during the reviews, verification or validation. A

29. 8.3.5 Design and Development outputs
• Design and development outputs should meet
the input requirements
• be adequate for the subsequent processes
• include reference monitoring requirements
• Specify characteristics of the products and
services essential for their intended purpose
and for safe provision. P/D/R/A

30. 8.3.6 Design and Development
changes
• Organisation should maintain documented
information on
– Design and development reviews
– Authorization of changes
– Decisions taken to prevent adverse impacts
– P/D/R/A

31. 8.4 Control of externally provided
products and services
• Products and services could be supplied to the
organisation for incorporation in its products
and services
• Products and services could be directly
supplied to customer on behalf of the
organisation
• Process(es) for making a product/providing a
service itself could be provided by an external
organisation

32. 8.4.2 Type and extent of control on
external suppliers
• Externally provided processes should be within
the control of the QMS
• Controls should be on the processes as well as
the products
• Controls should be appropriate to the a) impact
of the external supplier on the organisation’s
ability to supply acceptable products b) the
existing controls of the supplier. These controls
will include inspection and verification.

33. 8.4.3 Information for external
providers
• Organisation to provide information in the
form of (P/D/R/A)
– Requirements for products, services
– Approval of products, services
– Competence of people
– Interactions with external providers (reviews)
– Monitoring of the performance of external
providers

34. 8.5 production and service provision
• Controlled conditions for production provision
– Availability of documented information D
– Availability of monitoring resources A
– Implementation of monitoring and measurement A
– Use of suitable infrastructure and environment A
– Appointment of competent people D
– Validation of certain processes R
– Implementation of error proofing activities A
– Implementation of release , post release and delivery
activities A

35. 8.5.2 Identification and traceability
• Organisation to
– Identify outputs when it is necessary for products
– Identify status of outputs with respect to
monitoring and measurement
– Uniquely identify the outputs when required for
traceability P/D/R/A

36. 8.5.3 property belonging to customers
or external providers
• Property belonging to customers and external
providers need to be identified, verified and
protected when it is in the control of the
organisation. P/D/R/A
• When the property is lost, damaged or stolen
it should be reported to the owner Of the
property. P/D/R/A
• The property may be tangible or intangible.

37. 8.5.4 Preservation
• Organisation should preserve the outputs
during production provision to the extent it is
necessary to ensure conformity to
requirements P/D/R/A

38. 8.5.5 Post Delivery activities
• Post delivery activities should be in line with
– Statutory and regulatory requirements
– Risk associated with installation or commissioning
– Usage during life time of the product including
disposal or recycling of the product
– Customer requirements
– Customer feedback

39. 8.5.6 Control of changes
• Review changes in the production provision
and control them. P/D/R/A
• Retain results of reviews of changes , actions
arising from the reviews and the persons
authorising the changes subsequent to the
reviews P/D/R/A

40. 8.6 Release of the products
• Products can be released only after the intended
verification activities are completed. P/D/R/A
• Incase they have to be released, they have to be
approved by appropriate authority. P/D/R/A
• Organisation to retain documented information
on a) evidence of conformity of product with the
criteria and b) the identity of the person
authorising the release. P/D/R/A

41. 8.7 Control of non conforming outputs
• Outputs from processes which do not conform
to the requirements should not be delivered
to customer. P/D/R/A
• Organisation should take action depending on
the non-conformity and the effect of such
non-conformity on the use of the product.
P/D/R/A

42. 8.7 Control of non conforming outputs
• Organisation can deal with non conformities in
one of the following ways
– Correct the non conformity
– Segregate, contain, return or suspend the product
– Inform the customer (and request for decision)
– Obtain the authorization under concession
– When the outputs are corrected they should be again
verified for conformity.
– All information about the non conformity and
subsequent actions should be retained. P/D/R/A

43. 9. Performance evaluation
• 9.1 Monitoring, Measurement, Analysis and
information
– Organisation should decide what are the
measurements to be collected about the
processes or products and when and how the
measurements should be collected. P/D/R/A

44. 9.1.2 Customer satisfaction
• Organisation should monitor perceptions of
customers about the extent to which their
needs and expectations are being fulfilled by
the organisation while delivering the product
and service. P/D/R/A

45. 9.1.3 Data Analysis
• Whatever data comes from the monitoring and
measurement, it should be analysed. P/D/R/A
• By analysis the following can be evaluated
– Conformity of products
– Degree of customer satisfaction
– Effectiveness of QMS
– Successful completion of plans
– Effectiveness of risk management
– Performance of external providers
– Need for improvements (which process?) R

46. 9.2 Internal audit
• Audits will be conducted at planned intervals
with personnel who are qualified and in an
objective manner. A
• The entire audit programme shall be based on
the importance of the processes, changes to
QMS and the results of previous audits. D
• Results of audits should be reported and
actions taken without delay. R

47. 9.3 Management review
• Management should review the QMS at periodic
intervals for suitability, adequacy, effectiveness
and alignment with the strategic direction. A
• The inputs should include all measurement
results, customer feedback, effectiveness of
actions to address risks and performance of
external providers. D
• Outputs should include opportunities for
improvement, changes required and resource
needs. R

48. 10 Improvement
• 10.1 General
• Improvement should be for enhancing
customer satisfaction.
– Improving products and services to meet current
requirements and future needs
– Correcting, preventing or reducing undesired
effects of products and services
– Improving the performance and effectiveness of
QMS

49. 10.2 Non conformity and corrective
action
• 10.2.1
• When a non conformity occurs/complaint is
received D
– React to the non conformity, take action to correct
the non conformity
– Deal with the consequences (inc case correction is
not feasible)
– evaluate the need for actions to eliminate the
causes for non conformity so that it does not recur

50. 10.2 Non conformity and corrective
action
• Continued from last slide
– Implement actions needed
– Review the effectiveness of actions
– Update the risks (due to changes)
– Make changes in QMS, if needed
– Keep documented information regarding
corrective actions and results thereof. R

51. 10.3 Continual improvement
• Organisation should implement actions for
continual improvement of its QMS A