ISO 9001 is defined as the international standard that specifies requirements for a quality management system (QMS). Organizations use the standard to demonstrate the ability to consistently provide products and services that meet customer and regulatory requirements. It is the most popular standard in the ISO 9000 series and the only standard in the series to which organizations can certify. ISO 9001 was first published in 1987 by the International Organization for Standardization (ISO), an international agency composed of the national standards bodies of more than 160 countries. The current version of ISO 9001 was released in September 2015.

1. ISO 9001 : 2015
Latest Quality Management System
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2. Difference in clause
ISO 9001 : 2008 Vs. 2015
ISO 9001: 2008 ISO 9001:2015
• 0.Introduction
• 1.Scope
• 2.Normative reference
• 3.Terms and definitions
• 4.Quality Management System
• 5.Management Responsibility
• 6. Resource management
• 7. Product realization
• 8. Measurement, analysis and
improvement
• 0.Introduction
• 1.Scope
• 2.Normative reference
• 3.Terms and definitions
• 4.Context of the organization
• 5.Leadership
• 6.Planning
• 7.Support
• 8.Operation
• 9.Performance evolution
• 10.Improvement
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3. PDCA CYCLE FOR CLAUSES
• 9.Performance
evolution
• 10.Improvement
• 8.Operation
•4.Context of the
organization
•5.Leadership
•6.Planning
•7.Support
PLAN DO
CHECKACT
With this new
arrangement, the new
ISO 9001 strives to
give an additional
momentum to the
continuous and
systemic improvement
of processes within
organizations.
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4. DIFFERENT TERMINOLOGY IN ISO
9001:2008 AND ISO 9001:2015
ISO 9001: 2008
• Products
• Documentation, quality
manual, documented
procedures, records, instruction
• Work environment
• Monitoring and measuring
equipment
• Purchased product
• Supplier
ISO 9001:2015
• Products & services
• Documented information
• Environment for the operation
of processes
• Monitoring and measuring
resources
• Externally provided products
and services
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5. KEY ASPECTS- 7 QM PRINCIPLES
ISO 9001: 2015
Seven 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
ISO 9001:2008
Eight Quality Management
Principles
• 1.Customer Focused organization
• 2. Leadership
• 3.Involvement of people
• 4. Process Approach
• 5.System approach to
management
• 6. Factual approach to decision
making
• 7.Continual improvement
• 8. Mutually beneficial supplier
relationship.
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6. APPROACH OF ISO 9001
Process
Approach
P-D-C-A
Approach
Risk based
thinking
Key is to engage all 3 gears
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7. RISKED BASED THINKING
Risk:
• Effect of uncertainty on an expected
result
- ISO 9001:2015
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8. PROCESS APPROACH
PROCESS
Implementation
Identification
Management
Improvement
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9. PROCESS APPROACH
• Right Recourses:
• Qualified people
• Right Facilities/equipment
• Correct material
• Proven method
INPUT
• Process
ACTIVITY • Desired results:
• Quality products
• Quality services
• Customer satisfaction
OUTPUT
How is process measured?
Efficient
(No waste)
Effective
(Desired Results achieved)
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10. ISO 9001 REQUIREMENTS
REQUIREMENT
• “Shall” mandatory
• “Should” recommendation
• “Note” Guidance or clarification
• “Such as” Guidance only
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11. 4.0 CONTEXT OF THE ORGANIZATION
4.1
• Understanding the organization and its context
4.2
• Understanding the needs & expectations of the
interested parties
4.3
• Determining the scope of the quality management
system
4.4
• Quality Management System and its process
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12. 4.1Understanding the
organization and its context
Organization shall have determine
EXTERNAL
INTERNAL
Issues that are relevant to its
PURPOSE
&
STRATEGIC
DIRECTION
New
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13. 4.1Understanding the
organization and its context
Organization shall MONITOR &
REVIEW
Information related to internal & external issues
New
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14. 4.1Understanding the
organization and its context
INTERNAL ISSUES
• Values
• Culture
• Knowledge and
• Performance of the
organization
EXTERNAL ISSUES
It can be identified by using
the tool PESTLE
P - Political
E - Economical
S - Social
T - Technological
L - Legal
E – Ethical/Environmental
New
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15. 4.1Understanding the organization and
its context
Now this is new in ISO
9001 and we really
need to understand the
context of the business
/ organization by
examine what are
internal & external
issues that are
currently effecting
business or issues that
may have potential
impact on
organization.
The SWOT analysis is
useful tool for this process.
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16. 4.2 Understanding the needs &
expectations of the interested parties
Determine
• Relevant interested parties
• Relevant requirements of
interested parties
• Monitor and review the
information
Monitor and review
• Information and these interested
parties and
• Their relevant requirements
 Management
 Business Partner/Investor
 Staff
 Worker
 Union
 Distributor
 Channel Partner
 External Service Providers
 End users
 Contract workers
 Corporate shared service providers
 Statutory bodies
 Income tax department
 Judiciary
 Particular communities
 Particular state
 System certification bodies
 Consultants/Trainers
 Mediators
 Any Individual
List of potential interested
parties
New
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17. 4.3 Determining the scope of the quality
management system
Determine the scope
• Boundaries and applicability of
the QMS
On the basis of
(ISO 9001:2015)
 The external and internal
clauses(4.1)
 The requirements (4.2)
 Product & services
provided
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18. 5.0 LEADERSHIP
5.1
• Leadership & commitment
5.2
• Policy
5.3
• Organizational
roles,responsibilities and authority
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19. 5.1 Leadership & commitment
Top
management
to ensure
Communication
for quality
management
principle
That system
achive its intended
results
Engaging,directing
and supporting
persons
Promotion of
improvements
Supporting for
other relevant
management roles
Availability of
resources for QMS
implementation
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20. 5.2 POLICY
5.2.1/5.2.2 Quality Policy
• Quality Policy to support Strategic Direction
•Policy to be made available to the relevant
Interested Parties
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21. 5.3 ORGANISATIONAL ROLES ,
RESPONSIBILITIES AND AUTHORITIES
Top management should ensure that the responsibilities &
authorities for relevant role are assigned, communicate &
understood with in organization.
Top management shall assigned responsibilities and authority for:
• Ensuring that the QMS System conforms to the requirements of the
international standard.
• Ensuring that the processes are delivering their intended output.
• Reporting to the performance of the Quality Management System
and on opportunity for improvement in a particular to top
management.
• Ensuring the promotion of customer focus throughout the
organization.
• Ensuring the integrity of the QMS is maintained when change to the
QMS are planned & implemented.
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22. 6.0 PLANNING
6.1
• Action to address risk &
opportunities
6.2
• Quality objectives an planning to
achieve them
6.3
• Planning for changes
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23. 6.1 Action to address risk &
opportunities
6.1.1 & 6.1.2 When planning for the QMS
• To consider
- The issue (Referred to in 4.1) and the requirements (Referred to
in 4.2) and
• To determine the risk & opportunities that need to be addressed.
• To plan action
- To address these risk & opportunities.
- How to integrate & implement the actions into QMS. (See 4.4)
- Evaluate the effectiveness of these action.
Intent: To give assurance that the quality management system
can achieve its intended result, enhance desirable effects, prevent
or reduce, undesired effects ; achieve improvement
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24. 6.2 Quality objectives an
planning to achieve them
6.2.1 The organization shall establish quality objectives at relevant function,
levels and processes needed for the quality management system.
The quality objectives shall :
a) Be consistent with the quality policy;
b) Be measurable;
c) Take into account applicable requirement
d) Be relevant to conformity of products and services and to enhancement
of customer satisfaction.
e) Be monitored
f) Be communicated
g) Be update as appropriate
The organization shall maintain documented information on the quality
objectives.
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25. 6.2 Quality objectives an
planning to achieve them
6.2.1 When planning how to achieve its quality objectives,
the organization shall determine:
a) What will be done.
b) What resources will be required ;
c) Who will be responsible;
d) When it will be completed ;
e) How the result will be evaluated
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26. 6.3 Planning for changes
•In a planned manner
•To consider
-The purpose of changes and potential
consequences
-Availability of resources and,
-Allocation/reallocation of responsibility and
authority
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27. PLANNING
7.3 Awareness
7.4
Communication
7.5 Documented
Information
7.2 Competence
7.1 Resources
Earlier the Title was:
•Resource Management Clause-6
•Control of Monitoring & Measuring Device 7.6
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28. 7.0 SUPPORT
7.1
• Resources
7.2
• Competence
7.3
• Awareness
7.4
• Communication
7.5
• Documented Information
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29. 7.1 RESOURCES
7.1.1 General
a) To assess capability and constraints on existing internal
resources.
b) What needs to be obtained from external providers
7.1.2 People
Determine and provide the persons necessary for the
effective implementation of its quality management
system and for the operation and control of its processes.
7.1.3 Infrastructure
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30. 7.1.4 ENVIRONMENT FOR THE
OPERATION OF PROCESSES
Human and physical factors also to be included now
Social(e.g. stress-reducing, burn proof prevention,
emotionally protective.)
Physical (e.g. airflow, hygiene)
Note: Where third- party certification to ISO 45001 (or
equivalent) is recognized. It may be used to demonstrate the
organization’s conformity to the personnel safety aspects of this
requirement (IATF Requirement)
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31. 7.1.6 Organizational Knowledge –
New Heading
Determine the
knowledge
Maintain Knowledge
Make knowledge
available
Acquire or access
#any necessary
additional knowledge
and required updates
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32. 7.2 COMPETENCE – ON THE JOB
TRAINING (earlier 6.2.2.3)
The organization shall:
a) Determine the necessary competence of person(s) doing work under
its control that affects the performance and effectiveness of the
quality management system.
b) Ensure that these persons are competent on the basis of appropriate
education ,training or experience.
c) Where applicable , take actions to acquire the necessary competence
and evaluate the effectiveness of the action taken.
Note: Applicable actions can include, for example the provision of
training to the mentoring of , or the reassignment of currently
employed persons, or the hiring of contracting of competent persons.
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33. 7.3 AWARENESS
Maintain documented information to demonstrate that
all employee are aware of
• Their impact on product quality
• Importance of their activities in achieving, maintaining,
and improving quality, customer requirements and
• The risk involved for the customer with non-conforming
product.
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34. 7.4 COMUNICATION
The Organization shall determine the internal and
external communication relevant to the quality
management system, including:
a) On what it will communicate;
b) When to communicate
c) With whom to communicate
d) How to communicate
e) Who communicate
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35. 7.5 DOCUMENTED INFORMATION
7.5.1 General
The Organization’s Quality management system shall include:
a) Document information required by this internal Standards;
b) Documented information Determined by the organization
as being necessary for the effectiveness of the Quality
Management System.
Note: The Extent of the documented information for a quality
management system can differ from one organization to
another due to:
- The size of the Organization and its type of activities ,
processes, products and services.
- The complexity of Processes and their interactions.
- The competence of persons.
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36. 7.5 DOCUMENTED INFORMATION
• Creating and updating documented information
(earlier 4.2.3-Control of documents) New
heading7.5.2
• Control of document information (earlier 4.2.4 –
Control of Record) New Heading (adopted from
ISO 9001:2015)
7.5.3
Now both requirements are donated
as documented information
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37. 8.0 Operation
8.1
• Operational Planning & Control
8.2
• Requirements for products & services
8.3
• Design and development of products & services
8.4
• Control of externally provided processes, products & services
8.5
• Production & service provision
8.6 • Release of products & Services
8.7
• Control of Non conforming outputs
Note: Earlier the title was Product
Realization and was covered in
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38. 8.2 Requirements for products &
services
8.2 Requirement
for products and
services
8.2.1 Customer
Communication
8.2.2Determining
the requirements
for products and
services
8.2.3 Review of
the requirements
for products &
services
8.2.4 Changes to
requirements for
products and
services
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39. 8.4 Control of externally provided
processes, products & services
• Products and services are provided directly to the
customer(s) by externally providers on behalf of
the organization;
• A process or part of a process, is provided by an
external provider as a result of a decision by the
organization.
• To include all products and services
- subassembly, sequencing, sorting, rework and calibration
services etc.
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40. 8.4.2 Types and extent of control
The Organization shall:
• Ensure that externally provided processes remain within
the control of its quality management system.
• Define both the controls
- On an external provider
- On an resulting output
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41. 8.5.4 Preservation
The organization shall preserve the output during
production and service provision, to the extent
necessary to ensure conformity to the
requirements.
Note: Preservation on include identification,
handling, contamination control, packaging,
storage, transmission or transportation and
protection.
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42. 8.5.5 Post –delivery activities
Determine the extent of post delivery activities
required, consider following:
• Statutory and regulatory requirement
• The potential undesired consequences associated
with its products and services
• The nature, use and intended lifetime of its
products and services
• Customer requirements
• Customer feedback
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43. 8.5.6 Control of changes
• Review and control changes for production or
service provision, to the extent necessary;
• Retain documented information describing
- The result of the review changes
- The person authorizing the change
- Any necessary action arising from the review
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44. 9.0 Performance Evaluation
9.1
• Monitoring measurement, analysis
and evolution
9.2
• Internal Audit
9.3
• Management Review
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45. 9.0 Performance Evaluation
9.1 Monitoring measurement, analysis and evaluation
(earlier 8 measurement, analysis and improvement)
9.1.1 General(earlier 8.1)
• What needs to be monitored and measured
• The methods of monitoring, measurement, analysis and
evolution need to ensure valid result.
• When the monitoring and measuring shall be performed
• When monitoring and measurement shall be analyzed and
evaluated.
• Retain appropriate documented information as evidence
of the results.
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46. 9.1.3 Analysis and evaluation
(earlier 8.4 analysis of data)
• Degree of customer satisfaction.
• The performance and effectiveness of the quality
management system
• If planning has been implemented effectively
• The effectiveness of action taken to address risks and
opportunities
• The need for improvements to the quality management
system
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47. 9.2 Internal Audit
• 9.2.1 The organization shall conduct internal audit at
planned intervals to provide information on whether
the quality management system
a) Conform to:
1) The Organization's own requirements for it’s a
quality management system.
2) The requirements of this international standard.
b) It effectively implemented and maintained.
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48. 9.3 Management Review
9.3.1 General
Top management shall review the
organization’s quality management
system, at planned intervals, to ensure
its continuing suitability, adequacy,
effectiveness and alignment with
strategic direction of the organization.
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49. 9.3.2 Management Review Inputs
The management review shall be planned and carried out taking into
consideration:
a) The status of actions from previous management reviews;
b) Change in external and internal issues that are relevant to the quality
management system,;
c) Information on the performance & effectiveness of the quality management
system, including trends in:
1) The Customer satisfaction and feedback from relevant interested parties;
2) The extent to which quality objectives have been meet.
3) Process performance and conformity of products and services;
4) Non conformities and corrective actions
5) Monitoring & measurement results
6) Audit results;
7) The performance of eternal providers
d) The adequacy of resources;
e) The effectiveness of actions taken to address risks & opportunities (see 6.1)
f) Opportunities for improvement.
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50. 10 IMPROVEMENT
10.1
• General
10.2
• Non conformity and corrective action
10.3
• Continual Improvement
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51. 10.2 Non conformity and
corrective action
(Earlier 8.5.2 corrective action)
React to the conformity and as applicable:
• Take action to control and correct it.
• Deal with the consequence;
• Update risk and opportunities determined during
planning, if necessary;
• Corrective actions shall be appropriate to the effects of
the nonconformities encountered.
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52. 10.3 CONTINUAL IMPROVEMENT
• The organization shall improve the suitability,
adequacy and effectiveness of the quality
management system.
• The organization shall consider the results of
analysis and evaluation, and outputs from
management review, to determine if there are needs
or opportunities that shall be addressed as part of
continual improvement.
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53. END OF SLIDE
Thank you
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