Microsoft PowerPoint - QMS22 - CE

ISO 9001:2015
Interpretation
About us
and Application
Global Partner for Business Success
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QMS22_CE1
ISO 9001:2015 Interpretation and Application
Slide: 2
Opening and
0 Introduction

QMS22_CE1
Slide: 3
Introduction & Housekeeping
§ Name cards – write your name as you wish to be referred on

the card provided
§ Introduction of delegate
§ Who you are,
§ What you do,
§ Where are you from,
§ What you hope to gain from the course
§ Anything else of interest (hobbies etc.)
Except in case of emergency, delegates are requested to

switch off mobile phone or turn into silent mode during the course.
This is to avoid disruption to the course and other delegates.

QMS22_CE1
ISOISO
9001:2015
9001:2015
Interpretation
Interpretation
andand
Application
Application
Slide: 4
Course Objectives
To provide delegates with the following knowledge:

•An interpretation of the new requirements
•An understanding of the rationale and the foundation of the
new standard
•Actions required to establish, implement and achieve a
successful certification
•Step-by-step application guide and “know-how” to setup a
Quality Management System that conforms to the ISO
9001:2015 Standard

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Slide: 5
Time table (Day 1)

TIME SESSION
9:00 am – 9:15 am 0. Opening and Introduction
1. The ISO 9001 Evolution
9:15 am – 10:30 am 2. Understanding the High Level Structure, Terminology and Concepts
3. The Foundation of the Standard
10:30 am – 10:45 am Tea & Coffee Break
4. ISO 9001:2015 Requirements
Ø Clause 4: Context of the Organization
10.45 am – 1:00 pm Ø Clause 5: Leadership
Ø Clause 6: Planning
Ø Clause 7: Support
1:00 pm – 2:00 pm Lunch Break
Ø Clause 8: Operation Tutor may adjust
2:00 pm – 3:30 pm the timing to
Ø Clause 9: Performance Evaluation
maximize learning
3:30 pm – 3:45 pm Tea & Coffee Break
3:45 pm – 4:45 pm Ø Clause 10: Improvement
4:45 pm – 5:00Global
pm Partner
Summary and EndSuccess
for Business of Day 1
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Slide: 6
Time table (Day 2)

TIME SESSION
Tutor may adjust
9:00 am – 9:15 am Day 1 Recap the timing to
5. Introduction to the Route of Certification maximize learning
9:15 am – 10:30 am
6.Setting up the Quality Management System Milestone
10:30 am – 10:45 am Tea & Coffee Break
7. Management Commitment and the Quality Policy
10.45 am – 1:00 pm
8.Overview of QMS Strategic Planning
1:00 pm – 2:00 pm Lunch Break
9. Introduction to Process Approach and Process Control
2:00 pm – 3:00 pm
10. Establishing Documented Information
11. Application and Implementation of Quality Management System
3:00 pm – 3:30 pm
12. Reviewing the Quality Management System Progress
3:30 pm – 3:45 pm Tea & Coffee Break
13. Preparing and Performing Internal Audit
3:45 pm – 4:45 pm
14. Preparing and Performing Management Review
4:45 pm – 5:00 pm 15. Summary and end of course

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Slide: 7
The ISO 9001

1 Evolution

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Slide: 8
The ISO 9001 Evolution
• Evolution of the ISO 9001

Standard
• ISO 9000 Series
• Rationale for the revision
• Main changes from previous
version

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Slide: 9
Evolution of ISO 9001 Standard
Fifth Edition
2015 Risk-Based Thinking

2008
2000 Quality Management System
– process approach
1994
1987 Quality system

- 20 elements

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Slide: 10
ISO 9000 Series
Standard Title Remark

ISO 9000:2015 QMS - Fundamentals & Vocabulary -
ISO 9001:2015 QMS - Requirements -
ISO/TS 9002 QMS - Guidelines for the New project
application of ISO 9001:2015 approved
ISO 9004:2009 Managing for the sustained success -
of an organization – A quality
management approach
ISO 19011:2011 Guidelines for auditing -
management systems

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Slide: 11
Rationale for the revision

• Periodic Review
• Adapt to maintain
relevance to
changing needs –
user survey 2011*
• Standardization of
Management
Systems structure -
high level structure
* Results of survey – concepts to be included
of ANNEX SL
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Slide: 12
Three Pillars of Sustainable Development

E-business
Trade facilitation
Emerging
Good business economies
practices
Dissemination of Alleviating poverty

new technologies Economic
Environmental Growth
Consumer protection
management
Life cycle analysis & Worker protection

green labelling Environmental Social
Integrity Responsibility
GHG emissions & Health services
climate change
Energy efficiency & Security
renewable resources
Fair trading
Water, soil & air quality Waste Ethics
management

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Standards supporting the three pillars
Consistent and aligned? à the need for Annex SL
AS 9100 (Aerospace)
ISO 27001 (Information Security)
ISO 20000 (Information Technology) ISO 28001 (Supply chain security
Economic ISO 9001 (Quality)
TL 9000 (Telecommunication)
Growth
ISO 55000 ISO 22000 (Food Safety)
(Asset) ISO 50001
(Energy) ISO 22301 (Business Continuity)
ISO 14001 (EMS)
ISO 18617
(Sustainable Purchasing) ISO 45001
Environmental Social (Occupational Health & safety)
ISO 14064 (Greenhouse Gas)Integrity Responsibility
ISO 20121 SA 8000 (Social Responsibility)
ISO 14040 (Lifecycle) (Sustainable Event)
ISO 39001 (Road safety)

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Slide: 14
Main changes from previous version

• The adoption of the High Level Structure in Annex SL
• Explicit requirement for risk-based thinking to support and
improve the understanding and application of the process
approach
• Fewer prescribed requirements (more freedom)
• Less emphasis on documents
• Improved applicability for services
• A requirement to define the boundaries of the QMS
• Increased emphasis on organizational context
• Increased leadership requirements
• Greater emphasis on achieving desired outcomes to improve
customer satisfaction.
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Slide: 15
Understanding the
High Level Structure,
2 Terminology and
Concepts

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Understanding the New Structure, Terminology

and Concepts
• High level structure (Annex SL)

• New terms and definitions

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Annex SL
Appendix 2
Annex SL
•High level structure
Proposals for •Identical core text
management
system •Common terms and
ISO/IEC standards core definitions
Directives,
Part 1
Consolidated
ISO
Supplement –
Procedures
specific to ISO

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Slide: 18
The Intent of Annex SL
• Consistency and alignment of all Management System

Standards (MSS)
• Contributes to integrated management system
Discipline- FUTURE
Annex SL specific
requirements ISO MSS
Same overall “look” & “feel”

JJJJJJJJ
Consistent and compatible

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Slide: 19
High Level Structure

Introduction 1. Scope
2. Normative references
3. Terms and definitions
4. Context of the organization
5. Leadership
6. Planning
7. Support Identical
8. Operation core text
9. Performance evaluation
10. Improvement

ISO 9001:2015
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Introduction 7. Support Identical Core Text

1.Scope 7.1 Resources Discipline specific &
2.Normative references 7.1.1 General enhancement
3.Terms and definitions 7.1.2 People
4.Context of the organization 7.1.3 Infrastructure
4.1 Understanding the organization and its context 7.1.4 Environment for the operation of
4.2 Understanding the needs and expectations of processes
interested parties 7.1.5 Monitoring and measuring resources
4.3 Determining the scope of the quality management 7.1.6 Organizational knowledge
system 7.2 Competence
4.4 Quality Management System and its processes 7.3 Awareness
5.Leadership 7.4 Communication
5.1 Leadership and commitment 7.5 Documented information
5.1.1. General 7.5.1 General
5.1.2. Customer focus 7.5.2 Creating and updating
5.2 Policy 7.5.3 Control of documented information
5.2.1. Establishing the quality policy
5.2.2. Communicating the quality policy
5.3 Organizational roles, responsibilities and authorities
6.Planning
6.1 Actions to address risks and opportunities
6.2 Quality objectives and planning to achieve them
6.3 Planning of changes
ISO 9001:2015
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8. Operation Identical Core Text

8.1 Operational planning and control Discipline specific &
8.2 Requirements for products and services enhancement
8.2.1 Customer communication
8.2.2 Determining the requirements for products and 8.5 Production and service provision
services 8.5.1 Control of production and service
8.2.3 Review of the requirements for products and provision
services 8.5.2 Identification and traceability
8.2.4 Changes to requirements for products and 8.5.3 Property belonging to customers or
services external providers
8.3 Design and development of products and services 8.5.4 Preservation
8.3.1 General 8.5.5 Post-delivery activities
8.3.2 Design and development planning 8.5.6 Control of changes
8.3.3 Design and development inputs 8.6 Release of products and services
8.3.4 Design and development controls 8.7 Control of nonconforming outputs
8.3.5 Design and development outputs
8.3.6 Design and development changes
8.4 Control of externally provided processes, products
and services
8.4.1 General
8.4.2 Type and extent of control
8.4.3 Information for external providers

ISO 9001:2015
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9. Performance evaluation
9.1 Monitoring, measurement, analysis & evaluation Identical Core Text
9.1.1 General Discipline specific &
enhancement
9.1.2 Customer satisfaction
9.1.3 Analysis and evaluation
9.2 Internal audit
9.3 Management review
9.3.1 General
9.3.2 Management review inputs
9.3.3 Management review outputs
10. Improvement
10.1 General
10.2 Nonconformity and corrective action
10.3 Continual Improvement

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Major differences in terminology

Refer to ISO 9000:2015 for terms & definitions
ISO 9001:2015 ISO 9001:2008

Documented information Documentation, quality manual,
documented procedures, records
Products and services Products
Externally provided products and services Purchased product [inclusive of outsourced

process(es)]
Not used Exclusions (to scope)
Environment for the operation of processes Work environment
External provider Supplier

Monitoring & measuring resources Monitoring & measuring equipment
Not used Management representative

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Some New Terms and Definitions

Refer to ISO 9000:2015 for terms & definitions
3.7.9 *Risk 3.6.6 Statutory requirement

3.8.6 *Documented information 3.6.7 Regulatory requirement
3.7.8 Performance 3.6.15 *Innovation
3.4.6 Outsource 3.7.7 Service
3.11.3 Monitoring 3.8.4 Information system
3.1.3 *Involvement 3.9.1 Feedback
3.2.2 *Context of the organization 3.9.3 Complaint
3.5.12 *Strategy 3.11.1 Determination
Terms which were not defined in ISO 9000:2005 but used in ISO 9001:2008 (i.e Top
Management, Monitoring and Performance), now defined in ISO 9001:2015 (refers to ISO
9000:2015)
*Terms not previously used

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Explanations of Verbs
Verbal forms used in ISO 9001:2015

“Shall” indicates a requirement
“Should” indicates a recommendation
“May” indicates a permission
“Can” indicates a possibility or a capability

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Activity 1 – Understanding terms and definitions
Using your own words, explain the meaning of the new

terms and definitions as assigned by tutor, example:
Team 1 - Context of the organization, Risk
Team 2 - Performance, Objective, Quality Objective
Team 3 - Product, Service
Team 4 - Measurement, monitoring

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The Foundation of
3 the Standard

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The Foundation of the Standard
• The quality management

principles
• Process approach
• Plan, Do, Check, Act cycle
• The QMS Model
• Risk-based thinking

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The Quality Management Principles
The Foundation of the QMS standards:

ISO 9000:2015 / ISO 9001:2015 ISO 9000:2005
1. Customer Focus 1. Customer Focus
2. Leadership 2. Leadership
3. Engagement of People 3. Involvement of People
4. Process Approach 4. Process Approach
5. System Approach to Management
5. Improvement 6. Continual Improvement

6. Evidence-based Decision Making 7. Factual Approach to Decision Making
7. Relationship Management 8. Mutually Beneficial Supplier

Relationships

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Slide: 30
Process Approach
• Understanding and managing interrelated processes as a
system contributes to the organization’s effectiveness and
efficiency in achieving its intended results
Example of a
process approach
system

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Process Approach
Application of process approach enables:

a) Understanding & consistency in meeting requirements
b) The consideration of processes in terms of added value
c) The achievement of effective process performance
d) Improvement of processes based on evaluation of data &
information

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Process Approach
Schematic representation of the elements of s single process

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Plan, Do, Check and Act Approach
Establish the objectives of the system and its processes;

P resources needed to deliver results in accordance with
customers’ requirements and the organization’s policies;
identify and address risks and opportunities
Implement what was planned;

D
Monitor and (where applicable) measure processes and
C products/services against the policies, objectives, requirements
and planned activities, and report the results
Take actions to improve performance,

A as necessary

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The QMS Model

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Risk-based Thinking
An organization needs to plan and
implement actions to address risks
and opportunities – a basis for
increasing effectiveness of the QMS,
achieving improved results and
preventing negative effects.
• Risk – effect of uncertainty; it is often expressed in terms of a

combination of the consequences of an event and the associated
likelihood of occurrence
• An effect can be positive or negative
• A positive deviation arising from a risk can provide an opportunity, but not
all positive effects of risk results in opportunity

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Activity 2 – Quality Management Principles
• Work in group, cite example how organizations apply

the Quality Management Principles (as assigned by
tutor), and
• What are the benefits can be achieved from the
application(s)?

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ISO 9001:2015
4 Requirements

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ISO 9001:2015 Requirements
• Understand clause by clause

of the standard
• Activities to apply the
knowledge

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Clause 4:
Context of the
Organisation

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Clause 4 in the QMS model

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All new/enhanced
4 Context of the organization requirement
• More strategic high-level, conceptual

understanding of the factors impacting
(positively/negatively) the planning of
the QMS
• The context is limited to the scope of
ISO 9001:
• Where an organization needs to
demonstrate its ability to consistently
provide products and services that
meet customer and applicable
statutory and regulatory requirements
• Aims to enhance customer satisfaction

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4.1 Understanding the organization and its

context All new/enhanced requirement
External Issues Organization

(international/national/
regional/local)
§Legal
§Technology
§Competition
§Market
§Culture Intended
§Society Internal Issues: Result(s) of the
§Economic environments §Values QMS
§Culture •Conformity of
§Knowledge product/service
•Enhanced
Review Determine §Performance customer
(see 9.3) (4.1) satisfaction
Monitor
Business Environment
(see 9.1)

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4.2 Understanding the needs and New/enhanced

expectations of interested parties requirement
Customers Determine relevant

interested parties
Owners
Determine relevant
Suppliers & Partners requirements
Unions
Review Determine
Regulators (see 9.3)
(4.2)
Society
(competitors/pressure groups)
Bankers Monitor
(see 9.1)
Employees

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4.3 Determining the scope of the QMS
Determine and document scope (products/services covered)

Justification for non-application for 9001 requirements (previously exclusion)
Scope of QMS
*Consider: Establish
§External & internal issues
Conformity with
§Requirements of relevant interested Implement
ISO 9001
parties
§Products and services
Maintain
Process 1 Process 2 Process x

Continually
improve
*New/enhanced requirement documented information
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4.4 QMS and its processes
Scope of QMS
Process 1 Process 2 Process x
Determine the processes and
•determine process inputs/outputs
•determine process sequence/interaction
•determine and apply criteria, methods, monitoring, measurements,
performance indicators for effective operation and control of processes
•determine and provide resources
•assign process responsibilities and authorities
•*address the risks/opportunities
•*evaluate the process and implement any changes needed
•improve the process and the QMS
documented Maintained to support the operation

*New/enhanced
Retained to have confidence of implementation requirement
information

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Slide: 46
Activity 3 – Understanding the context of an

organization
Select an organization in a specific industry sector,

then determine
- Relevant external and internal issues
-How these issues affect the organization’s QMS
performance

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Clause 5:
Leadership

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Leadership and Commitment
Leading people
Influencing people
Commanding people
Guiding people

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5.1 & 5.1.1 Leadership and commitment

Demonstrate leadership and commitment through the following:
*Accountable for effectiveness of QMS
Quality policy & objectives – *compatible with the context and strategy
*Ensure integration QMS requirements into core business process
*Promote the use of process approach and risk-based thinking
Provide resources Communicate importance
*Ensure QMS achieve intended results
*Engage, direct and support other persons to
contribute to the effectiveness of QMS
Promote improvement
*Support other relevant management roles to *New/enhanced
demonstrate their leadership Requirement

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*New/enhanced
5.1.2 Customer Focus Requirement
Demonstrate leadership and commitment by ensuring:
Customer requirements & statutory/regulatory requirements

are determined, *understood and *consistently met
*Risks/opportunities affecting QMS outcomes are
determined and met
*The focus on enhancing
customer satisfaction is
maintained

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5.2 Policy
Quality Policy
Communication
§Is appropriate to the purpose and Available and maintained
*context of the organization and as documented
support its strategic direction information
§Provides framework for setting objectives
§Includes commitment to satisfy applicable Communicated,
requirements understood and *applied
§Includes commitment to continual within the organization
improvement of the QMS
*Available to relevant
*New/enhanced requirements interested parties, as
appropriate

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5.3 Organizational roles, responsibilities and

authorities..1/2
• There is *no requirement for appointing a

“management representative”; however the
responsibilities and authorities still remain.
Ø responsibilities and authorities previously held by a
management representative can now be assigned to
more than one person.

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5.3 Organizational roles, responsibilities and

authorities..2/2
Top management shall assign responsibility
and authority for
•Ensuring the QMS conforms to ISO 9001
•*Ensure processes deliver intended outputs
•Reporting performance of QMS and opportunities for

improvement
•Promotion of customer focus
•Ensuring QMS integrity when changes planned and

implemented
*New/enhanced requirement
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Clause 6:
Planning

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Planning – 6.1 Actions to address risks and

opportunities..1/2 All new requirement
Risks/Opportunities
External & Internal Issues Requirements Give assurance QMS
can achieve results
Enhance desirable
effects
Prevent, reduce
undesired effects
Achieve improvement
Planning the QMS

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Planning – 6.1 Actions to address risks and

opportunities..2/2 All new requirement
Determine Plan actions to Plan how to

address them
Risk Opportunities • Avoid risk Integrate &
• Take risk to pursue an implement
opportunity actions into
• Eliminate source QMS
§ Escalating cost § Cost • Change
§ Missed rationalization likelihood/consequence Evaluate
shipment § Localized • Sharing risk effectiveness of
§ Flooding, sourcing • Retaining risk by
actions
natural disaster § Poka Yoke informed decision
§ Limitation of § Reduce cycle
resources time • Adoption of new Note: the
§ Loss of § Reduce practices
traceability paperwork/ • Launching new product
requirement on
§ Legal exposure redtape • Opening new markets “preventive
§ etc § etc • Addressing new clients action” has been
• Building partnerships deleted
• Using new technology
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6.2 Quality objectives and planning to achieve

them
Ø Consistent with quality policy PLAN

Ø Measurable WHAT will be done
Ø *Take into account
applicable requirements what RESOURCES will
Ø Relevant to conformity of be required
products/services and WHO
enhancement of customer will be responsible
Quality satisfaction
Ø *Monitored WHEN
Objectives
it will be completed
Ø *Communicated
documented Ø *Be updated as how the results will be
information appropriate EVALUATED
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6.3 Planning of changes
Consideration:
Purpose of change & potential

consequences
The integrity of the QMS
DETERMINE Availability of resources
the need for change to
Allocation or reallocation of
QMS
responsibilities and authorities
CARRIED OUT
in a planned manner

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Activity 4 – Understanding risks and

opportunities
Based on the previous activity,

Brainstorm on some risks and opportunities
related to the organization’s QMS.

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Clause 7:
Support

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7.1 Resources 7.1.1 General
Consider:
DETERMINE
•capabilities & constraints of internal
PROVIDE resources
•needs to be obtained from external
Resources for providers
Establish QMS
Implement
Maintain
Continually
improve

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7.1 Resources *New/enhanced requirement
Resources Requirements
*7.1.2 Determine and provide necessary persons
People for effective implementation of QMS,
operation and control of processes
7.1.3 Determine, provide and maintain for the operation

Infrastructure of its processes and to achieve conformity
e.g. buildings & utilities, equipment, transportation,
ICT
7.1.4 Determine, provide and maintain for the operation
Environment for of its processes and to achieve conformity
the operation of e.g. social (e.g. non-discriminatory, calm, non-
processes confrontational), psychological (e.g. stress-
reducing, burnout prevention, emotionally
protective) and physical (temperature, heat
humidity, light, airflow, hygiene, noise)

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7.1 Resources
7.1.5 - *Resources mean > equipment; e.g Survey
M&M Resources tools / questionnaires , Visual sensory
inspectors
- Suitable & maintain fitness for use
For equipment:
- Verification/calibration or both to recognized standard
- Identification to determine calibration status
- Safeguarding from adjustments, damage or
deterioration
- Determine validity of previous results if equipment
unfit for use & take action
*New/enhanced documented information

requirement
on fitness for purpose
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7.1 Resources
*7.1.6 - Determine knowledge required
Organizational - Maintain and make available
knowledge - Consider the need for additional
knowledge /updates when
addressing changes
Note: knowledge specific to an organization; gained by

experience. It is information used and shared to achieve the
organization’s objectives)
Internal sources: External sources:

Intellectual property, knowledge gained, lessons Standards, academia,
learned, capturing or sharing undocumented conferences, knowledge from
knowledge/experience, results of improvement customer/providers
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7.2 Competence *New/enhanced requirement
• Determine competency for those who

“*affect the performance and effectiveness of the QMS”
(previously “affecting conformity to product requirements”)
• Competent – education, training, experience
• Actions to achieve competence can include, e.g.

•provision of training
•mentoring documented
•re-assignment of currently employed persons information
•hiring or contracting of competent persons. Evidence of
competence
• Evaluate effectiveness of action

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7.3 Awareness
• *This clause is separated from competence

• Awareness:
Quality policy
Relevant quality objectives
Contribution to the effectiveness of the Editorial change
QMS, benefits of improved performance
*Implications of not conforming to QMS *New/enhanced requirement

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7.4 Communication
*WHEN to *WITH WHOM to

communicate communicate
*WHAT to *HOW to communicate

communicate
*WHO communicates
Internal communication *External communication

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7.5 Documented Information..1/2
More freedom in documentation
Document ISO
Previous Documented
Record Version information 9001:2015
• ‘retain documented information as evidence of....’ i.e. records

• ‘maintain documented information’ to mean documentation
other than records

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7.5 Documented Information..2/2
7.5.2. Identification & description (e.g. title, date, author, reference number)
Creating & Format (language, software version, graphics, media)
Updating
Review and approval
Ensure available and suitable for use

Ensure adequate protection
7.5.3.
Control Distribution, Storage, Control of Retention &
access, retrieval, preservation, changes disposition
use legibility
*Retained evidence – shall be protected from unintended alterations

Includes documented information *New/enhanced requirement
-Required by ISO
-Required by the QMS
-Of external origin
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Clause 8:
Operation

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8.1 Operational planning and control
To meet requirements for the *To implement actions determined in clause 6

provision of products & (risk & opportunities, quality objectives,
services changes)
Determine the requirements for products & services

Plan Establish criteria for the process and acceptance of
Implement & products & services
Control
the processes Determine the resources needed
Implement process control as per criteria
(see also 8.4 for
outsourced *Control planned changes and review
processes) consequence of unintended changes (see also
8.5.6), take mitigation action as necessary
DetermineGlobal
and Partner
keep documented information
for Business Success
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8.2 Requirements for products and services
8.2.1. Customer communication

Providing information relating to products &
services
Handling enquiries, contracts or order, including
changes
Obtaining customer feedback, including
complaints
*Handling or controlling customer
property
*Establishing specific requirements for *New/enhanced
contingency action, where relevant requirement

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8.2.2. Determining the requirements for products & services
Product & service requirements are defined

(including those considered necessary by the
organization, statutory/regulatory requirements)
*Organization can meet the claims for

the products and services offered
Shelf life
Nutrition

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8.2.3. Review of the requirements for products & services

• Conduct review prior to commitment
• Resolve differences
• Confirmation if no documented statement from customer
REVIEW Requirement specified by customer

Requirement not stated by customer, but necessary for
intended/specified use, where known
*Requirement specified by the organization
Statutory/regulatory requirements applicable to products &
services
Differing contract or order requirements
documented Results of review

information *Any new requirements for products/services
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8.2.4. Changes to requirements for products and services
Amend relevant documented information
Ensure relevant persons made aware of

the changed requirements
documented Amended requirements

information

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8.3 Design and development of products and

services *New/enhanced requirement
8.3.1. *General
Design & Development Process

to ensure the subsequent provision of products and services
Establish
Implement
Maintain

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8.3.2. Design and development planning
Consider Design &

a)*Nature, duration, complexity of the D&D Development stages
activities & control
b)The required process stages, including reviews
c)Verification & validation
d)Responsibilities & authorities
e)*Internal & external resource needs
f)The need to control interfaces of those involved S1-------------------
g)*The need for involvement of customers and S2----------------
user groups S3-------------
h)*The requirements for subsequent provision
of products and services
i)*Level of control expected by customer/
interested parties
j)*The necessary documented information
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8.3.3. Design and development inputs

Inputs
Determine requirements essential for the – adequate, complete,
specific types of products & services. unambiguous
- Resolve conflicting inputs
Consider:
a)Functional & performance requirements
b)Information from previous similar D&D
activities
c)Statutory & regulatory requirements
d)*standards or codes of practices
e)*Potential consequence of failure due
to the nature of products/ services
documented
D&D inputs
information
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8.3.4. Design and development controls
Controls to ensure
a) *Results to be achieved are defined
b) D&D review conducted
c) Verification activities conducted
Expected Results??
d) Validation activities conducted
e) *actions arising from review/ Verification----
verification/validation are taken
f) Documented information retained Validation------
Review-------
documented
information
Review,
verification,
validation activities
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8.3.5. Design and development outputs
Outputs
a) Meet input requirements
b) Adequate for subsequent processes for
provision of products/services
c) Include or reference *monitoring and
measuring requirements & criteria
d) Specify characteristics essential for intended
purpose and their safe & *proper provision
Outputs
Specification
User manual
formulation
Instruction
production
or service
provision
Product/
software
Drawing
Recipe/
Costing
documented
D&D outputs
information
for

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8.3.6. Design and development changes
Identify No adverse impact

Changes to on conformity to
inputs/outputs
Review
requirements
Control
documented § D&D Changes

§ Results of review
information § *Authorization of
changes
§ Actions taken to prevent
adverse impacts

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8.4 Control of externally provided processes,

products and services
8.4.1. General
Ensure externally provided *processes, products and services conform
to requirements
*Determine the controls when: Determine &

a) Products/services from external apply criteria
providers incorporated into
organization’s own products Evaluation
documented
information
and services Selection
b) Products/services provided
directly to the customer(s) on *Monitoring
behalf of the organization performance
c) Process (or part of a process) is
provided by external provider Re-evaluation
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8.4.2. Type and extent of control

• Externally provided processes remain within the QMS control
• Define the *controls on external provider and the resulting output
• Verification or other activities
Consideration: e.g. externally provided services:

a) Potential impact on the organization’s Pest control~ transportation~
ability to consistently meet process~ cleaning ~ security~
requirements training ~call center~
b) *The effectiveness of the maintenance ~record
controls applied by external management~ laboratory ~etc
provider
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8.4.3. Information for external providers
Communicate requirements: Ensure

a)Process, products and services to be provided adequacy
b)Approval of products/services, methods, processes, before
equipment; release of products/services communication
c)Competence (inclusive of qualified personnel)
to external
d)Their interaction with the organization’s QMS
e)*Control & monitoring of their performance
provider
f)Verification or *validation activities at the external
provider’s premises
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8.5 Production and service provision
8.5.1. Control of production and service provision
Controlled conditions (as applicable) shall include:
a)Documented information defining characteristics of products/services,

activities to be perform, *results to be achieved
b)Availability and use of monitoring & measuring resources
c)Monitoring & measurement activities to verify process control or outputs and
acceptance criteria for products and services met
d)Use of suitable *infrastructure and process environment
e)*Competence & qualification
f)Validation & periodic revalidation
g)*Implementation of actions to prevent human error
h)Implementation of release, delivery and post-delivery activities
documented information
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8.5.2. Identification and traceability
• Suitable means to identify outputs

• Identify status of monitoring and measurement
• Where traceability is a requirement – control unique identification and retain

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8.5.3. Property belonging to customers or external providers
• Control of property belonging to customer or *external providers

• Exercise care
• Identify, verify, protect and safeguard
• Report - if lost, damaged or found unsuitable for use & retain documented
information on what occurred
Include material, Contractor’s

Components, tools & property
equipment, customer
premises, intellectual
property, personal data
Customer’s property
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8.5.4. Preservation
• Process outputs to be preserved to the extent necessary to maintain
conformity to requirements
Include identification,
handling,
*contamination
control, packaging,
storage,
*transmission or
transportation,
protection

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8.5.5. *Post-delivery activities
• Meet requirements for post-delivery activities

• Consideration for extent of post-delivery activities that are
required:
• Statutory & regulatory requirements
• Potential undesired consequences associated with
products/services
• Nature, use and intended lifetime or products/services
• Customer requirements
• Customer feedback
Examples: replacement,
repair, maintenance,
recycling, final disposal
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8.5.6. *Control of changes
• *Changes for production or service provision – need review and

control
• *Results of review
documented
• *Person authorizing
information
change
• *Any necessary actions

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8.6 Release of products and services
Plan
• Implement planned arrangement
(see 8.1)
at appropriate stages to verify
product/service requirements
have been met
Criteria?
• Release products/services only if Implement
planned arrangements verification
completed or otherwise
& release
approved by a relevant authority Criteria?
and customer (as applicable) (see 8.6)
Release
• Documented information:
Evidence of conformity with
acceptance criteria & traceability
of person authorizing release documented information

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8.7 Control of nonconforming outputs
• Identified and controlled to prevent unintended use Detection of NC

or delivery output/product/
service
• Take appropriate action based on nature of
nonconformity and its effect
Decision
• Action: correction, *segregation, *containment,
*return or suspension, *informing customer,
authorization (concession)
• Correction requires verification Actions on the
output/product/
• Nonconformity description service
documented • Actions taken
information • Concession obtained
• *Authority deciding the action
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Clause 9:
Performance
Evaluation

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9.1 Monitoring, measurement, analysis and

evaluation 9.1.1 General
*WHAT needs to be
monitored & measured
*HOW (Methods)
- ensure valid *EVALUATE
results performance
&
effectiveness
*WHEN the of QMS
monitoring and
measuring performed
*New/enhanced requirement *WHEN the results to be

analysed and evaluated
Evidence of results
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9.1.2 Customer satisfaction
• Monitor customers’ perceptions of the

degree their requirements fulfilled
• Determine the methods for obtaining,

monitoring and reviewing this information

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9.1.3 Analysis and evaluation
Analyse and
Results of analysis used to evaluate:
*evaluate data &
a)Conformity of products/services
information
b)Degree of customer satisfaction
c)The performance & effectiveness of
the QMS
d)*If planning has been
implemented affectively
e)*Effectiveness of actions
addressing risks/opportunities
f)Performance of external providers
g)Need for improvements to the QMS
Analysis methods include statistical

techniques

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9.2 Internal audit … 1/3
At planned interval
To provide information on whether the QMS:

•conforms to the organization’s own
requirements and also the requirements of this
International Standard
•Is effectively implemented and maintained

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Planning
methods requirements
frequency responsibilities reporting
Audit
programme
Importance of the *Changes affecting Results of

processes the organization previous audits
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*Results Correction &

Ensure objectivity corrective
reported to
& impartiality of action
relevant
selected auditors
management
Evidence of audit
programme
Criteria &
implementation &
scope
results
*New/enhanced
requirement Audit

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9.3 Management review..1/2
9.3.1. General
Inputs 9.3.2 Outputs 9.3.3
-Planned interval
-Ensure continuing suitability,
adequacy, effectiveness &
*alignment with strategic
direction
* New/enhanced
requirement

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9.3 Management review..2/2

Status of actions from previous reviews Decisions &
Changes in *external/internal issues actions
§Improvement
Customer satisfaction & *feedback of
Information & trends on QMS
opportunities
performance & effectiveness
interested parties §Need for

*Extent of quality objectives met changes
§Resource needs
Process performance & conformity of product/ service
Nonconformities & corrective actions
*Monitoring & measurement results
documented
Audit results
information
*Performance of external providers
*Adequacy of resources * New/enhanced
requirement
*Effectiveness of actions on risks/opportunities
Opportunities for improvement
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Clause 10:
Improvement

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10 Improvement 10.1 General
Determine & select Improving products and services to

opportunities for improvement meet requirements
(also to address future requirements)
Implement actions
*Correcting, preventing or
reducing undesired effects
Improving *performance &
effectiveness of QMS
Can include:
1. Correction
2. Corrective action
3. Continual improvement
* New/enhanced 4. Breakthrough change
requirement 5. Innovation
6. Re-organization
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10.2 Nonconformity and corrective action

Nonconformity
*React – control, correct &

deal with consequences
§ Review & analyse NC

Evaluate the need for action to
§ Determine causes
prevent recurrence or
§ *Determine if similar NC exist or
*occurrence elsewhere
could potentially occur
Implement action
Review effectiveness
§ *Nature of nonconformities
*Update risks/opportunities § *Actions
§ Results of CA
*Make changes to QMS if
necessary
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10.3 Continual improvement
Results of analysis & evaluation Outputs from management review
Needs or
Opportunities
Performance
Continual Improvement
Time
QMS – suitability, adequacy & effectiveness

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Introduction to the
5 route of certification

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Certification Process
Maintain &
Standard Establish Implementation Continually Improve
ISO
9001:2015
Requirements
Initial Audit (Stage 1) Initial Audit (Stage 2) Surveillance and

Recertification
Check System set-up and Check effective
correct application of ISO implementation of QMS
9001
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Role of The Certification Body
• To provide independent verification that the organizations

QMS conforms with the ISO 9001 requirements.
• To provide a basis for avoiding the need for multiple audits
by second parties
• To undertake regular surveillance audits to verify the QMS
is being maintained and continually improved to meet the
intended results
• To identify aspects of the QMS that need improvement

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Benefits of Certification
• Recognition of the QMS is able to

meet requirements
• Improves company profile
• As a “qualification” to bid for tender,
contract
• Verification by independent body
• As a baseline for further improvement
to achieve sustainable business

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Setting up the
6 Quality Management
System Milestone

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Action plan
• Gap analysis
• Develop an implementation plan
• Provide appropriate training and
awareness for all relevant parties
• Conduct internal audit and
management review
• Liaise with certification body for
certification audit

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Phase 1 – Planning and Gap Analysis
• Project milestone (Gantt Chart)

• Understanding the context of the organization and the
needs and expectations of interested parties
• Define scope
• Resource requirements:
§ Appointment of committee
and key personnel
§ Allocation of Fund
§ Training
• Select certification body

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Phase 2 – System Design and Development
• Determine the organizational

context
• Conduct QMS planning
• Business Process mapping
• Define policy and objectives
• Define necessary documented
information
• Assign owners
• Design & develop documented
information
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Phase 3 - Implementation
• Deployment and communication of policy and

objectives
• Distribution of documented information
• Documented information / process(es)
walkthrough
• Awareness programs for all staff
• Maintaining documented information

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Phase 4 – Review and Improvement
• Performance evaluation
• Internal audit
• Management Review
• Corrective action
• Fine-tune system
• Revisit and amend project milestone (if needed)
• Certification audit (stage 1 & 2) by Certification
Body

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Activity 5 – Action plan
Working towards certification to ISO 9001:2015:

- Determine what are the activities required, and
- Create a simple milestone on the flipchart and present it
to the rest of the class

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Management
7 Commitment and the
Quality Policy

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Who is Top Management?
Person or group of people who directs and controls an

organization at the highest level
(ISO 9000:2015; Clause 3.1.1)
Note 1 to entry: Top management has
the power to delegate authority and
provide resources within the
organization.
Note 2 to entry: If the scope of the

management system (3.5.3) covers only
part of an organization, then top
management refers to those who direct
and control that part of the organization.

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Management Commitment
Top management shall demonstrate

leadership and commitment with respect to
the QMS.
Top Management – Strategic level Employee(s) – Operational level
Establish and communicate the Quality Awareness of Policy and contributes to
Policy and Quality Objectives achieving the Objectives
Integrate QMS requirements into the Understand and carry out processes
organization’s business process taking into consideration the risk-
Promote process approach and risk- opportunities to achieve the expected
based thinking output
Engage, direct and support management Supported and guided by top

and staff management in achieving the
organization’s QMS Strategic Plan

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Accountability of Top Management
Management Representative (MR) is no longer a requirement

Assignment
Clause 5.3
Responsibilities and Authorities
One Person (retain existing QMR)
Top
Management OR
A Group (> one person)

Accountability

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Process approach and risk-based thinking

Process Approach
Top Management to How? (Method)

promote the • Use the process approach to define the overall
awareness and the QMS and its processes
use of “process • Impart process approach and risk-based thinking
approach” and “risk- during the establishment of business process
based thinking” map and risks
• Assigning responsibilities for risk management
• Arrange training programmes to ensure
awareness on process and risk management
Risk-based Thinking

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Policy
Quality Policy
•Commitment to
satisfy applicable
requirements Strategic direction
•Commitment to
continually improve
the QMS
Quality Objectives setting

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Activity 6 – Quality Policy
Tutor will display a Quality Policy to the rest of the class.

Work in your group:
1. Discuss if the Quality Policy meets the requirements of
Clause 5.2.
2. List 2 Quality Objectives that are consistent with the
Quality Policy.

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Overview of QMS
8 Strategic Planning

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QMS Strategic Planning
The intention of ISO 9001:2015 clauses

is not for the organization to plan /
establish their QMS following the actual
clause sequence in the Standard.
Strategic Planning

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Activity 7 – QMS Strategic Planning
Based on the understanding of ISO 9001:2015 on Day 1,

arrange the clauses below in the right sequence in order to
get a the big picture of QMS strategic planning:
Clause 4.1 , 4.2, 4.3, 4.4, 6.1, 6.2 and 6.3

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Organizational Context – Needs & Expectations

of the Interested Parties
Customers
Owners Organization
Suppliers & Partners
Unions
Regulators
Intended Result(s) of
the QMS
Society
•Conformity of
(competitors/pressure groups)
product/service
•Enhanced customer
satisfaction
Bankers
Employees

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Activity 8 – Understanding the needs and

expectations of interested parties
As how the teams have identified the external and internal

issues in Activity 3, the teams are now required to:
- identify the relevant interested parties, and
- their needs and expectations
for the same industry sector chosen in Activity 3

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Determine the
Scope of the QMS
Scope will determine

•What is included or not included in the system
•What is considered internal or external
Determining the Scope
Customer The management of Plant A has to decide the scope

requires Plant
A to design &
manufacture
Plant A outsources the

Plant A outsources the logistics to the supply chain
design & development to function which operates a MS
the R&D function

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Risks and Opportunities
_ Risk
RISK
+ Opportunity
- Take actions
- Integrate and implement
actions into its QMS
- Evaluate the effectiveness

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Risks and Opportunities Register
QMS - Risk & Opportunity Register

Doc #: Rev #: Last Review Date:
1. Identify and analyse risk/opportunity affecting the intended output of the management system
2. Actions on risks include avoding risks, taking risk to pursue an opportunity, eliminating risk source, changing likelihood or consequence, sharing risk, retaining r
3. Actions on opportunities may include adoption of new practices, launching new products, opening new markets, addressing new clients, building partnerships, u
Leader :
Team Members : Initial RO
S ignificant? Y /N
Related
Internal/ Description
Rating
Risk Source or Current Control/
External of Risk/ R/O Consequence Action
No Cause Existing Situation
Issues or Opportunity
Requirements
= Consequences
RISK + Likelihood
Note: You already have R&O identified in
Activity 4. You can use them to develop the ISO9000:2015; Clause 3.7.9 (Note 4)
risk register.

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QMS and Its Processes
Determine processes
needed and their sequence:
- Management processes
- Operational processes
- Support processes
- Performance evaluation
and Improvement
processes
Business Process Map/Flow/Chart

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Example of Business Process Map

(Design and Manufacturing)

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Activity 9 – QMS Processes
Work in group, brainstorm and give examples of:

1) Management processes
2) Operational processes
3) Support processes
4) Performance evaluation and Improvement processes

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Introduction to
9 Process Approach
and Process Control

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What is a Process?
• An activity that receives inputs and converts them to outputs
• A QMS will have a network of linked processes hence output from
one process becomes input to another process
• Follows PDCA cycle to achieve the holistic management of the QMS
and its processes with an overall focus on risk-based thinking
• Have objective(s) to drive the process
• Each stage can be seen as a ‘Value Adding Transition’ to achieve
conformity to product / service and / or organization’s
requirements.
• Address risks and opportunities
Note: The key processes, with their lines of flow,

make up what we call the Business Process Map/Flow/Chart
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The “SIPOC” Way
Suppliers, Inputs, Process, Outputs, Customers

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Detailed Analysis of a Process
Quality Policy è Quality Objectives è Customer Satisfaction & Conforming Products & Services
People Other Resources

• Roles, Responsibilities, • Infrastructure
Authorities • Environment for the operation of processes
• Competence • Monitoring & measuring resources
• Awareness • Organizational knowledge
• Communication
• Product/service
Output
Process
Input Risks & Opportunities • Interface with

• Actions to address Risks & next process
Opportunities integrated into the • Records
• Material/WIP • Nonconforming
• Interface with process
product/waste
previous • Documented • Performance indicators
process Risk & Opportunity
information of how • Performance evaluation
• Requirement/ Source
process works • Improvement
instruction Risk & Opportunity
Criteria & Method Performance Results Effect

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Activity 10 – Process Approach
Work in group, use the SIPOC approach to expand the

processes that you have identified in your previous activity
following the table and its content below:
No. Source(s) of Input Process Output Receiver(s) of
Inputs Outputs

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Establishing
11 Documented
Information

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Documentation Structure
Business Process Map

on a dashboard screen
with hyperlink to other
QUALITY Policy / Process Map documentation
MANUAL
WHAT is done,
WHO does it , and
OPERATING PROCEDURES WHEN
SUPPORT DOCUMENTATION
e.g. Work Instructions "HOW it is done"
Checklists
Drawings
NB: A 4th Level would be ‘Quality Records’
Traditional documentation structure vs. Modern structure

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Quality Management System Documentation

Format (1/2)
Before develop necessary documented

information, always ask the question:
Who needs these documents?
Therefore, the documents must be:

ü Understandable (in any language)
ü Easily identified and interpreted
ü Simple
ü Ensure available suitable for use

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Quality Management System Documentation

Format (2/2)
Organization can choose whether to create / retain the

documented information:
• manually or
• electronically
*Retained evidence shall be protected

from unintended alterations
- Uneditable version of softcopy
- Prohibition in using erasable pen in any

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Activity 11 – Documented Information
Work in group, identify 5 clauses in the ISO 9001:2015

Standard where the word “Documented Information”
appears. Explain why the documented information you have
identified are needed.

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Application and
11
Implementation of
Quality Management
System

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Application and Implementation (1/4)
Remember what had been planned?

Now is the time to try out the system through implementation
Implementation
means
“Do what you have planned”
“Walk the talk”

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• Conduct briefing on documented information (i.e plan,

procedure, work instruction) to all the departments before
official application and implementation
• Introduction of new procedures (departmental and
systems)
• How to use forms/checklists
• Briefing to all staff on

• Company Quality Policy, and
• Quality Objectives

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• Ensure all retained documented information (previously

known as Record) formats are in place
• Distribute the official copies of the procedures, work
instructions and specifications
• Ensure that the necessary infrastructure have been
provided e.g. server, storage racks, filing cabinets,
documents stations

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• Communicate and deploy the quality policy and quality

objectives to all levels
• Implement performance monitoring tools to assess
performance against the quality objectives
• Analyze and evaluate data
• Implement corrective action and improvement programs

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Reviewing the Quality

11 Management System
Progress

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Reviewing The QMS
• Role of top management is to carry out systematic

evaluation of QMS:
Suitability Fits the organization, its operation, its

context
Adequacy Meets the requirements of the standard
and implemented appropriately
Effectiveness Achieving desired results
• Includes determining the need for action

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Evaluating Processes Within The QMS
• Ask the following questions in relation to every process

being evaluated:
ü Is the process identified and properly defined?
ü Are responsibilities and authorities assigned?
ü Are we addressing our risks and opportunities?
ü Are applicable documented information maintained and
implemented?
ü Are applicable documented information retained to show
evidence of activities are carried out as planned?
ü Is the process effective (and efficient)?
• Collective answers can determine result of evaluation

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REMINDER!
• For any changes to the quality management system, the

organization shall consider items mentioned in Clause 6.3 of
the Standard
• Changes are necessary → improvement
• No unauthorized changes are allowed

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Evaluating The QMS Progress
• Ask the following questions in relation to every process

being evaluated:
• Are we on time on the progress?
• Are the processes fully implemented in accordance with
the process-based approach and risk-based thinking?
• Evaluating the progress can be checked against the
Milestone Chart established.
• Status of the process can be checked during internal audit

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11
Preparing and Performing
Internal Audit

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Verification on the QMS
• The established quality management systems should be

verified (CHECK)
• Improvement can be made by following the PDCA cycle.

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Stages of Internal Audit
Audit programme establishment
Trained auditor(s) assigned - to individual audit Audit Preparation
Planning done : e.g. Talk to manager, Read documentation, Create

audit plan, Create trails, Create checklists
Hold Opening Meeting

Conducting An Audit
Actual audit : Follow trail, talk to staff concerned, (check previous
nonconformities/findings cleared)
Agree findings then write up:

- What is good
- Nonconformities/findings
- Observations/improvements
- Follow-up action
Reporting Findings
Closing Meeting : Present the findings and Follow-Up
Follow-up : Correction and Corrective action - performed and checked

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Auditor Selection
• Auditors must be selected and TRAINED

• Preferable with Technical and/or Operational
knowledge
• Understands the ISO 9001:2015
requirements
• Auditors to ensure objectivity and the
impartiality of the audit process

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11
Preparing and Performing
Management Review

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Fine Tuning the Quality Management System
The company quality management system is a LIVING

(dynamic) system.
Therefore, the system can be AMENDED/IMPROVED (ACT)

from time to time, but with adherence to the ISO 9001
requirements (Clause 6.3).

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Management Review
1. Top management shall review QMS at planned intervals

to ensure continued suitability, adequacy and
alignment with the strategic direction of the
organization.
2. Review must include assessment of:
a) Opportunities for improvement
b) Need for changes in:
i. QMS
ii. Quality policy
iii. Quality objectives

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Management Review Preparation
1. Agenda to be circulated
2. Members to prepare data or results for presentation
3. This includes key performance indexes, graphs or
statistical techniques
4. Ensure participation of Top Management

QMS22_CE1
Slide: 169
Conducting Management Review
Top Management shall review the essential inputs as

required by the Standard and conclude the decisions and
actions needed as the results of the Management Review
Clause Clause
9.3.2 9.3.3
Management Review

QMS22_CE1
Slide: 170
Activity 12 – Management Review
Work in group, list down 5 items that you think a

certification body auditor is likely to ask when auditing the
Top Management in regards to Management Review.
Determine what audit evidence for each of the check item
you would want to show the auditor.

QMS22_CE1
Slide: 171
Summary and
11 End of Course

QMS22_CE1
Slide: 172
Summary (1/2)
1. Organization needs to understand its organizational context;
determining the external and internal issues, needs and
expectation of interested parties for business strategic
planning in achieving the intended results of the QMS.
2. Determine and manage its risks and opportunities; removal
of “Preventive Action”.
3. Emphasis on “Organizational Knowledge” and “Prevention of
Human Error”.
4. Enhanced top management leadership role in taking
accountability for the effectiveness of the QMS.

QMS22_CE1
Slide: 173
Summary (2/2)
5. Top Management to promote and use the process-based
approach and risk-based thinking in planning the QMS to
achieve the intended results
6. Quality Manual and Management Representative are no
longer a requirement. However, the organization can choose
to retain them with the understanding that the Top
Management shall be the person accountable to the
effectiveness of the QMS
7. Create timeline to track the progress of establishment and
implementation of QMS

QMS22_CE1
Slide: 174
Q&A
Session

QMS22_CE1
Slide: 175
~ END OF COURSE ~
THANK YOU FOR CHOOSING
NEVILLE CLARKE


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ISO 9001:2015

Global Partner for Business Success

Global Partner for Business Success

Introduction & Housekeeping

§ Name cards – write your name as you wish to be referred on

Except in case of emergency, delegates are requested to

Global Partner for Business Success

To provide delegates with the following knowledge:

Global Partner for Business Success

Time table (Day 1)

Time table (Day 2)

Global Partner for Business Success

The ISO 9001

Global Partner for Business Success

The ISO 9001 Evolution

• Evolution of the ISO 9001

Global Partner for Business Success

Evolution of ISO 9001 Standard

2015 Risk-Based Thinking

1987 Quality system

Global Partner for Business Success

ISO 9000 Series

Standard Title Remark

Global Partner for Business Success

Rationale for the revision

Three Pillars of Sustainable Development

Dissemination of Alleviating poverty

Life cycle analysis & Worker protection

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Standards supporting the three pillars

Consistent and aligned? à the need for Annex SL

Global Partner for Business Success

Main changes from previous version

Global Partner for Business Success

Understanding the New Structure, Terminology

• High level structure (Annex SL)

Global Partner for Business Success

Global Partner for Business Success

The Intent of Annex SL

• Consistency and alignment of all Management System

Same overall “look” & “feel”

Global Partner for Business Success

High Level Structure

Global Partner for Business Success

Introduction 7. Support Identical Core Text

8. Operation Identical Core Text

Global Partner for Business Success

Global Partner for Business Success

Major differences in terminology

ISO 9001:2015 ISO 9001:2008

Externally provided products and services Purchased product [inclusive of outsourced

Not used Exclusions (to scope)

Environment for the operation of processes Work environment

External provider Supplier

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Some New Terms and Definitions

3.7.9 *Risk 3.6.6 Statutory requirement

*Terms not previously used

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Verbal forms used in ISO 9001:2015

“Should” indicates a recommendation

“May” indicates a permission