TRANSITION TO ISO

9001:2015

ISO Briefing
Part 2

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Q. Why is the norm being revised?

ISO survey and ISO directive

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Transition to ISO 9001:2015

Aims of the revision
• A solid framework for 10 years – the norm should provide
a stable set of core requirements for the next ten years
• General approach – that is nevertheless relevant to
organizations of all sizes and types, across all industries and
sectors
• Process management – the current focus on effective
process management should be maintained
• Structural compatibility with ISO 14001 etc.- Structured
according to Annex SL to the ISO Directive including text
elements and definitions
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Transition to ISO 9001:2015

Aims of the revision
• Simplification
– Implementation in organizations and effective conformity
assessment
– Language, to aid understanding and ensure the consistent
interpretation of requirements
• Taking account of changes
– In QMS practices and technology since the last major revision (in
2000)
– In organizational working environments, which have become
increasingly complex and dynamic
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What is ISO 9001-2015

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What is QMS
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Transition to ISO 9001:2015

Major differences in Terminology
ISO 9001:2008
Products
Exclusions
Management representative
Documentation, Quality Manual,
documented Procedures and Records
ISO 9001-2015
PRODUCTS & SERVICES
Not used, instead APPLICABILITY of requirements (due
to size of the organization, the management mode it
adopts, the range of the organization’s activities, and the
nature of the risks and opportunities it encounters)
Not used (similar responsibilities and authorities are
assigned but no requirement for a single management
representative
DOCUMENTED INFORMATION

WORK ENVIRONMENT ENVIRONMENT FOR THE OPERATION OF

PROCESSES

Monitoring and measuring equipment Monitoring and measuring resources

PURCHASED PRODUCT EXTERNALLY PROVIDED PRODUCTS AND

SERVICES

SUPPLIER EXTERNAL PROVIDER


New Structure, terminology
and concepts
Risk-based Thinking
•Organization is required to
understand its context (4.1) and
determine the risks and
opportunities that need to be
addressed (6.1)
•Since the key purpose of the
QMS is to act as preventive tool.
Consequently there is no separate
clause of sub-clause titled
“Preventive Action”
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•Concept of preventive action is
expressed through a risk-based
approach in formulating QMS
requirements
•Prescriptive requirements was
reduced and replaced by
performance-based requirements
•There is no formal requirement or
documented risk management
process
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Transition to ISO 9001:2015

Quality Management Principles
ISO 9001:2008 ISO 9001-2015

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) Improvement 5) Continual Improvement

6) Evidence-based Decision Making 6) Factual approach to Decision-Making

7) Relationship Management 7) Mutually Beneficial Supplier Relationship

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Transition to ISO 9001:2015

Structure of ISO 9001 standard
2015 version 2008 version

Introduction Introduction

0.1 General 0.1 General

0.2 Quality Management Principles 0.2 Process Approach

0.3 Process Approach 0.3 Relationship with ISO 9004

0.3.1 General 0.4 Compatibility with other management systems

0.3.2 Plan-do-check-act-cycle

0.3.3 Risk-based thinking

0.4 Relationship with other management

system standards
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THANK YOU! 