What changes will ISO 9001:2015

bring?

Introduction

This presentation will cover the following topics:

The ISO 9001 Revision Process
Key Inputs to ISO 9001:2015
The High Level Structure
Key Changes in ISO 9001:2015
Implementation of the HLS in ISO 9001:2015

ISO 9001 revision process

Key Inputs to ISO 9001:2015

ISO Mission
Develop high quality voluntary
International Standards:
Facilitate international exchange
of goods & services
Support sustainable and equitable
economic growth
Promote innovation
Protect health, safety and
environment

ISO Mission

Develop, maintain and support products* that enable organizations worldwide to improve
their performance by establishing generic QMS requirements providing guidance and
support.

* ISO 9000, ISO 9001, ISO 9004 & other guidance documents

Worldwide ISO 9001 survey

A worldwide ISO 9001 survey was conducted. The survey questioned what the most
important concepts were to follow for a successful QMS. The results were based on 6,299
answers and the top 6 concepts are as followed:
1.
2.
3.
4.
5.
6.

Integration of Risk Management

Resource Management
Systematic problem solving and learning
Voice of the customer
Knowledge management
Measures (examples are performance, satisfaction and ROI.)

Key Inputs

Set of stable requirements to last 10 years, 2015 until 2025.

Incentivate process approach and effective process management.
INPUT Process OUTPUT
Changes in practices to QMS and technology.
Facilitate implementation in any organisation.
Effective verification by first, second and third party organizations.
Simplified language and text
Quality Management Principles Process approach include concept of system
Simpler language for better understanding.

High Level Structure

Alignment of management systems standards

Identical titles and core text

Generic basic vocabulary

High-Level Structure Annex SL Common main structure, common sub-clauses common

terms and definitions

New Structure for Management Systems Standards

High Level Structure

High Level Structure

10

High Level Structure

11

Key Changes in ISO 9001:2015

Exclusions
No text for possible exclusions of requirements
Intent remains as per clause 1.2 of present standard
Leadership
Role of Management Representative eliminated
Quality policy / objectives compatible with strategic
direction
Integration of QMS requirements into business
processes
Goods and services
product goods and services
New term to make the standard more generic and
more applicable to service organizations

12

Key changes
Reduction of the prescriptive nature of some
Requirements
Monitoring and measuring equipment
Evidence of fitness for purpose
Development of goods and services
Processes for the development
Control of development processes
Development transfer
Necessary documented information
Context of the organization
Two new clauses:
4.1 Understanding the
organization and its
context
4.2 Understanding the needs
and expectations of
interested parties

13

Key changes
Significant changes
Process approach
New clause: Process approach
Determination of risk to conformity of goods
and services and to customer satisfaction
Knowledge as a resource
Determine the knowledge necessary for the operation of
the QMS and its processes
Knowledge shall be maintained, protected and made
available as necessary
Foresee the need for changes in knowledge and the risk of
not acquiring it in a planned and timely manner.

14

Key changes
Documented information
No mention of a Quality Manual
Outsourcing of goods and services
Control of external provision of goods and services
Risk-based approach to determine
type and scope of controls
Risk and preventive action
Key purpose of a management system is to act as
preventive tool
Risk-based thinking introduced in all clauses
* Risk = effect of uncertainty

15

What is risk-based thinking?

Something we all do automatically and often

Subconsciously
Concept of risk > always implicit in ISO 9001
Risk-based thinking
already part of process approach
makes preventive action part of the routine
Risk often seen as negative
Risk-based thinking can also help identify
opportunities = positive risk

16

Where is risk addressed in ISO 9001:2015?

Main objectives of ISO 9001:
To provide confidence in the organizations
ability to consistently provide customers with
conforming goods and services
To enhance customer satisfaction
The concept of risk relates to the
uncertainty in achieving those objectives

17

Where is risk addressed in ISO 9001:2015?

In Clause 4 > the
organization is required
to determine risks that
can affect its ability to
meet objectives

In Clause 5 > top

management are
required to commit to
ensuring Clause 4 is
followed

In Clause 6 > the

organization is required
to plan and take action
to address risks and
opportunities

In Clause 8 > the

organization is required
to have processes which
identify and address
risk in its operations

In Clause 9 > the

organization is required
to consider risks and
opportunities when
determining what
needs to be monitored,
measured, analyzed and
evaluated

In Clause 10 > the

organization is
required to improve
by responding to
changes in risk and
opportunities

18

What should you do?

19

Implementation of the High-Level Structure

20

Implementation of the High-Level Structure

21

Implementation of the High-Level Structure

22

Implementation of the High-Level Structure

23

Implementation of the High-Level Structure

24

Model of a process-based QMS

25

Single process within the system

26

ISO 9001:2015 High Level Structure

27

Leadership

28

Leadership

29

ISO 9001:2015 High Level Structure

30

Planning

31

Planning

32

ISO 9001:2015 High Level Structure

33

Support

34

Support

35

Support

36

Support

37

ISO 9001:2015 High Level Structure

38

Operation

39

Operation

40

Operation

41

Operation

42

Operation

43

Operation

44

Operation

45

ISO 9001:2015 High Level Structure

46

Performance evaluation

47

Performance evaluation

48

ISO 9001:2015 High Level Structure

49

ISO 9001:2015 High Level Structure

50

ISO 9001:2015 High Level Structure

51

Conclusions
More leadership and commitment from top management
Process approach as a requirement
Risk definition and management
Quality objectives at relevant functions, levels and Processes
Organizational knowledge as a resource
Documented information
Planned and controlled operation
Performance evaluation

52

It is not yet September 2015

This is not the final version ...
Some things can change ...
Hopefully the new standard will come out
right

53