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What changes are there Vision
in & Mission
ISO 9001:2015
Model of a process-based QMS:2015
Vision & Mission
Model of a process-based QMS:2015
Vision & Mission
 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 the service organizations
 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:
1.Understanding the organization and its context
2.Understanding the needs and expectations of interested
parties
 Key Changes in ISO
No.
9001:2015
ISO 9001:2008 No. ISO 9001:2015
0 Introduction 0 Introduction
1 Scope 1 Scope
2 Normative Reference 2 Normative Reference
3 Terms and Definitions 3 Terms and Definitions
4 Quality Management System 4 Context of the Organisation
5 Management Responsibility 5 Leadership
6 Resource Management 6 Planning
7 Product Realisation 7 Support
8 Operations
8 Measurement, Analysis and 9 Performance Evaluation
Improvement
10 Improvement
 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.
 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
 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
 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
 Where is risk addressed in ISO
9001:2015?
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
What should you do?
ISO 9001:2015 High Level Structure
ISO 9001:2015 High Level Structure
ISO 9001:2015 High Level Structure
ISO 9001:2015 High Level Structure
ISO 9001:2015 High Level Structure
ISO 9001:2015 High Level Structure
ISO 9001:2015 High Level Structure
ISO 9001:2015 High Level Structure
ISO 9001:2015 High Level Structure
ISO 9001:2015 High Level Structure
ISO 9001:2015 High Level Structure
ISO 9001:2015 High Level Structure
ISO 9001:2015 High Level Structure
ISO 9001:2015 High Level Structure
ISO 9001:2015 High Level Structure
ISO 9001:2015 High Level Structure
ISO 9001:2015 High Level Structure
ISO 9001:2015 High Level Structure
ISO 9001:2015 High Level Structure
ISO 9001:2015 High Level Structure
ISO 9001:2015 High Level Structure
ISO 9001:2015 High Level Structure
ISO 9001:2015 High Level Structure
ISO 9001:2015 High Level Structure
ISO 9001:2015 High Level Structure
ISO 9001:2015 High Level Structure
ISO 9001:2015 High Level Structure
ISO 9001:2015 High Level Structure
ISO 9001:2015 High Level Structure
THANK YOU

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