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WHATS’ NEW IN

ISO 9001:2015
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

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ISO 9001 revision process

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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

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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. Integration of Risk Management


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

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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.
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‘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

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‘High Level Structure’

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‘High Level Structure’

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‘High Level Structure’

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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

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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

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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.

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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

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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

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Where is risk addressed in ISO
9001:2015?
Main objectives of ISO 9001:

•“To provide confidence in the organization‟s


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

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Where is risk addressed in ISO 9001:2015?
In Clause 4 > the In Clause 8 > the
organization is required organization is required
to determine risks that to have processes which In Clause 10 > the
can affect its ability to identify and address organization is
meet objectives” risk in its operations required to improve
by responding to
changes in risk and
In Clause 5 > top opportunities
In Clause 9 > the
management are
organization is required
required to commit to
to consider risks and
ensuring Clause 4 is
opportunities when
followed
determining what
needs to be monitored,
measured, analyzed and
In Clause 6 > the evaluated
organization is required
to plan and take action
to address risks and
opportunities

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What should you do?
Implementation of the High-Level
Structure

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Implementation of the High-Level
Structure

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Implementation of the High-Level
Structure

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Implementation of the High-Level
Structure

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Implementation of the High-Level
Structure

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Model of a process-based QMS

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Single process within the system

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ISO 9001:2015 High Level Structure

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Leadership

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Leadership

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ISO 9001:2015 High Level Structure

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Planning

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Planning

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ISO 9001:2015 High Level Structure

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Support

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Support

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Support

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Support

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ISO 9001:2015 High Level Structure

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Operation

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Operation

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Operation

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Operation

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Operation

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Operation

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Operation

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ISO 9001:2015 High Level Structure

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Performance evaluation

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Performance evaluation

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ISO 9001:2015 High Level Structure

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ISO 9001:2015 High Level Structure

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ISO 9001:2015 High Level Structure

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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

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