S02 Standards, Principles and Definitions - 2017

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IRCA CERTIFIED ISO 9001:2015


AUDITOR/LEAD AUDITOR TRAINING
COURSE
(QUALITY MANAGEMENT SYSTEMS)
Section 2 - Standards, Principles & Definitions
To ensure that delegates from differing backgrounds, are all familiar
with baseline quality terminology. To list the 7 quality principles and
interrelationships of the applicable standards

QUALITY MANAGEMENT PRINCIPLES

Engagement
of People
Process
Leadership
Approach

Customer Relationship
Focus Management

Evidence-
Based
Improvement Management Decision
Making

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PRACTICE - QUALITY MANAGEMENT PRINCIPLES

Split in teams and study cl. 2.3 of ISO 9000:2015


Tutor assigns QM principles to your team
Pick a team leader(s) to present the gist of your assigned QM principle(s) to the rest of the group
Use any visuals that will help you – flipchart, PowerPoint, Prezi

ISO 9000 SERIES

ISO 9001:2015
QMS
ISO 9000:2015
Requirements Fundamentals
and Vocabulary

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ABOUT ISO 9001:2015

• Presents the requirements for a Quality Management Systems

• See cl. 1 Scope of ISO 9001:2015

ABOUT ISO 9000:2005

QMS Fundamentals and Vocabulary


Defines the QM Principles, the process approach
Provides definitions of the main terms used
Provides graphic representation of the interrelationship among various terms

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PDCA

Continuous Improvement
Plan Do

Act Check

Plan Do
Standard
Act Check

Consolidation through
Standard Standardization

ISO 9001:2015

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EVOLUTION OF QUALITY REQUIREMENTS

ISO 9000 series: 1987, 1994, 2000 and 2008

• Management of
To
functions and • Process management
manufacture and universal
application
From

ISO 9001:2015

Scope of Application of the Standard

-Applicable to companies of any type or size


-All requirements must be complied with
-Exclusions to the requirements are permitted only in clause 7. Product Realization
-All exclusions MUST be justified (required by cl. 4.2.2a)

Ref. Cl. 1.2

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TERMS & DEFINITIONS

COMMON TERMS AND DEFINITIONS - PRACTICE

Terms and definitions are in ISO 9000:2015

• Open up your copy of ISO 9000:2015


• Take turns to read out a definition
• Guess the term matching the definition
• Time limit is 15 minutes
• Try to cover as much as possible
• The person with the greatest number of correctly matched terms and definitions wins
• Wrong “match” will cost you points

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AUDITING PRACTICES AND CERTIFICATION SERVICES –


PRACTICE
ISO 19011
ISO 17021
Split in teams
Appoint a team leader
The tutor will appoint one of the standards above to you team
Draft a short presentation of your appointed standard’s:
• Scope and objectives
• Clause structure
• Main requirements

END OF SECTION 2

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