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ISO 9001:2015
Quality Management
Systems Foundation Course
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ISO 9001 i201 5

Quality Management
Systems Foundation Gourse
PARTICIPANT GUIDE
SAIGLOBAL LIMITED
Document Name. ISO 900'l QMS Foundation Course -"Participant Guide
Document lD: SAI-EDQN 9.01 08/15
Date of lssue. 1 August 2015
Condition of Use
O COPYRIGHT

SAIGLOBAL LIMITED

All rights reserved

This work is subject to copyright. No part of this work may be reproduced or

copied in any form or by any means (graphic, electronic or mechanical,
including photocopying, recording, taping or information retrieval systems)
without the written permission of SAI Global Limited ABN 67 050 611 642 or
as otherwise permitted by the operation of the law.

SAI Global Limited endeavours to ensure the accuracy of all information

contained herein and othenruise supplied. Advice or opinions given by SAI
Global in this publication or during the course of the relevant training provided
by SAI Global, represents the best judgement of SAI Global but (and to the
extent permitted by taw) SAI Global accepts no liability for any claims or
damages whether caused by its negligence (or that of any of its agents or
employees) or otherurise.

The user's attention is drawn to the provisions of the Trades Practices Act
(Commonwealth) '1974, as amended ("the Act'), which implies conditions and
warranties into certain contracts for the supply of goods and services. Where
such conditions and warranties are implied the liability of SAI Global shall be
limited, subject to the provisions of the Act, to the replacement or repair of
goods, or the supply of relevant goods or services.
CONTENTS
TRATNTNG W|THSAtGLOBAL..... ............ iii
COURSE OVERVIEW .......... vii
Module 1: Quality Management Systems - An lntroduction........ ..........1
Benefits of a Quality Management System ....................4
Activity 1 - Benefits of lmproving Quality Performance .............-,.....,5
ISO 9000 Series of Standards ....................7
Quality Management Principles ............... 10
Activity 2 - Quality Management Principles.. ................11
lnterested Parties ................. 13
Activity 3 - ldentifying lnterested Parties .....................14
Module 2: An ISO 9001 :2015 Based Quality Management System .....'17
Structure of the Standard ................ ...,..... 19
Annex SL Framework................. ..............21
ISO 9001 -Annex A: Clarification of New Structure, Terminology & Concepts. ..................,..22
Module 3: lntroduction, Scope, Normative References and Terms & Definitions2T
ISO 9001 :2015 lntroduction ....................29
Process Approach ...........,....30
Plan-Do-Check-Act Cyc1e........... ..............33
Activity4- ProcessApproach and PDCA ....................35
Risk Based Thinking...... .......39
Relationship to Other Management System Standards... ................41
Module 4: Context of the Organisation................
Understand the Organisation............. ......48
Understand Needs & Expectations of lnterested Parties.... .............49
Activity 5 - Context of the Organisation......... ,..........-..50
Determine the Scope of the Quality Management System ..............53
Quality Management System and its Processes .........54
Module 5: Section 5 - Leadership..... .............55
Leadership and Commitment............ .......57
Activity 6 - Leadership Requirements ............... ...........59
Quality Po1icy.......... ...........,,61
Activity 7 - Quality Policy.....,.... ...............62
Organisational Roles, Responsibilities and Authorities... ................65
Module 6: Section 6 - P1anning................ ..._..........67
Opportunities..................
Action to Address Risks and ....................70
Activity 8 - Risk Requirements................. ....................71
Quality Objectives and Planning ..............73
Activity 9 - Quality Objectives... ...............75
Planning Changes ................78

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 Module 7: Section 7 - Support ..................79
Resources ........81
Monitoring and Measuring Resources............,..... .......83
Activity 10 - Resource Management.......,........ ...........86
Competence and Awareness................ ....................... 89
Communication............... ....,.,..,.........,.....90
Documented lnformation.. ..,....,.......,-.......91
Activity 11 - No Documents? ..............,....93
Module 8: Section 8 - Operation............. ...........95
Operational Planning and Control. ...........97
Requirements for Products and Services ....................99
Design and Development of Products and Services .....................101
Control of Externally Provided Products and Services ..................104
Production and Service Provision .,........ 106
Activity 12 -Nonconformity Requirements........ .........111
Module 9: Section 9 - Performance Evaluation.. 113
Monitoring, Measurement, Analysis and Eva|uation.............,.. ......116
Activity 13 - Performance Evaluation ............ ...........121
Module 10: Section 10 - lmprovement..... 123
Activity 14 - lmprovement............ ..........127

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TRAINING WITH SAI GLOBAL
LEARNING THAT SUPPORTS BUSINESS NEEDS
SAI Global provides training services that address key business
management needs, including:

. Quality Management
. Occupational Health and Safety

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. Food Safety
. Risk, Compliance and Governance
and Business lmProvement
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NATIONALLY AND INTERNATIONALLY RECOGNISED TRAINING
SAI Global provides Nationally & Internationally recognised training. SAI Global
(RTO: 106919) is committed to the Australian Quality Framework for training
organisations, and able to deliver and assess against national competencies.
For further information about the SAI Global RTO please visit our training
website www. saiglobal.com/courses.

Here you can download the SAI Global Code of Practice which outlines our
commitment as an RTO:

. Administration and record keeping

. Access and equity
. Appeals process
. Assessment principles, methods and practices
. Certificates and statements of attainment
. Financial management
. Grievances and complaints
. Legislativecompliance
. Quality training and assessment policy
http://www. sa iq loba I. com/tra ninq/assurance/code-of-practice/
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 QUALIFICATIONS
Through SAI Global (RTO: 106919) you may gain a Qualification, such as a
Diploma or Advanced Diploma as part of the Australian Qualifications
Framework.

With a nationally recognised qualification under your belt, and your choice in a
number of management streams, we have the training you need to succeed at
each level of your organisation. From the best selling BSB51607 Diploma of
Quality Auditing to BS860407 Advanced Diploma of Management, SAI Global
has a range of qualifications to get you on track to learning.

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DO YOU HAVE SPECIFIC TRAINING NEEDS IN YOUR BUSINESS?

We can develop face-to-face or online training solutions for you

Need nationally and internationally recognised training?

Public Training - Face to Face

. Our public training runs all year round across Australia

. Venues in major capitals and some regional centres
, Gain knowledge, develop skills and build networks
. Training programs are delivered by qualified professionals and subject-
matter experts

Enjoying your training? Think there would be a benefit for more of your staff
to attend?

ln-house and customised training

. Address your team or company's specific skills gaps, challenges and

opportunities in the most appropriate format
. We'll come to youl Convenient training and/or coaching will be delivered
at a time and location convenient for your team
. Cost effective method for training groups of employees
. Receive the highest standards of specific shared learning and
understanding within your team
. Examples and context can be tailored to your organisation and industry
. Build a curriculum to meet your capability needs
. Ensure learning is aligned to your organisation's objectives

Contact Training Services on 1300 727 444 (Select Option #3) or email
trainingservices@saiglobal.com

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 We now offer many courses across OHS, Quality, Environmental
Management and Food Safety online!

Online Learning

. Employs best practice scenario based learning - put yourself in their

shoes
. Learn at your own pace from any computer
. Great for learning in remote areas
. Less downtime from work
. Many of our online courses can lead towards a qualification
. Tools and templates provided in many of our courses

lncorporate 360 degree learning

Blended Learning

. lncorporates a mixture of online and face-to-face

. Can provide a mix of theoretical knowledge that can then be applied ina
practical context in the classroom
. Reduces time
. Flexible learning

CONTACT SAI GLOBAL

Need help or further training support?
Online: www.saig lobal. com/courses
Phone: 1300727 444
Generalenquiries: training@saiglobal.com
!n-house enquiries: trainingservices@saiglobal.com

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COURSE OVERVIEW
PURPOSE
The course aims to provide students who have an existing basic knowledge
of, or experience in quality management, with an understanding of the

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. lnterpret the 'High Level Structure' approach to management systems
. Review the intent of ISO 9001 :2015
Lay a foundation of knowledge for quality management system
implementation based on ISO 9001

TARGET AUDIENCE
This course is designed for people who need to be familiar with the
requirements of the ISO 9001 standard such as but not limited to:
. Senior management
. Those considering implementing a new quality management system
. ISO 9001 auditors and quality practitioners
. Operations personnel
. Trainers and consultants

LEARNING OUTCOMES
Upon completion of this course, participants will be able to:
. Understand the purpose and benefits of a quality management system

' Have a greater understanding of the structure, content and the intent of
tso 9001
. Be able to explain the specific quality managemenlrelated requirements
of ISO 9001
. Be familiar with the terms and definitions used
. Have a greater understanding of the concept of the process model
. Through the use of the 'High Level Structure' identify the framework for a
generic management system

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 IN-CLASS ACTIVITIES
This course includes a range of in-class activities to help you apply your
knowledge of the standard.

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Activity 1 - ldentify benefits of improving quality performance.

Activity 2 - Match definitions to specific quality management principles

Activity 3 - Define the organisation's interested pafiies

Activity 4 - Process Approach and PDCA

Activity 5 - ldentify internal and external issues affecting the QMS for the
organisations specified

Activity 6 - ldentify the aspects of leadership and commitment with respect to

the quality management system

Activity 7 - ldentify purpose of a quality policy, then review and critique a

Quality Policy for BioGlobal

Activity 8 - ldentify areas of risk in your organisation and steps you would
take to mitigate them

Activity 9 - Devise quality objectives for BioGlobal

Activity 10 - Types of resources and their management

Activity 11 - ldentify alternatives to documents as a means of communicating

requirements

Activity 12 - ldentify how nonconformity requirement can be addressed in the

examples given

Activity 13 - Determine how an organisation monitors and measures quality

performance

Activity 14 - ldentify clauses of the standard on improvement

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PROGRAM MAP

Quality Management Systems

An lniroduction
-

An ISO 9001:2015.B€sed, Qu'a|lty

Management,:Systcm i ::,,,,,,,,

lntroduction, Scope, Normative References

and reim5 and D'cfii
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Context of the Organisation

Performance Evaluaiion

lmprovement

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 PROGRAM SCHEDULE

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Welcome and lntroductions 8.00 am - 8.30 am

: Module 1: Quality Management Systems - an lntroduction 8.30 am - 9.30 am

Module 2: An ISO 9001:2015 Based Quality Management System 9.30 am - '10.00 am

:10.00?m
Morning Break - 10.15 am
Module 3: lntroduction, Scope, Normative References and Terms
10.15am-11.00am
and Definitions

Module 4: Context of the Organisation 1 1.00 am - '1 1.30 am

Module 5: Leadership 11.30 am - 12.00 pm

L=E:n '12.00 pm -12;45'pm

Module 5: Leadership (cont..) 12.45 am - 1.15 pm

Module 6: Planning 1 .15 pm - 2.00 pm

Module 7: Support 2.00 pm -2.45 pm

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Afternoon Break pft u 3i00 pm'
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Module 8: Operation 3.00 pm - 3.45 pm

Module 9: Performance Evaluation 3.45 pm - 4.15 pm

Module 10 - lmprovement 4.15 pm - 4.45 pm

Wrap-Up and Course close 4.45 pm - 5.00 pm

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ICON REGISTER

COURSE NOTE
Where you see this icon, the associated text is a direct
quote from ISO 9001

LEARNING ACTIVITY
Where you see this icon, you are required to complete an
in-class activity

NOTES

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 INTRODUCTION
SAI Global is pleased to welcome you to this course and hopes it will meet
your learning expectations.

This is a one-day 'lSO 9001:2015 Foundation' training course provided by SAI

Global.

ln the introduction the trainer will review the course purpose and all aspects of
course administration, safety, use of cell phones and laptops, personal
messages and emergencies. You are encouraged to draw to his or her
attention any special needs you have regarding the location, meals, travel
arrangements or anything else which may concern you.

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