AOQ QLD 18 March 2014 presentation by

Michael McLean FAICD, FAOQ, CMC, JM

Managing Director ,McLean Management Consultants Pty Ltd
E: michael@mclean-mc.com.au W: www.mclean-mc.com.au

ISO 9001:2015 CD
Intent, Renewal, Integration
and Sustainment
Updated and extracts post the 7 March 2014 Paris
meeting attended by QR-008 Australian
representative Alex Ezrakhovich
ISO/TC 176/SC 2/WG23 N063
1

Disclaimers
Verbal statements made by the presenter may
represent personal opinions and/or interpretations

ISO/TC 176/SC 2/WG23 N063

the presentation includes information related to

the revision process up to and including 18 March
2014
further changes are likely to occur as the revision
process progresses
you may wish to consider the changes as these
occur and plan accordingly
2
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Purpose of presentation

ISO/TC 176/SC 2/WG23 N063

To provide an overview of the revision of

ISO 9001 which will be published in Sept 2015.
Four areas covered:
Intent
Renewal
Integration and
Sustainment

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Background to this presentation

developed by the ISO sub-committee
responsible for communicating key information
about the current revisions to ISO 9001

ISO/TC 176/SC 2/WG23 N063

this will be updated as the revision progresses

this presentation is available to anyone

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ISO facts
ISO is the International Organization for
Standardization
ISO is based in Switzerland, over 160 nations participate
with approximately 20,000 standards
ISO/TC 176/SC 2/WG23 N063

all ISO standards are based on consensus

ISO standards are usually developed by Technical

Committees (TCs) or their sub-committees, or by
Project Committees
ISO work involves experts nominated by their
national standards bodies
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ISO 9001:2015 development process

an international ballot agreed the need for revision
there are several distinct stages when developing
an ISO standard; the key ones being:
1. Working Drafts (WDs)
ISO/TC 176/SC 2/WG23 N063

2. Committee Draft (CD)

3. Draft International Standard (DIS)
4. Final Draft International Standard (FDIS)
5. International Standard (IS)
The standard is published after approval of the FDIS by
participating national standards bodies and is reviewed at regular
intervals after then.
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Key perspectives
ISO 9001 needs to:
maintain relevance
integrate with other management systems

ISO/TC 176/SC 2/WG23 N063

provide an integrated approach to organizational

management

provide a consistent foundation for the next 10 years

reflect the increasingly complex environments in which
organizations operate

ensure the new standard reflects the needs of all potential

user groups
enhance an organization's ability to satisfy its customers
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What was considered?

the results of an extensive web-based user survey
the increasing diversity of ISO 9001 users

developments in knowledge and technologies

ISO/TC 176/SC 2/WG23 N063

broader user interests

changes in industry

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Main changes
an emphasis on risk-based thinking (appended)
increased emphasis on achieving value for the
organization and its customers

ISO/TC 176/SC 2/WG23 N063

increase flexibility on the use of documentation

more readily applicable by service type
organizations
avoids outcome to use output and results

customers remain the primary focus

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High level structure

a new common format has been developed for
use in all management system standards
standardized core text and structure

ISO/TC 176/SC 2/WG23 N063

standardized core definitions

Organizations implementing multiple management systems
(e.g. quality, environmental, information security) can achieve
better integration and easier implementation*
*ISO has an IMS Guidebook
http://www.iso.org/iso/home/store/publication_it
em.htm?pid=PUB100068

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ISO/TC 176/SC 2/WG23 N063

ISO 9001:2008 Management System Requirements

slight changes expected in ISO 9001:2015
Application of a System of Processes within an organization, together
with Identification and Interactions of these Processes, and then
Management is referred to the Process-approach
ISO 9001 focuses on the effectiveness of the QMS in meeting
Customer Requirements
The 8 Quality Management Principles* should be demonstrated and
Cascaded through the Organization by Top Management (* Draft ISO 9001:2015 may have 7)
The 6 Mandatory (shall) Procedures only need procedures where
instances are needed to define requirements for..
3rd Party Bodies can only certify what the organization documents to
meet the requirements of a standard, even its Clause based instead of
Process-based. Q: Both are Certified but which one is both compliant to
standard AND meets the needs of the business by Identification and
Interactions of these Processes?
A Clause based QMS

A Process-based QMS

AS9100 Quality Management System Manual

http://www.cgg.com/data/1/rec_docs/1771_GRP_
QPM_MNL_01E_GroupQualityManual.pdf

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A sample ISO 9001:2008 MS hierarchy

MANAGEMENT SYSTEM MANUAL:
oPOLICY
oPROCESS
oPROCESS OWNERS
oPROCESSES TO ISO MS STANDARD MATRIX
PROCESS PROCEDURES
oFLOWCHART; FMEA; PCP
oSTANDARD WORK - RACI
oIT / ICT / ERP LINKS

oWORK INSTRUCTIONS
oSTANDARD OPERATIONS SHEETS
oROUTING CARDS

REFERENCES

ISO/TC 176/SC 2/WG23 N063

DOCUMENTS & RECORDS

MARKETING
SALES
ORDER REVIEW

QUALITY ISO 9001

PURCHASING
INDUSTRY OR 2ND PARTY OEM STDS

PRODUCTION
INSPECTION
PERSONNEL

ACCOUNTS

CUSTOMERS SPECIFICATIONS & REQUIREMENTS

INDUSTRY STANDARDS & REGULATIONS
oAutomotive - TS 16949
oHealth ACHS; Food - HACCP
oRail IRIS Rev. 02.1; RCSA SDS
oOil & Gas API 653

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A sample IMS hierarchy

MANAGEMENT SYSTEM MANUAL:
oPOLICY
oPROCESS
oPROCESS OWNERS
oPROCESSES TO ISO MS STANDARD MATRIX
PROCESS PROCEDURES
oFLOWCHART; FMEA; PCP
oSTANDARD WORK - RACI
oIT / ICT / ERP LINKS
oWORK INSTRUCTIONS
oSTANDARD OPERATIONS SHEETS
oROUTING CARDS

WORK

ISO/TC 176/SC 2/WG23 N063

REFERENCES

DOCUMENTS & RECORDS

STRATEGIC PLANS
MARKETING
SALES
PRODUCT & SERVICE DESIGN
PRODUCTION
PROCUREMENT
HUMAN RESOURCES
ACCOUNTING AND FINANCE

QUALITY ISO 9001

ENVIRONMENTAL ISO 14001
RISK ISO 3100
AERO DEFENCE AS 9100C
SAFETY AS 4801 (ISO 18001)
INDUSTRY OR 2ND PARTY OEM STDS
CUSTOMERS SPECIFICATIONS & REQUIREMENTS
INDUSTRY STANDARDS & REGULATIONS
oAutomotive - TS 16949
oHealth ACHS; Food - HACCP
oRail IRIS Rev. 02.1; RCSA SDS
oOil & Gas API 653

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ISO 9001:2015CD Structure and Terminology

ISO/TC 176/SC 2/WG23 N063

The structure of clauses is intended to provide a

coherent presentation of requirements rather than a
model for documenting an organizations policies,
objectives and processes;
There is no requirement for the structure of the quality
management documentation or a quality manual to
mirror that of the standard.
There is no requirement for the terms used by an
organization to be replaced by the terms used in the
standard to specify quality management system
requirements (for example organizations can use
records, procedures, protocols, etc. rather than
documented information).
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ISO 9001:2015 CD Structure

1/3

1
2
3
4

Scope
Normative references
Terms and definitions
Context of the organization

context
interested parties
scope of QMS
quality management system

ISO/TC 176/SC 2/WG23 N063

Leadership

general
management commitment
policy
roles, responsibility and authority

The high level structure and

common text is public information
and can be found in Annex SL of
the www.iso.org/directives

Planning

actions to address risks and opportunities

objectives and plans to achieve them
planning of changes

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ISO 9001:2015 CD Structure

2/3

7 Support

resources
competence
awareness
communication
documented information

ISO/TC 176/SC 2/WG23 N063

8 Operation

operational planning and control

determination of market needs and interaction with customers
operational planning process
control of external provisions of products and services
development of products and services
production of goods and provision of services
release of products and services
non conforming products and services
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ISO 9001:2015 CD Structure

3/3

9 Performance evaluation

monitoring, measurement, analysis and evaluation

internal audit

management review

ISO/TC 176/SC 2/WG23 N063

10 Improvement

Non-conformity and corrective action

improvement

Draft 7 Management Principles

QMP 1 Customer Focus
QMP 2 Leadership
QMP 3 Engagement and Competence of People
QMP 4 Process Approach
QMP 5 Improvement
QMP 6 Evidence-based Decision Making
QMP 7 Relationship Management
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ISO Handbook for small businesses and the

ISO 9001:2008 Continual Improvement Model
Baking firm

ISO/TC 176/SC 2/WG23 N063

http://www.iso.org/iso/home/news_index/news_archive/news.htm?Refid=Ref1709

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ISO Handbook for

small businesses and
the ISO 9001:2008
Continual
Improvement Model
Baking firm

ISO/TC 176/SC 2/WG23 N063

http://www.iso.org/iso/home/news_index/ne
ws_archive/news.htm?Refid=Ref1709

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The APQC has Process Frameworks which many industries

can use to design a Process-approach Quality or IMS
(NB: Processes are described as Verb & Noun)

ISO/TC 176/SC 2/WG23 N0X63

www.apqc.org
http://www.accenture.com/SiteCollectionDocuments/P
DF/Accenture_Using_Process_Frameworks_and_
Reference_Models_to_Get_Real_Work_Done.pdf

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Some Problem Solving or Corrective

Action Methods?

ISO/TC 176/SC 2/WG23 N063

Organizations can select what PS method suits:

PDCA - Dr Shewhart 1927; ISO 9001
PDSA - Dr Deming (Ref: Quality or Else NBC 1990)
SDSA [Standardize, Do, Check, Act] Imai Kaizen
8D US Military ~1930s Ford Motor Coy
IDEA [Investigate, Decide, Evaluate, Action] Scientific
OODA [Observe, Orient, Decide, Act] - US Airforce
SREDIM [Select, Record, Examine, Develop, Install, Maintain] IE/Lean
DMAIC Six Sigma - Motorola US Patents Trade & Service Mark 1987

TRIZ IFR:SRSA Ideal Final State: State Problem, Restate, Search, Adapt
http://www.qualitydigest.com/inside/quality-insider-column/triz-developing-flow.html

Root Cause Analysis methods like:

Ishikawas Fishbone, Classification and Process Cause & Effect
TS 16949 & AS 9100c [System, Design , Process FMEA]; FMECA
Fault Tree Analysis

Statistical Process Control Dr Shewhart 1927

Bell Telephone

Stability (Control Chart Voice of Process) before Capability (Histogram, Cp, Cpk Voice of Customer)

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ISO/TC 176/SC 2/WG23 N063

Toyota and GM University: 5 Why Analysis in

Problem Solving - IE Handbook, Work Simplification / Work Study

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ISO 9001:2015 CD Documented

Information or Documents & Records

ISO/TC 176/SC 2/WG23 N063

While this is a change in terminology from ISO

9001:2008, the term documented information does
not need to be adopted within an organizations
quality management system.
Organizations can choose to use terms which suit
their operations and the changes introduced by the
use of new technology.

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ISO 9001:2015 CD Control of external

provision of products and services

ISO/TC 176/SC 2/WG23 N063

Clause 8.6 Control of external provision of products

and services addresses all forms of external
provision, whether it is by purchasing from a
supplier, through an arrangement with an associate
company, through the outsourcing of processes and
functions of the organization or by any other means.

There is no requirement for the organization to adopt

the use of the terms external provider or external
provision within their quality management system.
Organizations can choose to use terms which suit their
operations.

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Other important Information

The revision of ISO 9001 will impact on other
related standards and documents.
Expect changes to:
ISO/TC 176/SC 2/WG23 N063

- industry-specific standards
- supporting documents

- Only the word ensure will be used in

the standard
- Establish implement maintain will be used
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ISO/TC 176/SC 2/WG23 N063

I need to ensure my organization . . .

knows about the key changes i.e. risk in
processes
understands the key concepts
plan to implement the new requirements by the
required Process-approach management
system design not just changing the clauses
from ISO 9001:2008 or others MSs
stay informed as the revision proceeds
take full advantage ISO 9001 for meeting the
needs of the business and then the Standard
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ISO 9001:2015 CD Context of the

organization

ISO/TC 176/SC 2/WG23 N063

There is no requirement in the standard for the

organization to consider interested parties which are
not be relevant.
There is no requirement to address a particular
needs and expectations of relevant interested
parties if the organization considers that need and
expectation not to be relevant.
The organization may decide to accept some
additional requirements to satisfy interested parties
going beyond what is strictly required by the
standard.
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Supporting documents
certification transition plan and timeframe
comparison of ISO 9001:2008 and 9001:2015
guidance documents e.g. the process approach
ISO 9001:2008 Process-approach guide
ISO/TC 176/SC 2/WG23 N063

http://www.iso.org/iso/04_concept_and_use_of_the_process_approach_for_management_systems.pdf

ISO 9001:2015 CD and Process-approach and

extract of the only process in the CI Model
http://www.iso.org/iso/home/news_index/news_archive/news.htm?refid=Ref1633
Supplier
Input

ISO9001:2015
8: Operation
Processes

Process
Output
1

Value- and Non Value adding activities:

Product
& Services

Client or
Customer
Outcome i.e.
Satisfaction
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What is next?

ISO/TC 176/SC 2/WG23 N063

Updates will be made available as

the revision proceeds

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ISO 9001:2015 Timeline

2013

2014

2015

June 2013 CD
(Committee Draft)

ISO/TC 176/SC 2/WG23 N063

April 2014 DIS

(Draft International
Standard)

July 2015 FDIS

(Final Draft International
Standard)

September 2015
Published
International Standard
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ISO 9001:2015 Certification

Transition Timeline
2015

2016

2017

2018

ISO/TC 176/SC 2/WG23 N063

September 2015
Published International
Standard

September 2015 start of 3 years transition period

to September 2018

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Federal Government supports UKs SC21 Aerospace and Defence

supplier improvement programs through the Department of Industry
Enterprise Connect Business Excellence Model. It is used in all their
business reviews. They also assess organizations Manufacturing
Excellence against the 20 CI and Lean Tools.

ISO/TC 176/SC 2/WG23 N063

They can provide up to 3 tranches of $20,000 rebates for TAS

consulting services including implementing or up-grading internal
systems to ISO 9001:2015 plus 7 other interventions
http://www.enterpriseconnect.gov.au

The EC Endeavour Awards are held yearly for a range of business

excellence, transformation, innovation, new product innovations,
leadership and business transformations. Sponsored by Manufacturers
Monthly Magazine.
Enterprise Connect Client Stories like our client:
http://www.enterpriseconnect.gov.au/media/Pages/ClientJourneys/Manufacturing/RPC-Technologies.aspx
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ISO/TC 176/SC 2/WG23 N063

Business Excellence
Manufacturing Excellence
Supplier Continuous Improvement Program

Overview

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Enterprise Connect (EC) Sustainable Continuous Improvement

Program
Step 1
ENGAGEMENT

Step 2
DIAGNOSTIC

3 Months
Business group
formation

Step 3
SCIP + TAS
CONSULTANCY
8-10 Months

Quality certification

Continuous
Sustainable
Improvement Plan

+12 Months
Award metrics

Endeavour Awards

Business Excellence

ISO/TC 176/SC 2/WG23 N063

Step 4
RECOGNITION

Metrics alignment

Industry recognition

Manufacturing
Excellence
Relationships
Code
of practice

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EC Determining Business Excellence

The structure of the model emphasises not only what a
business is achieving (RESULTS for Interested Parties /
Stakeholders from ISO 9000.1:1994) but also how the
results are being achieved (ENABLERS).
Enablers

Results

ISO/TC 176/SC 2/WG23 N063

Leadership

People

Processes,
Products &
Services

People
Results

Strategy

Customer
Results

Partnerships
& Resources

Society
Results

Key Results

Learning, Creativity & Innovation

The 8 and likely 7 ISO 9001:2015 quality management principles can be found in:
EFQM BEM
NIST MBNQA USA
UAE BEM
PSB Singapore BEM
ABEF Australia
UK Department of Trade and Industry - SC21

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EC Manufacturing Excellence
Operational Excellence has been developed from TQM/CI/SPC/JIT/Lean
improvement tools, techniques & philosophies.
The SCIP objective is to embed CI/Lean wider and deeper than before.
Operational Excellence for both operational and strategic activities via:
A diagnostic (20 questions score 0-4 - 35% of total score) and
A management commitment review (65% of score).
Note: Enablers and Results originally from ISO 9000.1: 1994

ISO/TC 176/SC 2/WG23 N063

People
Solve
Problems
Job / Design
Standardisation

Visual Metrics
/ Boards

Materials

Processes

Enablers

Transform

Information

Process+ :
Approach

Flow / Value

8 Wastes ,
MUDA, MURI

Deployment

KANBAN

Set-up/SMED

Results

5S

ToC / TPM /
OEE

SPC / Quality Tools Process FMEA + [P] Control Plans

ISO9004:2011 Process Q + E + S + R Mgt System

Assessment &
Review
+ISO 9000.1:1994

Results

Improvement*

Stakeholders
Interested
Parties+:
trends

targets
comparisons
causes
scope

Improvement* - Organisations can use their ISO9001 CA; PDCA; ISO TS16949 PDSA ; SDCA Kaizen,
36
OODA, IDEA, TRIZ, SREDIM (Work Study/Simplification), 8D; Six Sigma DMAIC
Date: