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 Who is QuEST Forum?

Global community of Service Providers, Suppliers & Liaisons

Jointly create, develop and share quality management standards,

best practices offerings and industry-leading resources

Develops & maintains TL 9000, an information and communication

technologies (ICT) industry quality management system standard
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 What Is ?
Created by the QuEST Forum

Globally recognized quality standard, designed to

improve communications products: hardware,
software and services

Built on ISO 9001 and the eight quality principles

Includes requirements for continual improvement,

customer satisfaction and reporting of industry
standard measurements
 QUEST FORUM ACADEMY
•Offers value to members and
prospective members by providing
educational opportunities
consistent with the intent of TL
9000 and the best practices
introduced at QuEST Forum’s
conferences.

•Provides a top-quality educational

system that supports quality and
process improvement focusing
upon the needs of the ICT industry.
 Insights into the new ISO
9001:2015
“Where It Is Today and 7 Things You Need
To Know Before Tomorrow”

QuEST Forum Webinar

August 26th 2015

Dr Nigel H Croft
Chair, ISO/TC176/SC2 (Quality Systems)

Aug 2015 7
 ISO 9001 – evolution, not
revolution!
 ISO 9001:1987/1994
 Prescriptive; clause-by-clause

 ISO 9001:2000/2008
 “Process Approach”, less documentation

 ISO 9001:2015
 Performance-based

 “Process + Risk-based thinking + PDCA”

 Forecast life-span till 2030!
Aug 2015 8
ISO Technical Committee TC 176
 “ISO” = International Organization for Standardization
 Confederation of National Standards Bodies
 Based in Geneva
 Standards development work is done by Technical /
Project Committees comprising experts nominated by
their national standards body or liaison organization.
 “TC 176” = Technical Committee Number 176 for Quality
Management and Quality Assurance
 “TC 176/SC 2” is the subcommittee responsible for ISO 9001
 QuEST Forum is a Liaison Member

Aug 2015 9
ISO/TC176/SC2 Mission
 To develop, maintain and support a portfolio of
products that enable organizations to improve their
performance and to benefit from the implementation of
a robust quality management system.
 To establish generic quality management system
requirements that provide the foundations to build
confidence in goods and services delivered
throughout the supply chain to organizations and
people worldwide.
 To provide guidance and support, where needed, to
ensure the continued credibility of our products.
Aug 2015 10
 ISO 9001
 “Specifies quality management system
requirements for organization to:
 demonstrate its ability to consistently provide
product that meets customer and applicable
regulatory requirements
 enhance customer satisfaction………”

An organization that demonstrates it is meeting these

requirements can then choose to be “ISO 9001
certified” by an independent certification body

Jan 2015 (c) TCA Global 2015 11

What is a “management system”?
 Formal definition.........
“set of interrelated or
interacting elements of an
organization to establish
policies and objectives, and
Hardware Software
processes to achieve those
(equipment) (methods)
objectives”
 In other words: Interact within processes
System should be results
focused
A “documented system” – Humanware
NOT a “system of (people)
documents”

(c) TCA Global 2015 12

 “Cause and effect”
“CONSISTENT,
Quality Management System CONFORMING
PRODUCTS”
Committed top management
Calibrated equipment
Competent people
Effectiveness =
“Ability to achieve
Monitoring & measurement Work instructions etc planned results”

Internal audits Documented procedures

Management review Etc etc etc

“POLLUTION PREVENTION,
Environmental Management System LEGAL REQTS, IMPROVED
ENV. PERFORMANCE ETC”

(c) TCA Global 2015 13

3 core concepts…………
 Identify the processes needed to achieve the
planned results
 Continually monitor the risks (“Risk-based
thinking”)
 Understanding “Cause and effect”
 Manage the processes and the system using
“PDCA”

(c) TCA Global 2015 14

 Act Plan
• How to improve • What to do?
next time? • How to do it?

Check Do
• Did things happen • Do what was
according to plan? planned

(c) TCA Global 2015 15

Change in focus
 Old (wrong!!):
 Correction
 Corrective action
 Preventive action
 “CAPA” is a good methodology, but the acronym is flawed!!
(Should be “PACA”??)
 New (correct!)
 Risk identification and mitigation (“prevention”)
 Containment
 Correction
 Corrective action (Needs ROOT CAUSE ANALYSIS!)
 Improvement (includes Kaizen, but also breakthrough
improvements, innovation etc)
(c) TCA Global 2015 16
Generic Process
How to carry out Process” – documented or not)
Extent of planning depends on RISK

DESIRED
INPUTS OUTPUTS CUSTOMER
“Set of interrelated
activities” (Internal or external)
“PRODUCT”
Other Interested
Parties
• Effect on Product conformance
• Environmental Aspects / Impacts
UNDESIRED OUTPUTS
• Health and Safety Risks
(“WASTE” / “POLLUTION” etc.)
• Social implications
• Energy usage
• Etc etc

MONITOR/MEASURE
(c) TCA Global 2015 17
Generic Process
How to carry out Process” – documented or not)

A
Extent of planning depends on RISK P
DESIRED
INPUTS OUTPUTS CUSTOMER
“Set of interrelated
activities” (Internal or external)
D “PRODUCT”
Other Interested
Parties
• Effect on Product conformance
• Environmental Aspects / Impacts
UNDESIRED OUTPUTS
• Health and Safety Risks
(“WASTE” / “POLLUTION” etc)
• Social implications
• Energy usage
• Etc etc

C MONITOR/MEASURE
(c) TCA Global 2015 18
System of processes
A P
C D
Input E
PROCESS E
AA PP Ouput E
CC DD
Input A Output A
PROCESS A

AA PP
Input C Input D
CC DD Ouput D
PROCESS C PROCESS D
Output C
AA PP AA PP
CC DD CC DD
Input B Output
PROCESS B B
AA PP
Output F
CC DD Internal Input F Internal
PROCESS F
Customer Customer
AA PP
CC DD Feedback

(c) TCA Global 2015 19

 Module 2

Harmonization of management
system standards

(c) TCA Global 2015 20

 Positioning of some ISO (and other) standards
Aerospace
I.T. Supply chain
ISO 27001 AS 9100
Service security
Telecomm ISO 20000
Information ISO 28001 Quality
TL 9000 Security (Reqts)
ISO 9001
Automotive Economic growth Food
ISO/TS 16949 Asset Safety
Environmental Mgt. Energy ISO 22000
(Reqts) Quality
ISO 55000 (Guidelines)
ISO 14001 ISO 50001
ISO 9004
Environmental (OHSAS 18001)
(Guidelines) Sustainable Future ISO 45001
Health &
Sustainable Safety
ISO 14004
Development Purchasing
ISO 18617 (SA 8000) Social resp.
ISO 14064
Environmental Social Requirements
integrity ISO 20121 responsibility
Greenhouse ISO 14067
Gas ISO 37001 Anti- ISO 26000 Social resp.
ISO 14046 bribery Guidance
Carbon
ISO 39001
Footprint ISO 14040 ISO 22301

July Water
2015 Sustainable(c) Nigel H Croft 2015 Business 21
footprint Life cycle events Road continuity
safety
Need for Alignment of
management system standards!
 ISO Joint Technical Coordination Group
(“JTCG”):
 Joint vision for management system standards
 High level structure for all ISO management systems
standards
 Identical sub-clause titles under the high level
structure
 Generic core vocabulary for management system
standards
 Aim is to make life easier for those who wish to
have a “single management system”
(c) TCA Global 2015 22
ISO Directives Part 1:2012 “Annex SL”

 Incorporates the recommendations of the JTCG

work
 Defines the common structure and format for all
new ISO management system standards and
revisions to existing standards
 Common text (approx 30% or more of each
standard will be identical text)
 Significant impact on revisions of ISO 9001 and
ISO 14001
(C) Nigel H Croft 2015 - All rights reserved 23
“Annex SL” High Level Structure
1. Scope 7. Support
2. Normative references • Resources
3. Terms and definitions • Competence
4. Context of the organization • Awareness
• Understanding the organization • Communication
and its context • Documented information
• Needs and expectations of 8. Operation
interested parties • Operational planning and control
• Determining the scope 9. Performance evaluation
• Management System • Monitoring, measurement,
5. Leadership analysis & evaluation
• Leadership and commitment • Internal audit
• Policy • Management review
• Roles, responsibility and 10. Improvement
authority • Non conformity and corrective
6. Planning action
• Actions to address risks & • Continual Improvement
opportunities
• Objectives and plans to achieve
them
(c) TCA Global 2015 24
 New “Matrix” structure of
Management System Standards
Core structure, format and text (“Annex SL”)
+

Increasing specificity
Quality (ISO 9001) Environment (ISO 14001) HSMS (ISO 45001) etc

Automotive Aerospace Telecomm Oil & Gas etc

BT Vodafone Verizon etc

Aug 2015 25
“7 things you need to know”
 New “Quality Management Principles”
 Customer Focus
 Leadership
 Engagement of people
 Process approach
 Improvement
 Evidence-based decision making
 Relationship management
These are the essence of ISO 9001:2015!!
(c) TCA Global 2015 26
Some changes to ISO 9001
 Complete reformatting to align with “Annex SL”
 “Products and services” instead of “product”
 More requirements for top (and other)
management
 “External provision of processes, products and
services” instead of “purchasing” – includes
outsourced processes
 “Documented information” instead of
“Documented procedures and records”
Aug 2015 27
Some new requirements...........

 New Clause 4.1 - “Context of the Organization”

 What are the external and internal factors that affect the
organization?
 Identification of “interested parties”
 Relevant needs and expectations of the relevant
Interested parties?
 Customer continues to be the primary (but not the
only!) interested party
 “Actions to address risks & opportunities”
 Guidance document available on [Link]
 Organizational knowledge (“lessons learned”)
 Actions to minimize human error
Aug 2015 28
Some “deleted” requirements.........

 Elimination of the term “preventive action”

 the concept still remains, and is actually reinforced
throughout the standard (by addressing “risk”)
 Elimination of specific (prescriptive)
requirements for
 A “Quality Manual”
 A “Management representative”

Aug 2015 29
Implementation guidance

 ISO 9001 Annex A provides clarification of

new structure, terminology and concepts for
ISO 9001:2015
 Work is underway to develop generic
implementation guidance for ISO 9001:2015
 to be numbered as ISO/TS 9002
 DTS (Draft Technical Specification) due out soon
 ISO/TC176 “Small Business Handbook” is also
being updated
Aug 2015 30
Transition to ISO 9001:2015
 Scheduled publication date September 15th 2015
 ISO/TC176, ISO/CASCO and IAF have approved a
3-year transition period
 All organizations are strongly encouraged to start
the transition as soon as possible
 Aim is to avoid “peak” of audits to the new standard near
end of transition period
 Avoid overload of CB resources

Aug 2015 31
 “7 things you need to do”
 Think about your current QMS – is it appropriate for your
organization’s context? Is it effective??
 Think about the relevant interested parties “beyond the
contractual customer”
 Start thinking “process + risk + PDCA”
 Discuss the new reinforced leadership requirements with
(all levels of) management
 Review all the requirements of ISO 9001:2015 proactively
(“How can it help us to improve??”
 Look out for ISO/TS 9002 (Implementation Guidance)
 Monitor what’s going on with the revision of TL 9000
(c) TCA Global 2015 32
 Conclusions
 ISO is aligning its portfolio of management system
standards
 Aim is to facilitate integration
 ISO 9001 is undergoing a “major revision”
 Scheduled publication Sept 15th 2015
 Significant changes in structure and clause sequence
 “Process Approach + PDCA + Risk-based thinking”
 Some new requirements
 TL 9000 revision is underway, due out Q3 2016
 Start preparing NOW!
(c) TCA Global 2015 33
 THANK YOU!
If you have further questions
please send them to
[Link]

(c) TCA Global 2015 34

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Answers
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