Quality Management Present and Future

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Quality Management –

Present and Future

Nigel H Croft

Chairman, ISO/TC176/SC2 – Quality Systems Chairman, ISO/TC176/SC2 – Quality Systems

Member, ISO/TC176 Chairman’s Strategic Advisory Group Member, ISO/CASCO Chairman’s Policy Committee

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OBJECTIVES

Present the latest developments in the ISO

9000 family, and plans for the future

Present APCER’s Interpretation Guide for

ISO 9001:2008;

Present the main results of the 2008 ISO

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Part 1

Latest developments in the

ISO 9000 family, and

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Overall Scenario of TC176

Development of generic QMS standards that have

broad application:

all market sectors

both private and public organizations

+/- 1,000,000 worldwide certifications to ISO 9001

Other guidelines produced by ISO/TC 176 assist

organizations in improving their quality management

processes.

ISO 9000

ISO 9004

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ISO/TC 176

CSAG

CALG

Automotive TG Spanish Trans TG

ISO 9001

ISO 9004

& others

SC 1

SC 2

SC 3

WG1 WG2 WG3 WG18 WG1 WG6 JWG Automotive TG Interpretations WG Arabic Trans TG

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SC2 Organizational Environment….

Technical Management Board ISO/ CASCO International Accreditation Forum ISO Central Secretariat SC2 SC1 SC3 TC176 JTCG* / Other TC’s P-members, Liaisons, Experts * Joint Technical

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Relationship with TC176…..

Participate actively in strategy development

via CSAG

TC176 Strategic Plan

TC176 “Portfolio”

Commit to deploy TC176 policies and

strategies via active participation in TCOG

Liaison with other SC’s

Liaison with other organizations outside of TC176

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Relationship with other TC’s

Joint Technical Coordination Group has made

considerable progress:

Establishing a joint vision for management system standards Developing a high level structure for all ISO management

systems standards

Identifying identical sub-clause titles under the high level

structure

Developing a draft generic core vocabulary for management

system standards

Initiating the revision of ISO 19011 into a generic guideline for

auditing all types of (non-financial) management systems

Next meeting in Buenos Aires May 3rd – 7th 2010

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Current SC2 Portfolio and

“Ecosystem”

ISO 9004 Support packages Small Business Auditing Practices Group ISO 10005 ISO 10006 ISO 10007 ISO 9001 Interpretations Small Business Handbook IWA’s Sector standards

(ISO and non-ISO) ISO/TS 16949

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The story so far……

1960’s – Defence, nuclear standards on Quality 1979 - BS 5750

1987 – ISO 9000 series

1990 – TC176 Strategic Plan “Vision 2000” 1994 – Revision to ISO 9000 series

1996 – ISO 14000 series published

2000 – Major revision of ISO 9000 family

2002 – TC176 Strategic Plan “Horizon 2010” 2004 – Revision to ISO 14001

2005 – Small revision to ISO 9000

2008 – Small revision (“amendment”) to ISO 9001 2009 – Significant changes to ISO 9004

2010 – New strategic plans being developed (TC176 and

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ISO 9001:2008

Primary objectives were:

to improve the existing ISO 9001:2000 standard;

to provide greater clarity and ease of use,

to improve compatibility with ISO 14001:2004

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Main changes in ISO 9001:2008

“No new requirements” (at the “macro-level”)

Changes to the wording of some clauses

(“Micro-level”)

Organizations should revisit their QMS to check if

better understanding leads to a need for change.

The changes are small, but they provide BIG

OPPORTUNITIES for organizations to take a step

back & look at the overall effectiveness of their

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Key inputs for ISO 9001:2008

Web based User Feedback Survey

conducted by ISO/TC 176/SC2

ISO/TC 176 approved interpretations

See

www.tc176.org/

for details

See

www.tc176.org/

for details

Some interpretation requests indicated need for

clarification of ISO 9001 text

The ISO 9001:2000 Introduction & Support

Package set of documents (

www.iso.org

)

ISO 14001:2004

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Impacts and benefits

Changes introduced in ISO 9001:2008

focused on high benefit / low impact cases

Some high benefit / high impact

improvements that were identified are being

saved for the next revision cycle

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Impact analysis

Impact Benefits

1 2 3

High Medium Low

1 Low 1 2 3

2 Medium 2 4 6

3 High * 3 6 9

1-2 Incorporate the change.

3-4 Additional analysis should be conducted prior to making the decision.

6-9 Do not incorporate the change.

Note: ‘*3 - high impact x high benefits’ - No change allowed, but we need to record details of proposed change, to provide input into future revisions .

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Implications of ISO 9001:2008

Changes were very small (but not “trivial”)

Some changes could not be incorporated due

to potentially large impact

TC176/SC2 formed Task Group to look at “Future

Concepts for possible incorporation into ISO

9001”

Long-term Strategic Planning for ISO/TC176

and TC176/SC2 underway, looking at entire

portfolio and “architecture”

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SC2 Task Group on “Future Concepts

for ISO 9001” now looking at……….

Integration of risk management

Enhanced focus on product conformance

Financial resources of the organization

Maintenance of infrastructure

Alignment with business management/

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Other concepts for possible

inclusion / enhancement

Process Management

Knowledge management

Results/Improvement/Effectiveness

Life cycle management (LCM)

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Other concepts for possible

inclusion / enhancement

Competence

Supply Chain Management (and

Outsourcing)

Use of Quality Tools

Communication

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Other concepts for possible

inclusion / enhancement

Structure of QMS and Relationship with Work

of JTCG

“Time/Speed/Agility” and Related Aspects

Impact of Technology and Changes in

Information Management

Role of Top Management in the QMS

Expanding the concept of Customer

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ISO 9004:2009

Very different from ISO 9004:2000, both in structure and

content.

Basis is still the eight quality principles but with additional

ideas incorporated:

Vision/mission/strategy development, innovation and learning.

‘Guidelines for self-assessment’ have evolved into a

‘Self-assessment tool’ (Annex A).

Guidance on two levels: one for top management and the other

at an operational level.

Risks are treated in a more visible way than before.

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Some topics addressed in ISO

9004:2009

Understanding organization’s business environment

Strategic management

Strategic planning

Mission, Vision, Policy and Objectives

Risk management

Knowledge management

Natural resources and life-cycle management

Key performance indicators

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Relation between ISO 9001 and ISO 9004

Sustained

success

Effective

And

Maturity

ISO 9004

(“Stepping stones”)

And

Efficient

Effective

Customers “All interested parties”

(“Stepping stones”)

ISO 9001

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Messages I’m hearing about

ISO 9001…..

From many users……

“We want NO CHANGE”

From High-tech (high risk) and/or mature users……….

“We want MORE!” (“We want to show we’re “BETTER!”)

From Low-tech (Low risk) and/or immature users and SME’s* From Low-tech (Low risk) and/or immature users and SME’s*

“We want LESS!” (“We want an easier option”)

* NOTE – I don’t agree that this is a function of SIZE

From the “Future Concepts for ISO 9001” TG

“Risk Management” ; “Output matters” etc

From the TC Chair

“CMM”!

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My personal ideas for ISO 9001 and

**ISO 9004 over the next 10 years*…..**

ISO 9001:2008

(Small changes)

ISO 9001:201x Part 2

(Relatively small changes)

ISO 9001:201x Part 1 (“Big”changes/ reductions ) ISO 9001:202x Parts 1, 2 & 3 (Small changes) * Still to be discussed and agreed within TC176/SC2! ISO 9004:2009

(Big changes) ISO 9004:201x

(Small (or no) changes)

ISO 9001:201x Part 3

(“Big” changes)

ISO 9004:202x

(Big changes) (Small changes)

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ISO 9001:201x

Part 1

Would be aimed at low-risk / low criticality organizations Many SME’s will come into this category (but not

necessarily!)

Part 2

“Default” – would be a continuation of ISO 9001:2008 with

relatively small changes

Basis for regulatory requirements, sector schemes etc

Part 3

Would be aimed at high-risk / high criticality organizations Plus mature organizations seeking a “differential”

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Possible additions for ISO

9001:201x Part 3

Long-term strategic planning

Organizational environment/Mission/Vision

Policy deployment

Extra focus on resource management

More use of statistical methods

Systematic problem solving

Customer satisfaction measurement

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Pro’s and con’s

Pro’s

Re-aligned revision dates (but “out of phase”) allows for “beta-testing” using ISO 9004

Allows for differentiation (step towards CMM-type). Customers

Con’s

Potential to confuse the market Possibility of devaluing existing

“product”

Perceived to be a return to the old towards CMM-type). Customers

decide which is required! Opportunity to re-gain lost

confidence in certification (Avoid repeating mistakes of past,

particularly re “Part 3”)

Continuity provided in “Part 2” Introduce new audience to ISO

9001 (“Part 1”- entry level)

“ISO 9001/2/3” – IT’S NOTNOT!!

A lot more work for SC2!!

Could be perceived as “favouring consultants and CB’s”

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High-Level Timing for ISO 9001

Systematic Review Justification Study Standards Drafting Process Design Specification Publication 3 Years 9 Mos. 3 Mos.

6 Mos. 3 Mos. 9 Mos. 3 Years 6 Mos. 2015?? 2012 2011 Q1/Q2 End 2010 SC2 Strategic Plan TG Concept Papers TC 176 Strategic JTCG Work

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Other things happening in

TC176…..

Guidance documents for ISO 9004:2009 out

for comment – to be published mid-2010

ISO 9001 Small Business Handbook recently

updated

ISO 19011 being revised (includes other

management systems)

ISO/TS 10004 in preparation (Guidelines for

monitoring and measuring Customer

Satisfaction)

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Part 2

Presentation of the APCER

Interpretation Guide for

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APCER - ISO 9001:2008

Interpretation Guide

Aim of the guide:

To provide a common platform for organizations,

consultants, trainers, and auditors to understand:

Intent of each clause of ISO 9001

Interpretation of the clause

Typical evidence that might be expected in order to

demonstrate conformity

To highlight the changes and opportunities introduced

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Contents of the interpretation

guide……….

Background to the development of ISO 9001:2008

Inputs

Design specification

Concept of “benefit versus impact”

Focus on high benefit / low impact for 2008 Focus on high benefit / low impact for 2008

Details of other standards and guides produced by

ISO/TC176

The role of CT80 in Portugal

Use of the 8 QMP’s, and PDCA Cycle

Clause-by-clause analysis of ISO 9001:2008, with

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Clause 0.1

Clause 0.1 now refers to the organizational environment, changes in that environment and associated risks.

Check to ensure that your QMS continues to be relevant

to the changing business environment in which you are

operating.

As you grow, your situation may change — new technologies,

market opportunities, consumer demands, threats etc.

Is the level of detail of your QMS and associated processes still

appropriate to the risks involved in your activities?

In the current financial climate, you should be looking to your

QMS to guide you through troubled times

Ensure that despite cutbacks etc, your product or service quality

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Clause 0.2

Text added to clause 0.2 to emphasize the importance of processes being capable of achieving desired outcomes.

Probably one of the most subtle but important changes

introduced in the new standard.

Emphasizes that the QMS should be achieving its primary

objective - “consistent, conforming products”

Did we all forget this??

Too much focus on documents and records, rather than on managing

processes to achieve desired results.

Take a long, hard look – is your system really producing the desired

outcomes for you, your customers, and your employees? If not, then why not? What needs to be changed?

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Clause 4.1

Clause 4.1 (e) now clarifies that process measurement may not be applicable in all cases (though all processes must be monitored).

Do you know the difference between monitoring and

measuring?

In some cases, you may have been induced by consultants

and/or auditors to come up with process measurements that are not practical, meaningful or useful, simply because ISO 9001 was understood to require them.

You might wish to re-evaluate the need for such

measurements, and to ensure that any measurements

that are necessary really do add value to your

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Clause 4.1

Notes have been added to explain more about outsourcing – what is meant by an “outsourced process” and what controls might be appropriate

Review the way you manage your outsourced

processes…………...

Are they being carried out in line with the requirements of ISO

9001:2008?

Can you introduce greater efficiencies by considering alternate

sourcing or imposing more meaningful monitoring initiatives?

Are there any indications of customer dissatisfaction with these

processes?

Could you benefit from outsourcing other processes?

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Clause 6.2

ISO 9001:2008 makes an important clarification that competence requirements relate not only to personnel whose work directly affects product quality, but also where it indirectly affects product quality via the operation of the QMS (e.g. purchasing, supplier evaluations, internal audits etc).

If you have previously limited your attention to

competence requirements for personnel directly involved

in production or service delivery processes, you should

assess where you may need to include other activities

such as those mentioned above, among others.

This might mean an extra work-load in the short-term,

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Clause 6.3

This clause now recognizes the importance of information technology (IT) in modern organizations and the effect that information systems can have on product conformity.

Not a new requirement, but the specific inclusion of IT as

an example of infrastructure provides you with an

opportunity to review your dependence on IT

Risk analysis of potential problems should a failure occur (system

crash, computer virus, loss of confidential data, file corruption etc).

No requirement to use IT in your QMS (many

organizations can operate quite effectively without it), but

where it is used, the risks must be understood and

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Clause 7.1

ISO 9001:2008 now strengthens the requirement for product realization planning to include measurement (as appropriate).

Need to think about and define what measurements you

need to make in order to ensure control over your

processes and conformity of the resulting product.

All processes have to be monitored, but it is not always feasible,

meaningful or cost-effective to establish measurements for everything.

Think about the reasons measurements might be needed (eg for

evidence of conformity to requirements, or to provide process control data for subsequent action) and the potential

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Clause 7.2.1

The standard now clarifies that post-delivery activities may include actions under warranty provisions, contractual obligations such as maintenance services, and supplementary services such as recycling or final disposal.

Need to think about the whole range of characteristics of your

product that can affect customer satisfaction.

These might include characteristics that are not “traditionally” identified These might include characteristics that are not “traditionally” identified

as being related to “product quality.”

As global environmental awareness increases, considerations such

as unnecessary packaging or end-of-life product disposal

(particularly for electronic and electrical items) become a concern

Take a positive and proactive approach to these issues, and you will not

only be meeting the intent of ISO 9001:2008 – you may be able to use them as a strategic marketing tool to gain an advantage over your

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Clause 8.2.2

This clause now expects management responsible for the area being audited to ensure that both correction and corrective actions are addressed as

appropriate with respect to detected nonconformities.

You must consider the need for correction of detected

nonconformities and recognize that it might not be

necessary or appropriate to take corrective action for all

nonconformities found during internal audits.

After a root cause analysis of the situation — and based on a

number of factors, including the risk and probability of a recurrence — you might decide that it’s sufficient simply to correct the problem, without the need for corrective action.

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Clause 8.5.2 & 8.5.3

The standard now makes it clear that it is the effectiveness of the corrective and preventive action that must be reviewed, not just the action itself.

You need to look carefully at the actions you

have initiated, and to make sure they are

achieving the intended results.

If the actions are to address specific real or

potential nonconformities (in product, process or

the quality management system), have they

successfully eliminated (or significantly reduced)

the problem or risk?

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Implications

“Transition” to ISO 9001:2008 should be very simple, but

not “automatic”

Organizations should take advantage of the changes to

re-assess the value of their QMS and make the most of

this BIG OPPORTUNITY

Is the QMS really delivering on its promise of “consistent,

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Part 3

Results of the 2008 ISO Survey

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ISO Survey 2008

Carried out by A.C. Nielsen on behalf of ISO

Survey based on data from Dec 31

st

2008

Survey now covers the following standards….

ISO 9001:2000/2008 (QMS)

ISO 14001:2004 (EMS)

ISO/TS 16949:2002 (Automotive)

ISO 13485:2003 (Medical devices)

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ISO Survey 2008

Summary is available for free download from

www.iso.org

More detailed breakdown of results, including

brochure & CD-ROM is available for

purchase from ISO

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Corrections to 2007 data

Correction of previous “over-counting” has

resulted in some distortions in 2008 survey

Data now collected directly from CB’s to eliminate

“multiple counting” of same cert

Result is that some countries have an

apparent REDUCTION in number of certs for

ISO 9001

Japan (-13 527)

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ISO Survey 2008…………

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Comparisons (ISO 9001)…..

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ISO Survey 2008…………

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Other standards……

Standard Certs Countries % Increase

2008 / 2007

ISO/TS16949 39 320 81(Largest are China, USA, Korea)

11.7%

ISO 13485 13 234 88 (Largest are Germany, USA, China)

1.9%

ISO 27001 9 246 82 (Largest are Japan, India, UK)

20.0%

ISO 22000 8 206 112 (Largest are Turkey, Greece, India)

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