ISO 9001:2008 Small Changes, BIG OPPORTUNITIES 9001:2008 ± Small Changes, BIG OPPORTUNITIES ... in...

April 2009 (c) Nigel H Croft 1

ISO 9001:2008

Small Changes,

BIG OPPORTUNITIES

Nigel H Croft

Founding Co-chairman, ISO 9000 Advisory Group

Co-Convenor TC176 Conformity Assessment Liaison Group

ISO/TC176 liaison representative to ISO/CASCO

Member, IAF/ILAC/ISO Joint Working Group

Member, ISO/IAF Auditing Practices Group

Small

Aim of the book:

To provide a common platform for organizations,

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

in the ISO 9001:2008 version

To explain some common misunderstandings



Management System

set of

interrelated or

interacting elements

to

establish policy and

objectives

and to

achieve those

objectives

Hardware

(equipment)

Software

(methods)

Humanware

(people)

Interact within processes


ISO 9001 Scope

Clause 1.1 -

requirements for organization to:

demonstrate ability to consistently provide product that

meets customer and applicable regulatory requirements

ISO 14001 and OHSAS 18001 have similar

performance-based objectives

DID WE ALL FORGET THIS???

May 2005 (c) Nigel H Croft 2005 5

What is the objective of

a management system audit?

Personal opinion (Nigel Croft)

and/or OHSAS 18001 requirements, and thereby provide objective evidence of an

Objectives:


What are we looking for? (Case of ISO 9001)

Evidence that the way things are being planned

meets the requirements of

Customers

Applicable legislation

ISO 9001:2000

Evidence that things are being done the way they

were planned


Basic Principles

of good auditing

Concentrate on the processes, not the

documents

Look at the results

System effectiveness

PDCA approach


Cause and EffectPROCESS

UNDESIRABLE OUTPUTS

Environmental Impacts

Health & Safety risks


PlanWhat to do?

How to do it?

DoDo what was

planned

CheckDid things happen

according to plan?

ActHow to improve

next time?

10

HOW TO PROVIDE CONFIDENCE?

(ISO 9001 example)

Accreditation Body

IAF Recognition

Organization

Certification Body

Customers

Confidence

ISO 9001:2008

ISO/TC176

(Translation) National Body

Confidence

Confidence

ConfidenceConfidence

-promoting activities

(ISO/CASCO)ISO 17011

ISO 17021-1

ISO 17021-2

ISO 17024

Confidence

Jan 2009 (C) Nigel H Croft 2009 - All rights reserved


ISO TC176

Standardization

Confederation of National Standards Bodies

Based in Geneva

Quality management and Quality Assurance


CSAG

SC 1 SC 2 SC 3

ISO/TC 176

CALG

WG1 WG2 WG3 WG18

TGx TGy TGz

WG1 WG6 JWG

Secretariat: Canada (SCC)

Chair: Dr Gary Cort

Vice-Chair Mr Li Tienan

Automotive TG

Interpretations WG Spanish Trans TG

Arabic Trans TG


CSAG

SC 1 SC 2 SC 3

ISO/TC 176

WG1 WG2 WG3 WG18

TGx TGy TGz

WG1 WG6 JWG

ISO

Chairman

Strategic

Advisory Group

CALG

Automotive TG


Arabic Trans TG


SC 1 SC 2 SC 3

ISO/TC 176

WG1 WG2 WG3 WG18

TGx TGy TGz

WG1 WG6 JWG

Conformity

Assessment

Liaison

Group

CSAGCALG

Automotive TG


Arabic Trans TG


SC 1 SC 2 SC 3

ISO/TC 176

WG1 WG2 WG3 WG18

TGx TGy TGz

WG1 WG6 JWG

ISO 9000 CSAGCALG

Automotive TG


Arabic Trans TG


SC 1 SC 2 SC 3

ISO/TC 176

WG1 WG2 WG3 WG18

TGx TGy TGz

WG1 WG6 JWG

CSAGCALG

Automotive TG


Arabic Trans TGomotive

Interp

ISO 9001

ISO 9004


SC 1 SC 2 SC 3

ISO/TC 176

WG1 WG2 WG3 WG18

TGx TGy TGz

WG1 WG6 JWG

CSAGCALG

Automotive TG


Arabic Trans TG

C

pretations WG

abic Trans T

ISO 19011

&

ISO 10000

series


Overall Scenario of TC176

Generic QMS standards 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

Others (ISO 10001/2/3; ISO 19011 etc)


1979 - BS 5750

1987 ISO 9000 series

1990

1994 Revision to ISO 9000 series

1996 ISO 14000 series published

2000 Major ISO 9000 revision

2002

2002 ISO 19011 published

2004 Revision to ISO 14001

2005 Small revision to ISO 9000 (not ISO 9001)


ISO Review process:

Requires continual review (every 5 years) to keep

standards up to date.

User inputs:

User questionnaire

Suggestions arising from the interpretation process.

Opportunities for increased compatibility with ISO 14001

Current trends:

Keeping up with recent developments in management

system practices.


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

Some interpretation requests indicate need for

clarification of ISO 9001 text

The ISO 9001:2008 Introduction & Support

Package set of documents (www.iso.org)

ISO 14001:2004


Results of User Survey (2003)

Responses from 941 users in 63 countries.

1477 individual comments

All four product categories (Hardware,

Software, Processed Materials and Services)

well represented.

Approx 80% of respondents were satisfied

with the ISO 9001:2000 standard.


337

70

5845

3932

28

25

20

229

58

UNITED STATES

CHINA

GERMANY

UNITED KINGDOM

MEXICO

JAPAN

CANADA

COLOMBIA

AUSTRALIA

ITALY

Other

Survey responses


Size of organization

271

377

290

3

small

medium

large

Blank


How long certified?

250

424

264

30

50

100

150

200

250

300

350

400

450

0-3 4-10 10+ BlankYEARS


How well does ISO 9001:2000

meet your needs?

137

565

14

167

16 42Excellent

Good

No comment (or NOT

APPLICABLE)Needs to be improved

Not adequate

Blank


Are you happy with the

process approach?

849

22

70

Yes

No

Blank


Most commented clauses /

813 (55%) of total 1477 comments related to:

4.1 General requirements

4.2 Documentation

6.2 Human resources

7.3 Design and development

7.5 Production and Service Provision

8.2 Monitoring and Measurement

8.5 Improvement


Objectives for ISO 9001

Initial objectives of ISO 9001:2008:

to improve the existing standard;

to provide greater clarity and ease of use,

to improve compatibility with ISO 14001:2004


Impacts and benefits

Changes to ISO 9001 focus on high benefit /

low impact cases

Some high benefit / high impact

improvements that were identified are being

saved for the next revision cycle

Criteria are shown in the following slides


Impact of changes to ISO 9001

Impact

Category

Criteria

High Additional or reduced requirements significantly affecting many users

Change in intent of requirement

Need for urgent revision of related QMS standards

Decreased compatibility with ISO 14001

Inconsistency within the ISO 9000 family

Need for recertification or significant transition period

Need for extensive user education or training

Medium Minor additional or reduced requirements for some users

Possible impact on understanding by many users

Need for limited changes of an organizations QMS documentation

Need for eventual revision of other QMS standards

No significant need for additional education or training for users

Creates a minimal requirement for recertification or transition period

Low No increased or reduced requirement

No change in intent of requirement

No impact on most users

No need for additional education or training for users


Benefits of changes to ISO

9001

Benefit

Category

Criteria

High Addresses a widely expressed specific user need by improving clarity and

eliminating confusion

Corrects an error in the existing standard

Eliminates inconsistencies within ISO 9001

Eliminates inconsistencies within the ISO 9000 family

Eliminates major problems of translation

Medium Improves clarity in regard to a widely expressed user need but may not eliminate

confusion and/or translation difficulty

Improves clarity in response to needs identified by some users

Increases compatibility with ISO 14001

Demonstrates willingness to respond to the wish to see improvement in compatibility

between ISO 9001 and ISO 14001 even though alignment is not a priority for this

amendment

Reduces problems of translation

Low Improves clarity only in response to low number of requests for improvement

Marginal improvement in clarity where benefit may be offset by risk of unintended

consequences, e.g. with respect to translation, interpretation

Changes not addressing a clear user need


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.

- - No change allowed, but we

need to record details of proposed change, to provide input into

future revisions .

Main changes in ISO 9001:2008

-

Changes to the wording of some clauses

-

Organizations need to 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

QMS


WRONG!


SMALL CHANGE, BIG

OPPORTUNITY #1 (Clause 0.1)

Clause 0.1 confirms that the intent of the standard is not to

impose uniformity of documentation

Consider your documentation:

Are you in the driving seat, or are you a slave to your documentation?

Did it make sense to structure your quality documentation in the way that

you have?

Does it really help you to manage your processes more effectively?

Do the people in your organization understand it?

Is it user-friendly?

Is it consistent with other documentation in your company?

Is there any value to making a change now?

Why not take this opportunity to streamline your documentation, and

eliminate those documents that are not adding value?


SMALL CHANGE, BIG

OPPORTUNITY #2 (Clause 0.1)Clause 0.1 now refers to the organizational environment, changes in that

environment and associated risks.

BIG OPPORTUNITY - 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

(and with them your reputation) does not suffer.


SMALL CHANGE, BIG

OPPORTUNITY #3 (Clause 0.1)ISO 9001:2008 clarifies that only statutory and regulatory requirements

applicable to the product must be addressed (not, for example, those related to

environmental, social, financial or other topics).

You might find it beneficial to use your QMS to ensure regulatory

compliance in these other areas, but ISO 9001 does not require it.

Of course, all statutory and regulatory requirements are important, and a prudent

organization will ensure they are meeting all of these.

BIG OPPORTUNITY - determine which statutory and regulatory

requirements should and could be addressed within your quality

management system, and whether they are being managed to

maximum benefit.

Why not make use of the structure and discipline of your QMS to

allow you to monitor your conformity to other statutory and

regulatory requirements?


SMALL CHANGE, BIG


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 -

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?


SMALL CHANGE, BIG


Reflect on the changes you may need to introduce as a result of the new ISO

9001:2008 standard, and think about using ISO 9004

BIG OPPORTUNITY is to read through ISO

9004 and get a sense of how it might apply to

your business

Make a self-assessment - identify your own

strengths and weaknesses and opportunities

for improvement.


SMALL CHANGE, BIG


ISO 9001:2008 mentions that ISO 9004 is currently being revised

Once the new ISO 9004 standard is

published, your BIG OPPORTUNITY will be

to use its guidance to determine whether your

QMS is structured in a way that will contribute

to your sustained, long-term success.


SMALL CHANGE, BIG


Some small editorial changes have been introduced for better alignment with

ISO 14001:2004

No impact on the requirements of ISO 9001, but

intent is to facilitate understanding for

organizations that have chosen to develop an

integrated management system

For organizations that presently maintain

separate systems, your BIG OPPORTUNITY is

to determine whether it makes sense from a

resource standpoint to consider moving toward

an integrated approach.April 2009 (c) Nigel H Croft 42

SMALL CHANGE, BIG


Re-emphasizes that the aim of the QMS should be to provide confidence in the

As you go through your QMS to check for

changes that might be needed, the BIG

OPPORTUNITY is always to keep in mind

the objectives mentioned in Clause 1.1 as

you do this.

Is your system helping you to achieve these

objectives?


SMALL CHANGE, BIG


Throughout ISO 9001:2008, the text has been modified (for consistency) to

address statutory and regulatory requirements.

regulatory requirements may sometimes be expressed as legal requirements.

erminology used in ISO 9001 and

(see www.iso.org) provides good dictionary definitions

for these terms.

BIG OPPORTUNITY is to make sure that you understand what is

might affect your product and your liabilities in the markets you

service.

How do you identify these requirements and any changes to them?

Are you currently addressing and meeting them?

Have you considered the risks involved to your image and reputation if

you do not? April 2009 (c) Nigel H Croft 44

SMALL CHANGE, BIG


9001:2008 it refers to any intended output resulting from the product realization

processes. It is not limited to final product.

Emphasizes that requirements related to the product are

applicable throughout the whole product realization

process, from purchasing through final delivery

(including post-delivery activities).

BIG OPPORTUNITY is for you to ensure that your

system address the requirements of purchased product

and intermediate product as well as final product being

delivered to your customer. This will help eliminate non-conforming product at an earlier stage, and

reduce your overall costs of quality


SMALL CHANGE, BIG


When reviewing the requirements of ISO 9001:2008, think about the scope of

When you first implemented your QMS, did it

include all the products and services you

provide, or only a small part of these?

BIG OPPORTUNITY is to look at the

advantages of extending your system to include

other parts of your business that could benefit

from better organization and discipline, even

though certification might not be needed.


SMALL CHANGE, BIG


Think about the application of the ISO 9001:2008 requirements in your

organization

As you review your QMS in the light of ISO 9001:2008,

there is a BIG OPPORTUNITY to check and make sure

it is properly applied throughout your organization.

Have you excluded any ISO 9001 requirements that maybe you

Have a long, hard look at the concept of product design and

Can you really justify excluding all the requirements of clause 7.3, or

What is the impact on your ability to provide confidence in your

products and services?


SMALL CHANGE, BIG

OPPORTUNITY #13 (Clause 2)

ISO 9001:2008 now refers to the ISO 9000:2005 version

understand? The BIG OPPORTUNITY is for you to

consult the principles and terminology given in ISO

9000:2005 and the many guidance documents produced

by ISO/TC176

then either you have misunderstood the requirement or

you are probably doing it wrong!


SMALL CHANGE, BIG

OPPORTUNITY #14 (Clause 3)

As you review the changes in ISO 9001:2008, think about the various

components of the product you provide

Are you applying your system to all of your intended

products?

Many organizations only think about the tangible products they

provide (particularly when it comes to design and development)

and forget about the service component of their product.

The BIG OPPORTUNITY is to consider very carefully

whether you have included all the different product

categories (hardware, software, service and processed

materials) that apply to your organization, and their


SMALL CHANGE, BIG


Note 1 to Clause 4.1 clarifies that the processes needed for the QMS include

not only processes for management activities, provision of resources and

product realization, but also those needed for measurement, analysis and

improvement.

The BIG OPPORTUNITY is for you to check and

make sure you are managing your

measurement, analysis and improvement

processes in terms of this clause 4.1.

Have you identified the intended outputs?

Have you allocated adequate resources?

Are you monitoring these processes to ensure they

are effective? April 2009 (c) Nigel H Croft 50

SMALL CHANGE, BIG


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.

Your BIG OPPORTUNITY through ISO 9001:2008 is to

re-evaluate the need for such measurements, and to

ensure that any measurements that are necessary really

do add value to your organization


SMALL CHANGE, BIG


Notes have been added to explain more about outsourcing what is meant by

The BIG OPPORTUNITY is for you to 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?

Might it be appropriate to bring some outsourced processes back

in-house?


SMALL CHANGE, BIG

OPPORTUNITY #18 (Clause 4.2.1)

ISO 9001:2008 now clarifies that a single document may address the

requirements for one or more procedures. Equally, an ISO 9001 requirement for

a documented procedure may be covered by more than one document

You may choose, for example, to address corrective and preventive action

in a single procedure (provided that the procedure covers all the

requirements of clauses 8.5.2 and 8.5.3).

For some processes like internal audit, it might be convenient to develop

two or three separate procedures (e.g. planning, execution and reporting)

that cover all the requirements of clause 8.2.2.

BIG OPPORTUNITY is to re-evaluate all your documentation.

Is it used?

Is it useful?

-

Can it be pruned down to be more readable?

Maybe use some figures, drawings or photographs to substitute words?


SMALL CHANGE, BIG


Clause 4.2.1 (c) and (d) mention that records are a type of documentation that

are required for the quality management system.

Although this change should have no impact,

here is another BIG OPPORTUNITY.

Have you considered developing check-lists to

control your processes instead of heavy

procedures - when complete, the check-list can

be used as a record?

You might want to try to eliminate duplicate

information on different records (time-consuming,

costly, and may introduce inconsistencies). April 2009 (c) Nigel H Croft 54

SMALL CHANGE, BIG


Explains that the only external documents that need to be identified and have

controlled distribution are those that are deemed necessary by the

organization for the planning and operation of the QMS.

Does not apply to all external documents that might be

used by your organization.

BIG OPPORTUNITY is to allow you more flexibility in the

way you control documents of external origin, based on

their impact on your QMS.

You might also want to consider bringing (or leaving) all

externally-generated documents under your document

control process, if you find this to be beneficial.


SMALL CHANGE, BIG


The sequence of this clause has been changed for greater clarity and better

alignment with ISO 14001.

No real implications, but the BIG

OPPORTUNITY would be for you to look at how

you might achieve better integration of the

records generated by your quality,

environmental and other management systems

in order to achieve greater efficiency.


SMALL CHANGE, BIG


The new version of the standard clarifies that the management representative

If you are currently using a part-time consultant as your

management representative the BIG OPPORTUNITY

yourselves and integrate the QMS into your day-to-day

work routine.

The consultant can still have an important role in helping

your MR to carry out his/her functions, but the subtle

and obliges you to take charge of your own destiny.


SMALL CHANGE, BIG


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, the BIG

OPPORTUNITY is to 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,

but it is likely to bring long-term benefits.


SMALL CHANGE, BIG


The change in sequence of the title of this clause to bring it in line with the

equivalent clause of ISO 14001 may have gone un-noticed.

Although the change is trivial, it does provide a

BIG OPPORTUNITY for you to think about the

ways in which you address the requirements of

your quality and environmental management

system (if you have one).

Do you use a common, integrated approach?

If not, then why not?


SMALL CHANGE, BIG


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 a BIG

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

mitigation measures put in place as appropriate.April 2009 (c) Nigel H Croft 60

SMALL CHANGE, BIG


This does not change any requirement (the note is

simply a partial repetition of the ISO 9000:2005 definition

BIG OPPORTUNITY is for you to consider the

implications of the work environment on your ability to

provide conforming products

Although not mentioned in the note, the ISO 9000:2005 definition

also includes psychological and ergonomic factors that can be

particularly relevant in a service provision situation.

You should look at the ISO 9000:2005 definition, for a better

understanding.April 2009 (c) Nigel H Croft 61

SMALL CHANGE, BIG


ISO 9001:2008 now strengthens the requirement for product realization

planning to include measurement (as appropriate).

BIG OPPORTUNITY during product realization planning

is 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

consequences of not making measurements for every process.


SMALL CHANGE, BIG


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.

BIG OPPORTUNITY is to think about the whole range of

characteristics of your product that can affect customer satisfaction.

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

competitors.


SMALL CHANGE, BIG


A note has been added to explain that design and development review,

verification and validation have distinct purposes. As such, they may be

conducted and recorded separately or in any combination as suitable for the

product and the organization.

BIG OPPORTUNITY is the greater flexibility in the way

you address design review, verification and validation.

If you have large, complex design and development projects for

high-risk equipment or services, you are likely to need formal and

distinct processes for these activities, which might be carried out

in various phases over a range of time.

For simple design and development process and low-risk

projects, it might be acceptable to carry out all activities at the

same time.


SMALL CHANGE, BIG


In addition to minor editorial changes in the body of Clause 7.3.3, a new note

has been added to explain that design and development outputs can also

include details for the preservation of product.

BIG OPPORTUNITY do the design outputs

provide sufficient confidence that your product

will not be damaged prior to delivery to its

intended point of use?

Should you be addressing product packaging or

handling information as an important output of

your design and development process?


SMALL CHANGE, BIG


The wording of this clause has been changed to clarify that identification may

be needed throughout the product realization process not only for the final

product

BIG OPPORTUNITY is to think about the ways in which

you identify your products (and services) during the

product realization process.

Are there benefits to be obtained by improving identification?

You might want to consider making temporary changes during

periods where non-conformities are occurring with a greater

frequency (to facilitate identification of nonconforming product, or

for enhanced problem-solving).


SMALL CHANGE, BIG


The note to this clause now explains that both intellectual property and

personal data should be considered customer property

There is a BIG OPPORTUNITY here, particularly

if you are working in the service sector.

Your customers are no doubt worried about fraud and

identity theft, so if you can demonstrate that you are

controlling this in an effective way, that should give

you a competitive advantage.

Such data might include credit card information

(internet purchases), address or passport details

(hotel check-in) or confidential medical information

(health service).April 2009 (c) Nigel H Croft 67

SMALL CHANGE, BIG


has been added regarding the use of computer software. The note describes

verification and configuration management as typical methods of satisfying the

intended application and maintaining suitability for use.

The editorial changes should have no impact.

BIG OPPORTUNITY is to consider the extent to which

computer software is used in the course of your

monitoring and measuring activities.

Do you know the impact of this software on the accuracy of your

results?

Are you confident that the software is up-to-date and suitably

protected against virus, memory loss, system crashes etc?

If not, then you might well be vulnerable! April 2009 (c) Nigel H Croft 68

SMALL CHANGE, BIG


A note has been added to explain that monitoring of customer perception can

include input from sources such as customer satisfaction surveys, customer

data on delivered product quality, user opinion surveys, lost business analysis,

compliments, warranty claims and dealer reports.

No new requirement, but you have a BIG OPPORTUNITY to review

the way in which you go about obtaining this information.

Are you obtaining valid, actionable information that will help give you the

meet the requirements of ISO 9001?

You might find it useful to consult the guidance given in ISO/TS

10004 Monitoring and measuring customer satisfaction.

refer exclusively to the contractual customer. It may include both

internal and external customers as well as consumers, clients, end

users, retailers, beneficiaries and purchasers.April 2009 (c) Nigel H Croft 69

SMALL CHANGE, BIG


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.

The BIG OPPORTUNITY is that you can now 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

correct the problem, without the need for corrective action.


SMALL CHANGE, BIG

OPPORTUNITY #36 (Clause 8.2.3)A note has been added here to clarify that when deciding on appropriate

monitoring and/or measurement methods, you should consider both the impact

on product conformity and on the effectiveness of your quality management

system.

When QMS processes do not achieve planned results,

you must now evaluate the need to make corrections

and/or take corrective action, regardless of the direct

impact on product conformity.

BIG OPPORTUNITY is for you to emphasize to all in

your organization that it is not only product realization

processes that are important. If system processes such as document control, management review,

internal audits and others are not achieving planned results, corrections

and/or corrective actions will also be needed.


SMALL CHANGE, BIG


The standard now makes it clear that it is the effectiveness of the corrective

action that must be reviewed, not just the corrective action itself.

This provides a BIG OPPORTUNITY for you to

look carefully at the corrective actions you have

initiated, and to make sure they are achieving

the intended results.

If the corrective actions are to address specific

nonconformities (in product, process or the

quality management system), have they

successfully eliminated (or significantly reduced)

the problem?April 2009 (c) Nigel H Croft 72

SMALL CHANGE, BIG


The standard now makes it clear that it is the effectiveness of the preventive

action that must be reviewed, not just the preventive action itself.

This provides you with a BIG OPPORTUNITY to look

carefully at the preventive actions you have initiated, and

to make sure they are achieving the intended results.

If the preventive actions are to address unfavourable

trends or specific potential nonconformities (in product,

process or the QMS), have they successfully prevented

the nonconformity from occurring? Were they successful

in terms of cost/benefit?


74

ISO 9001:2008 Implementation

Policy

(Joint communiqué published by ISO and IAF)

November 15th 2008 Publication of ISO 9001:2008

Before publication of ISO 9001:2008 no accredited certificates to new standard were allowed

New certificates only after a routine surveillance or recertification audit against ISO 9001:2008.

April 2009 (c) Nigel H Croft

ISO 9001:2008 Implementation

Policy (continued)

Up to Nov 15th 2009 certification / renewal to ISO 9001:2000 still permitted

Beginning Nov 15th 2009, no new certificates to ISO 9001:2000 allowed all audits to be conducted to ISO 9001:2008

From Nov 15th 2010 ISO 9001:2000 certificates will no longer be valid

75April 2009 (c) Nigel H Croft

Implications

No additional audits should be required

Auditors need to be aware of changes

Use ISO 9001:2008 Annex B

Organizations should take advantage of the changes to

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

this BIG OPPORTUNITY

76April 2009 (c) Nigel H Croft

Summary

The details of the quality management

OUTPUT MATTERS!

9001 Clauses 4.1 8.5.3!!



THANK YOU

[email protected]

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