update on iso 9000 and ohsas 18001, sii, 2005-05, c corrie

8/10/2019 Update on ISO 9000 and OHSAS 18001, SII, 2005-05, C Corrie

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Update on

ISO 9000

and OHSAS 18001

By

Charles Corrie

Secretary ISO/TC 176/SC 2


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ISO/TC 176 Published standards

TC 176

ISO/TS 16949:2002

Quality management systems -- Particular requirements forthe application of ISO 9001:2000 for automotive productionand relevant service part organizations

TC 176/SC 1

ISO 9000:2000

Quality management systems -- Fundamentals and vocabulary


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TC 176/SC 2ISO 9001:2000

Quality management systems -- Requirements

ISO 9004:2000

Quality management systems -- Guidelines for performanceimprovements


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TC 176/SC 2- continuedISO 10005:1995

Quality management -- Guidelines for quality plans

ISO 10006:2003

Quality management systems -- Guidelines for qualitymanagement in projects

ISO 10007:2003

Quality management systems -- Guidelines for configuration

management


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TC 176/SC 3

ISO 10002:2004

Quality management -- Customer satisfaction -- Guidelines forcomplaints handling in organizations

ISO 10012:2003

Measurement management systems -- Requirements formeasurement processes and measuring equipment

ISO/TR 10013:2001

Guidelines for quality management system documentation

ISO/TR 10014:1998

Guidelines for managing the economics of quality


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TC 176/SC 3- continued

ISO 10015:1999

Quality management -- Guidelines for training

ISO/TR 10017:2003

Guidance on statistical techniques for ISO 9001:2000

ISO 10019:2005Guidelines for the selection of quality management systemconsultants and use of their services

ISO 19011:2002Guidelines for quality and/or environmental managementsystems auditing


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ISO/TC 176 Other guidance

Selection and Use of ISO 9000 brochure

Quality Management PrinciplesISO 9000 Introduction and Support Package:

N524 - Guidance on ISO 9001:2000 clause 1.2 'Application'

N525 - Guidance on the Documentation Requirements of ISO 9001

N526 - Guide to the Terminology used in ISO 9001:2000 and ISO 9004

N544 - Guidance on the Concept and Use of the Process Approach for

management systems

N630 - Guidance on Outsourced ProcessesInterpretations

ISO Handbook: ISO 9001 for Small Businesses


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ISO 9001 Auditing Practices Group

Joint ISO/TC 176, ISO/CASCO and IAF team that produces

guidance notes focussed on 3rdparty management systemauditors, but useful to 1stparty auditors.

More than 20 papers posted on the web, e.g.:

The need for a 2-stage approach to auditing

Measuring QMS effectiveness and improvements

Identification of processes

Understanding the process approach Determination of the where appropriate processes

Now due to produce Accreditation Auditing guidance


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Web sites

www.iso.org (general guidance)

www.tc176.org(interpretations)

www.iso.org/tc176/sc2(ISO 9000 Introduction and Support package)

www.iso.org/tc176/ISO9001AuditingPracticesGroup(auditing guidance)


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ISO/TC 176 Work in Progress

TC 176 Interpretations

TC 176/SC 1

ISO/DAM/FDIS 9000

Quality management systems -- Fundamentals and vocabulary

TC 176/SC 2

ISO/FDIS 10005Quality management -- Guidelines for quality plans(Approved for publication)

+ Amendment to ISO 9001 and Revision of ISO 9004

+ Working with TC 207/SC 1 on a Joint Vision for futurerevisions of ISO 9001 and ISO 14001


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ISO/TC 176 Work in Progress

TC176/SC 3ISO/CD 10001

Quality management -- Customer satisfaction -- Guidelines for codes ofconduct

ISO/CD 10003

Quality management -- Customer satisfaction -- Guidelines for externalcustomer disputes resolution

ISO/DIS 10014

Quality management systems -- Guidelines for realizing financial andeconomic benefits

NWIP Guidelines for monitoring customer satisfaction

Systematic Review of ISO 10015 due to start in 2005


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Amendment to ISO 9001:2000 and

Revision to ISO 9004:2000

This follows from:

- a formal ISO process, for Systematic Reviews

- the 2004 ISO/TC 176/SC 2 User Feedback Survey

- the ISO/TC 176 Interpretations process

- papers from Japan, France and Spain indicating potential new

directions for ISO 9004

It also required the presentation of a Justification Study, and

agreement by ISO/TC 176, which was documented in a

Recommendation Report (These are also part of ISOs internal

processes for management systems standards).

This was only achieved in November 2004, so we are still in the

early stages of this work.


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Amendment to ISO 9001:2000 and

Revision to ISO 9004:2000

Currently developing and balloting Design Specifications for

the amendment /revision.

If these are approved, SC2 will commence drafting in

October, and will then follow the usual ISO development pathof CD, DIS, FDIS for the standards

Publication expected to be achieved in 2008


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Changes in the amendment to ISO 9001 to be extremely

limited. All inputs to be assessed using a decision matrix of

Benefits versus Impacts:

Decision matrix:


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Key to the Decision Matrix


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Examp les of Categories of Benef i ts

Increases compatibility with ISO 14001

1. HighConsiderable increases compatibility with ISO14001

2. MediumImproves the compatibility with ISO 14001

3. Lowhas no impact on the compatibility with ISO 14001

Improves translatability

1. Highsignificant improvement on translatability

2. Mediumslight improvement on translatability

3. Lowno improvement on translatability


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Examp les o f Categories of Impact

Increase in the number of specified records

1. Lowno additional records to be specified

2. Mediumfew additional records to be specified

(e.g. one or two new records required)

3. Highgreater than 2 addition records to be specified

Changes to existing processes

1. Lownegligible change to processes

2. Mediumrequires minimum change to processes

3. Highrequires extensive change to processes


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For ISO 9004

The Design Specification has proposed a new title:

Managing for sustainable success through Quality

and that the document be structured in 3 sections:

- A Top Managementsection, focussing on strategic

issues and describing managerial processes

- An Operational managementsection, giving practical

guidance on what to consider for achieving operational

improvement

- A self assessmentsection, giving tools for assessing

both Top management and Operational management

issues


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Note on the use of Sustainability

For the future ISO 9004, sustainability is not being used in the

context of sustainable development as in the field of

environmental management.

Sustainability is being used in the context of the issues that an

organization needs to deal with in order to remain successful in the

long term


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ISO 9004 will address additional Quality Principles

The future ISO 9004 will continue to be based on the

8 Quality management Principles, but will also give attentionto the additional principles of:

Ethics / Social issues

Mission and Vision of the organization

Adaptability / agility, flexibility and responsiveness

Management of Knowledge

Alignment with other management system elements

Linking Objectives and Actions to Results


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The standard will employ an expanded Process Approach

model:

Results:

Satisfied customers

and other interested

parties

Sustainably

developingorganization

Measurement,

analysis and

improvement

Management

responsibility

Resourcemanagement

Product

realization

Improvement & Innovation of Quality Management System

Feedback and learning

Strategic

Imperatives,

Expectation &

needs ofinterested parties.

Organizations

identity (Mission),

position and

Vision.

Organizations

external and

internal needs &

expectations


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4. Processes

4. 1Management responsibility4.2 Resources management

4.3 Product realization

4.4 Measurement, analysis and improvements

5. Results and sustainable organization

6. Feedback and learning

7. Strategic improvement and innovation of a qualitymanagement system


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For operating environment, identity and position of the

organization, ISO 9004 will focus its advice on:

Identification of the operational environment, the needs andthe expectations of customers and other interested parties,

materially affecting the organizations viability and definition of

its strategic imperatives.

The assessment of risks associated with the activities of the

organization to enable sustainable success and the

facilitation of preventive actions.

Compliance with laws and statutory regulations.


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For operating environment, identity and position of the

organization, ISO 9004 will focus its advice on:

The adaptability of the organization to its operationalenvironment related to its culture, learning and innovation.

The organizational profile in relation to its strategic vision

and values.

The way in which the organization makes decisions and

takes actions to achieve its objectives and goals for

sustainable success.


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For Results and Sustainability, ISO 9004 will focus its advice on:

How management assures that objectives and

actions will result in adding value.

The achievement of organizational objectives thatare derived from the strategic plan and which should

result in sustainable success of the organization.

The achievement of these objectives is a measureof the maturity of the management system.


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For Results and Sustainability, ISO 9004 will focus its advice on:

The degree of improvement of adaptability, flexibilityand responsiveness of the organization in relation to itsvision and objectives.

Analysis of the results achieved, as perceived byinterested parties.

Linking results to objectives and actions, includinglessons learned.


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In conclusion

The future ISO 9004 is set to make a significant leap

forward in management systems standardization.Its focuses on :

- Top Management and Strategy Deployment

- Sustainability, Social responsibility- Innovation, Flexibility, Agility

- Knowledge Management, Risk Management

- Results

This is a radical departure from anything ISO has

previously attempted


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OHSAS 18001 and OHSAS 18002

OHSAS 18001 was published in 1999; now 6 years old

Currently undertaking:

- Surveyof OH&S standards and Certificates to end of

2004 (a similar survey was done for 2003).Results currently being processed.

- A Systematic Review, to see if the standards need

changing

Submissions due by 1 June.


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Scope of 18001a) establish an OH&S management system to eliminate or

minimize risk to employees and other interested parties whomay be exposed to OH&S risks associated with its activities;

b) implement, maintain and continually improve an OH&Smanagement system;

c) assure itself of its conformance with its stated OH&S policy;

d) demonstrate such conformance to others;e) seek certification/registration of its OH&S management

system by an external organization; or

f) make a self-determination and declaration of conformancewith this OHSAS specification.

OHSAS 18002 gives application guidance on OHSAS 18001


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Facts and figures

OHSAS Standards and Certificates survey

(to October 2003)

31 guidance documents

23 requirement standards

Certification in 70 countries

8399 certificates in total 3898 to 18001 or direct equivalent


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2003 - OHSAS (or equivalent) survey results:

By Country:

No discernable pattern between:

- Large versus Small countries

- Developed versus developing countries

By Industrial sector:

Highest uptake has been in the chemical, construction,

engineering, and distribution sectors. Food sector also

prominent.


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The Future

Increasing adoption of 18001 as a national standard

in different countries

Development of OHS standards by

ANSI in the USA , and by CSA in Canada

Development of a CEN Guidance document

ISO ??????

June 2005 ISO/TMB meeting will be critical to this

issue


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Systematic Review

This will lead to a decision to either:- Confirm (unchanged)

- Withdraw

- Amend- Revise

the standards.

Expected outcome is for an Amendment.


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Drivers for change

- Ongoing revision to ISO 14001 for EMS, and the need for

the standards to remain compatible

(Note with ISO 9001:2000 revision, this merely led to revised

Correspondence tables being included in Annex A)- The need to reduce identified risks to a situation of being

As low as reasonably practicable or ALARP.

(Note, this is the only technical comment received against

18001 in 5 years)


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ISO 14001 compatibility

OHSAS 18001 was developed very closely against ISO

14001.

The publication of ISO 14001:2004 has not introduced any

significant new requirements, but has re-sequenced some

of the sub-clauses and introduced new sub-clauses.

The market may require OHSAS 18001 to maintain its

explicit level of compatibility with 14001, and for similar re-

sequencing to be introduced.

Alternately, the market may require stability and no changeto OHSAS 18001, with the relationship to ISO 14001 being

defined through revised correspondence tables.


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ALARPAs Low As Reasonably Practicable

ALARP could change the fundamental basis of the OHSAS

standards

At the moment risks are reduced to what the organization

considers to be tolerable, and makes a cost versus benefits

judgement as to where to set the level.

ALARP may require the organization to implement measures

beyond what it considers economically beneficial, but which

external observers may consider practicable.

This leads to questions concerning the subjective evaluationof what is practicable.

ALARP is already frequently required by regulations.


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Other OHSAS Project Group considerations

2004 Standards and certificates survey

An auditing standard (or a supplement to ISO 19011)

Auditor qualification criteria

ISO ?????

Why do so few small businesses understand or comply

with OHS regulations ?

(UK survey showed that 90% do not comply)


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Compatibility / Alignment / Integration

ISO 14001:2004 recently published

Already, a number of commentators have expressed the

view that the changes have not enhanced the alignment

of ISO 14001 to ISO 9001, and are calling for ISO to

improve this situation.

They do not accept the original objective of the revision,

which was to enhance the existing compatibility between

the two standards.


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Basic principles

The principles are very similar


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Terminology

Many similar terms are used in the differing standards,

however, their definitions appear to vary considerably.

Is this a problem ? Answer = No

Why not ? Because the underlying intent, or concept, of

the definitions are generally very similar


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General management systems requirements

(See ISO Guide 72)

Policy

Planning

Implementation and operation

Improvement

Management review

Both ISO 9001 and ISO 14001 cover these elements


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Structures: - ISO 9000 Process Approach

Management

responsibility

Measurement,

analysis and

improvement

Resource

management

Product realizationInput Output

Customers

Customers

Requirement

s

Satisfaction

Product

Continual improvement of

the quality management system


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Structures: - ISO 14001 Modified PDCA

Continual Improvement

Management Review

Checking and

Corrective Action

Environmental Policy

Planning

Implementation and

Operation

C tibilit / Ali t / I t ti


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Structures:

Structures themselves are a conceptual way of showing how thevarious management system elements fit together to form a

system.

They also attempt to show that individual elements of the

system cannot be treated in isolation, but have to be takentogether. The system will fail, if any one of those elements is

ignored.

The structures themselves are not a requirement to which

compliance has to be achieved.

Each representation has its own merits.


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Integration

Many voices are now saying to ISO that it should developintegrated standards.

ISO/TMB has established a group to look at many different

aspects of management system standardization, including

the need for common elements and structure, and howsuch work should be organized.

ISO/TMB has established a task group to develop an ISO

Handbook, to show howthe standards may be integrated

into an organizations management system


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Integration

Where is the pressure coming from for ISOto take further action ?

- Developing countries

- Micro / Small businesses- Large Global businesses


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Conflicting views between developing

countries and developed countries.

Developing countries view ISO 9001 and ISO 14001certification as a barrier to trade. They also suffer from a lack

of management systems infrastructure within their countries

(consultants, training courses, certification bodies), which

means the costs of obtaining certification are relatively

higher. They are pushing for IMS standards as a cheaper

alternative.

Developed countries have a lot more availability and choice

for their management systems infrastructures. Organizations

in developed countries therefore pick and choose

management systems programmes to differentiate

themselves, for competitive advantage.


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Micro / Small businesses

Micro/small businesses are considered vital to

the growth of all economiesMost have little or no management systems knowledge. In

the critical start-up phase, many are also faced with

(financial) resource shortages, and little time for executives

to be available to assist in the implementation of a formalsystem.

They are looking for standards that are simple to follow, can

be implemented quickly, and at low cost.


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Large Global Organizations

There are associations of large global organizations thatwish ISO to stop producing MSS. This is also impacting

many national standardization projects.

They are particularly critical of 3rdparty certification systems,

which they would wish to see disappear.

They want ISO to have extremely difficult criteria that have

to be met, before it starts work on MSS


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What strategies can ISO follow ?

- a very rigid one

- a very flexible one

- somewhere in-between (a pragmatic one)


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Integration - Conclusion

An organizations management system will be unique, and

will need to take account of many management systemprogrammes, both from within ISO and external to it.

Understanding the intention behind management

standards will enable the organization to integrate the

requirements of the standards into its own managementsystem in a planned and consistent manner.

Organizations need to learn to have the confidence to deal

with new MS initiatives. ISO can assist them with such

learning.

Business efficiencies can be achieved through the use of a

fully integrated system.


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IntegrationConclusion

Integration is usually applied to ISO 9001, ISO 14001 and

OHSAS 18001.Even when taken together, these do not cover the wider

scope needed by an organization for its management

system (e.g. they do not cover financial controls, personnel

management, IT/technology investment strategies,mergers and acquisitions, etc.)

To develop a standard for an integrated MSS at this time,

from the currently available components, would still not

meet the needs of all interested parties.


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TC176/SC2 TC207/SC1 JTG proposed

Joint Vision for ISO 9 1 and ISO 14 1

(being considered during 2005)

The future revisions of ISO 9001 and ISO 14001 will be

aligned and will seek to enhance further the current levels of

compatibility between the two standards, through the

promotion of identical:

titles,

sequence of titles,

text and definitions

that are permitted to diverge only where necessitated by

specific differences in managing environment or quality.

TC176/SC2 TC207/SC1 JTG proposed generic


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systems structure (being considered during 2005)

Context of the organization

Consideration of the needs and expectations of interested parties

(including customers and stakeholders)

Leadership- Commitment and actions by management

Support

Resources and other needs that enable the organization to function

Operations

Activities/processes that make the organization achieve its purpose

Performance evaluationMeasurement and data gathering, analysis and use

Improvement - Action to enhance the organization's performance


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T l A i M 2005

hank you

for your attention

Charles CorrieSecretary ISO/TC 176/SC 2

update on iso 9000 and ohsas 18001, sii, 2005-05, c corrie

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