Update on

ISO 9000
and OHSAS 18001
By

Charles Corrie
Secretary ISO/TC 176/SC 2

Tel Aviv, May 2005

ISO/TC 176 Published standards

TC 176
ISO/TS 16949:2002
Quality management systems -- Particular requirements for
the application of ISO 9001:2000 for automotive production
and relevant service part organizations
TC 176/SC 1
ISO 9000:2000
Quality management systems -- Fundamentals and vocabulary

Tel Aviv, May 2005

ISO/TC 176 Published standards

TC 176/SC 2
ISO 9001:2000

Quality management systems -- Requirements

ISO 9004:2000
Quality management systems -- Guidelines for performance
improvements

Tel Aviv, May 2005

ISO/TC 176 Published standards

TC 176/SC 2 - continued
ISO 10005:1995

Quality management -- Guidelines for quality plans

ISO 10006:2003
Quality management systems -- Guidelines for quality
management in projects
ISO 10007:2003
Quality management systems -- Guidelines for configuration
management

Tel Aviv, May 2005

ISO/TC 176 Published standards

TC 176/SC 3
ISO 10002:2004
Quality management -- Customer satisfaction -- Guidelines for
complaints handling in organizations
ISO 10012:2003
Measurement management systems -- Requirements for
measurement 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
Tel Aviv, May 2005

ISO/TC 176 Published standards

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 10019:2005
Guidelines for the selection of quality management system
consultants and use of their services
ISO 19011:2002

Guidelines for quality and/or environmental management

systems auditing

Tel Aviv, May 2005

ISO/TC 176 Other guidance

Selection and Use of ISO 9000 brochure
Quality Management Principles
ISO 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 Processes

Interpretations
ISO Handbook: ISO 9001 for Small Businesses
Tel Aviv, May 2005

ISO 9001 Auditing Practices Group

Joint ISO/TC 176, ISO/CASCO and IAF team that produces
guidance notes focussed on 3rd party management system
auditors, but useful to 1st party 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
Tel Aviv, May 2005

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)

Tel Aviv, May 2005

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 10005
Quality 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 future
revisions of ISO 9001 and ISO 14001
Tel Aviv, May 2005

ISO/TC 176 Work in Progress

TC176/SC 3
ISO/CD 10001

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

conduct
ISO/CD 10003
Quality management -- Customer satisfaction -- Guidelines for external
customer disputes resolution
ISO/DIS 10014
Quality management systems -- Guidelines for realizing financial and
economic benefits
NWIP Guidelines for monitoring customer satisfaction
Systematic Review of ISO 10015 due to start in 2005
Tel Aviv, May 2005

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.
Tel Aviv, May 2005

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 path
of CD, DIS, FDIS for the standards
Publication expected to be achieved in

Tel Aviv, May 2005

2008

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:

Tel Aviv, May 2005

Key to the Decision Matrix

Tel Aviv, May 2005

Examples of Categories of Benefits

Increases compatibility with ISO 14001
1. High Considerable increases compatibility with ISO
14001
2. Medium Improves the compatibility with ISO 14001
3. Low has no impact on the compatibility with ISO 14001

Improves translatability
1. High significant improvement on translatability
2. Medium slight improvement on translatability

3. Low no improvement on translatability

Tel Aviv, May 2005

Examples of Categories of Impact

Increase in the number of specified records
1. Low no additional records to be specified

2. Medium few additional records to be specified

(e.g. one or two new records required)
3. High greater than 2 addition records to be specified

Changes to existing processes

1. Low negligible change to processes
2. Medium requires minimum change to processes
3. High requires extensive change to processes
Tel Aviv, May 2005

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 Management section, focussing on strategic
issues and describing managerial processes

- An Operational management section, giving practical

guidance on what to consider for achieving operational
improvement
- A self assessment section, giving tools for assessing
both Top management and Operational management
issues
Tel Aviv, May 2005

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

Tel Aviv, May 2005

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 attention
to 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

Tel Aviv, May 2005

The standard will employ an expanded Process Approach

model:
Feedback and learning

Management
responsibility

Organizations
external and
internal needs &
expectations

Measurement,
analysis and
improvement

Resource
management

Organizations
identity (Mission),
position and
Vision.

Strategic
Imperatives,
Expectation &
needs of
interested parties.

Product
realization

Results:
Satisfied customers
and other interested
parties
Sustainably
developing
organization

Improvement & Innovation of Quality Management System

Tel Aviv, May 2005

Consistent Pair
A new approach to maintaining ISO 9001 and ISO 9004 as a
consistent pair will be developed, which is not dependent on
clause numbering and clause titles.
New main clauses have been proposed for ISO 9004 of:
1. Organizational environment (external and internal)

2. Organizations identity Principles, mission, vision and

position
3. Strategic imperatives of an organization for sustainable
success

Tel Aviv, May 2005

4. Processes
4. 1Management responsibility
4.2 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 quality
management system

Tel Aviv, May 2005

For operating environment, identity and position of the

organization, ISO 9004 will focus its advice on:

Identification of the operational environment, the needs and

the 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.

Tel Aviv, May 2005

For operating environment, identity and position of the

organization, ISO 9004 will focus its advice on:

The adaptability of the organization to its operational

environment 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.

Tel Aviv, May 2005

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 that
are derived from the strategic plan and which should
result in sustainable success of the organization.
The achievement of these objectives is a measure
of the maturity of the management system.

Tel Aviv, May 2005

For Results and Sustainability, ISO 9004 will focus its advice on:
The degree of improvement of adaptability, flexibility
and responsiveness of the organization in relation to its
vision and objectives.
Analysis of the results achieved, as perceived by
interested parties.
Linking results to objectives and actions, including
lessons learned.

Tel Aviv, May 2005

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
Tel Aviv, May 2005

OHSAS 18001 and OHSAS 18002

OHSAS 18001 was published in 1999; now 6 years old

Currently undertaking:
- Survey of 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.

Tel Aviv, May 2005

Scope of 18001
a) establish an OH&S management system to eliminate or
minimize risk to employees and other interested parties who
may be exposed to OH&S risks associated with its activities;
b) implement, maintain and continually improve an OH&S
management 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 conformance
with this OHSAS specification.
OHSAS 18002 gives application guidance on OHSAS 18001

Tel Aviv, May 2005

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

Tel Aviv, May 2005

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.

Tel Aviv, May 2005

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

Tel Aviv, May 2005

Systematic Review
This will lead to a decision to either:
- Confirm (unchanged)
- Withdraw
- Amend

- Revise
the standards.
Expected outcome is for an Amendment.

Tel Aviv, May 2005

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)

Tel Aviv, May 2005

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 resequencing to be introduced.
Alternately, the market may require stability and no change
to OHSAS 18001, with the relationship to ISO 14001 being
defined through revised correspondence tables.
Tel Aviv, May 2005

ALARP As 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 evaluation
of what is practicable.
ALARP is already frequently required by regulations.
Tel Aviv, May 2005

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)

Tel Aviv, May 2005

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.

Tel Aviv, May 2005

Compatibility / Alignment / Integration

Compatibility means that common elements of the two
series of standards can be implemented in a shared
manner, in whole or in part, by organizations without
unnecessary duplication or the imposition of conflicting
requirements.

(Based around ISO/IEC Guide 2:1996, term 2.2)

Note: Compatibility does not mean that the text of
common elements of the standards needs to be identical,
although they should be whenever practicable.

Tel Aviv, May 2005

Compatibility / Alignment / Integration

Alignment/ Compatibility is directed at:

- Basic principles
- Terminology
- General management system requirements
(but not the Technology specific requirements)
- Structures

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Compatibility / Alignment / Integration

Basic principles

The principles are very similar

Tel Aviv, May 2005

Compatibility / Alignment / Integration

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

Tel Aviv, May 2005

Compatibility / Alignment / Integration

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

Tel Aviv, May 2005

Compatibility / Alignment / Integration

Structures: - ISO 9000 Process Approach

Continual improvement of
the quality management system

Management
responsibility

Customer
s

Customer
s

Requirement
s

Resource
management

Input

Measurement,
analysis and
improvement

Product realization

Output
Product

Tel Aviv, May 2005

Satisfaction

Compatibility / Alignment / Integration

Structures: - ISO 14001 Modified PDCA

Continual Improvement

Environmental Policy

Management Review

Checking and
Corrective Action

Planning

Implementation and
Operation

Tel Aviv, May 2005

Compatibility / Alignment / Integration

Structures:
Structures themselves are a conceptual way of showing how the
various 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 taken
together. 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.

Tel Aviv, May 2005

Compatibility / Alignment / Integration

Integration
Many voices are now saying to ISO that it should develop
integrated 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 how
such work should be organized.
ISO/TMB has established a task group to develop an ISO
Handbook, to show how the standards may be integrated
into an organizations management system

Tel Aviv, May 2005

Compatibility / Alignment / Integration

Integration
Where is the pressure coming from for ISO
to take further action ?
- Developing countries
- Micro / Small businesses

- Large Global businesses

Tel Aviv, May 2005

Conflicting views between developing

countries and developed countries.
Developing countries view ISO 9001 and ISO 14001
certification 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.
Tel Aviv, May 2005

Micro / Small businesses

Micro/small businesses are considered vital to
the growth of all economies
Most 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 formal
system.
They are looking for standards that are simple to follow, can
be implemented quickly, and at low cost.

Tel Aviv, May 2005

Large Global Organizations

There are associations of large global organizations that

wish ISO to stop producing MSS. This is also impacting
many national standardization projects.
They are particularly critical of 3rd party 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

Tel Aviv, May 2005

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 system
programmes, 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 management
system 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.
Tel Aviv, May 2005

Integration Conclusion
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.

Tel Aviv, May 2005

TC176/SC2 & TC207/SC1 JTG proposed

Joint Vision for ISO 9001 and ISO 14001
(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.
Tel Aviv, May 2005

TC176/SC2 & TC207/SC1 JTG proposed generic

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 evaluation
Measurement and data gathering, analysis and use
Improvement - Action to enhance the organization's performance
Tel Aviv, May 2005

Thank you
for your attention

Charles Corrie
Secretary ISO/TC 176/SC 2
Tel Aviv, May 2005