go to top of page

ISO9001:2000

(Note: This article has been superseded by our later, more detailed article on the same subject.)

In late 2000, a new QA Standard was introduced to replace the previous standard, AS/NZS ISO9001:1994. This document sets out some basic introductory information about the new Standard, including:

• the reasons for its introduction
• the types of changes in the new Standard, and
• implications for HCi clients.

Why a new standard?

There are various reasons why the new Standard was introduced. The main ones are:

• Every 5 years, there must be a review of the Standard to ensure its currency and maximum useability. The last version was released in 1994, and the new Standard is the result of the 5 year review.
• There were several problems with the current 20 element model, for example it was hard for small businesses to implement the old version, and some industries also had problems with it.
• The previous version was oriented to manufacturing, and more and more non-manufacturing organisations were seeking to use the Standard. This required a re-think and re-structure.
• There was a proliferation of guideline standards released in the last few years. These aim at 'explaining' and 'clarifying' the Standard for specific industries or industry groups. It has been recognised that these guidelines Standards are not efficient, and the revised Standard is intended to remove the need for most of them.
• Management in the past few years has improved to focus on process-related management styles. The old Standard did not easily cater for or promote these styles.
• There has been a general recognition of the need to go beyond certification towards process improvement, and the new Standard integrates this concept.
• Many organisations now embrace a variety of compliance or management systems, including HACCP, ISO14000, etc. The old Standard did not cater for easy integration or compatibility with these other systems.

Changes to the overall structure of the QA Standards

The previous Standard

The old Standards ISO9001, 9002, 9003, 9004 depended on the type of quality system model to be applied. In addition, there were various guidelines to their application, and guideline standards that explained tools, techniques and definitions used within the standards.

The new ISO9001

In the new system, the old distinction between ISO9001 and 9002 (the main standards for design and non-design certification respectively) DISAPPEAR. So have the old ISO9003 and 9004.

Instead, there are now two stand-alone standards, each complementing the other.

The new 9001:

• Is the ONLY standard against which certification can occur
• Is capable of being tailored to meet the organisation's specific systems and activities

If you do not do a particular activity (eg. service), you don’t have to bother about it (compare this to the old standard where you had to address just about every section whether it affected you or not). Under the new ISO9001, you can OPT OUT of sections of the standard.

However, you cannot opt out of activities you actually undertake (eg. design). You used to be able to do this through opting for ISO9002 over 9001 but this will not permitted in the new regime.

Organisations previously certified to 9002 will now be certified to 9001.

The new 9001:

• Has increased compatibility with other standards (eg environment).
• Is based on 8 quality management principles. These are:
  • customer focus
  • leadership
  • involvement of people
  • process approach
  • system approach to management
  • continual improvement
  • factual approach to decision making
  • mutually beneficial supplier relationship

The new 9004:

• Provides guidance about process improvement issues, concepts and implementation
• Is designed to take organisations 'beyond' the ISO9001 Standard

There is no certification to 9004 - it acts as a supplement to ISO9001 only.

The new ISO9001 provides details of Quality Management Systems fundamentals and terminology.

Implementation of the new Standard

There will be a transition cycle of 3 years. This means that organisations will retain their old certification until they are re-audited to the new Standard. This will usually occur at the next 'triennial' audit for the certified organisation. Newly certified organisations will be audited against the new Standard.

An important point to note is that some certifying bodies, including Standards Australia, will in future limit the use of the certification 'mark' where only a small part of the organisation is certified. This means that unless a substantial part of the organisation is within the scope of the certification, then the whole organisation will not be able to use the 'tick' mark on their stationery, etc. Only the relevant division/branch, etc will be able to use the mark. This provides additional incentive for whole organisations to get certified.

Summary of changes in ISO9001:2000

The new Standard has been reorganised into four main sections:

• Management responsibility
• Resources management
• Product and/or service realisation
• Measurement, analysis and improvement

Sequence

The new Standard:

• Requires the organisation to have procedures that describe the sequence and interactive nature of processes. This was NOT in the old Standard.
• Requires the organisation to have instructions for the control of process activities.

Continual improvement and management requirements

The new Standard:

• Requires organisations to clearly demonstrate the control of organisational change processes. This was not in the old Standard.
• Requires an organisation to have system level procedures to describe the use of the quality policy, objectives, audit results, analysis of data, corrective and preventive action and management review to facilitate continuous improvement.
• Requires top management to provide a framework for establishing and reviewing quality objectives for each function, and policies within the organisation.
• Requires top management to appoint a member of management with defined responsibility for quality, including ensuring awareness of customer requirements throughout the organisation.
• Requires that an organisation must specify any reduction in scope on the quality manual.
• Requires that management review must now include conformance analyses and use data analysis (statistical analysis) as an input to the management review process.
• Requires that measurement results must be used to maintain and/or improve processes.
• Requires the organisation to analyse applicable data to provide information on:
  • the suitability, effectiveness and adequacy of the quality management system
  • process operation trends
  • customer satisfaction and dissatisfaction
  • conformance to customer requirements
  • characteristics of processes, products and/or services

Customer satisfaction

The new Standard specifies that customer needs and expectations must be determined and converted into requirements with the aim of achieving customer confidence
Organisations are required to measure customer satisfaction and dissatisfaction.

Organisations need to:

• Strengthen procedures to review customer feedback, product conformance, process performance, changes, etc
• Implement customer liaison system with the aim of meeting customer requirements
• Use customer satisfaction as one measure of system performance

Top management must create and maintain awareness of the importance of fulfilling customer requirements.

Resources

The new Standard says that an organisation must define resource needs including information, human resources, office facilities and work environment.

The organisation must ensure that the infrastructure needed to achieve product/service conformity, including workspace and associated features, equipment, maintenance and supporting services is available.

The new Standard says that the organisation must monitor and implement resource needs and how they are fulfilled, including health and safety, work methods, work ethics and ambient working conditions.

It also needs to ensure that resources are available to fulfil all defined tasks.

The new Standard says that an organisation must ensure that its systems operate to define required competencies for roles and evaluate effectiveness of training at defined intervals.

It needs to inform and educate employees about the significant impact of their work activities on quality (actual or potential), the benefits of improved personal performance and the potential consequences of departure from specified procedures.

It also needs to establish and maintain procedures for internal communication between the various levels and functions regarding the quality management system and its effectiveness.

Document control

The new Standard requires that changes to documents are identified. This may mean both the fact of change and the nature of changes to documents.

Legal Requirements

The new Standard requires that an organisation must establish and maintain a procedure to identify legal requirements applicable to quality aspects of the product/service.

Terminology

The new Standard has more generic terminology, applicable to all sorts of businesses and not just manufacturers
It uses the term 'organisation' rather than 'supplier' and 'supplier' rather than 'sub-contractor'.

Compatibility with ISO14000

The Standard is be more compatible and integrates better with other standards.

Implications of ISO9001:2000 for HCi clients

It makes off-the-shelf documentation harder to apply.

It requires changes to and re-structuring of documentation for many organisations, particularly if they have structured their documentation around the '20 sections' of the old Standard.

It requires the introduction of some new processes, eg. customer satisfaction measures.

It means that some organisational divisions may become involved in the quality system where they might have avoided it until now (eg. HR, office services).

It may mean that an organisation may not be able to use the Standards mark if only a part of the organisation is compliant

This article may be reproduced only with the permission of HCi (email HCi ). Copyright HCi, 2001.

Additional keyword: ISO9000:2000