QUALITY ASSURANCE AND QUALITY SYSTEMS

ISO9000, ISO9001, ISO9002, ISO14001, ISO/TS 16949 And Quality Assurance

The Quality Management Systems Approach

All business transactions can be seen as a chain of events (or a series of interconnected processes) from initial customer contact to after sales service. We can call this chain the 'value chain'. The links in the chain might be made up of:

• Accepting an enquiry
• Preparing a quotation
• Receiving an order
• Planning (and may be designing) the job
• Purchasing supplies
• Making a product or providing a service
• Delivery
• After sales service

To understand the current status of ISO9000 registration we need to discuss both the 1994 and the new 2000 versions of the standard.

ISO9000: 1994 is a generic standard in several parts:

ISO9001: Quality Systems - Model for Quality Assurance in Design/Development, Production, Installation and Servicing.

ISO9002: Quality Systems - Model for Quality Assurance in Production, Installation and Servicing.

ISO9003 - Quality Systems - Model for Quality Assurance in Final Inspection & Test.

These are the three standards against which a company may be assessed and registered by a third party assessment body. Points to note:

• They differ in scope only. ISO9002: 1994 should not be considered a lesser standard than ISO9001: 1994.
  
  
• ISO9001: 1994 shows the requirements broken down into 20 key requirements or clauses.
  
  
• ISO9001:1994 incorporates all the requirements of ISO9002 plus additional requirements for product design. ISO9002 uses the same clause numbers as ISO9001 but under the clause headed: 'design control' states that this does not apply.
  
  
• The majority of registered UK companies have been assessed to ISO9002: 1994.
  
  
• ISO9003: 1994 is rarely applied and is used mainly by stockists, ie companies who buy and supply goods without adding any value.
  
  
• All companies currently certified to one of the ISO9000: 1994 series of standards must up-grade their quality system to address the requirements of the year 2000 edition within the next three years ie by December 2003, or they will loose their registration.

Very few organisations have up-graded to ISO9000: 2000 yet, because:

1. The new standard was only released in December 2000
2. The changes must be fully implemented and supported by 3 to 6 months records for successful certification.

There are a number of other parts of the ISO9000: 1994 suite of specifications and these are published for guidance and interpretation only e.g. ISO9004 - Quality Management and Quality System Elements Guidelines.

Benefits of Implementing A Quality Management System

The benefits of implementing Quality Management Systems to ISO9000:1994 have been so hotly debated that it often seems that everybody and his dog has some opinion about it.

Many of the criticisms have been made by academics, wishing to promote a different (ie their own) approach to Quality Management or by organisations that have balked against the changes required and not actually attempted to implement the requirements. Illustrated here are the benefits reported by organisations that have been successfully registered to the standard:

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ISO9000 - Is Just Good Management Practice

The Requirements of ISO9000 are not alien to a well run business, they are in fact a good common sense approach to controlling order processing, value adding activities and ensuring that systems and output are properly measured and managed.

Many businesses experience difficulties climbing the growth curve due to the problems highlighted in the box below:

One of the most effective tools for addressing these problems is the application of the Quality Management Standard, ISO9000. The most common reason for seeking approval amongst SMEs has been customer pressure and not as an aid to future growth.

Yet it is well recognised that without sound operating procedures and delegation of authority and responsibility the company's growth may be severely restricted.

Third Party Certification

Many of these benefits can be achieved by working to the requirements, however having the system independently assessed and registered gives customers confidence in the working and management of the system.

There are approximately 65 independent assessing bodies in the UK, who are themselves accredited by UKAS to carry out 3rd party assessments to ISO9000.

The 6 largest bodies in the UK, cover most industry sectors are:

• BSI - British Standards Institute
• LRQA - Lloyds Register Quality Assurance (largest internationally)
• NQA - National Quality Association
• BVQI - Bureau Veritas Quality International
• DNV - Det norske Veritas Quality Assurance
• SGS Yarsley

Criticisms of the ISO9000: 1994 standard

Following an extensive international review of the opinions of users of ISO9000:1994. The following are the most significant shortcomings which were identified:

• The standard has a significant number of parts and supporting sections which are often confusing.
  
  
• The text of the standard is biased towards manufacturing companies and often needs interpretation for service organisations.
  
  
• The standard does not support flexibility in the approach for companies of different sizes and complexity and can be bureaucratic for SMEs.
  
  
• More recent Management System Standards (e.g. ISO14000) are a different layout and this does not aid integration of management systems.
  
  
• The standard does not promote continuous improvement.

ISO9000: 2000 A New Approach

The ISO9000 standard was extensively re-written and reviewed by a vast number of users via a series of committee and discussion drafts during 1999/2000. The amended standard was issued as ISO9000: 2000 in December 2000.

ISO9000: 2000 became effective from December 2000. However there is an overlap period of 3 years during which, ISO9000: 1994 and ISO9000: 2000 are both valid.

Organisations seeking approval can choose to be registered to either ISO9000: 1994 or ISO9000: 2000 up to Dec 2003. (This enables companies to register, who were developing their systems to ISO9000: 1994 at the time the new standard was released.)

ALL organisations certified to ISO9000: 1994 are required to up-grade to meet the ISO9000: 2000 requirements by Dec 2003 or they will loose their registration status.

ISO9000:2000 is a generic standard with different parts:

ISO9001 - This is the only part of the new standard against which an organisation can be certified. It replaces the former standards ISO9001: 1994, ISO9002: 1994, ISO9003: 1994

When assessed to the new standard the organisation's operations will be defined in a scope of approval. The assessing body will review this to ensure it reasonably represents the range of services offered to the market place.

In the past it has been possible for companies to register only a small part of their overall operation to ISO9000. This will not be so possible under the new rules. The assessing body will be required to ensure that there is no possibility of the extent of the approval being misinterpreted.

The scope of approval will cover such operations (as appropriate)

• Manufacture
• Service Delivery
• Sales and Marketing
• Distribution
• Installation
• Product Design
• After sales servicing

The number of supporting documents to the new standard has also been reduced.

In addition to above, You can read:

• The Eight Guiding Principles of ISO9000: 2000
• Advantages of the ISO9000: 2000 standard over the 1994 Edition
• The concept of Continual Improvement
• Implementing ISO9000: 2000 from scratch
• Up-grading Existing Systems to meet ISO9000: 2000
• Integrated Management Systems

ISO/TS 16949 and TS 16949 training

Get this comprehensive quality assurance document on ISO9000, ISO9001, download from here

ISO14001 can also be downloaded from here

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