FAQ 2

Q - What is the purpose of this site?

A - Dr Terry Russell, CEO of CENTRE FOR ISO9000 says: "My intention in providing this site is to help you to produce your own ISO9001 / ISO14001 / OHSAS18001 / ISO27001 system without spending a fortune in doing so. I want you to be able to produce a system which is of benefit to your organization". 

He goes on to say that he "wouldn't mind getting a modest income for his hard work and for the hard work of colleagues at Centre for ISO9000".

There are many ISO9000 systems which seem to be millstones around the necks of the businesses that use them. There is no need for this. A good business management system will meet the requirements of ISO 9001:2000. A good ISO 9001:2000 system will help an organization to grow and become more efficient.

Q  - What is ISO 9000 all about, anyway?

A - The purpose of ISO 9000 is to ensure that you meet your Customers requirements, and continue to improve the way in which you do so.

ISO9000 is a system where the things that tend to lead to good quality are properly managed, e.g.:

• understanding your customer's requirements, 
• planning the work effectively,
• supply of adequate training, equipment and information for the work processes,
• monitoring of the processes and services/products supplied to Customers
• continually improving the management of the processes

It also requires that:

• you keep records of certain activities (such as reviews of Customer orders, records of staff training, etc).
• (for a limited number of types of activity) you have written (printed or in electronic format) procedures which describes how an activity is conducted (such as Control of documents, Internal Quality Auditing, etc).
• you determine if your organization requires any other written instructions to ensure that staff conduct their work correctly (note, it's your decision!).

You must conduct your own checks ("Internal Quality Audits") in order to review how well your system is meeting ISO 9000 requirements and the requirements of your organization and of its Customers.

Also, the effectiveness of how your organization meets the requirements is then assessed by an impartial third party* - the "Quality Registrar" or "Certification Body" - BEWARE OF UNACCREDITED BODIES - CHECK THE UKAS OR ISO SITE FOR LISTS OF ACCREDITED BODIES!

If minor problems are found, your organization is given time to correct them, thus improving the effectiveness of the system. This means that you must keep enough records to prove that you are meeting the requirements. Sometimes this may result in keeping a record which you might no do so otherwise, but most organizations already keep enough records.

Q  - What's the history of ISO9000?

A - In 1979, the British Standards Institute published a series of standards, known as the BS 5750 series, for use by manufacturing companies. This was based on the more military product-specific NATO manufacturing standards, although substantially modified for application to Quality Management systems. This standard was enforced through assessments and audits.

In 1987, the British Standards Institute revised the standard to include service-providers as well as manufacturing companies. Additional requirements on internal verification by the company were added and the standard was generally clarified and strengthened. In 1988, the BS5750 standard was adopted by ISO without changes and was published internationally under the ISO 9000 name.

In 1994, ISO 9000 was again revised and published internationally. The changes involved the correction of some mistakes within the standard and more importantly, clarification of what was actually meant by many sections. In particular, the sections covering Process Control, Corrective Actions and, Servicing were strengthened and clarified.

In December 2000, the standard was re-structured. Although the new standard has many similarities to its previous version, there are many changes in emphasis. In particular on continually improving processes and products, and a reduced emphasis on the need for procedures.

It has also been substantially restructured so as to make the grouping of the requirements more sensible.

In addition, the various versions of ISO 9000 were withdrawn:

• ISO 9002, which was ISO 9001 without the design elements
• ISO 9003, which was only concerned with activities relating to final inspection of goods

These were replaced by ISO 9001:2000. Rather than selecting ISO 9001, ISO 9002 or ISO 9003, you now need to show which sections don't apply and give a good reason why they do not.

In October 2008, the standard will be updated once more. The changes will be quite trivial, being mainly concerned with moving some sentences into a more consistent order. However, there a few changes that may affect your system.

There are a number of other standards and guidance documents which have been amended to reflect the requirements of ISO 9000. For example :

The U.S. Food and Drug Administration (FDA) has revised its Good Manufacturing Practice (GMP) regulations for medical devices to follow ISO 9001 with appropriate additional requirements.

CEN and CENELEC have issued European standard, EN46001 - Specific Requirements for the Application of EN 29001 (ISO 9001) to Medical Devices. Medical device manufacturers doing business in the EC must comply with the quality system requirements of EN 46001, as well as those of the CE Marking requirements (described elsewhere on this web site).

The International Organization for Legal Metrology (OIML) has developed a document entitled: "Quality Assurance as Applied for Initial Verification of Measuring Instruments, " which provides guidance on the applicability and use of the ISO 9000 Standard Series in the manufacture of measuring instruments.

Today, the ISO 9000 series has all but replaced other, more parochial standards. In only a few short years, the term "ISO 9000" has become synonymous with quality - not just in English, but in most every language used to conduct trade and commerce.

Q - Is ISO9000 going to change?

A - Yes. The standard is constantly being reviewed and improved.

According to ISO procedures, all ISO standards, including those in the ISO 9000 series, must be reviewed and revised or reaffirmed at least once every five years. 

ISO9000 and related standards:

• The 2008 version of ISO9001 is now being drafted. See Terry's review of the latest draft.
• The Fundamentals and Vocabulary standard, ISO9000 was last updated in 2005.
• The Quality Standard, ISO 9001 was last updated in December 2000. 
  It replaced the former ISO 9001, 9002 & 9003, 1994  versions. 
  Next update  is due October 15th 2008.
• The Auditing Standard, ISO 19011 was last updated/issued in October 2003. It replaced the former ISO 10011.

Q - What does the term "FAQ" actually mean?

A - I don't know. It is a frequently asked question to which we have never found the answer. We will update this page if we ever find out.

Also, any organisation in receipt of Government or Local Authority funds, Lottery funds, etc is not permitted by the Government to accept non-UKAS accredited ISO 9000 certificates (Check the UKAS Web Site to see the Memorandum of Understanding between the UK Government and UKAS, which defines this aspect).