ISO 9001:2000 contains all of the requirements which you must address within your Quality Management System (QMS) to be certified. Most of these requirements could be considered by many organisations as 'common sense' topics which they probably already satisfy, e.g. sales, production and service provision, purchasing, control of records and files etc..

Because ISO 9001:2000 is generic in its nature, it is as relevant to a small single-person organisation delivering fresh flowers as it is to a large multi-national blue chip computer company.

The standard comprises of 8 clauses, which are:

1 Scope
2 References
3 Terms and definitions
4 Quality management system
5 Management responsibility
6 Resource management
7 Product realisation
8 Measurement, analysis and improvement

Clauses 4, 5, 6, 7 & 8 contain the operational control requirements which your auditor will assess during the on-site audit.

Scope of Registration

The ‘Scope of Registration’ is the description of the type of operations and processes that have been assessed during your audit so it is important to ensure that this is as prescriptive as possible. The auditor selected to conduct your assessment will have knowledge of your particular sector of work so most of the audit will be conducted using a ‘common-sense’ approach based on this knowledge. The ISO standard specifies controls that should be applied to each of the processes associated with how you work from enquiries to delivery.

All elements of ISO 9001 must be addressed. However, certain elements of the standard which may not be relevant to your type of operation can be ‘excluded’ as long as you declare and justify this before or during the audit process.

This will apply when:

• The ‘exclusion’ does not affect your ability to meet specified customer and regulatory requirements
  
  
• The ‘exclusion’ does not affect your ability to provide the correct products or services
  
  
• ‘Exclusions’ can only be justified if they are related to Clause 7 (Product realisation) of ISO 9001

The company's quality manual must also clearly identify why specific requirements of ISO 9001 have been excluded and the justification for that exclusion.

Certification and Accreditation Marks

As an ISO 9001:2000 Certified Company you will be supplied with, and are entitled to display, AJA and Accreditation Body (UKAS for example) Certification marks. There are certain restrictions on their use (which you will be advised of, but they are a perfect way to market your achievement of being assessed and registrared to the requirements of ISO 9001:2000.