FAQ 6

Q  What's involved in achieving ISO9000 registration?

A  ISO9000 requires that you have a system which meets the requirements of each of the Clauses of the standard. These include defining:

• The responsibilities of Top Management
• How staff are trained to do their job
• How suppliers are selected and monitored
• What checks are made on incoming goods
• What checks are made on outgoing items
• Controls of equipment which used used to produce or test your products or services
• The checks made to ensure that the system is working properly
• The recording and collection of  information about problems that are encountered
• The controls of the various documents used
• How the system is monitored and improved

But, you don't need for procedures for all of these activities. 

• For most of them, you only need to conduct the required activities and keep records that demonstrate this. 
• In some cases, ISO9001 also requires that you keep a record of certain activities.
• There are only 6  types of activity for which ISO 9001:2000 states that you must have a procedure (possibly 7 if any of your processes require validation)

If a sub-section of Clause 7 of the standard does not apply to your operations (e.g. you do not perform any after-sales servicing activities, etc) then you do not need to have procedures to cover the activity. However, your Quality Manual needs to state that the requirement does not apply, and to justify the statement.

Although the standard refers to "documents", these can be in printed or computerised formats. Indeed, many of my Clients now have completely paperless ISO 9000 systems produced by myself.

By determining what you actually do and then seeing how it can be improved, you will soon meet many of the requirements of ISO 9000. 

In addition, there are a few activities which the standard requires that you will probably not be conducting at present:

• A defined organisational structure
• Internal Quality Audits
• Management Review
• A formal training system

A defined organisational structure : Although you may already have an organisational chart, this section of the standard requires that the authorities and responsibilities of relevant people are clearly defined. This usually means an improvement on whatever exists in your organisation at present.

Internal Quality Audits : At present the head of the company may walk around and make comments about things he wants improved. An Internal Quality Audit is similar, except that it is conducted by a person with "no axe to grind", on a regular and systematic basis. The findings are recorded and solutions to any problems are agreed with whoever is responsible for the operation of the area in question. At an agreed time, a re-audit is conducted.

Management Review : Your company may well have Board meetings or Senior Management meetings, etc. The standard requires that you have a regular (every 3 -6 months is normal) meeting of the senior management where problems are brought to their attention and solutions determined. (The problems need not be individually brought to their attention. An analysis of trends is normally relevant) After this, the solution is implemented and then the result brought back to the next meeting, where the matter can be dropped or further solutions determined.

ISO 9000, when properly installed by an experienced consultant, will help to firstly standardise the tasks involved, and then to review problems and incrementally improve the system.

Formal Training System : You should already be aware of the previous experience and/or training of your staff. You should be aware of the required abilities needed to accomplish the various tasks within your organisation. You should also be aware of the abilities of your staff. Also, you should be aware of any future changes to your operations which may involve a requirement for new skills (new equipment, new products, etc)

By combining these facets of your knowledge, you will arrive at a set of requirements for further training, (on-the-job, external, etc) which will ensure that your staff are able to conduct the required tasks.

You should note that although the standard requires that you control most aspects of your business, it does not require that you have procedures to describe most of them. You will need to produce suitable records to prove that you conduct the activities in a suitable way, but you do not necessarily need formal procedures for most activities. However, in many cases, you may it useful to at least have a list of bullet-points which describe the basic flow of operations.