ISO 9001 preparation for registration
This is first and foremost a business decision. You must determine what you expect to gain from registering to the ISO 9001-2000 standard. In some cases your customers demand this registration. Registration is not cheap. For an organization with 100 people it is usually around $10,000 for the registration and there are annual audits that must be conducted that will cost approximately $4500. Different Certification Bodies have different rates. The numbers I am quoting here are average.
It may be a good idea to audit your organization for compliance to the standard. Buy a copy of the standard. Electronic is the best choice, you can load it on your computer and print out copies when needed. Study the standard, there is no confusing language. There is a standard that has definitions to explain exactly what is meant by some of the common words or phrases. It is referenced in the ISO 9001. It is the ISO 9000.
The audit process can be done by your own organization if you feel that you have a good understanding of the requirements, or you can hire a consultant or an auditor. I can provide the names of individuals that are fully qualified and do excellent work.
Once you have a full assessment of your Quality Management System and have reviewed the results at your Management Review you can make a decision to take action. Decide to contact a Certification Body (CB) referred to as a Registrar. Make certain the CB is registered to ISO 17021, or the ISO International community will not recognize the registration. You can have the CB schedule and conduct a Preliminary assessment. This will give you an idea of how you well your organization will do during an initial registration.
Registrations are conducted in 2 parts, the Stage 1 or Document review and the Stage 2 the initial assessment. If you want a preliminary assessment, make sure you have the CB conduct a Stage 1 at the same time. It saves money. The only risk is you must have the Stage 2 conducted within the timeframe determined by the CB, usually 6 months. Each CB must have a set of procedures describing how they will administer the Certification process. Their procedures must comply with ISO17021 and they must conduct business according to their own procedures.
Another path of pursuing registration is to contract with a consultant to act as a guide and help draft procedures and train employees. This method while the most expensive process at first, may be the cheapest in the long run. A good consultant can save you money even before the registration by showing you how to cut waste out of your processes. The consultant has seen the operations of hundreds of other organizations and will share with you the best practices. Albeit he can’t divulge anything that is proprietary, there are a number of processes for handling procedures and records that if done incorrectly can really eat your lunch. A good consultant can show you ways to reduce time for returning quotes or more effectively handling corrective actions. They can save you money on calibrating tools by showing your ways you can do it yourself.
If there are specific questions you have about the standard or the process send me a note. I will happy to answer any questions. That is the intent of this website.