The One And Only Requirement Of ISO 9001:2008
As part of developing this web site, I have been searching for ways to present the requirements of ISO 9001:2008 in the most simple form. Well, here it is ---
The one and only requirement of the ISO 9001:2008 is documentation!
If you want a document stating that your facility or faculties are ISO 9001:2008 certified then you must have documentation to prove compliance to the standard. They only way to prove compliance is documentation. When a registrar shows up at you door for your certification audit, you can try to convince them that you are compliant verbally but you will fail. You must present them with documented proof of compliance so they can complete a their documentation (report).
This drastic simplification is true for any audit based certification. If your company is public, you must have documents showing where all the money came from and where it went to pass an SCC audit. Auditor can’t take your word on anything, they must have the facts and the documents establish the facts.
Yes, the ISO 9000 standard includes a long list of items that must be addressed by a certified company . Many of there requirement specifically list documentation. A company quality manual is a requirement is obviously a documentation requirement. Operational procedures also an obvious documentation requirement. But now let’s look at some the more intrinsic elements of the standard.
The standard states that the company shall have a customer focus. This means that the company must maintain documentation showing that they focus on their customers. This is usually done by some form of customer feedback or customer satisfaction process that generates records (documentation) showing satisfied customers.
The result of the customer feedback or customer satisfaction are part of the input for management review meetings. Both the input and output from these meetings are considered quality records that should be maintained in according to the document control procedure. Every company meets to discuss quality but ISO certified companies must document these meetings.
The only way to show an improvement is by maintaining records that show a change to the documentation. The engineering change records (documents) are usually used to demonstrate that the product and service are continuously improving.
For most companies the biggest change in their design process is the requirement to generate organized documentation of the design process. The ISO standard formalized the need for design notebooks (documentation) to demonstrate that the product development process uses input and confirmation of output.
The result of internal audits is additional documentation to show that all the elements of the quality system are working and are in compliance with the ISO standard. The result are considered quality records and they are documentation.
OK, I hope that make the point and I hope that this helps companies that are confused about the requirements of ISO. In the most basic terms, the ISO standard only requires one thing – DOCUMENTATION.
The good news is that there are plenty of resources to help you create and maintain your documentation in an efficient way. This web site contains resources, both free samples and links to outside resources, to build a compliant quality system and pass a ISO 9001:2008 certification audit. Don't waste your time creating from scratch something that has been done before.