ISO 9001:2008 is an international standard that defines the requirements for a quality management system, the system by which your company can ensure that all of your processes are controlled and repeatable to ensure the quality of your products and services.
Your processes are normally controlled through the presence of and the audit of written quality ISO9001 procedures which define what has to be done.ISO 9001 defines best practice for each process within your organization to ensure control, however it only defines 6 mandatory procedures that you must have;
- Control of Documents (4.2.3)
- Control of Records (4.2.4)
- Internal Audits (8.2.2)
- Control of Non-Conforming Products (8.3)
- Corrective Action (8.5.2)
- Preventive Action (8.5.3
What is a Quality Procedure
A procedure is a statement of what will be done, when it will be done, and by whom. It is a set of instructions and intent that anyone in the company can follow (Not a top secret company document for management eyes only as one quality manager once told me!) It is a specific way to carry out a process, a set of clear instructions that the staff can refer to help them understand and conduct their daily work in an efficient and repeatable manner.
ISO 9001 says that only certain requirements within your quality management system have to have a documented procedure, other procedure requirements depend on the size and complexity of the processes and the overall system as well as the competence of the staff.
Simple ISO 9001 Procedure
Writing an ISO 9001 Procedure
An ISO 9001 procedure does not have to be a hundred page document telling the individual how and when to pick up a pen, check that there is ink of the correct hue before forming letters in the specifically highlighted box on form no.XYZ. Too many people and organizations over-complicate their ISO 9001 procedures.
If you split your procedures and work instructions then the procedures themselves can be very simple, remember that they only have to contain the right amount of information for the people doing the job to do it efficiently and in the best proscribed way. If your people are of high quality, well trained, experienced, or the process is very simple and obvious then there may be no need for a procedure at all.