Understanding ISO 9001:2000 can be difficult to the new comer. Then having the responsibility of trying to interpret and apply the standard to one’s organisational activities and management practices can seem like a headache.
QA-Z Consulting Specialists has provided information aiming at demystifying the intent of ISO 9001:2000 for the newcomer and existing Quality Managers. The task still remaining will be the know how to apply the concepts to one’s own procedures. However, having some explanation should be of considerable assistance.
Difference between documents and records: Records are historical evidence of some activity occurring. Documents do not record historical evidence of a member of staff or customer.
Documents can be drawings or diagrams, flowcharts, words on audiotape, images on videotape, company policies, machine operating instructions, standards, (external), procedures, management systems etc and information available from computers. Therefore, the control must be able to address all types of medium.
Control: Quality system standards are universal in their insistence on close and effective control of documentation throughout the Quality Management System. If documentation is essential to the system then control of that documentation is essential to the implementation and maintenance of the system. The system for control of documents must cover the total lifespan of each document.
For example, if an organisation installs fire extinguishers, then documents such as the templates of forms used to ensure that testing is undertaken, templates of forms on which customer details get recorded etc must be controlled. The control over the form’s lifespan will continue with the requirements of Record Control in the Standard.
Methods of control vary from organisation to organisation and between industries. Control is a specific and unique application not determined within the Standard. The only requirement of the Standard is what is to be controlled, not how.
Approval of documents applies to the method or procedure for approval to be undertaken when a new document is created, or an existing one changed. It must be shown what happens when documents are updated, how the re-approval occurs.
Those who create documents must know what is expected of them, for example, the status must be updated by one increment, either the date changed or the issue number changed and approval procedures understood etc.
The document controller must make sure that documents are available at points of use. For example, machine operating manuals, forms where necessary for use (either available electronically or manually).
Documents must remain readable and clearly titled. External documentation such as standards must be shown to be clearly identified, and distribution and collection controlled.
Control of documentation can either make or break a business of any size. This is always thoroughly checked during external assessments by Quality Auditors.