A common belief is that the standards’ requirements are satisfied if detailed procedures exist to define a system. Additionally, many managers and executives think that the ISO 9001 documented procedures for every element in the company results in better control and accountability. The nature and type of documented information that an organization needs to maintain or retain is dependent on the context and its operating environment. Although no requirements are enumerated in these standards for procedure format, more emphasis is placed on this than on the information contained within the procedures.
ISO 9001:2015 defines documented information as meaningful data that is required to be controlled and maintained by the organization and the medium on which it is contained. ISO 9001 documentation process is the way of creating control of documents. To be able to control the usage of correct and current documents, a master list of documents is prepared. It helps in simplifying the documentation requirement and may also lead to creation of an effective cross-referencing documentation system thus further simplifying the processes.
ISO 9001:2015 requires a documented procedure for controlling a nonconforming product. The standard doesn’t describe what the documented procedure should look like, how it should be titled, or even how it should be controlled. ISO 9001 doesn’t state that a scope, purpose, reference documents section, or any other type of format is required. The documented procedure can be a flowchart, a one-page instruction sheet, or a 15-page detailed document. It’s always the company’s requirements, although some of Ready-to-use ISO 9001:2015 document packages are available in the market that helps Organizations and provide good reference material to accelerate the process.
QMS 9001 documentation provides the following benefits and objectives:
- Communication of Information – needed by the organization to plan, operate and control its processes. The type and extent of the documentation will depend on the criteria listed above, as well as the degree of formality of communication systems and the level of communication skills within the organization, and the organizational culture.
- Evidence of conformity – provides evidence that what was planned and what has actually been done.
- Knowledge reservoir and sharing – to preserve and disseminate the organization’s experiences; business and technical know-how. A typical example would be a technical specification, which can be used as a base for design and development of a new product.
- Training tool – to train personnel in performing their responsibilities
- Consistency of performance – by having all personnel perform to the same method, practice or procedure
- Promote best practice – document the best way of performing activity using internal and external knowledge