Quality Management:Quality manual/Procedures/Control of documents

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In order to maintain this assurance a documented quality system has been developed to ensure and demonstrate that all work undertaken conforms to specification requirements. The system is structured in five levels.

  • Level 1: Policies – key system objectives
  • Level 2: Quality Manual – approach & responsibility
  • Level 3: Procedures – methods (Who, What, Where & When)
  • Level 4: Work Instructions – description of processes (How)
  • Level 5: Forms, Data & Records – evidence of conformance

All of the Quality Management System documents are controlled according to the Document Control Procedure (QP1). This procedure defines the process for:

Approving documents for adequacy prior to issue

Reviewing and revising as necessary and re-approving documents

Ensuring that changes and current revision status of documents are identified

Ensuring that relevant versions of applicable documents are available at points of use

Ensuring that documents remain legible and readily identifiable

Ensuring that documents of external origin are identified and their distribution controlled

Preventing the unintended use of obsolete documents

Ensuring that documents of external origin are identified and their distribution controlled The company uses standard forms and a local area network computer system with an electronic document management system which are updated as required. Documents which must be controlled but are not limited to:

Specifications and drawings

Process work instructions

Quality manual, mandatory procedures and associated forms

External documents Controlled documents are identified with a document name and document number

Procedures are referenced according to the ISO 9001:2008 element number

References

  • ISO 9001:2008 chapter 4.2.3
  • See all references here: References.