Part1Managementandinfrastructure研讨.ppt

World Health Organization * * 3. Control of documentation 3.1 Documentation is an essential part of the quality management system. The laboratory should establish and maintain procedures to control and review all documents (both internally generated and from external sources) that form part of the quality documentation. A master list identifying the current version status and distribution of documents should be established and readily available. The distribution and retrieval of documents (SOPs, and specifications etc.) should be done in a manner to ensure that current documents are used, and that superseded documents are retrieved. World Health Organization * * (a) each document, whether a technical or a quality document, has a unique identifier, version number and date of implementation; (b) appropriate, authorized SOPs are available at the relevant locations, e.g. near instruments; (c) documents are kept up to date and reviewed as required; (d) any invalid document is removed and replaced with the authorized, revised document with immediate effect; (e) a revised document includes references to the previous document; (f) old, invalid documents are retained in the archives to ensure traceability of the evolution of the procedures; any copies are destroyed; (g) all relevant staff are trained for the new and revised SOPs; and (h) quality documentation, including records, is retained for a minimum of five years. 3.3 A system of change control should be in place to inform staff of new and revised procedures. The system should ensure that: (a) revised documents are prepared by the initiator, or a person who performs the same function, reviewed and approved at the same level as the original document and subsequently released by the quality manager (quality unit); and (b) staff acknowledge by a signature that they are aware of applicable changes and their date of implementation. World Health Organization * * ? 4. Records ? 4.1 The laboratory should establish and mainta