ISO 17025 Manual and Documentation requirements for Laboratory Accreditation

ISO 17025 Laboratory Manual is a reference book provides information about internal procedures to be used as an agency policy for consumer testing, training of laboratory staff, report writing, security, research, evaluation of private laboratory reports and court testimony.

The laboratory must describe the QMS have a manual. ISO 17025 Manual, the organization and format of the documents in the QMS, as well as the roles and responsibilities of the personnel responsible for managing the QMS and to outline for the management of the technical procedures. The quality manual should also document the administrative, organizational and scientific aspects of the work of the laboratory necessary for the proper management.

ISO 17025 Manual is beneficial in following manner

• Recognition of technical competence for standard methods, non-routine methods and laboratory -developed methods we perform
• Inspection and product certification capabilities and / or services
• The overall quality of our administrative and technical system
• Audits by customers, regulatory authorities and accreditation bodies
• Comply with the requirements of ISO 17025 and ISO 900
• Customer satisfaction

The laboratory should also have an effective documented system for the secure storage of samples, both before and after examination; correlating the samples to other information provided with them, identifying any sub-samples prepared from the samples, and showing the progress of analysis, date of issue of the report of analysis and the date and subsequent means of disposal of any remaining sample after analysis. The system should be designed and operated to ensure that samples cannot be confused physically or when referred to in records or other documents

The use of ISO 17025 Document Packages ensures that the work being performed is under control and achieves its intended purpose, that the requirements of international quality standards are fulfilled and that the results of analyses of seized materials or biological samples can be used with confidence in any subsequent legal proceedings. The documentation should be readily available in the laboratory and accessible to all relevant staff. It should be continuously reappraised and updated to ensure that changing circumstances are taken into account.

The quality manager should ensure that all aspects of the laboratory's work are documented in the QMS and that new documents are created by competent personnel and authorized by designated staff before being issued. The quality manager should also ensure that all documents are subject to periodical review and, where necessary, revised to take account of changing circumstances and incorporate best practice. Once approved, the quality manager should arrange for documents to be made available to all relevant staff in their workplace. When changes have been made to existing documents, the quality manager should make sure that the changes are highlighted in the latest versions.

Henry Nelson has published many articles regarding ISO Certification. Henry has rich experience as a online publisher and prepared various Certification documents as per ISO guideline since large amount of years in his professional career.