Keeps in Mind while Preparing ISO 17025 Documents for Laboratory Accreditation

ISO 17025 documents provide interpretative criteria and recommendations for the application of ISO/IEC 17025 in all fields of testing and calibration for both applicant and accredited facilities. Applicant and accredited facilities must also comply with relevant field ISO/IEC 17025 application documents and any annexes, policies and/or technical circulars.

To help laboratories establish a program for a laboratory management system that is suitable for their size and workload, and that will meet their clients' needs Laboratories should document their policies and procedures for selecting subcontractors. Accredited laboratories using subcontractors are responsible for ensuring that the subcontractor has a satisfactory quality system and is competent to perform. ISO 17025 Document for Laboratory Accreditation will give guidance on ways that a laboratory may choose to fulfill the requirements of ISO/IEC 17025.

It is a good idea to describe the laboratory's documentation hierarchy in the quality manual. This usually consists of a documentation pyramid with the ISO 17025 Manual at the top, then Standard Operating Procedures and Work Instructions. There are no specific titles required for the hierarchy; one may call these documents anything that is appropriate and works for any organization. You should also refer to the second and third tier documents in the Quality Manual, where it is appropriate to refer to them. For instance, when someone describing their Internal Audit Program in the Quality Manual, it would be appropriate to refer to the Internal Audit Procedure.

It is important to assure that controlled documents are periodically reviewed to ensure their continued suitability for use, and their compliance with applicable requirements. Reviews should be done on an annual basis; however, ISO/IEC 17025 does not specifically require this. The object of the review is to determine whether the document continues to be suitable for use and compliant, or whether a revision will be necessary.

Points need to look after while documentation reviewing…..

• Documents are reviewed and approved by authorized personnel prior to issue, and are included on a master list which identifies the revision status and distribution.
• All necessary quality documentation is available where required, reviewed and revised to maintain suitability.
• Documents are removed where obsolete and suitably marked if retained for their legal or know ledge preservation purposes.
• Quality system documents must be uniquely identified and include:

1. Date of issue and/or revision identification
2. Total number of pages or a mark to signify the end of the document
3. Issuing authority

Michel Adrien has published so many articles regarding ISO Certification Documentation. As ISO Consultant profession since last many years Michel has rich experience in preparing such certification documents within ISO guideline to his global clients