This is an internal standard of quality set by the lab

They must be validated and accessible to all users In an LQM program, methods must be written in a consistent format through the lab. Laboratory quality management requires that all employees performing analytical procedures must be competent and trained by quality trainers. All accreditation organizations require that some form of a quality manual exist for each lab. The standard requires that the lab have written policies covering the selection and training of lab personnel, environmental conditions of the lab, test methods and validation, equipment and instrumentation, measurement traceability, method verification, sampling, as well as sample handling protocols.Īll of these policies are contained in the laboratory quality manual. The ISO/IEC 17025 Standard requires that the lab have writtenpolicies regarding organization, management review, document controls, contracts, purchasing, complaint handling, control of non-conforming test results, corrective action protocols, audits, and continual improvement. There are five key parts of a laboratory QMS: An electronic document control system provides this kind of assurance. The accreditation process includes a review of management systems and an assurance that a laboratory has a quality system that is documented and fully operational. The best time to get a laboratory quality management software system may be before accreditation rolls around. There are usually multiple copies of these binders in different parts of the lab, making updating these documents very time-consuming and error-prone. Many laboratories keep their policies and procedures in physical binders, trying to keep up with the endless paper trail of revised standard operating procedures and policies. Each document must be created, updated, approved, and archived in specific ways, or a laboratory will have deficiencies on the accrediting agency’s checklist. Additionally, in order to comply with accreditation, laboratories must establish an effective document control system. Document control is essential to the safety and efficacy of a lab. The best scenario would be that the day the lab opens, a laboratory QMS is in place.

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