| ISO 17025 Quality manual |
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| Written by R2Launch |
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ISO 17025, "General requirements for the competence of testing and calibration laboratories" is an ISO standard differs from "ISO 9000 in that it takes quality management systems a stage further by looking at the competence of the laboratory as well as the fitness for purpose of the quality management system. Predecessors
Some national systems (e.g. UKAS M10 in the UK) were the forerunners of ISO 17025:1999 but could sometimes be exceedingly prescriptive. ISO 17025 allows laboratories to carry out procedures in their own ways, but an auditor may require the laboratory to justify using a particular method. In common with other ISO quality standards, ISO 17025 requires continual improvement. Regular internal audits are expected to indicate opportunities to make the test or calibration better than it was. Additionally, the laboratory will be expected to keep abreast of scientific and technological advances in relevant areas. Unlike most ISO standards for systems, third party auditing and appraisal of the laboratory is not usually carried out by a certification body, but by the national organisation responsible for accreditation. Laboratories are therefore "accredited" under ISO/IEC 17025, rather than "certificated" (c.f. ISO 9000 series). The original standard, ISO 17025:1999 was withdrawn and replaced by ISO 17025:2005, though the differences between the two standards are small. Accreditation BodiesIn the US there are multiple Accreditation Bodies, NVLAP, L.A.B., Perry Johnson Laboratories, ACLASS, A2LA, ILAA and others. In other countries there is usually at least one Accreditation Body. The first laboratory accreditation bodies to be established were NATA in Australia (1948) and TELARC in New Zealand (1973) most other bodies are based on the NATA/TELARC model and include UKAS in the UK, FINAS in Finland and DANAK in Denmark to name a few. In order for accreditation bodies to recognize each others' accreditation, the International Laboratory Accreditation Cooperation (ILAC) worked to establish methods of evaluating accreditation bodies against another ISO standard (ISO/IEC Guide 58 - which became ISO/IEC 17011). Around the world, geopolitical regions such as the European Community, and Asia-Pacific, the Americas and others, established regional cooperation’s to manage the work needed for such mutual recognition. These regional bodies (all working within the ILAC umbrella) include European Accreditation Cooperation (EA), the Asia Pacific Laboratory Accreditation Cooperation (APLAC), Southern Africa Accreditation Cooperation (SADCA) and the Inter-American Accreditation Cooperation (IAAC). Within the United States of America, an organization was started to mutually recognize the work of these bodies. It is the National Cooperation for Laboratory Accreditation (NACLA). Many people perceive these arrangement bodies to be oversight groups for accrediting bodies, but they are really there to help accreditation bodies mutually recognize each other in a systematic and formal way. They also help regulators by formally recognizing the processes and competence of the accrediting body. They help build trust between accrediting bodies and for their biggest stakeholders - labs, the public and regulatory agencies. Within the USA, both A2LA and, as of April 2006, NVLAP, have decided to remove themselves from NACLA citing redundancy in accreditation as well as financial issues. A prerequisite for a laboratory to become accredited is to have a documented quality management system. The usual contents of the quality manual follow the outline of the ISO 17025 standard. This is as follows: 1.0 Scope 2.0 References 3.0 Terms and Definitions 4.0 Management Requirements 4.1 Organization 4.2 Management System 4.3 Document Control 4.4 Review of Requests, Tenders, and Contracts 4.5 Subcontracting of Tests and Calibrations 4.6 Purchasing Services and Supplies 4.7 Service to the Customer 4.8 Complaints 4.9 Control of Nonconforming Testing and/or Calibration Work 4.10 Improvement 4.11 Corrective Action 4.12 Preventive Action 4.13 Control of Records 4.14 Internal Audits 4.15 Management Reviews 5.0 Technical Requirements 5.1 Technical Requirements - General 5.2 Personnel 5.3 Accommodations and Environmental Conditions 5.4 Test and Calibration Methods and Method Validation 5.5 Equipment 5.6 Measurement Traceability 5.7 Sampling 5.8 Handling and Transportation of Test and/or Calibration Items 5.9 Assuring the Quality of Test and Calibration Results 5.10 Reporting the Results
Section 4.2 Management System outlines the documentation requirements for a laboratory. Specifically stating "The laboratory shall establish, implement and maintain a management system appropriate to the scope of its activities. The laboratory shall document its policies, systems, programmes, procedures and instructions to the extent necessary to assure the quality of the test and/or calibration results." ISO 17025" Subclause 4.2.5 states that "the quality manual shall include or make reference to the supporting procedures including technical procedures. It shall outline the structure of the documentation used in the management system." ISO 17025" Furthermore, ISO 17025 requires a laboratory to document procedures for the following activities:
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