MNS ISO/IEC 17025:2007

MNS ISO/IEC 17025:2007

General requirements for the competence of testing and calibration laboratories

Сорилтын болон шалгалт тохируулгын лаораторийн чадавхид тавих ерөнхий шаардлага
1 Scope 1.1 This standard specifies the general requirements for the capacity to carry out sampling, testing and / or calibration. This standard covers tests and calibrations using standard methods, non-standard methods, and methods developed by the laboratory. 1.2 Standards can be applied to any organization that tests and / or calibrates. For example, the first, second and / or in-house laboratories, tests and / or calibrations are the laboratories that are part of the verification or completion assurance engagements. This standard is applicable to all laboratories depending on the number of employees, depending on the size of the test and / or calibration work. If the laboratory does not carry out one or more of these activities, such as redistribution or the new method of handling / processing, do not apply the relevant clauses. 1.3 The texts, examples and clauses have been clarified in the statement. They do not necessarily reflect the nature of the requirements and the content of this standard does not constitute an integral part of this standard. 1.4 This standard is used to establish a management system in the quality, administration and technical aspects of the laboratory. The users of the laboratory services and the regulatory authority and the accreditation body shall comply with this laboratory's capability and standards. This standard does not apply to laboratory assurance. NOTE 1 The term "management system" in this standard is the quality, administrative and technical regulatory framework for laboratory operations. NOTE 2 Certification of management systems are sometimes referred to as accounting. 1.5 Compliance with regulatory and safety requirements of the laboratory shall not be subject to this standard. 1.6 If the testing and calibration laboratory meets the requirements of this standard, they shall have a system of management and calibration in accordance with the principles of ISO 9001 in their testing and calibration operations. Annex A illustrates the relationship between this standard and ISO 9001. This standard covers the requirements of the technical specifications for ISO 9001. NOTE 1 It is desirable to clarify and explain certain requirements to apply this standard to a single standard. Appendix B is intended for the use of specific sectors, particularly for accreditation bodies (see ISO / IEC 17011). NOTE 2 If the laboratory chooses to test or compile a calibration or part of the calibration, choose an accrediting body working according to ISO / IEC 17011.

1 Хамрах х ү рээ 1.1 Э нэх үү стандарт нь т үү вэрлэлт, сорилт болон / буюу шалгалт тохируулга ( калибровк) хийхэд тавих чадавхийн талаархи ер ө нхий шаардлагыг тогтооно. Энэ стандарт нь стандартын арга, стандартын биш арга болон лабораторийн боловсруулсан аргыг хэрэглэн г ү йцэтгэсэн сорилт болон шалгалт тохируулгыг хамарна. 1.2 Э нэх үү стандартыг сорилт болон / буюу шалгалт тохируулга г ү йцэтгэдэг ямар ч байгууллагад хэрэглэх боломжтой. Жишээлбэл, нэг дэх, хоёр дахь талын болон х ө ндл ө нгийн лабораториуд, сорилт болон/буюу шалгалт тохируулга нь хяналтын буюу б ү тээгдэх үү ний баталгаажуулалтын хэсэг болдог лабораториудыг тус тус багтаана. Энэх үү стандартыг ажиллагсдын тооноос буюу сорилт болон/буюу шалгалт тохируулгын ү йл ажиллагааны хамрах х ү рээний их, багаас ү л хамааран б ү х лабораторид хэрэглэх боломжтой. Лаборатори нь энэх үү стандартад заасан т үү вэрлэлт хийх, шинэ арга зохион б ү тээх/боловсруулах зэрэг нэг буюу хэд хэдэн ү йл ажиллагааг явуулдагг ү й бол холбогдох заалтын шаардлагыг хэрэглэхг ү й. 1.3 Бичвэр, жишээ, заалтыг ө гс ө н тайлбараар тодорхой болгосон. Тэдгээр нь шаардлагын шинж чанар агуулааг ү й б ө г өө д энэх үү стандартын салшг ү й б ү рэлдэх үү н хэсэг болохг ү й. 1.4 Энэх үү стандартыг лаборатори өө рийн чанар, захиргаа, техникийн ажиллагаандаа удирдлагын тогтолцоог бий болгоход ашиглана. Лабораторийн ү йлчилгээг хэрэглэгч, зохицуулах байгууллага м ө н итгэмжлэлийн байгууллага нь лабораторийн чадавхийг х ү лээн з ө вш өө р ө хд өө энэх үү стандартыг баримтална. Энэ стандартыг лабораторийн баталгаажуулалтанд хэрэглэхг ү й. ТАЙЛБАР 1 Энэх үү стандартын “удирдлагын тогтолцоо” гэдэг нэр томьёо нь лабораторийн ү йл ажиллагааг зохицуулдаг чанар, захиргаа, техникийн тогтолцоог хэлнэ. ТАЙЛБАР 2 Удирдлагын тогтолцооны баталгаажуулалтыг зарим тохиолдолд б ү ртгэл гэж нэрлэдэг. 1.5 Лабораторийн ажиллагаанд баримтлах зохицуулалтын болон аюулг ү й байдлын шаардлагад нийцэх байдлыг энэх үү стандартаар зохицуулааг ү й болно. 1.6 Хэрэв сорилтын болон шалгалт тохируулгын лаборатори нь энэх үү стандартын шаардлагад нийцэж байвал тэдгээр нь сорилт, шалгалт тохируулгын ү йл ажиллагаандаа MNS ISO 9001-ийн зарчимд м ө н адил нийцсэн ча нарын удирдлагын тогтолцоотой байна. А хавсралт нь энэх үү стандарт ба MNS ISO 9001-ийн хоорондын харилцан уялдааг харуулна. Энэх үү стандарт нь MNS ISO 9001 стандартад тусааг ү й техникийн чадавхид тавих шаардлагыг агуулсан болно. ТАЙЛБАР 1 Энэх үү стандартын шаардлагыг нэгдмэл байдлаар хэрэгж үү лэхийн тулд тодорхой шаардлагуудыг нь тодруулах, тайлбарлах хэрэгтэй байж болно. Онцлог салбарууд, ялангуяа итгэмжлэлийн байгууллагуудад зориулсан (ISO/IEC 17011-ийг ү знэ үү ) хэрэглээг бий болгох заалтыг В хавсралтад ө гс ө н болно. ТАЙЛБАР 2 Хэрэв лаборатори нь өө рийн сорилт, шалгалт тохируулгын б ү х ү йл ажиллагааг буюу хэсгийг нь итгэмжл үү лэхийг х ү свэл ISO/IEC 17011-ийн дагуу ажилладаг итгэмжлэлийн байгууллагыг сонгох хэрэгтэй.

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