AUTOSAR CTA Accreditation -
application rules for ISO 17025
https://www.autosar.org/fileadmin/standards/R3.1.5/CP/AUTOSAR_DS_Accreditation_application_of_ISO_17025.pdf
1.1 Related Documentation
1.1.1 Input documents
[1] Conformance Test Process Definition Path A-C https:/svn2.autosar.org/repos2/22_ReleasesAUTOSAR_DS_CT Path A-C.pdf
[2] Conformance Test Process Definition Path D https:/svn2.autosar.org/repos2/22_ReleasesAUTOSAR_DS_CT Path D.pdf
[3] AUTOSAR Conformance Test Agency Accreditation https:/svn2.autosar.org/repos2/22_ReleasesAUTOSAR_DS_Accreditation.pdf
[4] AUTOSAR CTA Accreditation - application rules for ISO/IEC Guide 65
https:/svn2.autosar.org/repos2/22_ReleasesAUTOSAR_DS_Accreditation - application of ISO Guide 65.doc
[5] AUTOSAR Glossary https:/svn2.autosar.org/repos2/22_ReleasesAUTOSAR_Glossary.pdf
1.1.2 Related standards and norms
[6] ISO/IEC 17025:2005 General requirements for the competence of testing and
calibration laboratories
[7] ISO/IEC 17000:2004 Conformity assessment – Vocabulary and general principles
[8] ISO/IEC 17011:2004 Conformity assessment – General requirements for accreditation bodies accrediting conformity assessment bodies
[9] ISO/IEC GUIDE 65:1996 General requirements for bodies operating product certification systems
[6] ISO/IEC 17025:2005 General requirements for the competence of testing and
calibration laboratories
ISO/IEC 17025:2017 General requirements for the competence of testing and calibration laboratories
https://www.iso.org/standard/66912.html
Bibliography
[1] ISO 5725-1, Accuracy (trueness and precision) of measurement methods and results — Part 1: General principles and definitions
[2] ISO 5725-2, Accuracy (trueness and precision) of measurement methods and results — Part 2: Basic method for the determination of repeatability and reproducibility of a standard measurement method
[3] ISO 5725-3, Accuracy (trueness and precision) of measurement methods and results — Part 3: Intermediate measures of the precision of a standard measurement method
[4] ISO 5725-4, Accuracy (trueness and precision) of measurement methods and results — Part 4: Basic methods for the determination of the trueness of a standard measurement method
[5] ISO 5725-6, Accuracy (trueness and precision) of measurement methods and results — Part 6: Use in practice of accuracy values
[6] ISO 9000, Quality management systems — Fundamentals and vocabulary
[7] ISO 9001, Quality management systems — Requirements
[8] ISO 10012, Measurement management systems — Requirements for measurement processes and measuring equipment
[9] ISO/IEC 12207, Systems and software engineering — Software life cycle processes
[10] ISO 15189, Medical laboratories — Requirements for quality and competence
[11] ISO 15194, In vitro diagnostic medical devices — Measurement of quantities in samples of biological origin — Requirements for certified reference materials and the content of supporting documentation
[12] ISO/IEC 17011, Conformity assessment — Requirements for accreditation bodies accrediting conformity assessment bodies
[13] ISO/IEC 17020, Conformity assessment — Requirements for the operation of various types of bodies performing inspection
[14] ISO/IEC 17021-1, Conformity assessment — Requirements for bodies providing audit and certification of management systems — Part 1: Requirements
[15] ISO 17034, General requirements for the competence of reference material producers
[16] ISO/IEC 17043, Conformity assessment — General requirements for proficiency testing
[17] ISO/IEC 17065, Conformity assessment — Requirements for bodies certifying products, processes and services
[18] ISO 17511, In vitro diagnostic medical devices — Measurement of quantities in biological samples — Metrological traceability of values assigned to calibrators and control materials
[19] ISO 19011, Guidelines for auditing management systems
[20] ISO 21748, Guidance for the use of repeatability, reproducibility and trueness estimates in measurement uncertainty evaluation
[21] ISO 31000, Risk management — Guidelines
[22] ISO Guide 30, Reference materials — Selected terms and definitions
[23] ISO Guide 31, Reference materials — Contents of certificates, labels and accompanying documentation
[24] ISO Guide 33, Reference materials — Good practice in using reference materials
[25] ISO Guide 35, Reference materials — Guidance for characterization and assessment of homogeneity and stability
[26] ISO Guide 80, Guidance for the in-house preparation of quality control materials (QCMs)
[27] ISO/IEC Guide 98-3, Uncertainty of measurement — Part 3: Guide to the expression of uncertainty in measurement (GUM:1995)
[28] ISO/IEC Guide 98-4, Uncertainty of measurement — Part 4: Role of measurement uncertainty in conformity assessment
[29] IEC Guide 115, Application of uncertainty of measurement to conformity assessment activities in the electrotechnical sector
[30] Joint BIPM, OIML, ILAC and ISO declaration on metrological traceability, 2011 2
[31] International Laboratory Accreditation Cooperation (ILAC) 3
[32] International vocabulary of terms in legal metrology (VIML), OIML V1:2013
[33] JCGM 106:2012, Evaluation of measurement data — The role of measurement uncertainty in conformity assessment
[34] The Selection and Use of Reference Materials, EEE/RM/062rev3, Eurachem 4
[35] SI Brochure: The International System of Units (SI), BIPM 5
1 Also known as JCGM 200.
2 http://www.bipm.org/utils/common/pdf/BIPM-OIML-ILAC-ISO_joint_declaration_2011.pdf
3 http://ilac.org/
4 https://www.eurachem.org/images/stories/Guides/pdf/EEE-RM-062rev3.pdf
5 http://www.bipm.org/en/publications/si-brochure/
others
ISO/IEC 17025 - General requirements for the competence of testing and calibration laboratories
https://www.iso.org/files/live/sites/isoorg/files/store/en/PUB100424.pdf
JIS Q 17025
JIS Q 17025:2018 試験所及び校正機関の能力に関する一般要求事項 ISO/IEC 17025:2017 (IDT)
General requirements for the competence of testing and calibration laboratories
参考文献
[1] JIS Z 8402-1 測定方法及び測定結果の精確さ（真度及び精度）−第1部：一般的な原理及び定義 注記 対応国際規格：ISO 5725-1，Accuracy (trueness and precision) of measurement methods and results−Part 1: General principles and definitions
[2] JIS Z 8402-2 測定方法及び測定結果の精確さ（真度及び精度）−第2部：標準測定方法の併行精度及び再現精度を求めるための基本的方法 注記 対応国際規格：ISO 5725-2，Accuracy (trueness and precision) of measurement methods and results−Part 2: Basic method for the determination of repeatability and reproducibility of a standard measurement method
[3] JIS Z 8402-3 測定方法及び測定結果の精確さ（真度及び精度）−第3部：標準測定方法の中間精度 注記 対応国際規格：ISO 5725-3，Accuracy (trueness and precision) of measurement methods and results−Part 3: Intermediate measures of the precision of a standard measurement method
[4] JIS Z 8402-4 測定方法及び測定結果の精確さ（真度及び精度）−第4部：標準測定方法の真度を求めるための基本的方法 注記 対応国際規格：ISO 5725-4，Accuracy (trueness and precision) of measurement methods and results−Part 4: Basic methods for the determination of the trueness of a standard measurement method
[5] JIS Z 8402-6 測定方法及び測定結果の精確さ（真度及び精度）−第6部：精確さに関する値の実用的な使い方 注記 対応国際規格：ISO 5725-6，Accuracy (trueness and precision) of measurement methods and results−Part 6: Use in practice of accuracy values
[6] JIS Q 9000 品質マネジメントシステム−基本及び用語 注記 対応国際規格：ISO 9000，Quality management systems−Fundamentals and vocabulary
[7] JIS Q 9001 品質マネジメントシステム−要求事項 注記 対応国際規格：ISO 9001，Quality management systems−Requirements
[8] JIS Q 10012 計測マネジメントシステム−測定プロセス及び測定機器に関する要求事項 注記 対応国際規格：ISO 10012，Measurement management systems−Requirements for measurement processes and measuring equipment
[9] JIS X 0160 ソフトウェアライフサイクルプロセス 注記1 対応国際規格：ISO/IEC 12207，Systems and software engineering−Software life cycle processes 注記2 ISO/IEC 12207は，ISO/IEC/IEEE 12207:2017へ改訂されている。
[10] ISO 15189，Medical laboratories−Requirements for quality and competence
[11] ISO 15194，In vitro diagnostic medical devices−Measurement of quantities in samples of biological origin−Requirements for certified reference materials and the content of supporting documentation
[12] JIS Q 17011 適合性評価−適合性評価機関の認定を行う機関に対する要求事項 注記 対応国際規格：ISO/IEC 17011，Conformity assessment−Requirements for accreditation bodies accrediting conformity assessment bodies
[13] JIS Q 17020 適合性評価−検査を実施する各種機関の運営に関する要求事項
[14] JIS Q 17021-1 適合性評価−マネジメントシステムの審査及び認証を行う機関に対する要求事項−第1部：要求事項 注記 対応国際規格：ISO/IEC 17021-1，Conformity assessment−Requirements for bodies providing audit and certification of management systems−Part 1: Requirements
[15] JIS Q 17034 標準物質生産者の能力に関する一般要求事項 注記 対応国際規格：ISO 17034，General requirements for the competence of reference material producers
[16] JIS Q 17043 適合性評価−技能試験に対する一般要求事項 注記 対応国際規格：ISO/IEC 17043，Conformity assessment−General requirements for proficiency testing
[17] JIS Q 17065 適合性評価−製品，プロセス及びサービスの認証を行う機関に対する要求事項 注記 対応国際規格：ISO/IEC 17065，Conformity assessment−Requirements for bodies certifying products, processes and services
[18] ISO 17511，In vitro diagnostic medical devices−Measurement of quantities in biological samples−Metrological traceability of values assigned to calibrators and control materials
[19] JIS Q 19011 マネジメントシステム監査のための指針 注記 対応国際規格：ISO 19011，Guidelines for auditing management systems
[20] JIS Z 8404-1 測定の不確かさ−第1部：測定の不確かさの評価における併行精度，再現精度及び真度の推定値の利用の指針 注記 対応国際規格：ISO 21748，Guidance for the use of repeatability, reproducibility and trueness estimates in measurement uncertainty evaluation
[21] JIS Q 31000 リスクマネジメント−原則及び指針 注記 対応国際規格：ISO 31000，Risk management−Principles and guidelines
[22] JIS Q 0030 標準物質に関連して用いられる用語及び定義 注記 対応国際規格：ISO Guide 30，Reference materials−Selected terms and definitions
[23] JIS Q 0031 標準物質−認証書，ラベル及び附属文書の内容 注記 対応国際規格：ISO Guide 31，Reference materials−Contents of certificates, labels and accompanying documentation
[24] JIS Q 0033 認証標準物質の使い方 注記 対応国際規格：ISO Guide 33，Reference materials−Good practice in using reference materials
[25] JIS Q 0035 標準物質−認証のための一般的及び統計的な原則 注記 対応国際規格：ISO Guide 35，Reference materials−Guidance for characterization and assessment of homogeneity and stability
[26] ISO Guide 80，Guidance for the in-house preparation of quality control materials (QCMs)
[27] ISO/IEC Guide 98-3，Uncertainty of measurement−Part 3: Guide to the expression of uncertainty in measurement (GUM:1995)
[28] ISO/IEC Guide 98-4，Uncertainty of measurement−Part 4: Role of measurement uncertainty in conformity assessment
[29] IEC Guide 115，Application of uncertainty of measurement to conformity assessment activities in the electrotechnical sector
[30] Joint BIPM, OIML, ILAC and ISO declaration on metrological traceability, 2011 2)
[31] International Laboratory Accreditation Cooperation (ILAC) 3)
[32] International vocabulary of terms in legal metrology (VIML), OIML V1:2013
[33] JCGM 106:2012，Evaluation of measurement data−The role of measurement uncertainty in conformity assessment
[34] The Selection and Use of Reference Materials, EEE/RM/062rev3, Eurachem 4)
[35] SI Brochure: The International System of Units (SI), BIPM 5)
注2) http://www.bipm.org/utils/common/pdf/BIPM-OIML-ILAC-ISO̲joint̲declaration̲2011.pdf
3) http://ilac.org/
4) https://www.eurachem.org/images/stories/Guides/pdf/EEE-RM-062rev3.pdf
5) http://www.bipm.org/en/publications/si-brochure/
JIS Q 17025:2018 試験所及び校正機関の能力に関する一般要求事項
General requirements for the competence of testing and calibration laboratories
https://www.nite.go.jp/data/000088207.pdf
[7] ISO/IEC 17000:2004 Conformity assessment – Vocabulary and general principles
ISO/IEC 17000:2020 Conformity assessment — Vocabulary and general principles
https://www.iso.org/standard/73029.html
Bibliography
[1] ISO 3534 (all parts), Statistics — Vocabulary and symbols
[2] ISO 9000:2015, Quality management systems — Fundamentals and vocabulary
[3] ISO 15189, Medical laboratories — Requirements for quality and competence
[4] ISO/IEC 17011, Conformity assessment — Requirements for accreditation bodies accrediting conformity assessment bodies
[5] ISO/IEC 17020, Conformity assessment — Requirements for the operation of various types of bodies performing inspection
[6] ISO/IEC 17021-1, Conformity assessment — Requirements for bodies providing audit and certification of management systems — Part 1: Requirements
[7] ISO/IEC TS 17021-4, Conformity assessment — Requirements for bodies providing audit and certification of management systems — Part 4: Competence requirements for auditing and certification of event sustainability management systems
[8] ISO/IEC TS 17023, Conformity assessment — Guidelines for determining the duration of management system certification audits
[9] ISO/IEC 17024, Conformity assessment — General requirements for bodies operating certification of persons
[10] ISO/IEC 17025, General requirements for the competence of testing and calibration laboratories
[11] ISO/IEC TS 17027, Conformity assessment — Vocabulary related to competence of persons used for certification of persons
[12] ISO/IEC TR 17028, Conformity assessment — Guidelines and examples of a certification scheme for services
[13] ISO/IEC 17029, Conformity assessment — General principles and requirements for validation and verification bodies
[14] ISO/IEC 17030, Conformity assessment — General requirements for third-party marks of conformity
[15] ISO 17034, General requirements for competence of reference material producers
[16] ISO/IEC 17040, Conformity assessment — General requirements for peer assessment of conformity assessment bodies and accreditation bodies
[17] ISO/IEC 17043, Conformity assessment — General requirements for proficiency testing
[18] ISO/IEC 17050-1, Conformity assessment — Supplier's declaration of conformity — Part 1: General requirements
[19] ISO/IEC 17065, Conformity assessment — Requirements for bodies certifying products, processes and services
[20] ISO 19011, Guidelines for auditing management systems
[21] ISO 19600, Compliance management systems — Guidelines
[22] ISO/IEC Guide 2, Standardization and related activities — General vocabulary
[23] ISO Guide 30, Reference materials — Selected terms and definitions
[24] ISO/IEC Guide 99, International vocabulary of metrology — Basic and general concepts and associated terms (VIM)
[25] Glossary, Agreement on Technical Barriers to Trade: https://www.wto.org/english/thewto_e/glossary_e/glossary_e.htm