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| articles:iso17025-2017_oe_requirements-1 [2019/08/31 14:28] – rrandall | articles:iso17025-2017_oe_requirements-1 [2023/02/01 18:38] (current) – rrandall |
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| Unlike ISO 9001:2015 & AS9100:2016, ISO/IEC 17025:2017 is much more clear in stating its requirements relating to documentation (e.g., procedures). Hence the reason it doesn't need a //definition// for "documented procedure". | Unlike ISO 9001:2015 & AS9100:2016, ISO/IEC 17025:2017 is much more clear in stating its requirements relating to documentation (e.g., procedures). Hence the reason it doesn't need a //definition// for "documented procedure". |
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| | While ISO/IEC 17025:2017 does not //specifically// require a Quality Manual, it does state: |
| | <box 80% round blue|**8.1.1 General**> |
| | The laboratory shall establish, document, implement and maintain a management system that is capable of supporting and demonstrating the consistent achievement of the requirements of this document and assuring the quality of the laboratory results. In addition to meeting the requirements of Clauses 4 to 7, the laboratory shall implement a management system in accordance with Option A or Option B. |
| | </box> |
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| | Also, a critical point to recognize is that ISO/IEC 17025:2017 states: |
| | <box 80% round blue|**8.2 Management system documentation (Option A)**> |
| 8.2.4 All documentation, processes, systems, records, related to the fulfilment of the requirements of this document shall be included in, referenced from, or linked to the management system. | 8.2.4 All documentation, processes, systems, records, related to the fulfilment of the requirements of this document shall be included in, referenced from, or linked to the management system. |
| | </box> |
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| | For this reason, //most// laboratories choose to have a Quality Manual. |
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| These include: | \\ |
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| ^ # ^ Documents & Procedures ^ Sec. ^ | ^ # ^ Documents & Procedures ^ Sec. ^ |
| | 1 | The laboratory shall define and //**document**// the __range of laboratory activities__ for which it conforms with this document. The laboratory shall only claim conformity with this document for this range of laboratory activities, which excludes externally provided laboratory activities on an ongoing basis. | 5.3 | | | 1 | The laboratory shall define and //**document**// the __range of laboratory activities__ for which it conforms with this document. The laboratory shall only claim conformity with this document for this range of laboratory activities, which excludes externally provided laboratory activities on an ongoing basis. \\ <wrap hi>**[The __range of laboratory activities__ is typically referred to as the "scope".]**</wrap> | 5.3 | |
| | 2 | The laboratory shall: \\ c) //**document**// its procedures to the extent necessary to ensure the consistent application of its laboratory activities and the validity of the results. \\ <wrap em>**[SUBJECTIVE REQUIREMENT - while "//the extent necessary//" is completely subjective, this requirement can only be verified through confirming "__consistent application__" of the laboratories "activities and the validity of the results."]**</wrap> | 5.5c | | | 2 | The laboratory shall: \\ c) //**document**// its procedures to the extent necessary to ensure the consistent application of its laboratory activities and the validity of the results. \\ <wrap em>**[SUBJECTIVE REQUIREMENT - while "//the extent necessary//" is completely subjective, this requirement can only be verified through confirming "__consistent application__" of the laboratories "activities and the validity of the results."]**</wrap> | 5.5c | |
| | 3 | The laboratory shall //**document**// the competence requirements for each function influencing the results of laboratory activities, including requirements for education, qualification, training, technical knowledge, skills and experience. \\ <wrap hi>**[This documentation //may// exist in "Job Descriptions", Competency Matrices, etc.]**</wrap> | 6.2.2 | | | 3 | The laboratory shall //**document**// the competence requirements for each function influencing the results of laboratory activities, including requirements for education, qualification, training, technical knowledge, skills and experience. \\ <wrap hi>**[This documentation //may// exist in "Job Descriptions", Competency Matrices, etc.]**</wrap> | 6.2.2 | |
| | **12** | The laboratory shall have a //**procedure**// for the transportation, receipt, handling, protection, storage, retention, and disposal or return of test or calibration items, including all provisions necessary to protect the integrity of the test or calibration item, and to protect the interests of the laboratory and the customer. Precautions shall be taken to avoid deterioration, contamination, loss or damage to the item during handling, transporting, storing/waiting, and preparation for testing or calibration. Handling instructions provided with the item shall be followed.| 7.4.1 | | | **12** | The laboratory shall have a //**procedure**// for the transportation, receipt, handling, protection, storage, retention, and disposal or return of test or calibration items, including all provisions necessary to protect the integrity of the test or calibration item, and to protect the interests of the laboratory and the customer. Precautions shall be taken to avoid deterioration, contamination, loss or damage to the item during handling, transporting, storing/waiting, and preparation for testing or calibration. Handling instructions provided with the item shall be followed.| 7.4.1 | |
| | **13** | The laboratory shall have a //**procedure**// for monitoring the validity of results. The resulting data shall be recorded in such a way that trends are detectable and, where practicable, statistical techniques shall be applied to review the results. This monitoring shall be planned and reviewed and shall include, where appropriate, but not be limited to: \\ a) use of reference materials or quality control materials; \\ b) use of alternative instrumentation that has been calibrated to provide traceable results; \\ c) functional check(s) of measuring and testing equipment; \\ d) use of check or working standards with control charts, where applicable; \\ e) intermediate checks on measuring equipment; \\ f) replicate tests or calibrations using the same or different methods; \\ g) retesting or recalibration of retained items; \\ h) correlation of results for different characteristics of an item; \\ i) review of reported results; \\ j) intralaboratory comparisons; \\ k) testing of blind sample(s). | 7.7.1 | | | **13** | The laboratory shall have a //**procedure**// for monitoring the validity of results. The resulting data shall be recorded in such a way that trends are detectable and, where practicable, statistical techniques shall be applied to review the results. This monitoring shall be planned and reviewed and shall include, where appropriate, but not be limited to: \\ a) use of reference materials or quality control materials; \\ b) use of alternative instrumentation that has been calibrated to provide traceable results; \\ c) functional check(s) of measuring and testing equipment; \\ d) use of check or working standards with control charts, where applicable; \\ e) intermediate checks on measuring equipment; \\ f) replicate tests or calibrations using the same or different methods; \\ g) retesting or recalibration of retained items; \\ h) correlation of results for different characteristics of an item; \\ i) review of reported results; \\ j) intralaboratory comparisons; \\ k) testing of blind sample(s). | 7.7.1 | |
| | **14** | The laboratory shall have a //**procedure**// that shall be implemented when any aspect of its laboratory activities or results of this work do not conform to its own procedures or the agreed requirements of the customer (e.g. equipment or environmental conditions are out of specified limits, results of monitoring fail to meet specified criteria). The //**procedure**// shall ensure that: \\ a) the responsibilities and authorities for the management of nonconforming work are defined; \\ b) actions (including halting or repeating of work and withholding of reports, as necessary) are based upon the risk levels established by the laboratory; \\ c) an evaluation is made of the significance of the nonconforming work, including an impact analysis on previous results; \\ d) a decision is taken on the acceptability of the nonconforming work; \\ e) where necessary, the customer is notified and work is recalled; \\ f) the responsibility for authorizing the resumption of work is defined.| 7.10.1 | | | **14** | The laboratory shall have a //**documented**// process to receive, evaluate and make decisions on complaints. \\ <wrap hi>**[While the word //procedure// is not used here, this is typically interpreted as the intent.]**</wrap> | 7.9.1 | |
| | **15** | The organization’s nonconformity control process shall be maintained as //**documented information**// including the provisions for: \\ − defining the responsibility and authority for the review and disposition of nonconforming outputs and the process for approving persons making these decisions; \\ − taking actions necessary to contain the effect of the nonconformity on other processes, products, or services; \\ − timely reporting of nonconformities affecting delivered products and services to the customer and to relevant interested parties; \\ − defining corrective actions for nonconforming products and services detected after delivery, as appropriate to their impacts (see 10.2). | 8.7.1 | | | **15** | The laboratory shall have a //**procedure**// that shall be implemented when any aspect of its laboratory activities or results of this work do not conform to its own procedures or the agreed requirements of the customer (e.g. equipment or environmental conditions are out of specified limits, results of monitoring fail to meet specified criteria). The //**procedure**// shall ensure that: \\ a) the responsibilities and authorities for the management of nonconforming work are defined; \\ b) actions (including halting or repeating of work and withholding of reports, as necessary) are based upon the risk levels established by the laboratory; \\ c) an evaluation is made of the significance of the nonconforming work, including an impact analysis on previous results; \\ d) a decision is taken on the acceptability of the nonconforming work; \\ e) where necessary, the customer is notified and work is recalled; \\ f) the responsibility for authorizing the resumption of work is defined.| 7.10.1 | |
| | **16** | The organization shall maintain //**documented information**// that defines the nonconformity and corrective action management processes. | 10.2.1 | | | 16 | Laboratory management shall establish, //**document**//, and maintain policies and objectives for the fulfilment of the purposes of this document and shall ensure that the policies and objectives are acknowledged and implemented at all levels of the laboratory organization. \\ <wrap hi>**[While not specifically required, this is typically accomplished through a Quality Manual.]**</wrap> | 8.2.1 | |
| | | 17 | The policies and objectives shall address the competence, impartiality and consistent operation of the laboratory. \\ <wrap hi>**[Often overlooked are the requirements that must be included in the above documented "__policies and objectives__". Particularly "competence" & "impartiality".]**</wrap> | 8.2.2 | |
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| <note tip>**# 2 ** \\ For guidance on documenting "a general description of relevant interested parties", read: [[articles:context_of_the_organization|Context of the Organization... and "Interested Parties"]]</note> | <WRAP center round tip 80%> |
| | **# 1 ** \\ For information on how to create/craft the language of the "__range of laboratory activities__" reference the applicable ANAB Administrative Process Rule: \\ • [[https://anab.qualtraxcloud.com/ShowDocument.aspx?ID=9162|PREPARING A DRAFT SCOPE OF ACCREDITATION FOR ISO/IEC 17025 CALIBRATION LABORATORIES]] \\ • [[https://anab.qualtraxcloud.com/ShowDocument.aspx?ID=12602|PREPARING A DRAFT SCOPE OF ACCREDITATION FOR ISO/IEC 17025 DIMENSIONAL MEASUREMENT LABORATORIES]] \\ • [[https://anab.qualtraxcloud.com/ShowDocument.aspx?ID=9161|PREPARING A DRAFT SCOPE OF ACCREDITATION FOR ISO/IEC 17025 TESTING LABORATORIES]]</WRAP> |
| <note tip>**# 3** \\ Guidance from ISO on crafting an acceptable QMS "scope" can be found online in the: [[https://committee.iso.org/files/live/sites/tc176sc2/files/documents/ISO%209001%20Auditing%20Practices%20Group%20docs/General/APG-Scope2015.pdf|ISO 9001 Auditing Practices Group Guidance on: "Scope of ISO 9001, Scope of Quality Management System (QMS) and Scope of Certification"]]</note> | |
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| <note important>**# 3** \\ When asked "//Is it allowable for an organization to claim non-applicability with any sub-clause or sub-paragraph of 9100-series?//", the response contained in the IAQG official [[https://www.sae.org/iaqg/projects/9100-2016_clarification_table.pdf|"AS 9100:2016 Series Clarifications"]] stated: \\ //"Yes. Organizations can claim non- applicability even down to a shall statement or portions of a shall statement."// \\ \\ Also, when asked "//Is it required that any non-applicability with a requirement be documented in the scope section of the __Quality Manual__?//", the response contained in the IAQG official [[https://www.sae.org/iaqg/projects/9100-2016_clarification_table.pdf|"AS 9100:2016 Series Clarifications"]] stated: \\ //"No. It is required that any non-applicability with a clause or “shall” statement be documented information but does not have to be documented in the scope section of a __Quality Manual__."//</note> | |
