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| articles:iso17025-2017_oe_requirements-1 [2019/08/31 13:13] – rrandall | articles:iso17025-2017_oe_requirements-1 [2023/02/01 18:38] (current) – rrandall |
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| ISO/IEC 17025 is a much more technical QMS standard that ISO 9001. And while previous versions were better written, the 2017 version still offers significant value. This article discusses the minimum "Objective Evidence" actually required by the standard. Any interpretations beyond these minimum requirements (e.g., by an internal or external auditor) are based purely on subjective //opinion//. | ISO/IEC 17025 is a much more technical QMS standard that ISO 9001. And while previous versions were better written, the 2017 version still offers significant value. This article discusses the minimum "Objective Evidence" actually required by the standard. Any interpretations beyond these minimum requirements (e.g., by an internal or external auditor) are based purely on subjective //opinion//. |
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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". These include: | 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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| ^ # ^ Documents & Procedures ^ Sec. ^ | While ISO/IEC 17025:2017 does not //specifically// require a Quality Manual, it does state: |
| | 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 | | <box 80% round blue|**8.1.1 General**> |
| | 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 | | 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. |
| | 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. | 6.2.2 | | </box> |
| | 4 | a description of the processes needed for the quality management system and their application throughout the organization; | 4.4.2 | | |
| | 5 | the sequence and interaction of these processes; | 4.4.2 & 4.4.1b | | |
| | 6 | assignment of the responsibilities and authorities for these processes. | 4.4.2 | | |
| | 7 | Quality policy | 5.2.2.a | | |
| | 8 | Quality objectives | 6.2.1 | | |
| | 9 | a register of the monitoring and measuring equipment (that includes: the equipment type, unique identification, location, and the calibration or verification method, frequency, and acceptance criteria). | 7.1.5.2 | | |
| | 10 | The organization shall "determine" and "maintain" //**documented information**// "to the extent necessary:" \\ 1. to have confidence that the processes have been carried out as planned; \\ 2. to demonstrate the conformity of products and services to their requirements; \\ <wrap em>**[SUBJECTIVE requirement - to be determined by the ORGANIZATION (as per 7.5.1b)... NOT the auditor.]**</wrap> | 8.1.e | | |
| | 11 | 8.3.4.1 When tests are necessary for verification and validation, these tests shall be planned, controlled, reviewed, and //**documented**// to ensure and prove the following: \\ a. test plans or specifications identify the test item being tested and the resources being used, define test objectives and conditions, parameters to be recorded and relevant acceptance criteria; \\ b. test procedures describe the test methods to be used, how to perform the test, and how to record the results; \\ c. the correct configuration of the test item is submitted for the test; \\ d. the requirements of the test plan and the test procedures are observed; \\ e. the acceptance criteria are met. \\ <wrap hi>**[While this requirement does not include the words "maintained" or "retained", it is generally interpreted as applying in part to "test plans" (or specifications), "test procedures", and to the "test results" (i.e., record)]**</wrap>| 8.3.4.1 | | |
| | **12** | Controlled conditions shall include, as applicable: \\ a. the __availability__ of //**documented information**// that defines: \\ 1. the characteristics of the products to be produced, the services to be provided, or the activities to be performed; \\ 2. the results to be achieved; \\ <wrap hi>**[This documented information //may// be provided by the customer (e.g., Drawings)]**</wrap> | 8.5.1.a | | |
| | 13 | c. the implementation of monitoring and measurement activities at appropriate stages to verify that criteria for control of processes or outputs, and acceptance criteria for products and services, have been met; \\ 1. ensuring that //**documented information**// for monitoring and measurement activity for product acceptance includes: \\ - criteria for acceptance and rejection; \\ - where in the sequence verification operations are to be performed; \\ - measurement results to be retained (at a minimum an indication of acceptance or rejection); \\ - any specific monitoring and measurement equipment required and instructions associated with their use; | 8.5.1.c1 | | |
| | **14** | 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 organization shall maintain //**documented information**// that defines the nonconformity and corrective action management processes. | 10.2.1 | | |
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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> | 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. |
| | </box> |
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| <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> | For this reason, //most// laboratories choose to have a Quality Manual. |
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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> | \\ |
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| <note important>**# 5** \\ When asked "//Is using the process diagram in Figure 2 from clause 0.3.2, in your quality manual for interaction between the processes sufficient?//", 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. 9100-series standards are a process-based standard with requirements to identify the organization’s QMS processes and their interaction. The diagram on page 8 of 9100-series includes the relationships of the 9100-series sections 4 through | ^ # ^ Documents & Procedures ^ Sec. ^ |
| 10. This diagram is not intended to define an organization’s processes and their interaction. Additional information is available from the [[https://committee.iso.org/files/live/sites/tc176sc2/files/documents/ISO%209001%20Auditing%20Practices%20Group%20docs/Auditing%20to%20ISO%209001%202015/APG-Processes2015.pdf|ISO 9001 Auditing Practices Group website]] and [[https://www.sae.org/iaqg/projects/9100-2016changes.pdf|IAQG 9100 Key Changes Presentation]] on the topic Process Management/Approach. \\ In addition, Annex A.1 of the standard provides this statement: “The structure of clauses is intended to provide a coherent presentation of requirements, rather than a model for documenting an organization’s policies, objectives, and processes.”//</note> | | 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 | |
| <note tip>**# 5** \\ //Most// AS 9100D auditors prefer to see "the sequence and interaction" of your QMS processes in "Turtle Charts" because that is how the auditor's [[https://www.sae.org/iaqg/forms/disclaimer9101fform3ul.htm|SAE AS 9101F, Form 3 "Process Effectiveness Assessment Report"]] (a.k.a. "PEAR" form) is structured. However, if using "flow charts" to document "the sequence and interaction" of your QMS processes, preference should be given to using the [[https://www.omg.org/spec/BPMN/|"Business Process Model and Notation" (BPMN™) Standard]] for flow charting your processes.</note> | | 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 | |
| | | **4** | The laboratory shall have //**procedure(s)**// and retain records for: \\ a) determining the competence requirements; \\ b) selection of personnel; \\ c) training of personnel; \\ d) supervision of personnel; \\ e) authorization of personnel; \\ f) monitoring competence of personnel. | 6.2.5 | |
| <note tip>**# 2 thru 8** \\ While AS 9100 does NOT require a "Quality Manual", it is generally a good idea to do so as a "defensive measure" because: \\ 1. Addressing all of the requirements of AS 9100D in a "Quality Manual" (at a policy level) the business can argue that it has addressed the more //subjective// requirements (contained throughout AS 9100D) that do not specifically require "objective evidence", and \\ 2. Including references to the sources for the business's interpretations can immediately dismiss many //subjective// interpretations that an auditor may have. \\ \\ Also, a "Quality Manual" can improve efficiency through providing a single source addressing items 2 thru 8 from the above chart.</note> | | 5 | The requirements for facilities and environmental conditions necessary for the performance of the laboratory activities shall be //**documented**//. | 6.3.2 | |
| | | **6** | The laboratory shall have a //**procedure**// for handling, transport, storage, use and planned maintenance of equipment in order to ensure proper functioning and to prevent contamination or deterioration. | 6.4.3 | |
| <note important>**# 9** \\ The IAQG official [[https://www.sae.org/iaqg/projects/9100-2016_clarification_table.pdf|"AS 9100:2016 Series Clarifications"]] states: //The 9100-series clause 7.1.5.2 was not intended to force organizations to have the register specifically include the "equipment type, unique identification, location, and the calibration or verification method, frequency, and acceptance criteria.” The organization is required to have this information for equipment listed on the calibration register but not specifically in the register.// </note> | | **7** | When intermediate checks are necessary to maintain confidence in the performance of the equipment, these checks shall be carried out according to a //**procedure**//. | 6.4.10 | |
| | | **8** | The laboratory shall have a //**procedure**// and retain records for: \\ a) defining, reviewing and approving the laboratory’s requirements for externally provided products and services; \\ b) defining the criteria for evaluation, selection, monitoring of performance and re-evaluation of the external providers; \\ c) ensuring that externally provided products and services conform to the laboratory’s established requirements, or when applicable, to the relevant requirements of this document, before they are used or directly provided to the customer; \\ d) taking any actions arising from evaluations, monitoring of performance and re-evaluations of the external providers. | 6.6.2 | |
| <note tip>**# 9** \\ Consistent with the above "official" interpretation, almost no one identifies the “method” or “acceptance criteria” in their “register” (database)... unless they have a full in-house calibration laboratory. What auditors typically see is: \\ 1. the “method” identified on the calibration certificate (from the calibration/metrology lab). \\ 2. the “acceptance criteria” either identified in the calibration certificate (from the calibration/metrology lab) OR for the company to have a copy of the calibration “method” that was used (containing the acceptance criteria). \\ \\ While the company could have the instrument specifications, if those specifications can’t be matched to the actual calibration method used, then there is no way to confirm that was the actual “acceptance criteria” used in performing the calibration. </note> | | **9** | The laboratory shall have a //**procedure**// for the review of requests, tenders and contracts. The //**procedure**// shall ensure that: \\ a) the requirements are adequately defined, documented and understood; \\ b) the laboratory has the capability and resources to meet the requirements; \\ c) where external providers are used, the requirements of 6.6 are applied and the laboratory advises the customer of the specific laboratory activities to be performed by the external provider and gains the customer's approval; \\ d) the appropriate methods or procedures are selected and are capable of meeting the customers' requirements. | 7.1.1 | |
| | | **10** | The laboratory shall use appropriate methods and //**procedures**// for all laboratory activities and, where appropriate, for evaluation of the measurement uncertainty as well as statistical techniques for analysis of data. | 7.2.1.1 | |
| <note important>**# 12** \\ When asked whether clause no. 8.5.1a) of ISO 9001:2015 "availability of documented information" means "maintain documented information”, the " | | **11** | The laboratory shall retain the following records of validation: \\ a) the validation //**procedure**// used; | 7.2.2.4 | |
| [[https://committee.iso.org/files/live/sites/tc176sc2/files/documents/Interpretations/ISO9001_2015_Approved_Interpretations.doc|Official ISO 9001:2015 Inerpretations from ISO TC/176/SC2]]" stated "No". And explained "//The terms “available” and “maintain” are not synonyms, and the use of “availability” was deliberate. “Available” means “able to be used or obtained, or accessible”, whereas “maintain” means “cause or enable to continue”. The “maintenance” of documented information is not explicitly required by Clause 8.5.1(a), but is addressed by other parts of ISO 9001:2015. Clause 8.5.1 (a) requires the documented information to be “available” so that it can be used, not just “maintained” (i.e. preserved). The documented information that needs to be available under Clause 8.5.1(a) is part of the quality management system documentation, and therefore has to be managed in accordance with Clause 7.5.//".</note> | | **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 | |
| | | **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 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 | 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 important>**# 14 & 15** \\ There are only 2 requirements in AS9100D for documented "procedures"; "nonconformity control" (8.7.1) & corrective action (10.2.1). These 2 procedures can be (and often are) combined into a single procedure.</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> |
