Title Page
-
Laboratory/Site
-
Conducted on
-
Prepared by
-
Location
Internal Assessment
8. Management System Requirements
8.1 Options
-
8.1.1 Management system<br>• supports and demonstrates the consistent achievement of the requirements of the Standard<br>• assures the quality of the laboratory results<br>• allows the requirements of clauses 4 to 7 to be met<br>• is in accordance with either Option A or Option B
-
8.1.2 OPTION A, As a minimum, the laboratory management system shall address the clauses 8.2 to 8.9<br><br>8.1.3 OPTION B, Laboratory that has established and maintains a management system, in accordance with the requirements of ISO 9001:2015 and that is capable of supporting and demonstrating the consistent fulfillment of the requirements of clauses 4 to 7, also fulfills at least the intent of the management system requirements specified in clauses 8.2 to 8.9
8.2 Management System Documentation
-
8.2.1 Policies and objectives<br>• are established, documented for the fulfillment of the Standard<br>• are acknowledged and implemented at all levels of the laboratory
-
8.2.2 Competence, impartiality consistent operations<br>• are addressed by the polices and objectives
-
8.2.3 Laboratory management<br>• provides evidence of commitment to the development of the management system<br>• continually improves the management system’s effectiveness
-
8.2.4 Reference to the management system<br>• of all documentation, processes, systems and records
-
8.2.5 Access to parts of the management system<br>• is available to personnel
8.3 Control of Management System Documents
-
8.3.1 Control of documents<br>• both internal and external documents relating to the fulfillment of the requirements of the Standard
-
8.3.2 Document control process<br>a) documents are approved by authorized personnel prior to issue<br>b) documents are periodically reviewed and updated as necessary<br>c) changes and current revision status of documents are identified<br>d) relevant versions of documents are available and their distribution controlled as necessary<br>e) documents are uniquely identified<br>f) unintended use of obsolete documents is prevented
8.4 Control of Records
-
8.4.1 Records retention<br>• to demonstrate fulfillment of the requirements of the Standard
-
8.4.2 Controls<br>• are implemented for<br>- identification<br>- storage<br>- protection<br>- back-up<br>- archive<br>- retrieval<br>- retention times<br>- disposal<br>• are established for<br>- retention periods to satisfy contractual obligations<br>- confidentiality commitments<br>- access and availability
8.5 Actions to Address Risks and Opportunities
-
8.5.1 Risks and opportunities are considered <br>a) to assure the management system achieves its intended goals<br>b) to achieve the laboratory objectives<br>c) to prevent (or minimize) undesired impacts and potential failures<br>d) to achieve improvement
-
8.5.2 Plan<br>a) actions to address risks and opportunities<br>b) how to<br>- implement actions into the management system<br>- evaluate the effectiveness of actions
-
8.5.3 Actions to address risks and opportunities<br>• are proportional to the potential impact on the validity of the laboratory results
8.6 Improvement
-
8.6.1 The laboratory shall identify and select opportunities for improvement and implement any necessary actions.<br>NOTE: Opportunities for improvement can be identified through the review of the operational procedures,<br>the use of the policies, overall objectives, audit results, corrective actions, management review, suggestions from<br>personnel, risk assessment, analysis of data, and proficiency testing results.
-
8.6.2 The laboratory shall seek feedback, both positive and negative, from its customers. The feedback shall be analyzed and used to improve the management system, laboratory activities and customer service.<br>NOTE: Examples of the types of feedback include customer satisfaction surveys, communication records and review of reports with customers.
8.7 Corrective Actions
-
8.7.1 Nonconformities<br>• when occur, the laboratory shall<br>a) react and, as applicable, take action, correct the issue and address the consequences<br>b) evaluate the need for action to eliminate the cause so that it does not recur<br>c) implement any action necessary<br>d) review the effectiveness of any corrective action<br>e) update any risk and opportunities<br>f) makes any necessary changes to the management system
-
8.7.2 Corrective action taken<br>• is appropriate to the effects of the nonconformity
-
8.7.3 Records retained<br>a) of the nature of the nonconformity, cause(s) and any action(s) taken<br>b) of the outcomes of corrective action
8.8 Internal Audits
-
8.8.1 Conducted at planned intervals<br>• to establish whether the management system<br>a) conforms to<br>- the laboratory’s requirements, including laboratory activities<br>- the requirements of the Standard<br>b) is effectively implemented and<br>maintained
-
8.8.2 Audit requirements<br>a) is planned and implemented, including frequency, defined responsibilities and reporting, taking into account<br>- the importance of the laboratory activities concerned<br>- changes affecting the laboratory<br>- the results of previous audits<br>b) audit criteria and the scope of each audit are defined<br>c) audit results are reported to relevant management<br>d) corrective actions, where necessary, are implemented promptly<br>e) records of the audit program, including outcomes, are retained
8.9 Management Reviews
-
8.9.1 Review of management system<br>• is conducted at planned intervals by laboratory management to ensure<br>- continued suitability, adequacy and effectiveness<br>- covers the stated policies and<br>objectives related to the fulfilment of the<br>Standard
-
8.9.2 Records of inputs<br>• including information related to<br>a) changes in internal and external issues<br>b) fulfillment of objectives<br>c) suitability of policies and procedures<br>d) status of actions from previous reviews e) outcomes of recent internal audits<br>f) corrective actions<br>g) assessment by external bodies<br>h) changes in volume, type and range of laboratory activities<br>i) customer and personnel feedback j) complaints<br>k) effectiveness of any implemented improvements<br>l) adequacy of resources<br>m) results of risk identification<br>n) outcomes of the assurance of validity of results<br>o) any other relevant factors
-
8.9.3 Records of outputs<br>• include all decisions and actions relating to<br>a) effectiveness of the management system<br>b) improvement of the laboratory activities relating to satisfying the requirements of the Standard<br>c) provision of required resources d) any need for change(s)
If Option B, the following documentation is required
-
1) evidence the management system is certified by a certification body, or by another signatory to the International Accreditation Forum (IAF) Multilateral Recognition Agreement (MLA).<br>2) evidence that the certification body's accreditation covers ISO/IEC 17021-3 i.e. the certification body can certify management systems to ISO 9001:2015.<br>3) copies of the most recent certification audit report(s) issued by the certification body covering the laboratory’s management system in full.<br>4) confirmation from the certification body of the closeout of any non-conformities raised during certification audits.<br>5) evidence the certification of the management system covers the laboratory activities covered by its scope of accreditation.<br>6) supports the facility fulfilling consistently the requirements of ISO/IEC 17025:2017 to assure the quality of results.
8.2 Management System Documentation
-
8.2.1 Policies and objectives<br>• are established, documented for the fulfillment of the Standard<br>• are acknowledged and implemented at all levels of the laboratory
-
8.2.2 Competence, impartiality consistent operations<br>• are addressed by the polices and objectives
-
8.2.3 Laboratory management<br>• provides evidence of commitment to the development of the management system<br>• continually improves the management system’s effectiveness
-
8.2.4 Reference to the management system<br>• of all documentation, processes, systems and records
-
8.2.5 Access to parts of the management system<br>• is available to personnel
8.3 Control of Management System Documents
-
8.3.1 Control of documents<br>• both internal and external documents relating to the fulfillment of the requirements of the Standard
-
8.3.2 Document control process<br>a) documents are approved by authorized personnel prior to issue<br>b) documents are periodically reviewed and updated as necessary<br>c) changes and current revision status of documents are identified<br>d) relevant versions of documents are available and their distribution controlled as necessary<br>e) documents are uniquely identified<br>f) unintended use of obsolete documents is prevented
8.4 Control of Records
-
8.4.1 Records retention<br>• to demonstrate fulfillment of the requirements of the Standard
-
8.4.2 Controls<br>• are implemented for<br>- identification<br>- storage<br>- protection<br>- back-up<br>- archive<br>- retrieval<br>- retention times<br>- disposal<br>• are established for<br>- retention periods to satisfy contractual obligations<br>- confidentiality commitments<br>- access and availability
8.5 Actions to Address Risks and Opportunities
-
8.5.1 Risks and opportunities are considered <br>a) to assure the management system achieves its intended goals<br>b) to achieve the laboratory objectives<br>c) to prevent (or minimize) undesired impacts and potential failures<br>d) to achieve improvement
-
8.5.2 Plan<br>a) actions to address risks and opportunities<br>b) how to<br>- implement actions into the management system<br>- evaluate the effectiveness of actions
-
8.5.3 Actions to address risks and opportunities<br>• are proportional to the potential impact on the validity of the laboratory results
8.7 Corrective Actions
-
8.7.1 Nonconformities<br>• when occur, the laboratory shall<br>a) react and, as applicable, take action, correct the issue and address the consequences<br>b) evaluate the need for action to eliminate the cause so that it does not recur<br>c) implement any action necessary<br>d) review the effectiveness of any corrective action<br>e) update any risk and opportunities<br>f) makes any necessary changes to the management system
-
8.7.2 Corrective action taken<br>• is appropriate to the effects of the nonconformity
-
8.7.3 Records retained<br>a) of the nature of the nonconformity, cause(s) and any action(s) taken<br>b) of the outcomes of corrective action
8.8 Internal Audits
-
8.8.1 Conducted at planned intervals<br>• to establish whether the management system<br>a) conforms to<br>- the laboratory’s requirements, including laboratory activities<br>- the requirements of the Standard<br>b) is effectively implemented and<br>maintained
-
8.8.2 Audit requirements<br>a) is planned and implemented, including frequency, defined responsibilities and reporting, taking into account<br>- the importance of the laboratory activities concerned<br>- changes affecting the laboratory<br>- the results of previous audits<br>b) audit criteria and the scope of each audit are defined<br>c) audit results are reported to relevant management<br>d) corrective actions, where necessary, are implemented promptly<br>e) records of the audit program, including outcomes, are retained
8.9 Management Reviews
-
8.9.1 Review of management system<br>• is conducted at planned intervals by laboratory management to ensure<br>- continued suitability, adequacy and effectiveness<br>- covers the stated policies and<br>objectives related to the fulfilment of the<br>Standard
-
8.9.2 Records of inputs<br>• including information related to<br>a) changes in internal and external issues<br>b) fulfillment of objectives<br>c) suitability of policies and procedures<br>d) status of actions from previous reviews e) outcomes of recent internal audits<br>f) corrective actions<br>g) assessment by external bodies<br>h) changes in volume, type and range of laboratory activities<br>i) customer and personnel feedback j) complaints<br>k) effectiveness of any implemented improvements<br>l) adequacy of resources<br>m) results of risk identification<br>n) outcomes of the assurance of validity of results<br>o) any other relevant factors
-
8.9.3 Records of outputs<br>• include all decisions and actions relating to<br>a) effectiveness of the management system<br>b) improvement of the laboratory activities relating to satisfying the requirements of the Standard<br>c) provision of required resources d) any need for change(s)
Completion
-
Comments/Recommendations
-
Conducted by: Name and Signature
