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  • Auditing impartiality

    How do you audit impartiality 

    Auditing impartiality involves systematically determining the extent to which the requirements for safegaurding impartiality are met. i.e. needs identified, processes in place. This is achieved by stating each clause requirement as audit criteria, obtaining objective evidence and evaluating it to confirm conformity or not. Objective evidence is data that supports the existence of something. The evidence itself is usually a document, record or could be a statement of fact, for example, “at the time of the audit, the Quality Policy was displayed in the laboratory". In an audit, evidence can be obtained through various means, for example document review, or interviews and observation. What you need to look for is covered in the answer below.

    how do you ensure impartiality in a testing laboratory according to ISO17025:2017?"

    Impartiality is important to maintain the trust and confidence of customers and other involved parties. It means that a laboratory must not be influenced or appear to be influenced in any way that would affect laboratory activities. These activities include processes of the ISO 17025 management system, including for example procurement and maintenance. A laboratory must structure the organization and activities in a way that will safeguard impartiality – i.e. not allow commercial, financial, or other pressures to compromise the quality of results or objectives. 

    To achieve this:

    • Avoid potential conflict of interest and ensure fairness / unbiased actions by structuring the laboratory and greater organization reporting lines to ensure independence.
    • Structure Management commitment by establishing an impartiality policy, facilitating training, developing the quality culture, including communicating the importance of safeguarding impartiality. Keep records to provide evidence.
    • Perform risk and opportunity assessments to identify where risks may arise and opportunities for improvement and minimizing or eliminating risks to impartiality.
    • Include impartiality in Management Review discussion of policies, risk assessments and other activities.
    • Establish processes to identify and evaluate ongoing threats to impartiality through for example, internal audits, root cause analysis and effective corrective actions, including management support of the corrective action process.

    The ISO 17025 toolkit at https://advisera.com/17025academy/iso-17025-documentation-toolkit/, covers this requirement; specifically through the Quality Manual https://advisera.com/17025academy/documentation/quality-manual/ and the ISO 17025 document template: Addressing Risks and Opportunities Procedure at https://advisera.com/17025academy/documentation/addressing-risks-and-opportunities-procedure/

    For more information, have a look at other advice answers on the topic of impartiality:

  • SOP and authority record

    When they say the procedure can that be guideline or does it have to be an SOP? Also I thought in the std when it specifies that procedure then you need an SOP? But for audit and management review i have a record template and not SOP. 

    By definition a procedure is a specified way to carry out an activity or a process, where a process results in an intended output, through a set of interrelated or interacting activities, involving one or more inputs.

    ISO 17025 is risk-based, leaving the decision to the laboratory on how a procedure is established, communicated, and documented if necessary. ISO 17025 Clause  5.5 c) states the need to document procedures to the extent necessary to ensure the consistent application of laboratory activities and the validity of the results. So no, a procedure does not have to be a documented Standard Operating Procedure (SOP). If the Standard, however, mandates a documented process or procedure, it must be documented.  

    You referred to internal audits and management review.  For audits, you need a program, which can be a record, however  there are requirements such as methodology, planning requirements and responsibilities; which need to be included either in a Quality Manual or for ease of use, a documented procedure. The purpose of a procedure would be to describe all audit-related activities - the audit program, selecting an auditor, conducting individual audits and reporting.

    Again, although it is not mandatory to have a documented Management Review procedure, it is commonly used. The procedure helps ensure systematic and periodic review of the Quality Management System (QMS) by the laboratory.

    Have a look at the ISO 17025 document templates: Internal Audit Procedure and Management Review Procedure and their associated records in the toolkit preview at https://advisera.com/17025academy/iso-17025-documentation-toolkit/

    2. For the authority record is it a list of staff, names, employee ID#, with list required authority and do they sign the form? Or is it a general document with all the information such as technician ,specialist, manager, Director, etc"

    A laboratory is required to document the organizational and management structure as well as the personnel authority and responsibilities, along with other requirements. For clarity, this can be achieved through an organogram in the Quality Manual and a Competence, Training and Awareness Procedure. Personnel accepts responsibilities, usually as part of an employment contract or job description.  Authority is not merely signed for.  An Approval and Authorization Record is used to specify a responsibility or activity along with the evaluation and authorisation of personnel, once deemed competent.

    Have a look at the ISO 17025 toolkit at https://advisera.com/17025academy/iso-17025-documentation-toolkit/ and preview or link to the Quality Manual, Competence, Training and Awareness Procedure and Approval and Authorization Record

    Also have a look at the article List of mandatory documents required by ISO 17025:2017 at https://advisera.com/17025academy/blog/2019/08/30/list-of-mandatory-documents-required-by-iso-170252017/, for information on mandatory and commonly used non-mandatory ISO 17025 documents and records.

  • GDPR vs. EU Dir 95/46/EC

    EU Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data has been replaced by GDPR as you can see on the official EU website: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex%3A31995L0046

    Here you can find the full text of GDPR: https://advisera.com/eugdpracademy/gdpr/

    If you want to know more about GDPR you may consider enrolling in this online EU GDPR Foundations Course:

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