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SOP and authority record

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Guest user Created:   Jun 09, 2020 Last commented:   Jun 09, 2020

SOP and authority record

1. 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.

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

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ISO 17025 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 17025 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

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Tracey Evans Jun 09, 2020

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.

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