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The latest iteration of ISO 17025:2017 was revised for harmonization with ISO 9001:2015. Whenever changes are applied to standards, the first questions that come to mind are: “Which documents are required?” and “How many documents are required?” For currently accredited systems, your questions may be something like: “What changes are required to our current documents?” or “What new documents do we need to generate to ensure compliance?” The ISO 17025:2017 standard actually requires fewer documents than the 2005 revision. In this article, you’ll find a snapshot of what documents you need to have to be compliant with the 2017 revision of ISO 17025.

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Mandatory documents for ISO 17025:2017

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The documents listed below are must-haves according to ISO 17025:2017. Keep in mind that if you exclude some of the clauses from the scope of your implementation, then documents for those clauses will not be required for your lab.

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• Document and Record Control Procedure (Clauses 8.2.1, 8.3 & 8.4)
• Quality Policy (Clauses 8.2.1 & 8.2.2)
• Competence, Training and Awareness Procedure (Clause 6.2.5)
• Externally Provided Products and Services Procedure (Clause 6.6.2)
• Facilities and Environment Procedure (Clause 6.3)
• Equipment and Calibration Procedure (Clauses 6.4.3 & 6.5)
• Customer Service Procedure (Clauses 7.1.1 & 8.6)
• Test and Calibration Method Procedure (Clauses 7.2.1 & 7.2.2)
• Quality Assurance Procedure (Clauses 7.7.1 – 7.7.3)
• Sampling Procedure (Clauses 7.3, 7.5 & 7.8.5, applicable only to laboratories that do sampling)
• Handling of Laboratory Test or Calibration Items Procedure (Clause 7.4)
• Complaint, Nonconformity and Corrective Action Procedure (Clauses 7.9 – 7.10 & 8.7)
• Testing Report Procedure (Clauses 7.8.2 & 7.8.3, applicable to testing laboratories that write test reports)
• Calibration Report and Certificate Requirements Procedure (Clauses 7.8.2 and 7.8.4, applicable to calibration laboratories that write calibration certificates)

Mandatory records for ISO 17025:2017

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Records are generated to demonstrate compliance with the standard and related internal procedures and serve as evidence during audits. Here are all the required records according to ISO 17025:2017:

• List of Internal and External Documents (Clauses 8.2.4 & 8.3.1)
• List of Types of Records (Clause 8.4)
• Registry of Records for Detention/Central Archive (Clauses 8.3.2f & 8.4.1)
• Quality Objectives (Clauses 8.2.1 & 8.2.2)
• Training Program (Clause 6.2.3)
• Training Record and Performance Monitoring (Clause 6.2.2)
• Record of Attendance (Clause 6.2.2)
• Competence Approval and Authorization Record (Clauses 5.6 & 6.2.5e)
• Supplier Evaluation and Approval Record (Clause 6.6.2a)
• List of Approved Suppliers of Products and Services (Clause 6.6.2a)
• Record of Laboratory Environmental Controls (Clause 6.3.3)
• List of Laboratory Equipment (Clause 6.4.13a)
• Calibrated Equipment Record (Clause 6.4.13a)
• Calibration Record (Clause 6.4.13e)
• Equipment Maintenance Record (Clause 6.4.13g)
• Customer Order Review (Clause 7.1.1a)
• Method Verification, Validation and Development Record (Clauses 7.2.1 & 7.2.2)
• Sampling Plan (Clause 7.3.1) (as applicable)
• Sampling Report (Clause 7.3.3) (as applicable)
• Corrective Action Report (Clause 8.7.3)
• Complaint, Nonconformity and Corrective Action Report Log (Clause 8.7.3)
• Measurement Uncertainty Record (Clause 7.6.3)
• Audit Nonconformity Report (Clause 8.8.2d)
• Internal Audit Report (Clause 8.8.2e)
• Management Review Record (Clause 8.9.2)

Commonly used non-mandatory ISO 17025 documents and records

You should also maintain any other documents and records that you have identified as necessary to ensure your management system can be maintained efficiently and improve over time, such as:

• Addressing Risks and Opportunities Procedure (Clauses 8.5.2 & 8.5.3)
• Report of Customer Satisfaction (Clause 8.6.2)
• Internal Audit Procedure (Clause 8.8.2)
• Management Review Procedure (Clause 8.9)

Think of the enormous benefit to you and your laboratory

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You might be overwhelmed with all the documents and records listed here, but try to think in a positive way – such documents will help you organize your laboratory in a better way, and help you not to forget something that might prove to be very important.

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For more help with managing the documents and all other aspects of the implementation project, download this free, easy-to-use Project Plan for ISO/IEC 17025 implementation.

About the author:

Chany Runnels has a BS in Biology and an MBA with a concentration in Organizational Management. She has consulted in healthcare, industry, and government, providing roadmaps for the implementation of Quality Management Systems. She has successfully led laboratories in the manufacturing verification of medical devices, which were distributed domestically and internationally. These devices were compliant with FDA cGMP and modeled in accordance with ISO 13485. Previously serving as a Forensic Biology SME, she has been qualified as an auditor for ISO 17025/Forensic Testing Agencies and the FBI’s QAS.