Mandatory documents for ISO 17025:2017
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.

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
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)