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)
ISO 17025 QUALITY REQUIREMENTS

1. Quality manual – contains links of Management System Requirements (process

and procedures) which includes:

a. Quality policy
b. Quality objectives
c. Quality objectives monitoring sheet
d. Structural requirements
e. Legal Documents (evidence of ownership and registrations)
f. Scope of work (scope of accreditation)
g. Organizational chart
h. Authorizations

2. MANAGEMENT SYSTEM REQUIREMENTS

2.1 Impartiality and confidentiality Procedure

a. Confidentiality Acceptance form

b. Impartiality policy
c. Risk to impartiality monitoring sheet
d. Risk Assessment records

2.2 Management system documentation

2.2.1 Documents control procedure

a. Change request form
b. Document for archive or disposal form
c. Master list and distribution list of documents

2.2.2. Records Control Procedure

a. List of records
b. Locations and retention period record

2.2.3 Internal Audit Procedure

a. Internal Audit report
b. Internal Audit non-conformity report
c. Corrective and preventive action form
d. Audit plan
2.2.4 Management Review Meeting Procedure
a. Management Review meeting form (agenda with attendance)
b. Minutes of meeting

2.2.5. Corrective Action Procedure

a. Corrective action form

2.2.6. Actions to Address risks and Opportunities Procedure

a. Risk assessment database file
b. Risk and Opportunity for Improvement Form

2.2.7. Improvement Procedure

a. Improvement monitoring sheet

2.2.8 Control of Non-Conforming Procedure

a. Hold and release tag
b. Service Report Form

2.2.9. Customer Complaints Procedure

a. Complaints and feedback form

3. Process Requirements

3.1 Externally provided products and services procedure

a. List of approve suppliers
b. Supplier Evaluation Form
c. Supplier Re-Evaluation Form
d. Purchase Request Form
e. Inspection form for Incoming Critical Supplies/Equipment

3.2 Review of requests, tenders and contracts Procedure

a. Customer Service Request Form

3.3 Complaints Procedure

a. Complaints Record Form
b. Corrective and preventive action form

3.4 Control of data and information management Procedure

a. Software Validation record
ISO 17025 Technical Requirements

1. Personnel Procedure

a. Trainings
b. Training calendar
c. Training report
d. Technical training effectiveness evaluation
e. Skill Matrix
f. Authorization/ Appointment Letter
g. Responsibilities List
h. Job description List
i. qualifications List
j. List of Competence requirements

2. Equipment Procedure

a. Traceability information (Metrological Traceability)

b. Equipment Master list
c. Details and calibration status of equipment form
d. Preventive Maintenance Plan
e. Calibration Plan
f. Statistical techniques Report
g. Control chart

3. Facilities and Environmental Conditions Monitoring Procedure

a. Environmental conditions monitoring form

b. Security Procedure
c. Cleaning and safety procedure
d. Housekeeping Checklist

4. Process Requirements

4.1 Handling, transport and storage procedure

a. Equipment Tag

4.2 Receiving and releasing procedure

a. Incoming and Outgoing register
b. Receiving Record
c. Releasing Record
d. Equipment Control Tag
e. Certificate Receive form
4.3 Technical records
a. Accomplished Measurement Data Sheets
b. Calibration Certificates
c. Measurement Uncertainty calculation
d. Intermediate check records
e. Preventive Maintenance Records
f. Validation Records

4.4 Selection and Verification of Methods Procedure

a. Verification and Validation Form
b. Calibration Procedure List
c. Technical worksheets (Measurement Data Record Sheet)
d. Operating instructions/work instructions list
e. International / National Standards List

4.5 Validation of Methods Procedure

a. Validation Check form
b. Validation Report and Approval Form
c. Evaluation of Measurement Uncertainty Procedure
d. Measurement uncertainty budget and calculator

4.6 Ensuring the validity of results

a. Intermediate check procedure
b. Intermediate check Form
c. Preventive maintenance procedure
d. Preventive maintenance plan
e. Equipment History Card
f. PT/ILC results
g. PT/ILC Plan
h. PT/ILC Analysis report
i. Functionality check form
j. Control Charts –see under Equipment
k. Replicate Test Results
l. Repeatability and Reproducibility Results
m. Reporting of Results – requirements for certificates
n. Calibration results (Measurement Data Sheet)
o. Calibration certificate format which includes:
p. Reporting statements of conformity guide
q. Reporting opinions and interpretations guide
r. Amendments procedure