ISO/IEC 17025:2017 Requirements: List of

Documents Outline and Summary

One of the most challenging parts during establishing a calibration or testing lab is to
start the documentation requirements, even if there is an established guide (ISO 17025)
that we can read and follow.

 My first time reading it (ISO 17025 Standard) is very overwhelming. It seems that after
reading the manual, you easily forget the next requirements to do.

I have created this outline as per my experience during the assessments (ISO 17025
Accreditation).  You can use this outline to format your Calibration Quality Manual or
Quality Management System and create the necessary documents records, procedures,
and forms as per the Standard ISO 17025 requirements.

The outlines are designed where a related form and records are included under each
procedure.

ISO 17025 Standard is not a certification standard, but an accreditation standard which
is very challenging. ISO 17025 accreditation focuses more on the competencies of the
labs in terms of personnel, equipment, environment, and facilities, not just complying
through documented evidence but through actual demonstrations of ISO 17025
requirements.

If you are planning to establish or manage a calibration laboratory as per ISO/IEC

17025 Standard, this is a good outline to guide you in completing your documentation
requirements and to make sure you follow the mandatory procedures of ISO
17025:2017.
The requirements here are not 100% complete, every lab has its unique design in terms
of documenting the implementation of ISO 17025 requirements but it is a good start to
have a Calibration Laboratory Management System that is in alignment with the
mandatory procedures ISO 17025.

You can copy and create an ISO 17025 calibration audit checklist based on the below
outline. Improvement is welcome so please feel free to comment.
 
ISO 17025 Quality Requirements
1.
1.  Structural requirements

  Legal Documents (evidence of ownership and registrations)
   Scope of work (scope of accreditation)
  Organizational chart
  Authorizations 
2.     Management System Requirements
 Impartiality and confidentiality Procedure
 Confidentiality  Acceptance form

 Impartiality agreement
 Risk Assessment records 
 Risk to impartiality monitoring sheet

 Management system documentation

  Quality manual – contains links of Management System
Requirements (process and procedures) which includes: 
 Quality policy

 Impartiality Policy
 Quality objectives
 Quality objectives monitoring sheet
 Documents control procedure

 Change request form
 Document for archive or disposal form
 Masterlist and distribution list of documents
 Records Control Procedure

 List of records
 Locations and retention period record
 Internal Audit Procedure

 Internal Audit report
 Internal Audit non-conformity report
 Corrective and preventive action form
  Audit plan
 Management Review Meeting Procedure

 Management Review meeting form (agenda with
attendance)
 Minutes of meeting
 Corrective Action Procedure

 Corrective action form
 Actions to Address Risks and Opportunities Procedure

 Risk assessment database file
  Risk and Opportunity for Improvement Form
 Improvement Procedure

 Improvement monitoring sheet
 Process Requirements
 Externally provided products and services procedure
 List of approve suppliers
 Supplier Evaluation Form
 Supplier Re-Evaluation Form
 Purchase Request Form
 Inspection form for Incoming Critical Supplies/Equipment
 Review of Requests, Tenders, and Contracts Procedure
 Customer Service Request Form
 Complaints Procedure
 Complaints and feedback form
 Corrective and preventive action form
 Control of Non-conforming Procedure
 Hold and release tag
 Service Report Form
 Control of data and information management Procedure
 Software Validation record
2.

ISO 17025 Technical  Requirements

Personnel  Procedure
 Training
 Training calendar
 Training report
 Technical training effectiveness evaluation
 Skill Matrix
 Authorization/ Appointment Letter
 Responsibilities List and Acceptance

 Job description List and Acceptance

 qualifications List
 List of Competence requirements
 Equipment Procedure
 Traceability information (Metrological Traceability)
 Equipment Master list
 Details and calibration status of equipment form
  Preventive Maintenance Plan
 Calibration Plan
 calibration interval procedure
 Statistical techniques Report
 Control chart
 Facilities and Environmental Conditions Monitoring
Procedure
 Environmental conditions monitoring form
 Security Procedure   
 Safety procedure
 Housekeeping Checklist
 Process Requirements
 Handling, Transport, and Storage Procedure
 Equipment Tag
 Receiving and Releasing Procedure
 Incoming and Outgoing register
 Receiving Record
 Releasing Record
 Equipment Control Tag
 Certificate Receive form
 Technical records
 Accomplished Measurement Data Sheets
 Calibration Certificates
 Measurement Uncertainty calculation
 Amended Calibration Reports
 Selection and Verification of Methods Procedure
 Verification and Validation Form
 Calibration Procedure List
 Technical worksheets (Measurement Data Record Sheet )
 Operating instructions/work instructions list
 International / National Standards List
 Validation of Methods Procedure
 Validation Check form
 Validation Report and Approval Form
 Evaluation of Measurement Uncertainty Procedure
 Measurement uncertainty budget  and calculator
 Ensuring the validity of results
 Intermediate check procedure
 Intermediate check form
 Intermediate check records
 Preventive maintenance procedure
 Preventive maintenance plan
 Preventive maintenance records
 Equipment History Card
 PT/ILC  results
 PT/ILC Plan
 PT/ILC Analysis report
  Functionality check form
 Control Charts –see under Equipment
 Replicate Test Results
 Repeatability and Reproducibility Results
 Reporting of Results  – requirements for certificates
 Calibration results (Measurement Data Sheet)
 Calibration certificate format  which includes:
 Reporting statements of conformity guide
 – Decision Rule implementation procedure

 Reporting opinions and interpretations guide

 Amendments procedure
2. Other Records  and Forms which are used depending on the Laboratory Design
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Calibration Laboratory
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