ISO 17025 Documents | Manual, Procedures, Audit Checklist

ISO/IEC 17025 Documentation - Manual Proceudres, Templates, Audit Checklist

What to Include in ISO/IEC 17025 Documents

The ISO 17025 documents for ISO/IEC 17025 certification can be easily implemented using 4 tier documentation structure. The lists of various types of documents are listed below.

Flexibility in ISO 17025 Documentation

ISO 17025 documentation should allow flexibility to the organization in developing Good laboratory practices and management system. ISO 17025 Documentation which may differ from one laboratory to other due to:

  1. Size of the laboratory and type of its activities
  2. Complexity of processes and their interactions,
  3. Training and competence of personnel

Developing ISO/IEC 17025 System Documentation

In a quality system, work activities are described in written documents and carried out in a planned way. The structure of documents under ISO 17025 standards are:

Quality policy
Mission statement
Quality manual
Description of quality system, how standards are applied and policy
Describe how processes which affect quality are carried out
Work instruction
Additional detail on how specific jobs are carried out
Forms to show evidence that system is followed

Tier 1. Contents of ISO 17025 Manual

ISO 17025 Quality manual should normally include the following though not necessarily in the same order:

Tier 2:  ISO 17025 Procedures

ISO 17025 procedures are core of Documentation System:

Tier 3: Test procedures/ SOPs/ Work instructions

To achieve standard of workmanship -

Tier 4: Forms and records

Supporting document. To record and distribute information.

Records Required by ISO/IEC 17025

List of Records:

List of Recommended ISO/IEC 17025 Documentation Templates