ISO 17025 Documents: Essential Resources for Laboratory Accreditation

ISO 17025 is the internationally recognized standard for testing and calibration laboratories, ensuring quality, competence, and consistency in laboratory operations. To achieve and maintain compliance, laboratories require a comprehensive set of ISO 17025 documents, including manuals, procedures, templates, audit checklists, and SOPs. Global Manager Group offers these essential resources for establishing a structured and effective quality management system (QMS).

Key ISO 17025 Documents and Their Purpose

1. ISO 17025 Quality Manual

• A sample manual outlining the laboratory’s quality policy and management’s commitment to quality and competence.

• Covers a macro-level strategy for implementing the QMS in a laboratory.

• Ensures compliance with ISO 17025 requirements by providing structured guidelines.

• Acts as a reference document for continuous improvement in laboratory practices.

2. ISO 17025 Procedures

• Detailed documentation covering the implementation of laboratory procedures in compliance with QMS requirements.

• Includes 22 procedures addressing document control, internal audits, corrective actions, and handling of non-conforming testing/calibration.

• Helps define laboratory control measures and standard operating processes.

3. ISO 17025 Exhibits

• Includes 8 exhibits such as calibration periodicity of instruments, control charts, and proficiency testing records.

• Provides additional guidance on laboratory best practices and compliance with accreditation requirements.

4. ISO 17025 Templates and Formats

• A set of 70 templates and formats to assist in documenting essential records such as test request forms, calibration certificates, training records, audit reports, and risk assessment records.

• Standardized templates streamline documentation and ensure compliance with ISO 17025.

5. Standard Operating Procedures (SOPs)

• Defines laboratory best practices and work instructions.

• The two SOPs included in ISO 17025 documentation help laboratories standardize tasks such as:

o Sample handling and storage

o Instrument calibration and maintenance

• Well-documented SOPs enhance operational efficiency and reduce inconsistencies.

6. ISO 17025 Risk Template

• A pre-designed risk template to identify, evaluate, and mitigate risks associated with testing and calibration processes.

• Helps laboratories ensure continual improvement and compliance with accreditation requirements.

7. ISO 17025 Audit Checklist

• A comprehensive audit checklist with over 200 customizable questions covering key areas such as:

o Compliance with quality policy

o Implementation of documented procedures

o Equipment calibration and maintenance

o Staff training and competence

o Internal audit findings and corrective actions

• Simplifies internal audits and ensures compliance with ISO 17025 requirements.

Benefits of Using ISO 17025 Documentation Kits

• Time-Saving and Cost-Effective: Ready-made templates reduce the effort needed to create QMS documents from scratch.

• Easy to Customize: All documents are editable, allowing laboratories to tailor them with their name, logo, and specific details.

• User-Friendly and Simple Language: Designed for easy understanding and quick implementation.

• Audit-Ready: The ISO 17025 audit checklist ensures laboratories meet accreditation requirements efficiently.

• Comprehensive Coverage: Addresses all aspects of laboratory accreditation and compliance with ISO 17025.

Conclusion

ISO 17025 documentation is crucial for establishing, maintaining, and improving a laboratory QMS. Proper documentation ensures compliance, streamlines internal processes, and prepares laboratories for successful accreditation. Laboratories can leverage Global Manager Group's well-structured manuals, audit checklists, procedures, and templates to enhance their quality management system and achieve ISO 17025 accreditation effectively. For more information visit: https://www.globalmanagergroup.com/Products/test-lab-accreditation-manual-procedures-documents.htm/