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:
- Sample handling and storage
- 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:
- Compliance with quality policy
- Implementation of documented procedures
- Equipment calibration and maintenance
- Staff training and competence
- 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/
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