ISO 17025 is an international standard for testing and calibration laboratories. One of the requirements of this standard is the development and implementation of a quality manual. A quality manual is a document that outlines the laboratory’s quality management system, including its policies, procedures, and processes.
In this blog post, we’ll take a closer look at ISO 17025 quality manuals, including their purpose, contents, and benefits.
Purpose of ISO 17025 Quality Manual
The primary purpose of an ISO 17025 quality manual is to provide a comprehensive guide to the laboratory’s quality management system. It serves as a reference document for laboratory staff, customers, and accreditation bodies, and it outlines the laboratory’s policies, procedures, and processes for ensuring the quality of its testing and calibration services.
Contents of an ISO 17025 Quality Manual
An ISO 17025 quality manual should contain the following elements:
- Scope: This section outlines the laboratory’s scope of accreditation, including the tests or calibrations that it is accredited to perform.
- Normative references: This section lists the relevant standards, regulations, and other documents that the laboratory follows.
- Terms and definitions: This section defines the key terms and concepts used in the quality manual.
- Management system: This section outlines the laboratory’s quality management system, including its policies, procedures, and processes for ensuring the quality of its testing and calibration services.
- Management responsibility: This section outlines the responsibilities of laboratory management, including its commitment to quality, customer satisfaction, and continual improvement.
- Resource management: This section outlines the laboratory’s processes for managing its resources, including its personnel, facilities, equipment, and materials.
- Process management: This section outlines the laboratory’s processes for managing its testing and calibration services, including its procedures for sample handling, analysis, and reporting.
- Measurement uncertainty: This section outlines the laboratory’s procedures for estimating and reporting measurement uncertainty.
- Internal audit: This section outlines the laboratory’s procedures for conducting internal audits of its quality management system.
- Management review: This section outlines the laboratory’s procedures for conducting regular management reviews of its quality management system.
Benefits of ISO 17025 Quality Manual
It provides several benefits to the laboratory, including:
- Improved quality: By documenting its quality management system, the laboratory can identify areas for improvement and implement corrective actions to enhance the quality of its testing and calibration services.
- Compliance: An ISO 17025 quality manual helps the laboratory ensure compliance with the requirements of the standard and with regulatory requirements.
- Accreditation: It is a requirement for accreditation to the standard. By developing and implementing a quality manual, the laboratory can demonstrate its commitment to quality and its ability to provide accurate and reliable testing and calibration services.
- Customer satisfaction: By ensuring the quality of its testing and calibration services, the laboratory can improve customer satisfaction and build trust with its customers.
Conclusion
An ISO 17025 quality manual is a key component of a laboratory’s quality management system. It outlines the laboratory’s policies, procedures, and processes for ensuring the quality of its testing and calibration services. By developing and implementing a quality manual, the laboratory can improve the quality of its services, ensure compliance with the standard and regulatory requirements, and build trust with its customers.