Is ISO 9001 or ISO/IEC 17025 right for your organization?
Exploring ways to elevate your existing quality management system can be a difficult and overwhelming task. However, the International Standards Organization (ISO) has created standards that, when met, are the key to elevating your quality management systems. Whether it’s a corporate standalone management system or a combination of systems, each standard provides a framework to implement your management system. ISO 9001 and ISO/IEC 17025 are two standards that can potentially provide a framework for improvements, but which one is right for your organization?
What is ISO 9001?
ISO 9001 is a quality management system requirements standard designed for most organizations, regardless of size. The standard requires organizations to demonstrate that they can consistently provide products and services that meet customer needs and provides a layout for organizations to maintain high efficacy of their quality management system.
This standard primarily focuses on fundamental concepts and quality management principles such as interested parties, customer focus, leadership, engagement, process approach, and improvement. These elements contribute to creating a well-rounded management system focusing on the organization’s approach and philosophy of management systems. Organizations that also have testing and/or calibration facilities typically use an additional standard because ISO 9001 does not focus on the laboratory’s competency to perform a specific test or calibration.
What is ISO/IEC 17025 and how is it different from ISO 9001?
ISO/IEC 17025 was created to promote confidence in the operation of testing, calibration, and sampling laboratories. This system may operate outside of the organization’s corporate quality management system. ISO/IEC 17025 integrates elements from both the management system and technical competency of the laboratory providing, an additional layer of accountability and integrity to your organization’s overall quality. Becoming accredited to ISO/IEC 17025 can also give your customers confidence in your organization’s ability to provide accurate results. ISO/IEC 17025 was created to provide confidence in the technical competency within the laboratory. With generally identical management system requirements, a laboratory must also be in conformance with technical elements. These include, but are not limited to:
- The facilities environmental conditions
- Identifying equipment and verifying that the equipment meets a method’s specification(s) and has traceability
- If sampling occurs, how it is handled
- Handling of test and calibration items
- Technical records and reports
Elements taken from the list above, in combination with other technical requirements, and your management system, can form a solid and confident laboratory quality management system. Not only will your organization be able to demonstrate an effective management system, but it will also demonstrate that your laboratory has a system in place to ensure the accuracy of testing and calibration results.
With the brief descriptions above, your organization now has a general idea regarding what both standards can provide. If you are only concerned with the integrity of your management system, ISO 9001 may be more appropriate. However, if you want or need an additional layer of confidence in your laboratory activities, ISO/IEC 17025 is the better option. For further information, please contact us at A2LA.org/contact-us.