You might be wondering what the ISO standards are and, more importantly, what your lab needs and what you need to look for in a calibration solutions company. Both ISO/IEC 17025 and ISO 9001 have requirements and meet the specific needs of industries across the board. First, let’s look at the similarities and differences between the two.
What is ISO 9001
ISO 9001 is defined as the international standard that specifies requirements for a quality management system (QMS). Organizations use the standard to demonstrate the ability to consistently provide products and services that meet customer and regulatory requirements. ISO 9001 is a standard that a company is certified in.
What is ISO 17025
ISO/IEC 17025 is the highest quality management system and the primary standard for calibration laboratories. This standard is intended to be used as a requirement for the competence, impartiality, and consistent operation of testing and calibration laboratories of all sizes or numbers of employees, regardless of industry.
It applies only to bodies implementing a certification service. So, for example, this could be an ISO 17025-accredited lab delivering an accredited calibration or testing certificate.
ISO 9001 Certification Details
ISO 9001 certification applies to an entire organization. It’s an effective tool for management but does not include the necessary technical content to show that test/inspection/calibration data are reliable. It is the most popular standard in the ISO 9000 series and the only bar in the series to which organizations can certify.
ISO 9001 standard helps with:
- Organize processes
- Improve the efficiency of processes
- Continuous improvements
Minimum Set of QMS Requirements for ISO 17025
A minimum set of Quality Management System (QMS) requirements are needed for the ISO 17025:2017 standard, similar to ISO 9001:2015. They are:
- Management Reviews
- Management system documents control
- Documentation of management system
- Corrective action
- Handling risks and opportunities
- Records control
- Internal audits
Who Needs the Accreditation?
Labs that perform calibration and do not make products that need to meet ISO 17025 requirements, not necessarily ISO 9001. Suppliers who need reliable calibration backed by a quality system should seek out labs accredited to ISO 17025.
How They Can Benefit Your Lab’s Experience
Suppose your lab wants to work with an accredited calibration company. In that case, finding an ISO 9001 registered company with a state-of-the-art ISO 17025 accredited laboratory will benefit you. They will be able to apply risk-based thinking and a process approach to the requirements of ISO 17025, to manage risks and drive improvement more efficiently for your lab.