Understanding the Differences and Similarities Between ISO 17025 and ISO 9001

Understanding the Differences and Similarities Between ISO 17025 and ISO 9001

ISO 9001

You might be wondering what the ISO standards are and more significantly what does your lab need and what do 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.  Let’s look at the similarities and differences between the two.

What is ISO 9001

They define ISO 9001 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.  For this reason, ISO 9001 is a standard that a company is certified in.

What is ISO 17025

ISO/IEC 17025 is the highest standard quality management system and the primary standard for calibration laboratories. They intend this standard to be used as requirements 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.  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 specifically the only standard in the series to which organizations can certify.

ISO 9001 standard helps with: (remove with)

  • Specifically, organize processes
  • Improve the efficiency of processes
  • Continuous improvements

Minimum Set of QMS Requirements for ISO 17025

There is a minimum set of Quality Management System (QMS) requirements that are needed for the ISO 17025:2017 standard, which are similar to those found in ISO 9001:2015.  Such as:

  • Improvement
  • Management Reviews
  • Management system documents control
  • Documentation of management system
  • Corrective action
  • Handling risks and opportunities
  • Records control
  • Internal audits

The Basic Difference between ISO 17025 and ISO 9001

ISO 17025 is only for calibration and testing laboratories whereas they can apply ISO 9001 to any organization.

Who Needs the Accreditation?

Labs that perform calibration and do not make products that need to meet ISO 17025 requirements, and not necessarily those of ISO 9001.

Suppliers who specifically need reliable calibration backed by a quality system should seek out labs accredited to ISO 17025.

How They Can Benefit Your Lab’s Experience

If your lab is looking to work with an accredited calibration laboratory than it would benefit you to find a company that is a registered company with a state-of-the-art ISO 17025 accredited laboratory.  They will be able to apply risk based thinking and a process approach to the requirements of the ISO 17025, to manage risks and drive improvement more efficiently for your lab.