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Mark Hammar

ISO 17025 vs. ISO 9001 – Main differences and similarities

If you noticed the release of the 2017 update of ISO 17025:2017, you might wonder what this standard is all about, and how it relates to ISO 9001:2015 and the Quality Management System (QMS) in your organization. You might well ask: What is ISO 17025:2017, and how is it similar and different from ISO 9001:2015?

In this article, you will find out what the ISO 17025 standard is about, and how it relates to the ISO 9001 standard requirements.

What is ISO 17025:2017 about?

ISO 17025:2017, “General requirements for the competence of testing and calibration laboratories,” is the third edition of this standard. This standard is intended to be used as requirements for the competence, impartiality, and consistent operation of calibration laboratories of all sizes or number of employees, regardless of industry. The requirements of the standard include rules on impartiality and confidentiality when performing calibration (Clause 4), structural requirements for the company (clause 5), and requirements for resources needed to perform calibrations such as personnel, facilities, and equipment (clause 6).

Also included are all of the necessary process requirements for performing calibrations (clause 7). These include:

  • Reviewing quotes and contracts – How do you ensure that you can do exactly what the customer wants done?
  • Calibration methods – How do you select, verify, and validate the methods you use for calibrating?
  • Sampling – When you don’t do everything, how do you choose samples?
  • Handling items – What rules do you need to handle the test and calibration items that you are given?
  • Records – What technical records do you need to keep for the calibrations done on equipment?
  • Measurement uncertainty – How do you evaluate and report the measurement uncertainty of your calibration?
  • Result validity – How do you ensure that your results are valid?
  • Result reporting – How do you report on your results to customers, including both general and specific requirements, as well as updating reports?
  • Complaints and nonconforming work – How do you handle complaints, including the handling of calibrations you have done that are found to be nonconforming?
  • Data and IT management – How do you manage your information technology and data to ensure that data is preserved against misuse?

These requirements give you the detail you need to manage a calibration laboratory to ensure that the certifications you issue are correct and traceable to international standards. They are very specific requirements for this type of laboratory, and they also include some further requirements for a QMS in clause 8 (Management system requirements). However, how is this similar and different from ISO 9001:2015?

For more on what ISO 9001:2015 says about calibration of monitoring and measurement equipment, see this article: Monitoring and Measurement Equipment Control.

ISO 17025:2017 – What is similar to, and different from, ISO 9001:2015?

In many ways, the differences between ISO 17025:2017 and ISO 9001:2015 are due to the applicability of the standards. ISO 9001:2015 is applicable to all types of companies in all industries, whereas ISO 17025:2015 is only applicable to calibration laboratories in any industry. Because of this, the requirements of ISO 9001:2015 are very generic so that they can be applied in different industries, while the requirements of ISO 17025:2017 are very specific about what you need to implement in calibration laboratories.

For instance, the general requirements of ISO 9001:2015 on resources and processes are general for any industry, whereas ISO 17025:2017 tells you what resources you need and how each process should be done in a calibration laboratory.

Further similarities are found in clause 8 of ISO 17025:2017 regarding management system requirements. The ISO 17025:2017 standard explains that a QMS is necessary for the proper functioning of a calibration laboratory, and then gives you two options on what is needed (i.e., option A and option B). With Option B, it states that if you have a QMS that meets the requirements of ISO 9001, then you have everything you need.

If, however, you have not implemented ISO 9001, then there is a set of minimum QMS requirements that are needed for the ISO 17025:2017 standard, which is referred to as Option A. So, while ISO 9001 implementation is nice to have, it is not required to comply with ISO 17025:2017. These minimum requirements are very similar to those found in ISO 9001:2015, and include:

  1. Management system documentation
  2. Control of management system documents
  3. Control of records
  4. Addressing risks and opportunities
  5. Improvement
  6. Corrective actions
  7. Internal audits
  8. Management review

So, what is missing in your QMS if you just do the minimum requirements of ISO 17025:2017 rather than the requirements of ISO 9001:2015? Here is a quick top-level list:

  • Context of the organization – ISO 17025:2017 does not talk about identifying your internal and external issues or interested parties, or about establishing a QMS scope.
  • Leadership – Although some leadership commitment is implied, the listing of leadership commitments, including the quality policy, are not included in ISO 17025:2017.
  • Quality objectives – in ISO 9001:2015, these are important improvement goals for the QMS, but they are not included in ISO 17025:2017
  • Some support processes – While ISO 17025:2017 includes many resource and support requirements as they apply to calibration laboratories, it does not include all the requirements from ISO 9001:2015. For instance, ISO 17025:2017 does not include requirements about organizational knowledge.
  • Monitoring and measurement – While there are requirements about monitoring and measurement in ISO 17025:2017, these do not necessarily address all of the ISO 9001:2015 requirements.

Containing the operation clauses of ISO 9001:2015, the ISO 17025:2017 standard is basically a set of how-to instructions for calibration laboratories to address these requirements. This is the reason that Option B exists within the calibration standard, as some companies will find it helpful to implement all of ISO 9001:2015 rather than just the minimum.

For more on what ISO 9001:2015 says about operations, see this article on Managing Production and Service Provision using ISO 9001.

ISO 9001:2015 can provide further benefits over ISO 17025:2017

There are several reasons to implement ISO 9001:2015 even if you are a calibration laboratory, and these are the addition benefits you can gain. Some examples are the focused improvement opportunities gained by having quality objectives, and the ease of integrating other standards such as ISO 14001:2015 or ISO 45001:2018 to help find further improvements.

Remember, the choice is up to you to find the best way for your company to comply with their chosen standards, so think carefully when making these decisions.

For a better understanding of how the implementation process works, see this downloadable ISO 9001:2015 Implementation Diagram.

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