Mark Hammar 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 testing and calibration laboratories of all sizes or numbers of employees, regardless of industry. The requirements of the standard include general requirements regarding impartiality and confidentiality (clause 4), structural requirements (clause 5), and requirements for resources needed such as personnel and facilities, as well as technical resources such as equipment and environmental conditions (clause 6).
All the necessary process requirements are also included in the standard (clause 7). These are:
- Reviewing requests, tenders and contracts – How do you ensure that you can do exactly what the customer wants done?
- Method suitability – How do you select, verify, and validate the methods you intend to use?
- Sampling – When you perform the sampling before testing, what planning and documentation are required?
- Handling items – What procedures need to be followed for handling the testing and calibration items that you are going to report on?
- Records – What technical records should be kept, and what should they contain?
- 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 need to handle complaints and work you have done that is found to be nonconforming?
- Data and information management – How do you manage your data and laboratory information system to ensure it is valid and that you have access to what you need?
These requirements give you the detail to show competency in the laboratory activities you perform, according to international standards. In clause 8, management requirements are specified. 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 testing and calibration laboratories.
For instance, the requirements of ISO 9001:2015 on resources and processes are general for any industry, whereas ISO 17025:2017 is more specific and detailed for testing and calibration laboratories.
Similarities are found in clause 8 of ISO 17025:2017 regarding management system requirements. The ISO 17025:2017 standard explains that an overall management system is necessary to ensure consistent functioning of a laboratory, and gives laboratories the option of addressing those requirements within an existing ISO 9001 management system or another quality standard (option B)
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 and certification are nice to have, it is not required to comply with ISO 17025:2017. These minimum management requirements are very similar to those found in ISO 9001:2015, and include:
- Management system documentation
- Control of management system documents
- Control of records
- Actions to address risks and opportunities
- Improvement
- Corrective actions
- Internal audits
- Management reviews
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.
How ISO 9001:2015 can benefit ISO 17025:2017 laboratories
There are numerous added benefits if you include all the ISO 9001:2015 requirements (or principles, at least), rather than only meeting the minimum management requirements. For example, the clauses and language of ISO 9001 make understanding risk, context of the organization, documented information, quality objectives, and leadership clearer. This empowers laboratories to apply risk-based thinking and a process approach to address the requirements of ISO 17025, to manage risks and to drive improvement more efficiently.
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 Diagram of ISO 17025:2017 Implementation Process.
