ISO 17025: 2017 “General laboratory competency of testing calibration requirements” is the third edition of this standard. The intentions of this standard are to be used as impartiality, competence and consistent requirements of calibration laboratories of all sizes or number of employees regardless of the industry. The standard requirements include rules on impartiality and confidentiality while performing calibration (clause 4), the company’s structural requirements (clause 5) and the requirements for the resources needed to carry out calibrations such as facilities, personnel, and equipment (clause 6).
All the necessary process requirements for performing calibrations (clause 7) are also included. They include;
Quotes and contracts reviewal: How do you ensure you get exactly what the customer wants done?
Calibration methods: How do you do the selection, verification, and validation of the method used for calibrating?
Sampling: When you don’t want to do everything, how do you do the selection of samples?
Handling items: What rules requirement do you need in handling test and calibration items that are given to you?
Records: What technical record do you need in keeping calibrations done on the equipment?
Result reporting: How do you do the reporting to the customers? Do you include general and specific requirements and also updating reports?
Complaints & nonconforming: How do you deal with complaints, including calibrations handling that you’ve done that are found to be non-conforming?
Data & IT management: How do you do the management of information technology as well as data in ensuring that the data is preserved against misuse?
From these requirements, you give the details needed in managing a calibration laboratory to ensure that the certifications you give out are right and traceable to the international standards.
These requirements are very specific for this type of laboratory and they also include other further requirements for a QMS in clause 8 (Management System requirements).
ISO 17025:2017 – SIMILARITIES & DIFFERENCES FROM ISO 9001:2015
The applicability of the standards differentiates ISO 17025:2017 and ISO 9001:2015. ISO 9001:2015 can be applied to any type of company and in all industries, whereas ISO 17025:2015 can only be applied to calibration laboratories in any industry. Thus, ISO 9001:2015 requirements are very generic for them to be applied in any type of industry while ISO 17025:2017 are specific on what needs to be implemented in calibration laboratories.
An example: ISO 9001:2015 general requirements on the resources as well as processes are very general for any industry but ISO 17025:2017 tells you the resources required and how every process needs to be done in a calibration laboratory.
However, if you haven’t implemented ISO 9001, there are a minimum set of QMS requirements that are needed for ISO 17025:2017 standard that is referred to as option A. Implementing ISO 9001 is nice having it, it doesn’t have to comply with ISO 17025:2017. Such minimum requirements are quite similar to those that are found in ISO 9001:2015 and they include;
- Management reviews
- Management system documents control
- Documentation of management system
- Corrective actions
- Handling risks and opportunities
- Records control
- Internal audits
Things missing in QMS if ISO 17025:2017 minimum requirements but are included in ISO 9001:2015 requirements include;
The context of the organization: ISO 17025:2017 doesn’t talk about identification of your internal and internal issues or on establishment a QMS scope or interested parties.
Leadership: ISO 17025:2017 doesn’t include leadership commitments list that includes the quality policy.
Quality objectives: ISO 17025:2017 doesn’t include these essential QMS goals but they are included in ISO 9001:2015.