The difference between ISO 17025:2017 and ISO 9001:2015 is in the applicability of the standards. ISO 9001:2015 can be applied to all types of industries as its requirements are very generic, whereas ISO 17025:2017 is applicable only on calibration laboratories as its requirements are very specific as to what you need to implement in calibration laboratories.
ISO 17025:2017 explains that a Quality Management System is necessary for the proper functioning of a calibration laboratory, and then provides you with two options i.e. Option A and Option B.
If the laboratory has not implemented ISO 9001, then a minimum set of QMS requirements which are needed for the applicability of ISO 17025:2017, need to me fulfilled. This is referred to as Option A. On the other hand, Option B states that if you have a QMS which meets the requirements of ISO 9001:2015, then you have everything that you need.
However, it is important to note that while ISO 9001 implementation is nice to have, it is not required to comply with ISO 17025:2017.
If you fulfill just the minimum requirements of ISO 17025:2017 instead of requirements of ISO 9001:2015, some of the things that will be missing from your QMS are:
- Context of The Organization: ISO 17025 does not talk about identifying and specifying your interested parties, internal and external issues or about establishing the scope of our QMS.
- Quality Objectives: ISO 9001:2015 has important improvement goals for the QMS which are not included in ISO 17025:2017.
- Leadership: Although some leadership commitment is there, there is no listing of leadership commitments, including the quality policy, in ISO 17025:2017.
- Monitoring and Measurement: While there are some requirements of monitoring and measurement in ISO 17025:2017, these do not address all of the requirements of ISO 9001:2015.
- Some Support Processes: Though ISO 17025:2017 includes many support and resource requirements as it applies to calibration laboratories, but it does not include all the requirements from ISO 9001:2015. For example, it does not include requirements about organizational knowledge.
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 in the standard as some companies will find it helpful to implement all of ISO 9001:2015 requirements rather than just the minimum.
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