ISO 9001 – The main differences and similarities
If you consider the 2017 update to ISO 17025: 2017, you may be wondering what that standard is and how it relates to ISO 9001: 2015 and the quality management system (QMS) in your organization. You may ask: What is ISO 17025: 2017, and how does it work similarly and differently from ISO 9001: 2015?
In this article, you can learn what ISO 17025 is all about, and how it relates to the requirements of ISO 9001.
What is ISO 17025: 2017 about?
ISO 17025: 2017, “General requirements for qualification of testing and calibration laboratories”, and the third version of this standard. This standard is used as a requirement for the competence, impartiality, and performance consistent with calibration laboratories of any size or number of employees, regardless of industry. Standard requirements include the rules of neutrality and confidentiality when performing calibration (paragraph 4), structural requirements for the company (paragraph 5) and requirements for resources required for calibration such as personnel, facilities and equipment (paragraph 6).
It also includes all the necessary requirements for calibration (paragraph 7). This includes:
- Check quotes and contracts – How do you make sure you can do exactly what the customer wants?
- Calibration method – How can you select, validate and validate the methods you use for calibration?
- Sampling – How do you select samples when you are not doing everything?
- Managing items – What rules do you need to use to manage your test and calibration items?
- Records – What technical records do you need to keep for calibration of equipment?
- Measurement Uncertainty – How can you assess and report the instability of your calibration measurements?
- Result Validity – How can you make sure your results are valid?
- Result Reporting – How can you report your results to customers, including general and specific needs, as well as update reports?
- Complaints and Illegal Work – How do you handle complaints, including incompatible calibration?
- Data Management and Information Technology – How do you manage your data and information technology to ensure that data is protected against misuse?
These requirements give you the details needed to run a calibration lab. They are very specific requirements for this type of laboratory and also include some additional requirements for QMS in Section 8 (Management System Requirements). However, how is this similar and different from ISO 9001: 2015?
ISO 17025: 2017 – What is similar and different from ISO 9001: 2015 ?
In different ways, the difference between ISO 17025: 2017 and ISO 9001: 2015 is due to the application of standards. ISO 9001: 2015 is applicable to all types of companies in all industries, while ISO 17025: 2015 is only applicable to calibration laboratories in any industry. Therefore, the requirements of ISO 9001: 2015 are very general to be applicable in various industries, while the requirements of ISO 17025: 2017 are very specific about what you need to perform in the calibration laboratory.
For example, the general requirements of ISO 9001: 2015 are for resources and processes in general for each industry, while ISO 17025: 2017 tells you what resources you need and how each process should be calibrated in a laboratory. Did.
There are more similarities in paragraph eight of ISO 17025: 2017 regarding the conditions of the management system. ISO 17025: 2017 explains that a QMS system is essential for the proper operation of a calibration laboratory and then gives you the two options that are required (eg option A and option B). With option B, it states that if you have a QMS that meets the requirements of ISO 9001 and you have everything you need.
If, however, you have not implemented ISO 9001, there is a set of minimum quality management system requirements for ISO 17025: 2017 that is considered option A. Therefore, while ISO 9001 performance is good, it does not have to comply with ISO 17025: 2017. These minimum requirements are very similar to those found in ISO 9001: 2015 and include the following:
- Management system documentation
- Control system management documents
- File control
- Risks and opportunities
- Improvement
- Corrective actions
- internal audit
- Management review
So, what is missing in your QMS if you only meet the minimum requirements of ISO 17025: 2017 instead of the requirements of ISO 9001: 2015?
Here is a list of these:
Background of the Organization – ISO 17025: 2017 does not talk about identifying internal and external issues or areas of interest or creating a QMS domain.
Leadership – Although some leadership commitments are implicit, the list of leadership commitments, including quality policy, is not included in ISO 17025: 2017.
Quality Objectives – In ISO 9001: 2015, QMS improvement objectives are important, but they are not included in ISO 17025: 2017.
Some support processes – While ISO 17025: 2017 covers many of the resource and support requirements as applied to the calibration laboratory, it does not cover all of the requirements of ISO 9001: 2015. For example, ISO 17025: 2017 does not include organizational knowledge requirements.
Monitoring and measurement – While there are requirements for monitoring and measurement in ISO 17025: 2017, it does not necessarily meet all the requirements of ISO 9001: 2015.
The ISO 17025: 2017 standard, including the practical regulations of ISO 9001: 2015, essentially includes a set of instructions for calibration laboratories to address these requirements. This is because there is Option B in the calibration standard, as some companies find it useful to implement all of ISO 9001: 2015, not just the minimum.
ISO 9001: 2015 can offer more benefits than the ISO 17025: 2017 standard
There are several reasons to apply ISO 9001: 2015, even if you are a calibration lab, and these are benefits in addition to the benefits you can get.
For example, centralized improvement opportunities are achieved by achieving quality goals and facilitating the integration of other standards such as ISO 14001: 2015 or ISO 45001: 2018 to achieve further improvements.
Remember, finding the best way for your company to meet the standards of your choice. So think and act by making careful decisions.