Laboratory sampling, testing, and conformity assessment are crucial enabling factors for technology and trade. ISO/IEC 17025 assists in the harmonization of procedures and standard methods, facilitates cooperation between laboratories and other bodies, and promotes the acceptance of results between countries.
ISO/IEC 17025:2017 is the international standard that sets out the general requirements for the competent, impartial, and consistent operation of laboratories. It specifies the activities that must be included in laboratory operations to promote confidence in its ability to produce valid and consistently reliable testing, calibration, and sampling results.
The standard was published with collaboration between the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC).The requirements of the standard include
• General requirements regarding impartiality and confidentiality (clause 4)
• Structural requirements (clause 5)
• Requirements for resources needed such as personnel and facilities, as well as technical resources such as equipment
• Environmental conditions (clause 6).
• Process requirements (clause 7). These include:
o Reviewing requests, tenders and contracts – How do you ensure that you can do exactly what the customer wants done?
o Method suitability – How do you select, verify, and validate the methods you intend to use?
o Sampling – When you perform the sampling before testing, what planning and documentation are required?
o Handling items – What procedures need to be followed for handling the testing and calibration items that you are going to report on?
o Records – What technical records should be kept, and what should they contain?
o Measurement uncertainty – How do you evaluate and report the measurement uncertainty of your calibration?
o Result validity – How do you ensure that your results are valid?
o Result reporting – How do you report on your results to customers, including both general and specific requirements, as well as updating reports?
o Complaints and nonconforming work – How do you need to handle complaints and work you have done that is found to be nonconforming?
o 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?
• Management requirements (clause 8)
Why is ISO/IEC 17025:2017 accreditation a good idea for your organization?
• Assuring your laboratory’s creditability
• Creating an environment of professionalism and pride
• Creating a proactive risk-based business and quality culture, not reactive
• Increasing customer confidence
General Tech Services adhere to all the requirements of ISO 17025.
How is this similar and different from ISO 9001:2015?
Certification according to ISO 9001 is recognition that an effective management system is in place. ISO 9001 is applicable to all types of companies in all industries, whereas ISO 17025 is only applicable to testing and calibration laboratories. Similarities are found in clause 8 of ISO 17025:2017 regarding management system requirements. General Tech Services is ISO 9001 certified as well.
So, what will be missing in Quality Management System of the organization if they just have ISO 17025:2017 rather than the requirements of ISO 9001?
• 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.
Aside from that, there are ISO 17025 management requirements that are similar to ISO 9001:
• Internal audits
• Management reviews
• Actions to address risks and opportunities
• Improvements and corrective actions
• Management system documentation
• Control of management system document
• Control of records
• ISO 17025 doesn’t specify identifying internal and external issues or interested parties. Hence, you still need to determine the context of the organization and develop a QMS scope.
• ISO 9001 includes the formulation of quality objectives, unlike in ISO 17025.
• ISO 17025 doesn’t include leadership commitments nor quality policy.
• ISO 17025 has monitoring and measuring requirements, but these don’t inescapably address all of the requirements from ISO 9001.
• ISO 17025 has resource and support requirements, but it does not cover all ISO 9001 requirements.
General Tech Services is accredited under both ISO 9001 and ISO 17025 to meet all QMS requirements for assuring the best quality services to all customers. We have the widest IEC 17025 accreditation scope in UAE.
Contact us for industry best calibration services in the Middle East.
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