Following the update of ISO 17025 in 2017, the world of standards became intrigued about its relation to the Quality Management System (QMS) and ISO 9001:2015.
Here’s the thing—ISO 17025 has some aspects that relate to the requirements of ISO 9001. It can also lead to accreditation certification depending on an organization’s QMS.
To help you further understand these standards, QSE Academy has created this succinct explanation about their likeliness and dissimilarities.
What is ISO 17025:2017?
ISO 17025:2017, “General Requirements for the Competence of Testing and Calibration Laboratories,” is this standard’s third edition.
It serves as requirements for the competence, impartiality, and consistent operation of testing and calibration laboratories. This is regardless of an organization’s size or the number of employees.
ISO 17025:2017 includes general requirements regarding:
- Clause 4 – impartiality and confidentiality
- Clause 5 – structural requirements
- Clause 6 – resources such as personnel, equipment, technical, facilities, and environmental conditions
Meanwhile, Clause 7 encompasses important process requirements:
- Reviewing requests, tenders, and contracts– Ensure you can conduct precisely what the customer wants.
- Method suitability– Choosing, verifying, and validating methods.
- Sampling– Necessary planning and documentation for sampling before testing.
- Handling items– Procedures in handling the testing and calibration items.
- Measurement uncertainty– Evaluating and reporting the calibration’s measurement uncertainty.
- Result validity– Ensuring the validity of results.
- Result reporting– Reporting the results to customers, including both general and specific requirements, as well as updating reports.
- Data and information management– Handling data and laboratory information systems to guarantee validity and access.
- Complaints and nonconforming work– Managing complaints and corrective actions to nonconformances.
- Records – Developing and preserving technical records.
These requirements enable a laboratory to manifest competency in performing activities according to international standards.
ISO 17025:2017 vs ISO 9001:2015
Here’s the main difference—ISO 9001 applies to all kinds of businesses in all industries or sectors.
On the other hand, ISO 17025 is only valuable for testing and calibration laboratories.
When it comes to similarities, you can look into Clause 8 of ISO 17025 about management system requirements.
ISO 17025 implies the necessity of a management system to guarantee a laboratory’s consistent operation. It also provides the opportunity to address such requirements within a current standard’s management system.
For organizations not implementing ISO 9001, ISO 17025 needs a set of minimum QMS requirements.
Thus, ISO 9001 implementation and certification aren’t required in complying with ISO 17025. Yet, some organizations will find ISO 9001 useful in implementing ISO 17025.
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
- Corrective actions
- Management system documentation
- Control of management system document
- Control of records
Note that when your organization only has the minimum requirements of ISO 17025, rather than ISO 9001 requirements, you still have to address other factors.
First, 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.
Secondly, ISO 9001 includes the formulation of quality objectives, unlike in ISO 17025.
Next, ISO 17025 doesn’t include leadership commitments nor quality policy.
Moreover, ISO 17025 has monitoring and measuring requirements, but these don’t inescapably address all of the requirements from ISO 9001.
Finally, ISO 17025 has resource and support requirements, but it does not cover all ISO 9001 requirements.
How Can Your Organization Maximize Both ISO 9001 and ISO 17025?
As explained earlier, there are advantages to following all requirements of ISO 9001 before implementing ISO 17025.
For instance, ISO 9001 comes with clauses that make it easy to manage the context of the organization, quality objectives, leadership, and documented information.
Consequently, your laboratory can use a process approach and risk-based thinking in improving operational efficiency.
Keep in mind that your laboratory doesn’t necessarily need ISO 9001, but it’s an asset when pursuing ISO 17025 accreditation certification.
Should you need more information, we’ve allotted articles about ISO 9001 and ISO 17025 on our website.
QSE Academy also offers toolkits to help your laboratory implement these standards.