How Iso/iec 17025 Standard Differs From Iso 9001 Qms Standard

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What is ISO/IEC 17025:2017?
ISO 17025:2017, Overall requirements for the capability of testing and calibration laboratories, is the third edition of this standard. This ISO 17025 standard is proposed to be used as requirements for the capability, impartiality, and constant operation of testing and calibration laboratories of all sizes or numbers of employees, regardless of industry. The requirements of the standard contain general requirements regarding impartiality and confidentiality, structural requirements, and requirements for resources required such as personnel and facilities, as well as technical resources such as equipment and environmental conditions. All the essential process requirements are also included in the standard (clause 7). These are:
• Reviewing requests, tenders, and contracts: Confirm organization can conduct precisely what the consumer wants.
• Method suitability: Selecting, verifying, and validating methods.
• Sampling: Essential planning and ISO 17025 documents for sampling before testing.
• Handling items: Procedures in handling the testing and calibration items.
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... • Measurement uncertainty: Assessing and reporting the calibration’s measurement uncertainty.
• Result validity: Confirming the validity of results.
• Result reporting: Reporting the results to consumers, with both general and precise requirements, as well as updating reports.
• Data and information management: Handling data and laboratory information systems to assurance validity and access.
• Complaints and nonconforming work: Managing complaints and proper actions to nonconformances.
• Records: Developing and preserving technical records.
These requirements give the detail to show capability in the laboratory activities perform, according to ISO/IEC 17025 international standards.
What are the Differences and Similarities?
In several ways, the differences between ISO 17025:2017 and ISO 9001:2015 are due to the pertinence of the standards. ISO 9001:2015 is appropriate to all types of companies in all industries, whereas ISO 17025:2017 is only applicable to testing and calibration laboratories. For instance, the requirements of ISO 9001:2015 on resources and processes are overall for any industry, whereas ISO 17025:2017 is more precise and detailed for testing and calibration laboratories.
Similarities are found in ISO 17025:2017 regarding management system requirements. The ISO 17025:2017 standard explains that a general management system is essential to confirm constant functioning of a laboratory, and gives laboratories the option of addressing those requirements within an existing ISO 9001 management system or another quality standard. If, however, organization have not applied ISO 9001, then there is a set of minimum QMS requirements that are required for the ISO 17025:2017 standard. So, while ISO 9001 implementation and certification are nice to have, it is not essential to comply with ISO 17025:2017. These minimum management requirements are very similar to those found in ISO 9001:2015, and contain:
• Management system documentation.
• Control of management system documents.
• Control of records.
• Actions to address risks and opportunities.
• Improvement.
• Corrective actions.
• Internal audits.
• Management reviews.
So, what is missing in Quality Management System if organization just do the minimum requirements of ISO 17025:2017 rather than the requirements of ISO 9001:2015? Here is a quick top-level list:
• Context of the organization: ISO 17025:2017 does not talk about classifying internal and external problems or interested parties, or about establishing a Quality Management System scope.
• Leadership: Though some leadership commitment is implied, the listing of leadership commitments, with the quality policy, are not involved in ISO 17025:2017.
• Quality objectives: In ISO 9001:2015, these are significant development goals for the QMS, but they are not involved in ISO 17025:2017.
• Some support processes: While ISO 17025:2017 contains many resource and support requirements as they apply to calibration laboratories, it does not contain all the requirements from ISO 9001:2015. For instance, ISO 17025:2017 does not contain requirements about organizational knowledge.
• Monitoring and measurement: While there are requirements about monitoring and measurement in ISO 17025:2017, these do not essentially address all of the ISO 9001:2015 requirements.
Covering the process clauses of ISO 9001, the ISO 17025 standard is essentially a set of how-to instructions for calibration laboratories to address these requirements. This is the reason that Option B exists within the calibration standard, as some companies will find it helpful to execute all of ISO 9001:2015 rather than just the minimum.
How ISO 9001 can Benefit ISO 17025 Laboratories?
There are many benefits if organization contain all the ISO 9001:2015 requirements, rather than only meeting the minimum management requirements. For instance, the clauses and language of ISO 9001 make understanding risk, context of the organization, documented information, quality objectives, and leadership clearer. This allows laboratories to apply risk-based thinking and a procedure method to address the requirements of ISO 17025, to manage risks and to drive development more efficiently.
Source:
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