For organizations not implementing ISO 9001, ISO 17025 needs a set of minimum QMS requirements. It also provides the opportunity to address such requirements within a current standard’s management system. It implies the necessity of a management system to guarantee a laboratory’s consistent operation. When it comes to similarities, you can look into Clause 8 of ISO 17025 about management system requirements.
On the other hand, ISO 17025 is only valuable for testing and calibration laboratories. Here’s the main difference-ISO 9001 applies to all kinds of businesses in all industries or sectors. These requirements enable a laboratory to manifest competency in performing activities according to international standards. Records – Developing and preserving technical records.Complaints and nonconforming work – Managing complaints and corrective actions to nonconformances.Data and information management – Handling data and laboratory information systems to guarantee validity and access.Result reporting – Reporting the results to customers, including both general and specific requirements, as well as updating reports.Result validity – Ensuring the validity of results.Measurement uncertainty – Evaluating and reporting the calibration’s measurement uncertainty.Handling items – Procedures in handling the testing and calibration items.Sampling– Necessary planning and documentation for sampling before testing.Method suitability– Choosing, verifying, and validating methods.Reviewing requests, tenders, and contracts– Ensure you can conduct precisely what the customer wants.Meanwhile, Clause 7 encompasses important process requirements: Clause 6 – resources such as personnel, equipment, technical, facilities, and environmental conditions.Clause 4 – impartiality and confidentiality.It includes general requirements regarding: This is regardless of an organization’s size or the number of employees. It serves as a requirement for the competence, impartiality, and consistent operation of testing and calibration laboratories. ISO 17025:2017, “General Requirements for the Competence of Testing and Calibration Laboratories,” is this standard’s third edition. 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. Here’s the thing-ISO 17025 has some aspects that relate to the requirements of ISO 9001. 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.
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