Difference Between ISO 17025 and ISO 9001

ISO means International organization for standardization. ISO 17025 is for laboratory accreditation. ISO 9001 is for quality management systems, for organization needs. ISO 17025 assess the competence of a conformity assessment body (CAB). A CAB means a laboratory. This is a tool to demonstrate the true underlying quality of the analytical testing program. ISO 9001 is for management support, procedures, internal audits and corrective actions. It provides a frame work for existing quality functions and procedures.

The main difference between ISO 17025 and ISO 9001 is the accreditation and certification. ISO 17025 stands for accreditation, which means the recognition of competence of specific technical competence. ISO 9001 stands for certification, which means accordance with a standard assessed by management systems, certified by any independent body that is internationally agreed. Also, there is the difference with the accurate products. ISO 9001 does not mean accurate products are produced. For that, product should be approved by ISO 17025. Every conformity assessment body should have the ISO 17025 accreditation, but ISO 9001 certification may not be necessary.

There are five main clauses in ISO 17025 and there are eight principles of ISO 9001. Out of the five clauses of ISO 17025, two of those are the main clauses and from the two the clause number 04 stands for management requirement, which is derived from ISO 9001:2000 version. ISO 9001 is to demonstrate the ability of the organization to provide consistently product that meet customer and applicable regulatory requirements, also to address the customer satisfaction through the effective application of the system including processes for continual improvement and prevention of nonconformity. ISO 17025 is for developing the quality of the conformity assessment body, administration and technical systems of the conformity assessment body that governs the operation of the calibration and testing laboratory.

ISO 9001 provides a foundation for continuous improvement, while ISO 17025 does not directly provide the foundation for continual improvement, but under clause number 04 that was stated. ISO 17025 governs the technical requirements of a laboratory but ISO 9001 does not include the technical requirements of an organization. This clause (clause number 5-Technical requirement) includes factors, which determine the correctness and reliability of the tests and calibrations performed in laboratory. But ISO 9001 does not contain the factors that determine correctness and reliability of tests and calibrations.