Due to the nature of the business, testing and calibration laboratories have to maintain strict quality control with proper documentation and a qualified, professional staff. From sampling identification, labeling, testing, analysis and documenting test results, testing and calibration labs have to work within strict guidelines. ISO 17025 certification gives testing and calibration laboratories the same type of accreditation that ISO 9001 gives to manufacturing and service organizations. As a globally recognized quality standard, ISO 17025 certification can attract more business and expand a company’s client base and profitability.
ISO/IEC 17025:2005 specifies the general requirements for the competence to carry out tests and/or calibrations, including sampling. It covers testing and calibration performed using standard methods, non-standard methods, and laboratory-developed methods. It is applicable to all organizations performing tests and/or calibrations. These include, for example, first-, second- and third-party laboratories, and laboratories where testing and/or calibration forms part of inspection and product certification.
ISO 17025 has two main clauses—Management Requirements and Technical Requirements. The management requirements are the same as in ISO 9001:2000. Therefore, a calibration and testing laboratory that is certified in ISO 17025, will also operate in compliance with ISO 9001:2000. Management requirements focus on the effectiveness of the quality management system.
As with other ISO certifications, companies can decide to complete the steps in-house or hire a consultant to manage the certification process. A thorough understanding of the ISO 17025 standard is the first step. The company should then conduct a gap analysis to determine the laboratory’s current stage of compliance with the ISO 17025 Standard requirements. While most laboratories have to meet stringent technical requirements, they may be lacking in the management quality system components such as documentation and document control.
The results of the Gap Analysis are the basis for the Quality Plan and Implementation Strategy. Once the standard requirements are satisfied, an Internal Audit will determine if there are still gaps in the Quality System. Once these are satisfied, it is time to contact an ISO 17025 registrar who will conduct and independent certification audit.