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 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.
The technical requirements pertain to the lab operations, reporting of tests and calibrations, equipment, testing and staff competency. Like other ISO quality standards, ISO 17025 requires extensive documentation and the creation of a detailed quality system and quality manual. This extensive documentation system, if it does not already exist, requires the time and effort of management and calibration and laboratory personnel. Before beginning the ISO 17025 certification process, a company should weigh the benefits against the time and costs involved.
ISO 17025 has five clauses:
- Scope. This clause covers the technical operations of the laboratory and the quality management system that ensures that the laboratory is operated in a quality manner.
- Normative References.
- Terms and Definitions
- Management Requirements. This section covers documentation, document control, corrective action and internal audit. The most of the sections follow the requirements of ISO 9001:2000.
- Technical Requirements. Most of these come from the ISO Guide 25, and include personnel, selection of methods, validation of methods, estimation of uncertainty of methods and measurement traceability.
The ISO 17025 Certification Process
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.
Benefits of ISO 17025 Certification
There are several benefits to completing the process for ISO 17025 certification:
- Recognition in the testing and calibration laboratory industry as an ISO 17025 certified facility.
- A competitive edge over competitors who are not certified in a globally-accepted quality system.
- Clearly document processes and procedures within a quality management system.
- A system to continuously improve both the management and technical aspects of the business
- Improved customer service and higher customer satisfaction with laboratory testing and calibration services.
- An internal audit process to identify non-conformance to standards and a process for corrective action and updating the quality system to the new quality standards.