ISO 17025 includes the requirements for the Quality Management System (ISO 9001) related to calibration and testing as well as technical requirements for the performance efficiency of laboratories in their implementation of testing and calibration activities.
ISO Accreditation is the process of providing recognition to an organization for its competence in performing specific tasks in which certification of competency, authority, or credibility is presented. Accreditation is a voluntary, third-party-reviewed process. Organizations that issue credentials or certify third parties against official standards are formally accredited by accreditation bodies (e.g. Estonian Accreditation Center); hence they are sometimes known as “accredited certification bodies”. The accreditation process ensures that their certification practices are acceptable, typically meaning that they are competent to test and certify third parties, behave ethically, and employ suitable quality assurance.
The quality management system is the key to implementing the standard successfully. It begins with good documentation that reflects your business and operations, and the requirements of ISO 17025. First, we start with discussions and interviews to learn the nature, functions, and operations of your laboratory. With this information, we can prepare an easy-to-understand quality management system that meets the requirements for ISO 17025 accreditation. Most importantly, we prepare a quality management system that reflects your existing operations as much as possible.
We will determine whether the existing process meets the requirements specific to ISO 17025 or not. If your processes are not aligned with the requirements, we will provide valuable suggestions for further improvement. With your consent, we will include these suggested processes into your quality management system.
We will assist you in collecting and analyze your calibration or testing data to prepare an uncertainty budget. Afterward, based on the collected data, we will help you determine your measurement uncertainty and provide you with a custom report. This report will give you an insight into the quality of your lab tests/calibrations.
Lastly, you need to pass a proficiency test conducted by an authorized third party. We can guide you with finding a third party where possible.
We have had our ISO/IEC 17025 accredited testing laboratory since 2000. Maria Kulp is also a technical assessor of the Estonian Accreditation Center since 2010. We offer ISO accreditation consultancy services geared towards helping small, medium, and large size laboratories with quality assurance system implementation according to international ISO/IEC 17025 standard.