What Is ISO 17025 Certification?
ISO 17025 is an internationally recognized quality certification for testing and calibration laboratories. It establishes the criteria for the competence, impartiality, and consistent operation of these laboratories. This means that any laboratory holding this certification has proven their ability to perform accurate and reliable tests and calibrations. As such, this is an essential certification for any lab that provides cleaning, sterilization, and any other type of validation services.
The ISO 17025 standard was first published in 1999 by the International Organization for Standardization (ISO). It was revised in 2005 and the latest version, ISO 17025:2017, was released in November 2017. This standard is applicable to all types of laboratories, regardless of size or level of complexity. However, validation laboratories in particular use this as a guideline for all tests they perform on products.
Why Is This Standard so Important?
Obtaining ISO 17025 certification demonstrates a laboratory’s commitment to quality and continuous improvement. It provides assurance to customers that the facility has met internationally recognized standards and is able to produce reliable results. This can lead to increased confidence in the accuracy of test or calibration data, ultimately leading to better decision-making for businesses and organizations.
Additionally, ISO 17025 accredited laboratories have access to more business opportunities. Many industries and government agencies have regulatory requirements that their suppliers or service providers to hold this certification in order to ensure the quality and accuracy of their products or services. Having this certification can give laboratories a competitive edge in the market and attract new clients.
What Are the Requirements for ISO 17025?
To become an ISO 17025 accredited lab, facilities must undergo a thorough assessment by a certification body. General Requirements for the Competence of Testing and Calibration Laboratories is an international quality standard which is accepted worldwide. The standard contains all of the requirements that testing and calibration laboratories have to meet if they wish to demonstrate that they operate a management system, are technically competent, and are able to generate technically valid results.
Testing and calibration laboratories that comply with this International Standard also operate in accordance with ISO 9001.
The laboratory must also have trained and competent staff, documented procedures for all testing and calibration activities, and a robust quality control system in place. Continual improvement is a key requirement as well. Laboratories must regularly review and update their processes to ensure they are meeting the required standards and delivering accurate results.
HIGHPOWER’s ISO Accredited Laboratory
HIGHPOWER conformed to the requirements of the United States Food and Drug Administration’s 21 CFR Part 820, Quality Systems Regulations for the first 25 years of our existence. In 2014 we became accredited to the ISO 17025 quality standard, and we still abide by it to this day.
HIGHPOWER is audited for compliance to the ISO 17025 standard by A2LA, a world leader in quality system accreditation services. As such, you can rest assured that when you work with us, you are working alongside a premium ISO 17025 accredited laboratory.
See HIGHPOWER’s ISO 17025 Scope of Accreditation for a list of accredited tests. You can also contact us directly with any questions you have about our accreditation status.