ISO 17025 is the most important standard for microbial testing laboratories. Accreditation is a third-party confirmation that verifies that the laboratory is competent, reliable and credible. For a laboratory, quality means the obtained results are consistently accurate. Ensuring quality involves the management, skills of the staff, the methods used, the equipment required, the operating culture and the working conditions.
An ISO 17025 laboratory means quality is assured
Standard ISO 17025:2017 General requirements for the competence of testing and calibration laboratories sets out the general requirements for research laboratories for competent, impartial, and consistent operation.
Our ISO 17025 accreditation is for antimicrobial susceptibility tests (MIC tests). Gaining accreditation meant auditing the operations of the whole company, requiring profound documenting of all processes, from the procurement of our equipment and chemical reagents to documenting how we create reports.
The whole quality team worked hard to fulfil the accreditation requirements for the quality assurance (QA) system. We wrote standard operating procedure (SOP) documents for every aspect of the work that is done in the laboratory. This was no easy task because every test requires specific knowledge on how to do it and the steps can be quite different. It is definitely worth it though; our quality work aims to produce as much value for our customers as possible.
Quality starts with people understanding quality
At Biosafe, we’ve seen to it that every aspect of our work is based on quality. A big chunk of quality operations revolves around making sure all the people in the company know how to uphold it.
We see to it that:
- our personnel are proficient and impartial,
- they have all the appropriate resources,
- they know and follow the standard operating procedures,
- they keep to all standards and regulatory requirements,
- they ensure the suitability and functionality of the equipment used through maintenance and calibration,
- there’s an open and continuous improvement atmosphere, and
- they have the appropriate premises to do their work in the best way possible.
Deviations and Quality Assurance (QA)
Our laboratory tests are in line with the relevant standards and guidelines, and the protocols are followed strictly. If there are deviations in the work or the test results, there’s always a profound troubleshooting session to follow. All our laboratory analyses include appropriate controls to verify that the method has worked correctly, and the results obtained on that test are accurate. Sometimes the results obtained by the controls do not fall within the approved range defined for them. In this case, a deviation from the test is recorded, the processing of which seeks to find the cause of the incident, and corrective measures are taken to prevent the recurrence of the incident.
The analysis is, of course, repeated.
Biosafe is ISO 17025 accredited
Developing our laboratory quality standards led us to get FINAS, the Finnish Accreditation Service — the national accreditation body in Finland, to evaluate our performance. Biosafe’s laboratory is now ISO 17025 accredited. Our Quality Manager Meeri Sutinen has written about her experience on what the journey was like from start to finish.
We use the latest standards (2022)
International Organization for Standardization ISO 17025: General requirements for the competence of testing and calibration laboratories requirements for the competence of testing and calibration laboratories
The Clinical and Laboratory Standards Institute CLSI M07: Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically
The Clinical and Laboratory Standards Institute CLSI M100: Performance Standards for Antimicrobial Susceptibility Testing
High quality is of utmost importance to us to be able to deliver our customers high-quality reports with correct and confirmed results. As laboratory and quality managers, that’s our promise to you.