UK: +44 (0) 1925 737 237 US: +1 (307) 264 1572 info@perfectusbiomed.com

QUALITY ASSURANCE

Perfectus Biomed are dedicated to providing a high-quality service to our clients.

Our services are underpinned by our Quality Management Systems, which ensure the confidentiality, impartiality, quality and integrity of our laboratory studies by ensuring product and service quality levels, customer satisfaction and company objectives are achieved.

  

Our laboratory is audited regularly by Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom Accreditation Service (UKAS), British Standards Institution (BSI) and also by our clients to ensure compliance to each of our quality systems:

  1. ISO 9001 certification for the development and provision of standardised and customised microbiological services, biological evaluation, materials testing and site audits.
  2. ISO 17025 accreditation (Competence of Testing and Calibration Laboratories) for EN 1276 and six biofilm test methodologies
  3. Good Laboratory Practice (GLP) compliance in accordance with directive 2004/9/EC.

For more about our quality systems in the UK and USA please get in touch. 

ISO 9001;

Perfectus Biomed are certified by BSI to ISO 9001, which is the international standard that specifies the requirements for a quality management system. The standard is used to:

  • Demonstrate the ability to consistently provide products and services that meet customer and regulatory requirements.
  • Enhance customer satisfaction through effective application of the system.

This is achieved by controlling documentation, resources, infrastructure, work environment, equipment and production using a process-based approach. The ISO 9001:2015 certification brings quality and continuous improvement into the business to achieve the intended results in accordance with the quality policy and strategic direction of the organisation. The standard introduces risk and opportunity management to identify business opportunities that contribute to bottom line improvements.

Please see a copy of our ISO 9001 certificate.

ISO 17025 Accreditation;

Perfectus Biomed were the first laboratory globally to gain UKAS accreditation for six biofilm test methodologies to ISO 17025 (No. 9192); Minimum Biofilm Eradication Concentration (MBEC), CDC Biofilm Reactor, Drip Flow Biofilm Reactor and the Single Tube method. We also have EN 1276 accredited to this standard.

UKAS is the recognised accreditation body for the United Kingdom. They assess organisations that provide testing and calibration services to internationally recognised standards. Accreditation by UKAS demonstrates competence and performance capability of the evaluators. The accreditation requires laboratories to demonstrate that they operate a quality system and generate technically valid results to a global standard to provide consistency.

Please see a copy of our UKAS Schedule of Accreditation.

Good Laboratory Practice;

Perfectus Biomed Ltd (UK) are a GLP-compliant laboratory, demonstrating compliance with OECD Principles of Good Laboratory Practice. GLP is a quality control system of the processes and conditions under which non-clinical health and environmental studies are conducted, recorded, reported and archived. The GLP quality system uses a set of OECD principles to assure the quality and integrity of laboratory studies and the integrity of data produced by harmonising testing procedures.

As a GLP-compliant testing facility, our laboratory and processes are regularly inspected by MHRA, which includes a review of:

  • GLP quality systems
  • Inspection of facilities
  • Audit of completed and on-going studies

Our statement of GLP compliance can be found here.

Perfectus Biomed offer GLP-compliant, UKAS-accredited in vitro testing to provide the data required to support products through global regulatory processes. Our expertise and knowledge are fundamental to the services we provide. Please get in touch for further information.

Get in Touch

We are happy to help with your microbiological requirements and with any other queries you may have.

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Perfectus Biomed

Perfectus Biomed, a UKAS accredited microbiological contract testing company, represents the new wave of scientific businesses that are proud to call Daresbury home.

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