ISO 17025 Accreditation
The aim of an accreditation procedure is to establish trust in the services fulfilled. Accreditation is required to represent the level of conformity assessment activities in terms of technical competence.
ISO 17025 accreditation certifies the technical competence of laboratories to perform specific tasks such as testing, sampling, and calibration. Accreditation guarantees that the results are obtained according to valid methods and procedures that comply with precise standards.
| Accugenix® Identification Lab Services | Endosafe® Endotoxin Lab Services* |
|---|---|
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* Note: Assays are carried out according to European Pharmacopoeia Chapter 2.6.14, Bacterial Endotoxins. Since January 2000, this text has been harmonized with the Japanese and American Pharmacopoeias, JP 4.01 and USP <85>, respectively.
ISO 17025 Accreditation by Facility
- Dublin, Ireland
- Ecully, France
- Kaarst, Germany
- Melbourne, Australia
- Navi Mumbai, India
- Newark, DE, USA
- Singapore
- Incheon, South Korea
Is GMP certification a requirement for identification services?
Good GMP (Good Manufacturing Practices) is the minimum regulations required for the release of products related to the manufacture and sale of food and beverages, cosmetics, pharmaceutical products, dietary supplements and medical devices for pharmaceuticals. The need for GMP certification is not specifically required for microbial identification services. Please note that the Accugenix laboratories are ISO 17025 certified. ISO 17025 accreditation does have a very similar framework to that of the GMP requirements. Additionally, the Quality Management Systems at our sites are designed to meet GMP requirements as reflected within validation, document control, training, deviation, change control, and quality management review.
ISO 9001 Certification
ISO 9001:2015: Quality Management Systems
ISO 9001:2015 concerns all of the activities carried out at the Charles River Microbial Solutions sites in Kaarst, Germany, Dublin, Ireland, Ecully, France, Singapore, Melbourne, Australia, and Incheon, South Korea as defined by the sale of material, equipment and reagents, provision of services, and training related to carrying out tests in laboratories in the field of endotoxin detection and microbial identification.
ISO 9001:2015 sets out the criteria for quality management systems. It can be used by any organization, large or small, regardless of the field of activity. In fact, ISO 9001:2015 is implemented by over one million companies and organizations in over 170 countries. The standards outlined in ISO 9001:2015 are based on a number of quality management principles, including a strong customer focus, the motivation and implication of top management, a process-oriented approach and continual improvement. Using these standards helps ensure that customers get consistent, quality products and services.
ISO 9001 Certification by Facility
- Kaarst, Germany
- Dublin, Ireland
- Ecully, France
- Singapore
- Melbourne, Australia
- Incheon, South Korea
- Navi Mumbai and Bangalore, India
About Charles River's Quality Assurance Organization
Our microbial solutions quality assurance organization is comprised of professionals with internationally recognized expertise in cGMP, pharmacopeia, various ISO standards, electronic record-keeping practices, computerized system validation, quality control, process validation, and aseptic processing.
Our regulatory affairs and compliance group is responsible for providing training and guidance to a wide range of clientele and Charles River employees. Our compliance experts liaise with senior management and operations staff to identify opportunities for continuously improving quality and working collaboratively with colleagues to achieve corporate strategic goals.
We conduct comprehensive internal inspections and host hundreds of client audits, successfully managing inspections by a wide-range of regulatory agencies including the FDA, and other international, federal, and local regulatory bodies.
About A2LA
Our microbial solutions group has chosen the American Association for Laboratory Accreditation (A2LA) as the global ISO 17025 accreditation body for our labs. Using a global organization such as A2LA ensures harmonization of our processes and provides transparency for our customers, regular verification of our methods, report validation, and identification of trends for continuous improvement. A2LA provides independent and world-recognized accreditation programs.
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