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Quality System Implementation
Test Laboratories |
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Why implementing a quality system? |
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Most test laboratories are subject to quality system regulations and/or quality system standards. The applicable regulations and/or standards will depend on the nature of the testing.
Even in the absence of mandatory regulations or standards, testing laboratories have an interest in the application of quality system principles in order to improve the efficacy of their operations and their competitiveness in the market. E.g. drug discovery testing, testing in context of clinical trials.
Some well known regulations and standards :
Good Laboratory Practices (GLP) : regulation applicable to testing in the context of a regulatory submission (e.g. toxicity testing in the pharmaceutical industry)
ISO17025 : quality system standard applicable to test and calibration laboratories
ISO15189 : quality system standard applicable to clinical test laboratories |
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What can Qarad do to achieve a quality system? |
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Whether your quality system still has to be built from scratch or only needs minor adjustments, Qarad can define what needs to be done to implement a quality system that is compliant with applicable regulations and/or quality system standards.
By gap analysis (audit), group training sessions, personal guidance, writing of documents, etc… we can give you the assistance that you need. We combine work in our office with on-site visits anywhere in the world. |
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Why is Qarad a valuable partner? |
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Qarad consultants have held positions in Quality Assurance, Quality Control, Regulatory Affairs and product development for more than 15 years. We have personally dealt with the problems you may encounter with the implementation of a quality system. Thanks to R&D positions in the in vitro diagnostics industry and QC positions in pharmaceutical biotech, we are very familiar with the development and validation of test methods. See “About Qarad” for more details.
As consultants, we have successfully assisted companies in achieving ISO certification. Company sizes varied from 1 to 100 employees. The test laboratories that we have assisted thus far are all active in the biotechnology field. We are fluent in English, French and Dutch, and have a passive knowledge (reading) of more languages. Therefore, we have been able to work with companies in more than 15 countries on 4 continents. |
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How to continue? |
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Contact us for more information. We would be happy to learn about your situation and to make a proposal which suits your needs.
Also find out about our standard training packages and the possibility of outsourcing QA tasks. |
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