Implementation of the ISO 17025 standard
Beyond Good Laboratory Practices
The implementation of an ISO standard , whatever it is, is a process marked by rigor , attention to detail which requires a good overview . The establishment of an industrial laboratory does not generally require the implementation of the ISO 17025 standard unless it is to perform analyzes whose results must be officially reported to meet regulatory compliance requirements or specific customer requirements.
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However, some companies do so in order to systematize and standardize their laboratory operations or to offer analyzes to their various establishments or to other members of the industry .
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The implementation of the ISO 17025 standard goes well beyond Good Laboratory Practices because it requires putting in place measures such as drafting procedures , having a very well referenced documentary system , having a very systematic complaints handling system, monitoring and supervision by management via management reviews. , etc.
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How to get there?
It is important to have the qualified personnel , facilities , equipment and materials available to you before you even start .
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One of the important elements will be the validation of the analytical methods and this mainly includes the physico-chemical and microbiological analyzes. The preventive maintenance program must also cover all equipment , machines and devices used as well as the premises themselves including storage areas and more. This is therefore a very systematic and detailed approach.
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Without going through all the points of the standard, it is important to mention that the mastery of analytical work is of prime importance and this implies for example: the use of reference materials and standards , participation in performance evaluation tests as well as the follow-up of non-conformities , corrective measures and preventive actions, etc.
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In order to implement the ISO 17025 standards within a reasonable period of time, it is strongly recommended to make it into a project and manage it as such. It should also be a team effort to benefit from pooling the expertise and experience of your staff.
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Recourse to an external resource is also useful to help you progress by taking an outside look at your process and by assisting you with certain parts or section of the standard for which you are less comfortable.
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Preparation for certification
Once you have finished developing all the points of the standard , it is important to put them all to the test . This is when you will identify what is missing so that you are ready to take the certification audit .
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Before asking a certification body to come and audit you, it is recommended to:
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Participate in a few performance reviews for all metrics to include in your audit scope
To carry out simulations / audit practices with your team
To perform audit simulations / practices with at least one external resource
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We are able to help you and accompany you to implement ISO 17025. We can assist you from the start and take you right through to preparation for the certification audit . This will allow you to benefit from professional advice and expertise to guide you and save time . You will thus be able to benefit more quickly from the recognition provided by ISO 17025 certification, which will allow you to comply with applicable regulatory and normative compliance requirements and those of your customers.
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