Easy to fall into the trap of including meaningless clauses just to match the standard. Pro- easy for auditors and easy to make sure you have addressed all the relevant clauses.Ĭon- usually not particularly user friendly nor do they necessarily reflect the flow of activities in your laboratory. Pros and cons of a Quality Manual structure that is determined by clause numbers in the standard: With this in mind, structure your QM in a way that is clear and staff can easily find what they are looking for. You want your QM/procedures to be read by staff and for them to actively engage with the processes. It is not a requirement that your QM reflect the numbered clauses of the standard. There is no ‘right’ or ‘wrong’ as far as structure is concerned. Quality Manuals come in all shapes and sizes. Reference to required records must also be included. All documentation must be referenced in some way in the QM. You may have a brief QM that refers to supporting stand-alone procedures and/or work instructions or you may include the procedures in the QM itself or have a combination of both. Although a formal QM is no longer a requirement of ISO IEC 17025, most laboratories find it helpful to document their processes this way. The QM is the skeleton that all other documentation hangs on. Keep documents simple and easy to follow - remember that you want people to read them!!ĭraw all elements from the above steps into a formal 'system', traditionally this has been a 'Quality Manual ('QM'). Document new processes where necessary and determine what records will be (or should be!) generated, bearing in mind the principle of traceability. Where possible, design any new processes in such a way that they complement current practices as this will make implementation simpler (and get the relevant staff involved as they likely know what will work and what won't!). Once the gaps in your current system have been identified, determine how these gaps will be addressed. The way to get staff to engage with your efforts to gain accreditation is to show them they are already halfway there and then get them involved in filling the gaps. It is highly likely there will be current practices in your laboratory that already meet the requirements of clauses in ISO/IEC 17025. It also contains some guidance comments which may be helpful. The NATA ISO/IEC 17025:2017 Gap Analysis is useful for clauses that are new to the standard following its revision. You could use the NATA Assessment Worksheet as a template. Conduct a gap analysis of your company's practices and existing documentation against ISO IEC 17025. The way that you document your system will affect how easily staff can engage with your quality system.įamiliarise yourself with ISO IEC 17025. A well structured quality system will support your laboratory operations, not be a burden. Documenting your ISO IEC 17025 compliant quality system is not just a matter of 'writing' a quality manual.
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