how effectively they meet the requirements.Ĭheck: The results of the validation are reviewed and the process is either approved (after successful validation) or improved further.Īct: The validated process is defined on a wider scale as a standard process and is made available to all the users within the organization.īy following the process approach, it is necessary to document the processes in all of the phases of the PDCA cycle, together with their current validation status. Plan: Processes are planned by analyzing the situation, by following the process requirements and deciding on the potential improvements.ĭo: Processes are examined on their validity in a test environment, i.e. The subsequent steps are followed and repeated: Therefore, processes are an essential component of all QM systems according to ISO Standards established processes, which are implemented using the PDCA cycle (Plan, Do, Check, Act). Quality management systems are all driven by processes.
#Iso 13485 standard pdf pdf
*If you would like to have the ISO compliance information as a file, you can get free access of the PDF version of this whitepaper here:
#Iso 13485 standard pdf software
On the basis of worked examples from the Labfolder ELN, we can see how a specialized software solution can facilitate preparation, implementation and execution of a certification. In this Whitepaper, we will explore which principles are the most important ISO Standards for laboratories to follow, and which requirements are related to laboratory management and documentation.Ī brief list of information about what makes a laboratory ISO compliant and other benefits of using an ELN can be found here. Software solutions can help to reduce the effort and costs as far as preparation and implementation of the certification and working in the certified environment is concerned. In some fields, for example medical engineering, the certification is even compulsory. Consequently, the certification of ISO Standards is for many laboratories an essential component of the organizational culture, as successfully receiving the certification, organizations can present their customers with external evidence of the implementation of the quality standards.
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The implementation of a quality management system is major step for many laboratories that want to ensure the consistent quality of their products and services.