The medical device audit checklist allows quality managers to document evidence of compliance based on processes, standard requirements, and process characteristics.
ISO 13485 that was initially published in 1996, underwent significant revisions in 2003 and again in 2016, including changes in guidelines that apply specifically to suppliers and manufacturers of medical device components. The standard also emphasizes that manufacturers are expected to use a risk-based approach to all quality processes, which reiterates the value of an ISO 13485 checklist.
Clause 8 of ISO 13485 focuses on the importance of audits. It details the need for a manufacturer to plan and conduct internal audits regularly. Essentially, it is mentioned that the audit plan must include an ISO 13485 audit checklist that details the required tasks to be performed. The lead auditor usually creates and maintains the audit checklist. The checklist structure gives the auditor the freedom to document compliance evidence based on processes, methods’ characteristics, and the audit standard’s requirements.
An ISO 13485 audit is evidence of the outcome of a process carried out by an auditor who reviews records of employees and compares them against planned arrangements to estimate if what is being carried out is what was intended.
A well-designed audit management system supports efficient management of audit checklists and supporting the auditing process.
Mobiom’s cloud-based data access with offline compatibility is one such tool that allows auditors to complete checklists.
Even when auditing at remote locations without proper network coverage.
Mobiom allows compliance audit checklist to be completed offline and synced with the database when back in network range.
This was mainly due to the improper submission of technical documentation of the MDR checklist.
The common issues which BSI was facing while reviewing the documentation of medical devices are:Manufacturers were not able to provide all the information about the device that is necessary for review.There was a poor representation of data.Technical information of the device was difficult to locate.To reduce these error rates, BSI set the proper format to submit the MDR audit checklist with a Subject Title: “MDR Documentation Submissions: Best Practices Guidelines”.For any technical documentation review we need the below 3 things:Context explaining what is requested and why?Technical documentation of deviceNeed confirmation of BSI to carry out the workThe submission therefore will include:The Cover letterIn a cover letter following details are necessary to include:Certificate # or Reference #Type of review like a new device, change in design, shelf life extension, etc.Brief product discussionBSI ref # for relevant submissionA brief explanation of what has been submitted and how it demonstrates compliance, what is affected and what is not?Technical DocumentationNew MDR requires submission of technical documentation with a complete set of documents even for the devices which are already certified under MDD or AIMD regulations.We help you to create the MDR audit readiness checklist with proper guidance on what documents are required.Submission Process Authorization A quotation with a signature is required before preceding the submission process.
If it is not ready then please contact the BSI scheme manager or BSI sales team.Procedure to Submit MDR Audit Readiness ChecklistBelow are some guidelines to submit this process:Notify BSI about an application to review.
New clients can submit the checklist via the sales team and previous clients can ask their scheme manager or a member of the administration team.Submit the checklist with a formal quotation.After submission of the signed quotation, BSI will assign UIN or relevant certificate number for your review.Manufacturers have to submit the MDR audit readiness checklist prior to the start of the detailed review process.
This ensures that all documents are included as a part of technical documentation The final assessment of the technical documentation can begin after receiving the signed quote together with all required documents.Important things to consider while preparing Technical documentation for submissionManufacturer personnell supportManufacturers need to ensure that proper resources like RA, QA, R, manufacturing, etc are available during documentation.
The more quickly information is provided the more quickly the documentation can be closed towards the documentation.Document AvailabilityEnsure proper availability of documents with proper references.
