What is Required for ISO 13485 Certification?


To ensure medical products will pass certification, here are the key objectives the project should follow: Define the scope. What is the medical device, and what is its purpose, intended market, classification? What is the collection related ISO product standard, and what are the regional regulations for this product? Conduct an ISO 13485 Audit & Gap Analysis - This is an audit that determines the level of compliance versus the standards that are being held. Develop a project plan� After the audit and gap analysis, define a corrective plan which lists all non-conformities, including how to fix problems to comply with ISO 13485 requirements and related regional standard implementation. Develop documentation� Put together the mandatory documentation that includes a Quality Manual, procedures, work instructions and documentation with evidence of proof of implementation. Develop & conduct training� This is one of the most important steps in this checklist. Provision of training to anyone who will be involved in any stage of the production of the medical device is mandatory. The first training educates the team on applicable requirements of the ISO 13485 standards, including those relevant to regional and product certifications. The next training is to set in place a Quality Management System that provides a standard for complying with work instructions and necessary sanitary procedures, as well as recording of proof of implementation on specific documentation. Implementation� A period of three to six months is given to implement the new Quality Management System and preparation of documentation to demonstrate compliance. Conduct an internal audit� The supplier should conduct an internal medical device audit to measure compliance and correct any noted deviations. This internal audit can also be conducted by a third-party auditor, such as Pro QC. Conduct a management review� If the Quality Management System is not implemented according to ISO 13485 procedure, and does not meet the defined policy and objectives, it must be adjusted to meet the necessary requirements. Apply for ISO certification� An external audit of ISO 13485 is the final step. This external audit is typically conducted by certification bodies. Based on the readiness of your organization, the certification body will issue the ISO 13485 certificate if you pass, or issue a non-conformance report that will require corrective actions. In the case of a non-compliance, Pro QC can advise and assist the applicant in implementing and validating those corrective actions. Once all non-conformance items are closed, the company can then re-apply for certification.

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