QUICK TIPS for ISO13485 by MedicalRegs.com

QUICK TIPS For Developing Your ISO 13485 QMS If You Want To Achieve ISo 13485 Certification, The Following Tips Will Help You Get There... Clearly define your scope Will you be performing manufacturing, design, distribution or combination of multiple activities? Your scope and associated procedures will be the basis for the certification audits identify your markets and corresponding regulations Will you require CE Marking under the MDR, TGA approval or US FDA 510k? incorporate in your qms additional procedures on regulatory requirements PMCF, vigilance, reporting, UDI-DI, etc. Also include references to regulatory and associated terminologies. identify third party application software that you are using to run your company CRM, purchasing, HR, sales, document management, etc. NOTE: Depending on the use of application software, you may need to perform software v&v Unless the software vendor has done this, but you need to know the impact on software updates develop procedures, work instructions & forms based on your scope of activities and regulatory requirements ISO 13485 generally states what procedures you should have, but not specific to your activities. You will need to make it specific so that you can actually implement the procedures. document associations Identify for each procedure referenced documents. Make it easy for the auditor to follow your procedures too. Document Change Control Before making a revision on a document, a change notice entry must first be approved then the assignee implements the change with required approval before a change notice can be closed out. Associate a document change with a capa, if it exist printed document work instructions and forms Ensure control of pre-printed copies of documents are current especially, forms used in production areas. effectiveness of training. training your staff is not enough You may find that your training procedure is inadequate or need to make adjustments or the staff is not qualified to perform his/her defined activities Your CAPA investigation may point you to training ineffectiveness and possibly from in-process or final inspection rejection criteria supplier monitoring & performance evaluation Meeting the initial supplier requirements are not enough. Supplier control is an ongoing process. You decide whether a supplier stays, needs to improve or goes away. CAPA: include containment action This will allow you time to investigate and prevent further exposure to risks. The CAPA entry will remain open until corrective and preventive actions are developed and ready for implementation. perform dry run on procedures This is your opportunity to determine the flow and Clarity of your procedures and make any adjustments before scheduling your first-stage audit Also perform mock internal audit Checklists are available all over the Internet, but make sure it is current. internal Audits can be spread over a 12 month period dividing procedures to be audited into groups Assess which groups of procedures to start with based on criticality and previous NCs. Don't forget to schedule the planned audits ! ISO 13485 Clarity MedicalRegs.com