Production and service controls are crucial to ensure that the medical devices manufactured or serviced meet customer requirements and regulatory requirements. Check if document control procedures are followed, and the system is adequately protecting sensitive information. Verify that records are maintained as per regulatory requirements and are easily retrievable. Check if all policies, procedures, and work instructions are documented and up to date. The next section of your ISO 13485 audit checklist should focus on documentation and records. The management team should also establish clear roles and responsibilities for quality management and provide appropriate training to employees. Ensure that the policy is well understood, adequately communicated, and aligned with regulatory requirements. This includes reviewing the company's quality policy, management responsibility, and training programs. The first section of the ISO 13485 audit checklist should focus on the management of the quality management system. Along those lines, we’ve put together an ISO 13485 audit checklist that will help quality managers and operations teams with conducting a comprehensive audit of their quality management system. To ensure the effectiveness of the system and maintain compliance, regular internal audits are necessary. The ISO 13485 standard provides a framework for a quality management system specifically for medical devices. Smithers Quality Assessments Client Portalįor medical device manufacturers, complying with quality management standards is essential to ensure patient safety and meet regulatory requirements.
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