![]() ![]() Whether your organisation is certified to EN ISO 13485:2012 (or ISO 13485:2003) or you’re interested in gaining certification to the revised Standard, or if you’re an internal auditor or a lead auditor wondering how and when the 2016 Standard will affect you, we’ve got some answers for you.Īll ISO standards are reviewed and revised regularly to make sure they remain relevant to the marketplace. Please contact us by email or phone and we will ensure your needs are our priority as we develop an agreed assessment programme Start your journey towards certification today #Iso 13485:2012 verification#– specific requirements for verification of the effectiveness of corrective and preventive actions – specific requirements for documentation and validation of processes for sterile medical devices – specific requirements for inspection and traceability for implantable devices – focus on risk management activities and design control activities during product development ![]() – controls in the work environment to ensure product safety Food and Drug Administration (FDA), or the Medical Devices Directive 93/42/EEC, required for doing business in the European Union Examples of market-specific regulatory requirements include 21 CFR 820, the Quality System Regulation for medical devices sold in the United States, enforced by the U.S. – the promotion and awareness of regulatory requirements as a management responsibility. Additionally, the ISO 9001 requirements regarding customer satisfaction are absent from the medical device standard. A principal difference, however, is that ISO 9001 requires the organization to demonstrate continual improvement, whereas ISO 13485 requires only that the certified organisation demonstrate the quality system is effectively implemented and maintained. While it remains a stand-alone standard, ISO 13485 is generally harmonized with ISO 9001. As a result, it includes some particular requirements for medical devices and excludes some of the requirements of ISO 9001 that may not be appropriate. The primary objective of ISO 13485 is to facilitate harmonized medical device regulatory requirements for quality management systems. ISO 13485:2003 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and regulatory requirements. ![]()
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