Safety and performance of medical devices are paramount in this highly regulated industry.
ISO 13485:2016 responds to the latest QMS practices, reflecting the evolution in medical device technology and changes in regulatory requirements and expectations. 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
– 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. Requirements include final decommission and disposal of the medical device’s life-cycle, design and development, production, storage and distribution, installation as well as delivery of medical device or related services that are safe for their intended purpose.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. ISO 13485:2016 standard defines quality management system requirements for organizations that are involved from initial stage of conception to production and post-production. Therefore, most of the service providers in the medical device industry sector understand the main objectives of ISO 13485, which is to harmonize medical device regulatory requirements for quality management system in order to have a quality medical devices and safe patients. Possibly more than any other type of manufactured product, the quality of medical devices has a direct impact on their work effectiveness as well as the safety of patients, and users.
ISO 13485 is evolving with medical devices to keep pace with modern innovation. Medical devices are revolutionizing medicine with breathtaking advances in the detection and treatment of many diseases.