The Global Harmonization Task Force, a committee of medical device manufacturing representatives and governmental regulation bodies, convened in 1992 to consider how to converge regulatory practices. To this end, the GHTF worked with ISO TC 210 to facilitate the convergence and assist international trade.
ISO 13485:2003 is the successful result of ISO TC 210 teamwork. Representatives from 29 countries participated in the process to develop the revised standard. Although the U.S. Food and Drug Administration maintains its independent quality system regulations, it recognizes the importance of maintaining consistency with ISO 13485 requirements. Accordingly, the FDA has changed regulations in response to comments received from those in the industry.
Because the two systems are closely related, medical device manufacturers can develop a quality management system that blends FDA requirements with ISO 13485:2003. In Canada , ISO 13485/88 was adopted in 1998. The Canadian Medical Devices Conformity Assessment System required medical device manufacturers to conform to ISO 13485/88.
Most medical device manufacturers selling to Canada are expected to quickly convert to ISO 13485:2003. In the European Union, EN ISO 13485:2003 will gradually replace the EN ISO 13485/88:2000 standards. Medical devices sold in the European Union must bear the CE Mark in conformity with the Medical Device Directives.
The EU adopted ISO 13485 as a harmonized standard for quality system requirements, replacing the European standard EN 46001.
ISO13485:2003 Medical Device Regulations ISO 13485 is the ISO 9000 for medical device manufacturers. Embracing the FDA's good manufacturing practices, this standard defines terms such as: medical device, active medical device, active implanted medical device, sterile medical device, and more.
This international standard 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 requirements and regulatory requirements applicable to medical devices and related services.
The primary objective of this standard is to facilitate harmonized medical device regulatory requirements for quality management systems. It includes some particular requirements for medical devices and excludes some of the requirements of ISO 9001 that are not appropriate as regulatory requirements. Because of these exclusions, organizations whose quality management systems conform to this standard cannot claim conformity to ISO 9001 unless their quality management systems conform to all the requirements of ISO 9001.
ISO 13485/88:1996 was used in conjunction with ISO 9001/2:1994. The revised standard is aligned with ISO 9001:2000 and includes process management principles. Because many components of ISO 9001 are excluded from ISO 13485:2003, management can't claim ISO 9001:2000 registration unless it seeks this QMS certification separately.
ISO 13485:2003 Medical devices--Quality management systems--Requirements for regulatory purposes was written for organizations that design, develop, produce, install or service medical devices. It's intended to promote global harmonization for medical devices and set a basis for quality system regulations worldwide.
ISO 13485:2003 is the single standard for all classes of medical devices. Its scope includes design and manufacture, but where regulatory requirements permit, design and development controls can be excluded from a company's management system.
ISO 13485:2003 mandates 18 documented procedures in specific areas. These areas include control of documents, control of records, design and development, purchasing, validation of computer software, validation of sterilization processes, identification, traceability, preservation of product, control of monitoring and measuring devices, feedback system, internal audits, control of nonconforming product, analysis of data, issue of advisory notice/adverse event reporting, corrective action and preventive action.
The standard's practical benefits include reducing barriers between international manufacturers and customers. Moreover, increased competition between medical device manufacturers could well lead to higher quality, lower prices and greater availability in developing countries.
Risk management ISO 13485:2003 specifically notes and refers to ISO 14971:2000 for guidance regarding risk management.
ISO 14971 distinguishes the manufacturer's management commitment as critical for an effective risk-management process. In particular, ISO 14971 demands that management identify and use individuals trained in risk-management techniques.
The personnel hired to perform these tasks should have knowledge of how the device is constructed, how the device works, what its intended use will be and how to apply the risk management process.
Manufacturers must analyze risk, evaluate probability for failure, make all possible attempts to control risk and then evaluate residual risks throughout the product life cycle. If a risk is identified during the design phase of a class III medical device, for example, it might be managed through actions taken at the production phase later in the cycle.
A risk can be identified during the production phase of a class I medical device and managed through actions taken during the post-production phase, once the product is on the market.
Risk management doesn't stop when the device goes into production, either. Manufacturers must monitor post-market information for events that might affect risk-management decisions. In this way, risk management becomes a closed-loop process. |
