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ISO 13485 IVD/Medical Device

ISO 13485 (In Vitro Diagnostic Devices / Medical Devices Quality Management System) Overview

The ISO 13485 Medical Device Quality Management System deals with the development, implementation, and maintenance of quality management systems designed for use by medical device manufacturers and suppliers as a requirement for regulatory purposes. Originally developed in the 1990s, this standard details the requirements for quality management systems that meet both client requirements and regulations in the European Union (EU), Canada, and other major markets around the world. ISO 13485 is similar in scope and purpose to ISO 9001, but part of ISO 9001 clause is excluded and special requirements for medical devices are added. Accordingly, ISO 9001 authentication cannot completely replace ISO 13485 authentication.
ISO 13485 (In Vitro Diagnostic Devices / Medical Devices Quality Management System) Feature and backgrounds
ISO 9001 stipulates requirements for a general organization's quality management system.
In contrast, ISO 13485 intends to unify the regulatory requirements applied differently to the quality management system of organizations providing medical devices in each country by stipulating the requirements for the quality management system of organizations that provide medical devices and related services. Medical devices are used in people, especially patients, and their role directly affects human life and health.
Due to such characteristics, a much higher level of safety is required for medical devices than for general products. To ensure this, ISO13485 includes special requirements applied to medical devices with regulatory intentions. Among the requirements of ISO9001, those that are not suitable for adoption as regulatory requirements were excluded from ISO13485:2016.

ISO 13485 (In Vitro Diagnostic Devices / Medical Devices Quality Management System) Contents

No. Title
4 Quality management system
4.1 General requirements
4.2 Documentation requirements
4.2.1 General
4.2.2 Quality Manual
4.2.3 Medical device file
4.2.4 Control of documents
4.2.5 Control of records
5 Management responsibility
5.1 Management commitment
5.2 Customer focus
5.3 Quality policy
5.4 Planning
5.4.1 Quality objectives
5.4.2 Quality management system planning
5.5 Responsibility, authority & communication
5.5.1 Responsibility and authority
5.5.2 Management representative
5.5.3 Internal communication
5.6 Management review
5.6.1 General
5.6.2 Review input
5.6.3 Review output
6 Resource management
6.1 Provision of resources
6.2 Human resources
6.3 Infrastructure
6.4 Work environment and contamination control
6.4.1 Work environment
6.4.2 Contamination control
7 Product realization
7.1 Planning of product realization
7.2 Customer-related processes
7.2.1 Determination of requirements related to product
7.2.2 Review of requirements related to the product
7.2.3 Communication
7.3 Design and development
7.3.1 General
7.3.2 Design and development planning
7.3.3 Design and development inputs
7.3.4 Design and development outputs
7.3.5 Design and development review
7.3.6 Design and development verification
7.3.7 Design and development validation
7.3.8 Design and development transfer
7.3.9 Control of design and development changes
7.3.10 Design and development files
7.4 Purchasing
7.4.1 Purchasing process
7.4.2 Purchasing information
7.4.3 Verification of purchased product
7.5 Production and service provision
7.5.1 Control of production and service provision
7.5.2 Cleanliness of product
7.5.3 Installation activities
7.5.4 Servicing activities
7.5.5 Particular requirements for sterile medical devices
7.5.6 Validation of processes for production and service provision
7.5.7 Particular requirements for validation of process for sterilization and sterile barrier system
7.5.8 Identification
7.5.9 Traceability
7.5.9.1 General
7.5.9.2 Particular requirements for implantable medical devices
7.5.10 Customer property
7.5.11 Preservation of product
7.6 Control of m onitoring and measuring equipment
8 Measurement, analysis and improvement
8.1 General
8.2 Monitoring and measurement
8.2.1 Feedback
8.2.2 Complaint handling
8.2.3 Reporting to regulatory authorities
8.2.4 Internal audit
8.2.5 Monitoring and measurement of processes
8.2.6 Monitoring and measurement of product
8.3 Control of nonconforming product
8.3.1 General
8.3.2 Actions in response to nonconforming product detected before delivery
8.3.3 Actions in response to nonconforming product detected after delivery
8.3.4 Rework
8.4 Analysis of data
8.5 Improvement
8.5.1 General
8.5.2 Corrective action
8.5.3 Preventive action

ISO 13485 (In Vitro Diagnostic Devices / Medical Devices Quality Management System) Introduction Effectiveness and Necessity

  • ISO 13485 is a certification for medical devices, and in most cases provides essential and advantage for medical device companies that export products to overseas markets. In the European Union, the complete satisfaction of European medical device regulations means allowing free trade of medical devices. The most important part of complying with the requirements of European medical device regulations is the evaluation independent of the establishment of a quality system. When manufacturers are active in the global market, focusing on international standards (e.g., ISO) not only offers several advantages, but in some countries this is stipulated by law. Canada, for example, requires medical device manufacturers selling in its own market to be certified for quality systems by ISO 13485.
The U.S Certification Body is constantly striving to become an excellent client-satisfied company by securing sincere and experienced judges to help domestic and foreign companies implement ISO 13485 and is confident that it can overcome various crises in the future by establishing and implementing internationally recognized quality systems.