Requirements of ISO 13485_2016

1. What are the complete requirements of ISO 13485:2016? ISO 13485:2016 is an international standard that specifies requirements for a quality management system (QMS) for organizations involved in the design, development, production, installation, and servicing of medical devices and related services. Here are the key requirements of ISO 13485:2016: Scope: The standard defines the scope of the QMS, specifying that it applies to organizations involved in the medical device lifecycle, including design, development, production, installation, and servicing. Normative references: ISO 13485:2016 references other relevant standards that organizations may need to comply with or consider when implementing their QMS. Terms and definitions: The standard provides definitions for key terms used throughout the document to ensure common understanding. Quality management system requirements: a. General requirements: Organizations must establish, document, implement, maintain, and continually improve a QMS in accordance with the requirements of ISO 13485. b. Documentation requirements: The standard outlines the documentation needed for the QMS, including the quality manual, procedures, and records. Management responsibility: a. Management commitment: Top management must demonstrate leadership and commitment to the QMS. b. Customer focus: Organizations must ensure that customer requirements are determined and met. c. Quality policy: A quality policy must be established, communicated, and maintained. d. Planning: Organizations must plan and document the QMS processes. Unit No – 514, 5th Floor, Sector – 48 Vipul Business Park, Sohna Road Gurgaon, Haryana, 122018 Phone: +91-7011768166, 8860610495 Email: support@siscertifications.com

2. e. Responsibility, authority, and communication: Roles, responsibilities, and authorities within the organization must be defined, documented, and communicated. Resource management: a. Provision of resources: Adequate resources must be provided for the establishment, implementation, maintenance, and improvement of the QMS. b. Human resources: Competence, awareness, and training requirements for personnel must be defined and addressed. c. Infrastructure: Facilities and work environment requirements must be determined and maintained. Product realization: a. Planning of product realization: Processes for product realization must be planned and documented. b. Design and development: If applicable, design and development processes must be controlled and documented. c. Purchasing: Control of suppliers and purchased materials must be established. d. Production and service provision: Processes related to production and service provision must be controlled and monitored. e. Control of monitoring and measuring equipment: Equipment used for monitoring and measurement must be controlled and calibrated. Measurement, analysis, and improvement: a. General: Organizations must plan and implement processes for monitoring, measurement, analysis, and improvement of the QMS. b. Monitoring and measurement: Performance of the QMS and product conformity must be monitored and measured. c. Control of nonconforming product: Procedures for addressing nonconforming products must be established. d. Analysis of data: Data collected from QMS processes must be analyzed to identify opportunities for improvement. Unit No – 514, 5th Floor, Sector – 48 Vipul Business Park, Sohna Road Gurgaon, Haryana, 122018 Phone: +91-7011768166, 8860610495 Email: support@siscertifications.com

3. e. Improvement: Organizations must take corrective and preventive actions to address nonconformities and prevent their recurrence. These are the core requirements of ISO 13485:2016, which provide a framework for organizations to establish and maintain a quality management system tailored to the specific needs of the medical device industry. Unit No – 514, 5th Floor, Sector – 48 Vipul Business Park, Sohna Road Gurgaon, Haryana, 122018 Phone: +91-7011768166, 8860610495 Email: support@siscertifications.com