ISO 13485:2003 Quality Management System Requirements

Who can be certified to ISO 13485:2003?

• Companies who currently manufacture private label medical devices, but want to eventually place these devices under their name on the market in the European Union
• Consultants that design, manufacture, and assemble medical and in vitro diagnostic medical devices.
• Manufacturers of in vitro diagnostic medical devices that want to distinguish themselves, and prepare for future IVD regulatory obligations to enter the EU.

 

What are the essential ISO 13485 system requirements?

 

4.1 Establish a quality system for medical devices	Develop a quality management system for medical devices, identifying the processes in your quality system Implement a quality management system for medical devices Monitor and maintain your medical device quality management system
4.2 Document your medical device quality system	Develop quality management system documents, including a manual and recording system
5.1 Support quality	Promote the importance of quality to meet customer and medical device requirements Develop a quality management system   Implement your quality management system Maintain your quality management system
5.2 Focus on customers	Identify customer requirements Meet customers requirements
5.3 Establish a quality policy	Define your quality policy to serve your organization's purpose, emphasizing the need to meet requirements and facilitating the development of quality objectives. Manage your quality policy by communication throughout your organization and reviewing your policy to ensure it's currency
5.4 Perform quality planning	Formulate measurable quality objectives for all functional areas that facilitate product development and conform to the quality policy Develop, implement, and improve your quality management system
5.5 Control your quality management system	Define, document and communicate responsibilities and authorities Appoint management representative to document, report, support and promote responsibilities and authorities Support internal communications
5.6 Carry out management reviews	Review quality management system, maintain a record of reviews Examine management review inputs; audit results, product conformity data, improvement suggestions, customer feedback, process performance, corrective and preventive actions, changes that might affect your system, changes in your regulatory requirements Take actions to improve quality system maintenance, improve products, and address your resource needs
6.1 Provide quality resources	Identify quality management system resource requirements needed to support the quality system, customer and regulatory requirements Provide quality management system resources
6.2 Provide quality personnel	Use competent personnel with the right experience education skills and training Support competence
6.3 Provide quality infrastructure	Identify building, workspace, hardware, software, utility, equipment, support service and maintenance needs Maintain your infrastructure
6.4 Provide quality environment	Identify work environment for medical products Identify your organization's health requirements, clothing requirements, cleanliness requirements, working condition requirements Implement needed work environment Manage needed work environment
7.1 Control realization planning	Plan product realization processes: Identify product quality objectives, risk management and record keeping requirements Develop product realization processes
7.2 Control customer processes	Identify your customers' product requirements Review your customers' product requirements Communicate with your customers
7.3 Control product design and development	Plan design and development Define design and development inputs Generate design and development outputs Carry out design and development reviews Perform design and development verifications Conduct design and development validations Manage design and development changes
7.4 Control your purchasing function	Ensure that your purchased products and suppliers meet requirements Document product purchases Verify purchased products
7.5 Manage production and service provision	Control production and service provision Validate production and service provision Identify and track your products Protect property supplied by customers Preserve your products and components
7.6 Control monitoring devices	Identify the monitoring and measuring that should be done Select devices that meet monitoring and measuring needs Develop monitoring and measuring procedures Calibrate your monitoring and measuring devices Safeguard your monitoring and measuring devices Validate your monitoring and measuring software before you use it Use devices to ensure that your products meet requirements
8.1 Perform remedial processes	Plan how remedial processes will be used to assure and maintain conformity Use remedial processes to demonstrate conformance
8.2 Monitor and measure quality	Gather feedback from your customers to monitor emerging problems Plan and perform regular internal audits Monitor and measure quality processes
8.3 Control your nonconforming products	Establish a nonconforming products procedure, defining how nonconforming products should be identified and controlled Identify and control your nonconforming products Re-verify nonconforming products that were corrected Control nonconforming products after delivery or use Maintain records of nonconforming products
8.4 Analyze quality information	Define quality management information needs to evaluate and maintain the quality system Collect quality management system data Provide quality management information about your customers, suppliers, products and processes
8.5 Take required remedial actions	Use audits, quality policy, quality objectives, management reviews and preventative action to help maintain the effectiveness of system Correct actual nonconformities Prevent potential nonconformities