ISO 13485 2003 is a global quality management standard for medical devices.
The following material starts with section 4 because ISO's requirements start there.
The following material starts with section 4 because ISO's requirements start there.
| 4 Systemic Requirements | |
| 4.1 Establish a quality system for your medical devices | • Develop a quality management system for medical devices. • Implement a quality management system for medical devices. • Maintain your medical device quality management system. |
| 4.2 Document your medical device quality system | 4.2.1 Develop quality management system documents. 4.2.2 Prepare quality management system manual. 4.2.3 Control quality management system documents. 4.2.4 Maintain quality management system records. |
| 5 Management Requirements | |
| 5.1 Support quality | • Promote the importance of quality. • Develop a quality management system. • Implement your quality management system. • Maintain your quality management system. |
| 5.2 Focus on customers | • Identify customer requirements. • Meet customer requirements. |
| 5.3 Establish a quality policy | • Define your quality policy. • Manage your quality policy. |
| 5.4.1 Formulate quality objectives. 5.4.2 Plan quality management system. | |
| 5.5 Control your quality system | 5.5.1 Define responsibilities and authorities. 5.5.2 Appoint management representative. 5.5.3 Support internal communications. |
| 5.6.1 Review quality management system. 5.6.2 Examine management review inputs. 5.6.3 Generate management review outputs. | |
| 6 Resource Requirements | |
| 6.1 Provide quality resources | • Identify your quality resource requirements. • Provide quality management system resources. |
| 6.2 Provide quality personnel | 6.2.1 Use competent personnel. 6.2.2 Support competence. |
| 6.3 Provide quality infrastructure | • Identify your infrastructure needs. • Provide needed infrastructure. • Maintain your infrastructure. |
| 6.4 Provide quality environment | • Identify needed work environment. • Implement needed work environment. • Manage needed work environment. |
| 7 Realization Requirements | |
| 7.1 Control planning | • Develop product realization processes. |
| 7.2 Control customer processes | 7.2.1 Identify customers' product requirements. 7.2.2 Review customers' product requirements. 7.2.3 Communicate with your customers. |
| 7.3 Control product development | 7.3.1 Plan design and development. 7.3.2 Define design and development inputs. 7.3.3 Generate design and development outputs. 7.3.4 Carry out design and development reviews. 7.3.5 Perform design and development verifications. 7.3.6 Conduct design and development validations. 7.3.7 Manage design and development changes. |
| 7.4 Control purchasing function | 7.4.1 Control purchasing process. 7.4.2 Document product purchases. 7.4.3 Verify purchased products. |
| 7.5 Manage production and service provision | 7.5.1 Control production and service provision. 7.5.1.1 Plan Production and service provision. 7.5.1.2 Manage product installation and servicing. 7.5.1.2.1 Clean products prior to installation. 7.5.1.2.2 Install products and verify installation. 7.5.1.2.3 Service products after installation. 7.5.1.3 Maintain product sterilization records. 7.5.2 Validate production and service provision. 7.5.2.1 Validate production and service processes. 7.5.2.2 Validate product sterilization processes. 7.5.3 Identify and track your products. 7.5.3.1 Develop procedures to identify products. 7.5.3.2 Establish procedures to track products. 7.5.3.2.1 Establish product traceability procedures. 7.5.3.2.2 Establish records for implantable devices. 7.5.3.3 Preserve product identity and status. 7.5.4 Protect property supplied by customers. 7.5.5 Preserve your products and components. |
| 7.6 Control monitoring and measuring devices | • Identify monitoring and measuring needs. • Select monitoring and measuring devices. • Develop monitoring and measuring procedures. • Calibrate monitoring and measuring devices. • Protect monitoring and measuring devices. • Validate monitoring and measuring software. • Use monitoring and measuring devices. |
| 8 Remedial Requirements | |
| 8.1 Perform remedial processes | • Plan remedial processes. • Implement remedial processes. |
| 8.2 Monitor and measure quality | 8.2.1 Gather feedback from your customers. 8.2.2 Plan and perform regular internal audits. 8.2.3 Monitor and measure quality processes. 8.2.4 Monitor and measure your products. 8.2.4.1 Monitor and measure characteristics. 8.2.4.2 Identify testers and inspectors. |
| 8.3 Control nonconforming products | • 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. • Collect quality management system data. • Provide quality management information. |
| 8.5 Take remedial action | 8.5.1 Maintain quality management system. 8.5.2 Correct actual nonconformities. 8.5.3 Prevent potential nonconformities. |
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