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ISO 9000 | ISO 14000 | Forum |
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Plain English Overview of ISO 13485 2003ISO 13485 is a Quality Management Standard for Medical Devices |
This web page
presents a plain English overview of the
ISO 13485 Quality Management Standard for Medical Devices.
It is based
on the final official version of this quality standard.
NOTE: ISO presents its requirements in
sections 4 to 8 of
ISO 13485 2003. Therefore,
the following material begins with section 4.
QUALITY MANAGEMENT STANDARD FOR MEDICAL DEVICES |
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ISO 13485 |
4 Systemic Requirements |
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4.1 |
Develop a quality management system for medical devices. Implement a quality management system for medical devices. Maintain your medical device quality management system. |
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4.2 |
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. |
QUALITY MANAGEMENT STANDARD FOR3 MEDICAL DEVICES |
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ISO 13485 |
5 Management Requirements |
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5.1 |
Promote the importance of quality. Develop a quality management system. Implement your quality management system. Maintain your quality management system. |
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5.2 |
Identify customer requirements. Meet customer requirements. |
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5.3 |
Define your quality policy. Manage your quality policy. |
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5.4 |
5.4.1 Formulate quality objectives. 5.4.2 Plan quality management system. |
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5.5 |
5.5.1 Define responsibilities and authorities. 5.5.2 Appoint management representative. 5.5.3 Support internal communications. |
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5.6 |
5.6.1 Review quality management system. 5.6.2 Examine management review inputs. 5.6.3 Generate management review outputs. |
QUALITY MANAGEMENT STANDARD FOR MEDICAL DEVICES |
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ISO 13485 |
6 Resource Requirements |
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6.1 |
Identify your quality resource requirements. Provide quality management system resources. |
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6.2 |
6.2.1 Use competent personnel. 6.2.2 Support competence. |
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6.3 |
Identify your infrastructure needs. Provide needed infrastructure. Maintain your infrastructure. |
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6.4 |
Identify needed work environment. Implement needed work environment. Manage needed work environment. |
QUALITY MANAGEMENT STANDARD FOR MEDICAL DEVICES |
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ISO 13485 |
7 Realization Requirements |
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7.1 Control planning |
Plan product realization processes. Develop product realization processes. |
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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. |
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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. |
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7.4 Control purchasing function |
7.4.1 Control purchasing process. 7.4.2 Document product purchases. 7.4.3 Verify purchased products. |
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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. |
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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. |
QUALITY MANAGEMENT STANDARD FOR MEDICAL DEVICES |
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ISO 13485 |
8 Remedial Requirements |
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8.1 |
Plan remedial processes. Implement remedial processes. |
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8.2 |
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. |
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8.3 |
Establish a nonconforming products procedure. 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. |
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8.4 |
Define quality management information needs. Collect quality management system data. Provide quality management information. |
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8.5 |
8.5.1 Maintain quality management system. 8.5.2 Correct actual nonconformities. 8.5.3 Prevent potential nonconformities. |
| OTHER ISO 13485 WEB PAGES |
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Introduction to ISO 13485 Quality System Standard for Medical Devices |
| Definitions for ISO 13485 Quality Standard for Medical Devices |
| ISO 13485 2003 Standard Translated into Plain English |
| How to Develop an ISO 13485 Quality Management System |
| ISO 13485 is a Quality Management Standard for Medical Devices |
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