ISO 13485 Medical Device Standard in Plain English

ISO 13485 2003 is a quality management standard for medical devices.
The following material translates this standard into Plain English. However,
this material is both general and selective. It is therefore incomplete. If you
need a detailed and complete version, please consider purchasing our
Title 45: ISO 13485 2003 Translated into Plain English.

ISO 13485 presents requirements in sections 4 to 8. Therefore,
the following material begins with section 4. Sections 1 to 3 cover a
variety of introductory and explanatory topics. These additional topics
are discussed in Title 45: ISO 13485 2003 Translated into Plain English.

	4. Systemic Requirements
4.1 Establish a quality system for medical devices	Develop a quality management system for medical devices. Identify the processes that make up your quality system. Describe your quality management processes.
4.1 Establish a quality system for medical devices	Implement a quality management system for medical devices. Use quality system processes. Control process performance.
	Maintain your medical device quality management system. Monitor the effectiveness of your processes. Maintain the effectiveness of your processes.
4.2 Document your medical device quality system	4.2.1 Develop quality management system documents. Develop documents to implement your quality system. Develop a file for each model or type of medical device. Develop a file for each type of related service.
	4.2.2 Prepare quality management system manual. Document your procedures. Describe how your processes interact. Specify the scope of your quality system. Justify exclusions and reductions in scope. Describe how your documentation is structured.
	4.2.3 Control quality management system documents. Approve documents before you distribute them. Provide the correct version of documents at points of use. Review and re-approve documents when you update them. Specify the current revision status of your documents. Monitor documents that come from external sources. Prevent the accidental use of obsolete documents. Preserve the usability of your quality documents. Retain obsolete documents for medical devices.
	4.2.4 Maintain quality management system records. Use your records to prove that requirements have been met. Develop a procedure to control medical device records. Ensure that your medical device records are useable. Retain records related to medical devices.

	5. Management Requirements
5.1 Support quality	Promote the importance of quality. Promote the need to meet customer requirements. Promote the need to meet medical device requirements.
	Develop a quality management system. Support the development of a quality system. Formulate your organization's quality policy. Set your organization's quality objectives. Provide needed quality resources.
	Implement your quality management system. Provide resources to implement quality management system. Encourage people to meet quality system requirements.
	Maintain your quality management system. Perform quality management reviews. Provide resources to maintain quality system.
5.2 Focus on customers	Identify customer requirements. Expect people to identify customer requirements.
	Meet customers requirements. Expect your organization to meet customer requirements.
5.3 Establish a quality policy	Define your quality policy. Ensure that it serves your organization's purpose. Ensure that it emphasizes the need to meet requirements. Ensure that it facilitates the development of quality objectives.
	Manage your quality policy. Communicate your policy throughout your organization. Review your policy to ensure its continued suitability.
5.4 Perform quality planning	5.4.1 Formulate quality objectives. Ensure that objectives are set for all functional areas. Ensure that objectives are set at organizational levels. Ensure that objectives facilitate product realization. Ensure that objectives support the quality policy. Ensure that objectives are measurable.
	5.4.2 Plan quality management system. *Plan the development* of your quality management system. Plan the implementation of your quality management system. Plan the improvement of your quality management system. Plan the modification of your quality management system.**
5.5 Control your quality management system	5.5.1 Define responsibilities and authorities. Document responsibilities and authorities. Communicate responsibilities and authorities. Define how people should interact with each other.
	5.5.2 Appoint management representative. Oversee your quality management system. Report on the status of your quality system. Support the maintenance of your quality system. Promote the importance of regulatory requirements.
	5.5.3 Support internal communications. Ensure that communication processes are established. Ensure that communication occurs throughout organization.
5.6 Carry out management reviews	5.6.1 Review quality management system. Plan regular reviews of your quality system. Evaluate the effectiveness of your quality system. Maintain a record of your management reviews.
	5.6.2 Examine management review inputs. Examine audit results. Examine product conformity data. Examine opportunities to improve. Examine feedback from customers. Examine process performance information. Examine corrective and preventive actions. Examine changes that might affect your system. Examine changes in your regulatory requirements. Examine previous quality management reviews.
	5.6.3 Generate management review outputs. Generate actions to improve maintenance of quality system. Generate actions to improve your organization's products. Generate actions to address your resource needs.

	6. Resource Requirements
6.1 Provide quality resources	Identify quality management system resource requirements. Identify resources needed to support the quality system. Identify resources needed to meet customer requirements. Identify resources needed to meet regulatory requirements.
	Provide quality management system resources. Provide resources needed to support the quality system. Provide resources needed to implement the quality system. Provide resources needed to maintain the quality system. Provide resources needed to meet regulatory requirements.
6.2 Provide quality personnel	6.2.1 Use competent personnel. *Ensure that your personnel have the right experience.* *Ensure that your personnel have the right education.* *Ensure that your personnel have the right training.* *Ensure that your personnel have the right skills.*
	6.2.2 Support competence. Define acceptable levels of competence. Identify your training and awareness needs. Establish training needs assessment procedures. Deliver your training and awareness programs. Evaluate effectiveness of training and awareness. Maintain a record of competence.
6.3 Provide quality infrastructure	Identify infrastructure needs. Identify your building needs. Identify your workspace needs. Identify your hardware needs. Identify your software needs. Identify your utility needs. Identify your equipment needs. Identify your support service needs. Identify your maintenance needs.
	Provide needed infrastructure. Provide needed buildings. Provide needed workspaces. Provide needed hardware. Provide needed software. Provide needed utilities. Provide needed equipment. Provide needed support services. Provide needed maintenance services.
	Maintain your infrastructure. Maintain your buildings. Maintain your workspaces. Maintain your hardware. Maintain your software. Maintain your utilities. Maintain your equipment. Maintain your support services. Maintain your maintenance services. Maintain a record of maintenance activities.
6.4 Provide quality environment	Identify needed work environment. Identify work environment for medical products. Identify your organization's health requirements. Identify your organization's clothing requirements. Identify your organization's cleanliness requirements. Identify your organization's working condition requirements.
	Implement needed work environment. Meet your organizations work environment needs. Meet your organization's health requirements. Meet your organization's clothing requirements. Meet your organization's cleanliness requirements. Meet your organization's working condition requirements.
	Manage needed work environment. Control your organization's work environment. Control your organization's health practices. Control your organization's clothing practices. Control your organization's cleanliness practices. Implement procedures to monitor working conditions. Establish special arrangements for contaminated products.

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Updated on December 28, 2011. First published on December 11, 2004.

ISO 13485 MEDICAL DEVICE

STANDARD TRANSLATED INTO PLAIN ENGLISH

4. Systemic Requirements

5. Management Requirements

6. Resource Requirements