State of the Art
ISO 13485 requires the control of "documents of external origin" such as regulations, standards and guidelines that impact the quality management system (QMS). Changes to these external documents must be identified and appropriate actions taken to maintain "state of the art" medical devices. For example, Essential Requirement 2 of the European Medical Device Directive states: "The solutions adopted by the manufacturer for the design and construction of the devices must conform to safety principles, taking account of the generally acknowledged state of the art."
Keeping up to date with evolving international regulations, standards and guidelines is always a challenge. It is one thing to become aware of revised documents; it is something else to determine the impact of the revisions on your QMS and devices.
Regulations, Standards, Guidance Documents
Regulations and guidelines issued by government bodies (like the European Commission or US FDA) and quasi-government bodies (like IMDRF) are free when obtained direct from the source. Standards cost money. Standards are typically less expensive when purchased directly from the issuing organization, or when purchased in compilations offered by organizations such as ASTM or AAMI.
Ways To Learn About External Document Updates
Once you obtain the documents you need, you must compare them to the prior version to determine what changes were made and how the changes impact your QMS and devices. Even if your QMS and devices are not affected by the changes, you will need to update your external document log/library and also update any references made to the external document in your internal documents.
Note: ASTM provides "redline" versions of their documents so you can easily identify changes. Finally, America has done something to be proud of...
Keeping up to date with evolving international regulations, standards and guidelines is always a challenge. It is one thing to become aware of revised documents; it is something else to determine the impact of the revisions on your QMS and devices.
Regulations, Standards, Guidance Documents
Regulations and guidelines issued by government bodies (like the European Commission or US FDA) and quasi-government bodies (like IMDRF) are free when obtained direct from the source. Standards cost money. Standards are typically less expensive when purchased directly from the issuing organization, or when purchased in compilations offered by organizations such as ASTM or AAMI.
Ways To Learn About External Document Updates
- Submit your list of controlled external documents to a document updating service and you can be notified when each document changes. For example, the Document Center will notify you of document updates for a nominal fee per document without obligation to purchase the document. Updating services are also offered by other companies such as Techstreet and IHS.
- Subscribe to free email updates directly from the issuing organization. For example, FDA CDRH and ASTM have mailing lists.
- Join AAMI to get updates on evolving ISO standards, often well in advance of the new standard being published. AAMI also has a very reasonably priced standards subscription service available to its members.
Once you obtain the documents you need, you must compare them to the prior version to determine what changes were made and how the changes impact your QMS and devices. Even if your QMS and devices are not affected by the changes, you will need to update your external document log/library and also update any references made to the external document in your internal documents.
Note: ASTM provides "redline" versions of their documents so you can easily identify changes. Finally, America has done something to be proud of...
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sam@lazzara.net
sam@lazzara.net
