{"id":141,"date":"2013-09-26T22:43:17","date_gmt":"2013-09-26T22:43:17","guid":{"rendered":"https:\/\/compliancems.com.au\/?p=141"},"modified":"2013-09-26T22:43:17","modified_gmt":"2013-09-26T22:43:17","slug":"iso-9001-13485-clause-4-2-4-control-and-retention-of-records-iso-22716-cosmetics-gmp-clause-17","status":"publish","type":"post","link":"https:\/\/compliancems.com.au\/?p=141","title":{"rendered":"ISO 9001 \/ 13485 clause 4.2.4 Control and retention of records | ISO 22716 Cosmetics GMP clause 17"},"content":{"rendered":"<h3><strong><span style=\"color: #000000;\"><span style=\"font-family: Calibri;\">Retention of records<\/span><\/span><\/strong><\/h3>\n<p><span style=\"color: #000000; font-size: small;\">Although ISO 9001 and ISO 22716\u00a0does not stipulate how long records must be retained for, ISO 13485 is more specific \u2013 <\/span><span style=\"font-family: Calibri;\"><i><span style=\"font-size: small;\"><span style=\"color: #000000;\">\u2018the organization shall retain the records for a period of time at least equivalent to the lifetime of the medical device as defined by the organization, but not less than two years from the date of product release by the organization <\/span>or as specified by relevant regulatory requirements<\/span><span style=\"color: #000000; font-size: small;\">\u2019<\/span><\/i><\/span><\/p>\n<p><span style=\"color: #000000;\">As per the Therapeutic Goods (Medical Devices) Regulations 2002, the manufacturer must keep all manufacturing records for at least 5 years from the last date of manufacture or the lifetime of the device, whichever is longer. Distribution records relating to Class AIMD, Class III or implantable Class IIb medical devices must be retained for inspection by the TGA for 10 years. 5 years is required for all other devices.<\/span><\/p>\n<p><span style=\"font-size: small;\"><span style=\"color: #000000;\">Similarly, the EU directives require the retention of manufacturing records for 5 years from the last date of manufacture or the lifetime of the device, whichever is longer. However, for implantable devices, records must be kept for at least 15 years from the last date of manufacture.<\/span><\/span><\/p>\n<p><span style=\"color: #800000;\"><strong>About CMS:<\/strong><\/span><\/p>\n<p><span style=\"color: #800000;\">Compliance Management Solutions is a Melbourne based consultancy assisting organizations in obtaining and maintaining TGA (medicinal products and medical devices ISO 13485) | ISO 9001 (Quality) | Cosmetics GMP ISO 22716 | AS\/NZS 4801 (OH&amp;S) | ISO 14001 (Environmental) certification and registration.<\/span><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Retention of records Although ISO 9001 and ISO 22716\u00a0does not stipulate how long records must be retained for, ISO 13485 is more specific \u2013 \u2018the organization shall retain the records for a period of time at least equivalent to the lifetime of the medical device as defined by the organization, but not less than two years from the date of product release by the organization or as specified by relevant regulatory requirements\u2019 As per the Therapeutic Goods (Medical Devices) Regulations 2002, the manufacturer must keep all manufacturing records for at least 5 years from the last date of manufacture or the lifetime of the device, whichever is longer. Distribution records[&#8230;]<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[],"class_list":["post-141","post","type-post","status-publish","format-standard","hentry","category-uncategorized"],"_links":{"self":[{"href":"https:\/\/compliancems.com.au\/index.php?rest_route=\/wp\/v2\/posts\/141","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/compliancems.com.au\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/compliancems.com.au\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/compliancems.com.au\/index.php?rest_route=\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/compliancems.com.au\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=141"}],"version-history":[{"count":3,"href":"https:\/\/compliancems.com.au\/index.php?rest_route=\/wp\/v2\/posts\/141\/revisions"}],"predecessor-version":[{"id":146,"href":"https:\/\/compliancems.com.au\/index.php?rest_route=\/wp\/v2\/posts\/141\/revisions\/146"}],"wp:attachment":[{"href":"https:\/\/compliancems.com.au\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=141"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/compliancems.com.au\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=141"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/compliancems.com.au\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=141"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}