{"id":131,"date":"2013-09-03T00:04:19","date_gmt":"2013-09-03T00:04:19","guid":{"rendered":"https:\/\/compliancems.com.au\/?p=131"},"modified":"2013-09-03T00:04:19","modified_gmt":"2013-09-03T00:04:19","slug":"tga-pharmaceuticals-iso-13485-medical-devices-iso-22716-cosmetics-gmp-iso-9001","status":"publish","type":"post","link":"https:\/\/compliancems.com.au\/?p=131","title":{"rendered":"TGA (Pharmaceuticals \/ ISO 13485 Medical Devices) | ISO 22716 Cosmetics GMP | ISO 9001"},"content":{"rendered":"<h1><span style=\"font-size: medium;\"><span style=\"color: #000000;\"><span style=\"font-family: Calibri;\"><strong>Vendor\/Supplier Evaluation<\/strong><\/span><\/span><\/span><\/h1>\n<p><span style=\"font-size: medium;\"><span style=\"color: #000000;\"><span style=\"font-family: Calibri;\">The method of\u00a0evaluating suppliers can be either done via\u00a0p<\/span><\/span><\/span><span style=\"font-family: Calibri;\"><span style=\"font-size: medium;\"><span style=\"color: #000000;\">hysical\/site audit or\u00a0d<\/span><\/span><\/span><span style=\"font-family: Calibri;\"><span style=\"font-size: medium;\"><span style=\"color: #000000;\">esktop audit.<\/span><\/span><\/span><\/p>\n<p><span style=\"font-size: medium;\"><span style=\"color: #000000;\"><span style=\"font-family: Calibri;\">The type and extent of control applied to the supplier shall be dependant upon the effect of the product on product realization\u00a0(final product). Rather than evaluating\u00a0<strong>all<\/strong> suppliers, use a risk based approach. When\u00a0desktop audits are performed, ensure that they record any certification the organisation has and\u00a0that you maintain a <strong>current<\/strong> certificate. There have been many instances where organizations have been caught out by regulators for not having the updated supplier certificate. Supplier re-evaluation\u00a0should also be performed; this can be as simple as asking for an updated registration certificate. When a supplier has no certification, use history of supply as grounds for approving the vendor.<\/span><\/span><\/span><\/p>\n<p><strong>About CMS:<\/strong><\/p>\n<p>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.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Vendor\/Supplier Evaluation The method of\u00a0evaluating suppliers can be either done via\u00a0physical\/site audit or\u00a0desktop audit. The type and extent of control applied to the supplier shall be dependant upon the effect of the product on product realization\u00a0(final product). Rather than evaluating\u00a0all suppliers, use a risk based approach. When\u00a0desktop audits are performed, ensure that they record any certification the organisation has and\u00a0that you maintain a current certificate. There have been many instances where organizations have been caught out by regulators for not having the updated supplier certificate. Supplier re-evaluation\u00a0should also be performed; this can be as simple as asking for an updated registration certificate. When a supplier has no certification, use history[&#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-131","post","type-post","status-publish","format-standard","hentry","category-uncategorized"],"_links":{"self":[{"href":"https:\/\/compliancems.com.au\/index.php?rest_route=\/wp\/v2\/posts\/131","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=131"}],"version-history":[{"count":2,"href":"https:\/\/compliancems.com.au\/index.php?rest_route=\/wp\/v2\/posts\/131\/revisions"}],"predecessor-version":[{"id":133,"href":"https:\/\/compliancems.com.au\/index.php?rest_route=\/wp\/v2\/posts\/131\/revisions\/133"}],"wp:attachment":[{"href":"https:\/\/compliancems.com.au\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=131"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/compliancems.com.au\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=131"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/compliancems.com.au\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=131"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}