{"id":216,"date":"2014-09-24T06:33:39","date_gmt":"2014-09-24T06:33:39","guid":{"rendered":"https:\/\/compliancems.com.au\/?p=216"},"modified":"2014-09-24T06:33:39","modified_gmt":"2014-09-24T06:33:39","slug":"iso-90012015","status":"publish","type":"post","link":"https:\/\/compliancems.com.au\/?p=216","title":{"rendered":"ISO 9001:2015"},"content":{"rendered":"<h1 style=\"text-align: justify;\">The International Organization for Standardization (ISO) is at work on a major revision to the <a href=\"http:\/\/www.tuv-sud.com\/activity\/auditing-system-certification\/iso-9001-quality-management-system-certification\" target=\"_self\">ISO 9001<\/a> standard, the internationally-recognized standard that outlines the principles for quality management systems. The revision is currently scheduled for publication in September 2015, and is expected to include a number of important changes for organizations currently holding ISO 9001 certification, as well as those contemplating the development and implementation of a quality management system.<\/h1>\n<h1 style=\"text-align: justify;\">This ISO 9001:2015 version follows the new high-level structure and comprises ten sections:<\/h1>\n<ol style=\"text-align: justify;\">\n<li>\n<h1>Scope<\/h1>\n<\/li>\n<li>\n<h1>Normative references<\/h1>\n<\/li>\n<li>\n<h1>Terms and definitions<\/h1>\n<\/li>\n<li>\n<h1>Context of the organisation<\/h1>\n<\/li>\n<li>\n<h1>Leadership<\/h1>\n<\/li>\n<li>\n<h1>Planning <span style=\"color: #ff9900;\"><i>(including Risk Analysis)<\/i><\/span><\/h1>\n<\/li>\n<li>\n<h1>Support<\/h1>\n<\/li>\n<li>\n<h1>Operation<\/h1>\n<\/li>\n<li>\n<h1>Performance evaluation<\/h1>\n<\/li>\n<li>\n<h1>Improvement<\/h1>\n<\/li>\n<\/ol>\n<h1 style=\"text-align: justify;\"><span style=\"color: #ff0000;\">How can you prepare?<\/span><\/h1>\n<h1 style=\"text-align: justify;\">Organisations that have established management systems should familiarise themselves with the changes and subsequently upgrade their management systems accordingly in 2015.<\/h1>\n<h1 style=\"text-align: justify;\">There will be a three-year transition period during which both the old and the new standard will apply in parallel. However, within the scope of certification, organisations should not leave the upgrade until the very end of the transition period. It is recommended that organisations upgrade their systems to the new standard at an early stage within the scope of a regular re-certification audit.<\/h1>\n<h1 style=\"text-align: justify;\"><span style=\"color: #ff0000;\"><strong>About CMS:<\/strong><\/span><\/h1>\n<h1 style=\"text-align: justify;\"><span style=\"color: #339966;\">Compliance Management Solutions is an Australian based consultancy assisting organizations in TGA | ISO 9001 (Quality) | Cosmetics GMP ISO 22716 certification, registration and consultation. Our services include:<\/span><\/h1>\n<ul style=\"text-align: justify;\">\n<li>\n<h1><span style=\"color: #339966;\">\u00a0<\/span><span style=\"color: #339966;\">Australian ARTG registration\/sponsorship\/consultancy (medical devices\/medicinal products)<\/span><\/h1>\n<\/li>\n<li>\n<h1><span style=\"color: #339966;\">Implementation and maintenance of Management Systems (TGA\/MDD\/ISO 13485\/Sterilization\/ISO 9001)<\/span><\/h1>\n<\/li>\n<li>\n<h1><span style=\"color: #339966;\">Management Systems audits \u2013 (TGA\/MDD\/ISO 13485\/Sterilization\/ISO 9001)<\/span><\/h1>\n<\/li>\n<li>\n<h1><span style=\"color: #339966;\">3rd Party Notified Body Certification Audits (MDD\/ISO 13485\/ISO 9001\/ISO 22716)<\/span><\/h1>\n<\/li>\n<li>\n<h1><span style=\"color: #339966;\">Quotations for ISO Certificate Transfer (can be transferred at surveillance audit)<\/span><\/h1>\n<\/li>\n<li>\n<h1><span style=\"color: #339966;\">Risk Management<\/span><\/h1>\n<\/li>\n<li>\n<h1><span style=\"color: #339966;\">Continuous improvement including Corrective\/Preventive Action<\/span><\/h1>\n<\/li>\n<li>\n<h1><span style=\"color: #339966;\">Validation including (Process\/Equipment Qualification\/Sterilization)<\/span><\/h1>\n<\/li>\n<li>\n<h1><span style=\"color: #339966;\">Machinery\/Equipment commissioning\/installation and troubleshooting<\/span><\/h1>\n<\/li>\n<li>\n<h1><span style=\"color: #339966;\">Complaint handling<\/span><\/h1>\n<\/li>\n<li>\n<h1><span style=\"color: #339966;\">Process Improvement using Lean Six Sigma methodologies<\/span><\/h1>\n<\/li>\n<li>\n<h1><span style=\"color: #339966;\">Web based compliance management software\u00a0<\/span><\/h1>\n<\/li>\n<\/ul>\n<h1 style=\"text-align: justify;\">George Loizou<br \/>\nCompliance Management Solutions<\/h1>\n<h1 style=\"text-align: justify;\">\u00a0E:\u00a0 <a href=\"mailto:gloizou@compliancems.com.au\">gloizou@compliancems.com.au<\/a> | M: +61 4 3312 4266<br \/>\nW: <a href=\"https:\/\/compliancems.com.au\/\">https:\/\/compliancems.com.au<\/a><\/h1>\n<h1 style=\"text-align: justify;\"><\/h1>\n","protected":false},"excerpt":{"rendered":"<p>The International Organization for Standardization (ISO) is at work on a major revision to the ISO 9001 standard, the internationally-recognized standard that outlines the principles for quality management systems. The revision is currently scheduled for publication in September 2015, and is expected to include a number of important changes for organizations currently holding ISO 9001 certification, as well as those contemplating the development and implementation of a quality management system. This ISO 9001:2015 version follows the new high-level structure and comprises ten sections: Scope Normative references Terms and definitions Context of the organisation Leadership Planning (including Risk Analysis) Support Operation Performance evaluation Improvement How can you prepare? Organisations that have[&#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-216","post","type-post","status-publish","format-standard","hentry","category-uncategorized"],"_links":{"self":[{"href":"https:\/\/compliancems.com.au\/index.php?rest_route=\/wp\/v2\/posts\/216","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=216"}],"version-history":[{"count":3,"href":"https:\/\/compliancems.com.au\/index.php?rest_route=\/wp\/v2\/posts\/216\/revisions"}],"predecessor-version":[{"id":219,"href":"https:\/\/compliancems.com.au\/index.php?rest_route=\/wp\/v2\/posts\/216\/revisions\/219"}],"wp:attachment":[{"href":"https:\/\/compliancems.com.au\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=216"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/compliancems.com.au\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=216"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/compliancems.com.au\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=216"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}