{"id":239,"date":"2015-03-04T19:58:17","date_gmt":"2015-03-04T19:58:17","guid":{"rendered":"https:\/\/compliancems.com.au\/?p=239"},"modified":"2015-03-04T19:58:17","modified_gmt":"2015-03-04T19:58:17","slug":"iso-9001-2015","status":"publish","type":"post","link":"https:\/\/compliancems.com.au\/?p=239","title":{"rendered":"ISO 9001 : 2015"},"content":{"rendered":"
The International Organization for Standardization (ISO) is at work on a major revision to the <\/span>ISO 9001<\/span><\/span><\/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.<\/span><\/h6>\n

\u00a0This ISO 9001:2015 version follows the new high-level structure and comprises ten sections: <\/span><\/p>\n

1.<\/span>\u00a0\u00a0\u00a0\u00a0\u00a0 Scope<\/span><\/span><\/h6>\n
2.<\/span>\u00a0\u00a0\u00a0\u00a0\u00a0 Normative references <\/span><\/span><\/h6>\n
3.<\/span>\u00a0\u00a0\u00a0\u00a0\u00a0 Terms and definitions <\/span><\/span><\/h6>\n
4.<\/span>\u00a0\u00a0\u00a0\u00a0\u00a0 Context of the organisation <\/span><\/span><\/h6>\n
5.<\/span>\u00a0\u00a0\u00a0\u00a0\u00a0 Leadership <\/span><\/span><\/h6>\n
6.<\/span>\u00a0\u00a0\u00a0\u00a0\u00a0 Planning (including Risk Analysis)<\/span><\/span><\/h6>\n
7.<\/span>\u00a0\u00a0\u00a0\u00a0\u00a0 Support <\/span><\/span><\/h6>\n
8.<\/span>\u00a0\u00a0\u00a0\u00a0\u00a0 Operation <\/span><\/span><\/h6>\n
9.<\/span>\u00a0\u00a0\u00a0\u00a0\u00a0 Performance evaluation <\/span><\/span><\/h6>\n
10.<\/span>\u00a0\u00a0 Improvement <\/span><\/span><\/h6>\n

How can you prepare?<\/span><\/p>\n

Organisations that have established management systems should familiarise themselves with the changes and subsequently upgrade their management systems accordingly in 2015. <\/span><\/h6>\n
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.<\/span><\/h6>\n

About CMS: <\/span><\/span><\/p>\n

Compliance Management Solutions is an Australian based consultancy assisting organizations in TGA\/MDD | ISO 9001 (Quality) | 13485 (Medical Devices) | Cosmetics GMP ISO 22716 certification, registration and consultation. Our services include: <\/span><\/p>\n

\u00d8<\/span> Australian ARTG registration\/sponsorship\/consultancy (medical devices\/medicinal products) <\/span><\/span>
\n\u00d8<\/span> Implementation and maintenance of Management Systems (MDD\/ISO 13485\/Sterilization\/ISO 9001) <\/span><\/span>
\n\u00d8<\/span> Management Systems audits \u2013 (MDD\/ISO 13485\/Sterilization\/ISO 9001) <\/span><\/span>
\n\u00d8<\/span> 3rd Party Notified Body Certification Audits (MDD\/ISO 13485\/ISO 9001\/ISO 22716) <\/span><\/span>
\n\u00d8<\/span> Quotations for ISO transfer of certificate <\/span><\/span>
\n\u00d8<\/span> Risk Management <\/span><\/span>
\n\u00d8<\/span> Continuous improvement including Corrective\/Preventive Action <\/span><\/span>
\n\u00d8<\/span> Validation including (Process\/Equipment Qualification\/Sterilization) <\/span><\/span>
\n\u00d8<\/span> Machinery\/Equipment commissioning\/installation and troubleshooting <\/span><\/span>
\n\u00d8<\/span> Complaint handling <\/span><\/span>
\n\u00d8<\/span> Process Improvement using Lean Six Sigma methodologies <\/span><\/span>
\n\u00d8<\/span> Web based compliance management software <\/span><\/span>
\n
\nCompliance Management Solutions
\nMelbourne, Australia<\/p>\n

E: gloizou@compliancems.com.au | M: 043312 4266
\nW: https:\/\/compliancems.com.au<\/span><\/p>\n","protected":false},"excerpt":{"rendered":"

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. \u00a0This ISO 9001:2015 version follows the new high-level structure and comprises ten sections: 1.\u00a0\u00a0\u00a0\u00a0\u00a0 Scope 2.\u00a0\u00a0\u00a0\u00a0\u00a0 Normative references 3.\u00a0\u00a0\u00a0\u00a0\u00a0 Terms and definitions 4.\u00a0\u00a0\u00a0\u00a0\u00a0 Context of the organisation 5.\u00a0\u00a0\u00a0\u00a0\u00a0 Leadership 6.\u00a0\u00a0\u00a0\u00a0\u00a0 Planning (including Risk Analysis) 7.\u00a0\u00a0\u00a0\u00a0\u00a0 Support 8.\u00a0\u00a0\u00a0\u00a0\u00a0 Operation 9.\u00a0\u00a0\u00a0\u00a0\u00a0 Performance[…]<\/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-239","post","type-post","status-publish","format-standard","hentry","category-uncategorized"],"_links":{"self":[{"href":"https:\/\/compliancems.com.au\/index.php?rest_route=\/wp\/v2\/posts\/239","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=239"}],"version-history":[{"count":3,"href":"https:\/\/compliancems.com.au\/index.php?rest_route=\/wp\/v2\/posts\/239\/revisions"}],"predecessor-version":[{"id":242,"href":"https:\/\/compliancems.com.au\/index.php?rest_route=\/wp\/v2\/posts\/239\/revisions\/242"}],"wp:attachment":[{"href":"https:\/\/compliancems.com.au\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=239"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/compliancems.com.au\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=239"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/compliancems.com.au\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=239"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}