{"id":8,"date":"2015-04-07T14:36:27","date_gmt":"2015-04-07T14:36:27","guid":{"rendered":"http:\/\/www.pinnacleeg.com\/iso\/2008\/07\/20\/the-modern-quality-manual\/"},"modified":"2015-04-08T12:53:03","modified_gmt":"2015-04-08T12:53:03","slug":"the-modern-quality-manual","status":"publish","type":"post","link":"http:\/\/www.pinnacleeg.com\/iso\/the-modern-quality-manual\/","title":{"rendered":"The Modern Quality Manual"},"content":{"rendered":"

It is hard to believe that so many years after the release of ISO 9001:2000 there are still a lot of \u201cold school\u201d perspectives and misconceptions about the role, form, and function of the \u201cquality manual\u201d (ISO 9001:2008 sub-clause 4.2.2). \u00a0I developed the Lean QMS\u00ae<\/sup> Map<\/a> (a 2-page graphical version of a quality manual) in 1999 and have registered countless companies to ISO 9001, TS 16949, TL 9000, AS9100, and ISO 13485 with it.\u00a0 Nevertheless, the use of a very small quality manual is still a hotly contested topic, even among my professional colleagues.<\/span><\/span><\/p>\n

Perhaps one of the reasons that many of us are still divided on the concept of a small quality manual is that we have not truly considered and understood the actual requirements. \u00a0ISO 9001 requirements for a quality manual are:<\/span><\/span>\u00a0<\/span><\/span><\/p>\n

    \n
  1. It must describe\/define the scope of the quality management system, <\/span><\/span><\/li>\n
  2. It must explain any excluded elements\/clauses, <\/span><\/span><\/li>\n
  3. It must define or reference the “documented procedures” that make up your quality management system, and <\/span><\/span><\/li>\n
  4. It must describe\/show the interaction of the quality management system processes <\/span><\/span><\/li>\n<\/ol>\n

    At no point does ISO 9001 stipulate how long the quality manual should be. \u00a0It does not even say that it should be a singe document. \u00a0Nor does it suggest that it should even be in text format.<\/span><\/span><\/p>\n

    Another possible source of confusion and diverging opinions is the use of the terms “procedure” and “processes”. \u00a0We can all agree that the intent of ISO 9001 is to serve as a process management platform. \u00a0However, it only applies the word “documented” to procedures. \u00a0This begs the question: should we not document our processes? \u00a0For those of us that practice more that just ISO compliance, the answer is: of course we should. \u00a0If you agree, then replace the word “procedure” with “process” and think about the requirements again. \u00a0Now the QMS must:<\/span>
    \n<\/span><\/span><\/p>\n

      \n
    1. Define or reference the “documented processes” that make up your quality management system, and <\/span><\/span><\/li>\n
    2. Describe\/show the interaction of quality management system processes.<\/span><\/span><\/li>\n<\/ol>\n

      Why not draw a picture of this on one or two pieces of paper? \u00a0Why use paper? <\/span><\/span>In my practice I do this all the time. \u00a0Hundreds of clients have embraced this approach and never has this been an issue with any registrar. \u00a0Granted, customers may want to see the details of the actual “documented process,” which is fine. \u00a0Show them the process(es) and show them how that process fits into the overall process based quality management system with your new short quality manual or Lean QMS\u00ae<\/sup> Map<\/a>.<\/span><\/p>\n

      Kirill Liberman, President<\/span><\/p>\n","protected":false},"excerpt":{"rendered":"

      It is hard to believe that so many years after the release of ISO 9001:2000 there are still a lot of \u201cold school\u201d perspectives and misconceptions about the role, form, and function of the \u201cquality manual\u201d (ISO 9001:2008 sub-clause 4.2.2). \u00a0I developed the Lean QMS\u00ae Map (a 2-page graphical version of a quality manual) in […]<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[3,4,5,7,10,11,12,13,14],"tags":[],"class_list":["post-8","post","type-post","status-publish","format-standard","hentry","category-as9100","category-continual-improvement","category-iso13485","category-iso9001","category-pinnacle-enterprise-group","category-process-improvement","category-quality-management-system","category-tl9000","category-ts16949"],"_links":{"self":[{"href":"http:\/\/www.pinnacleeg.com\/iso\/wp-json\/wp\/v2\/posts\/8","targetHints":{"allow":["GET"]}}],"collection":[{"href":"http:\/\/www.pinnacleeg.com\/iso\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"http:\/\/www.pinnacleeg.com\/iso\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"http:\/\/www.pinnacleeg.com\/iso\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"http:\/\/www.pinnacleeg.com\/iso\/wp-json\/wp\/v2\/comments?post=8"}],"version-history":[{"count":1,"href":"http:\/\/www.pinnacleeg.com\/iso\/wp-json\/wp\/v2\/posts\/8\/revisions"}],"predecessor-version":[{"id":45,"href":"http:\/\/www.pinnacleeg.com\/iso\/wp-json\/wp\/v2\/posts\/8\/revisions\/45"}],"wp:attachment":[{"href":"http:\/\/www.pinnacleeg.com\/iso\/wp-json\/wp\/v2\/media?parent=8"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"http:\/\/www.pinnacleeg.com\/iso\/wp-json\/wp\/v2\/categories?post=8"},{"taxonomy":"post_tag","embeddable":true,"href":"http:\/\/www.pinnacleeg.com\/iso\/wp-json\/wp\/v2\/tags?post=8"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}