{"id":7258,"date":"2016-05-03T09:46:51","date_gmt":"2016-05-03T13:46:51","guid":{"rendered":"https:\/\/www.oxebridge.com\/emma\/?p=7258"},"modified":"2016-05-05T18:05:24","modified_gmt":"2016-05-05T22:05:24","slug":"five-official-tc-176-rulings-on-iso-9001-you-probably-didnt-know-existed","status":"publish","type":"post","link":"https:\/\/www.oxebridge.com\/emma\/five-official-tc-176-rulings-on-iso-9001-you-probably-didnt-know-existed\/","title":{"rendered":"Five\u00a0Official TC 176 Rulings on ISO 9001 You Probably Didn&#8217;t Know Existed"},"content":{"rendered":"<p><img loading=\"lazy\" decoding=\"async\" class=\"alignright wp-image-7260\" src=\"https:\/\/www.oxebridge.com\/emma\/wp-content\/uploads\/2016\/05\/decree.jpg\" alt=\"decree\" width=\"185\" height=\"185\" srcset=\"https:\/\/www.oxebridge.com\/emma\/wp-content\/uploads\/2016\/05\/decree.jpg 300w, https:\/\/www.oxebridge.com\/emma\/wp-content\/uploads\/2016\/05\/decree-150x150.jpg 150w, https:\/\/www.oxebridge.com\/emma\/wp-content\/uploads\/2016\/05\/decree-45x45.jpg 45w\" sizes=\"(max-width: 185px) 100vw, 185px\" \/>ISO 9001 isn&#8217;t always well understood, as you can imagine. To help ensure some consistency, Technical Committee 176 &#8212; the authors of ISO \u00a09001 &#8212; issue &#8220;Official Interpretations&#8221; when a question is posed to them. The process is <a href=\"https:\/\/www.oxebridge.com\/emma\/isos-official-interpretation-process-is-broken-may-violate-wto\/\">laborious and slow<\/a>, and each request\u00a0must be framed to allow for either a &#8220;yes&#8221; or &#8220;no&#8221; answer, but eventually TC 176 issues a ruling. These are supposed to be upheld by third party certification body auditors, but unfortunately the CB auditors rarely consult the resulting file, and many don&#8217;t even know it exists. A few outright scoff at TC 176 and say they will do what they like anyway.<\/p>\n<p>But\u00a0arming yourself with the official TC 176 Interpretations is useful, since you can reference these when responding to a bogus audit finding, and thus win your appeal. You can find the complete set <a href=\"http:\/\/isotc.iso.org\/livelink\/livelink\/fetch\/2000\/2122\/-8835176\/-8835848\/8835872\/8835883\/customview.html?func=ll&amp;objId=8835883&amp;objAction=browse#_4.__Interpretations\">here<\/a>. But here are a selection of five\u00a0of the most eye-opening interpretations issued by TC 176 to date. Note that while these\u00a0are issued against the 2008 version\u00a0of ISO 9001,so I have included a likely ISO 9001:2015 applicability comment for each. Of course, my language isn&#8217;t binding, but it&#8217;s likely to be accurate.<\/p>\n<p><span style=\"font-weight: bold;\">1.) You <span style=\"text-decoration: underline;\">can<\/span> contract out the role of ISO management representative. (TC 176 RFI # 109)<\/span><\/p>\n<p style=\"padding-left: 30px;\"><span style=\"font-weight: bold;\">Ruling<\/span><span style=\"font-weight: bold;\">:\u00a0<\/span>TC 176 settled this a long time ago, but auditors and others still insist that the &#8220;management representative&#8221; cannot be a consultant or contractor. TC 176 ruled that management may assign this to a person who &#8220;<span style=\"font-style: italic;\">works for the company in a managerial capacity, is not a permanent member of staff, but works full-time on a contract basis<\/span>.&#8221;<\/p>\n<p style=\"padding-left: 30px;\"><span style=\"font-weight: bold;\">ISO 9001:2015 applicability:<\/span> this ruling <span style=\"font-weight: bold; font-style: italic;\">would <\/span>stand, as new standard removes\u00a0the requirement for a management representative entirely, so if a company wants to continue to use a contractor or consultant in such a role, they may.<\/p>\n<p><span style=\"font-weight: bold;\">2.) Maintenance records are <span style=\"text-decoration: underline;\">not<\/span> required. (TC 176 RFI # 111)<\/span><\/p>\n<p style=\"padding-left: 30px;\"><span style=\"font-weight: bold;\">Ruling:\u00a0<\/span>CB auditors have routinely demanded to see records of preventive maintenance of equipment and\/or facilities, despite there never having been a requirement in the standard for this. Eventually TC 176 ruled that no, ISO 9001 does not &#8220;require records of the maintenance of infrastructures.&#8221; This would include\u00a0preventive maintenance or any other kind of maintenance records. Having them may be a good idea, but it&#8217;s not a requirement.<\/p>\n<p style=\"padding-left: 30px;\"><span style=\"font-weight: bold;\">ISO 9001:2015 applicability:<\/span> the\u00a0ruling <span style=\"font-weight: bold; font-style: italic;\">would <\/span>stand under the new standard as well, since the 2015 version, under clause 7.1.3, does not require such records either.<\/p>\n<p><span style=\"font-weight: bold;\">3.) You do <span style=\"text-decoration: underline;\">not<\/span> have to notify the customer if you discover you sent them nonconforming product. (TC 176 RFI # 117)<\/span><\/p>\n<p style=\"padding-left: 30px;\"><span style=\"font-weight: bold;\">Ruling<\/span>: This one may shock you, but there&#8217;s no hard requirement for you to notify the customer if you later find out you sent them nonconforming product, even if the nonconformance is related to\u00a0their specific requirements. The ruling probably came about with some hesitation, but in the end TC 176 had to yield to the fact that the requirement simply was never put into the standard.<\/p>\n<p style=\"padding-left: 30px;\"><span style=\"font-weight: bold;\">ISO 9001:2015 applicability:<\/span> the\u00a0ruling <span style=\"font-weight: bold; font-style: italic;\">would probably <\/span>stand under the new version as well, but only because of poor wording in the new standard. It appears the authors intended to fix their mistake in ISO 9001:2008, but screwed it up again by poor wording, as clause 8.7.1 now requires the company to &#8220;<span style=\"font-style: italic;\">deal with nonconforming outputs in one or more of the following ways<\/span>&#8221; and then presents a list of four choices which includes &#8220;<span style=\"font-style: italic;\">notify the customer<\/span>.&#8221; However, since the literal language says &#8220;<span style=\"font-style: italic; font-weight: bold;\">one <\/span><span style=\"font-weight: bold;\"><span style=\"text-decoration: underline;\">or<\/span><\/span><span style=\"font-style: italic; font-weight: bold;\"> more ways<\/span>,&#8221; a company may select <span style=\"font-style: italic;\">other<\/span> options\u00a0from the four choices, and thus ignore &#8220;<span style=\"font-style: italic;\">notify the customer<\/span>,&#8221; and still be in literal compliance with the requirement.<\/p>\n<p style=\"padding-left: 30px;\"><span style=\"font-weight: bold;\">Note<\/span>: We should probably file a new RFI and get an updating ruling on this one, so proceed with caution. But technically, if TC 176 were to rule that customer notification was required, they should be forced to update the standard, because they&#8217;d be contradicting what they wrote. Since they don&#8217;t like doing that, they&#8217;d be forced to rule that no, you still are not obligated to notify the customer.<\/p>\n<p><span style=\"font-weight: bold;\">4.) New documents do <span style=\"text-decoration: underline;\">not<\/span> require review. (TC 176 RFI # 106)<\/span><\/p>\n<p style=\"padding-left: 30px;\"><span style=\"font-weight: bold;\">Ruling<\/span>: Wait&#8230; <span style=\"font-style: italic;\">what<\/span>? Yes, TC 176 ruled that new documents only require &#8220;approval&#8221; and no actual review. In their minds, they feel<span style=\"font-style: italic;\"> &#8220;some degree of checking, examination or assessment by the person or persons approving is inherent in <\/span>[the requirement for]<span style=\"font-style: italic;\">\u00a0&#8216;approval for adequacy&#8217;.&#8221;<\/span> Whenever a standard relies on something being &#8220;inherent&#8221; then you know you&#8217;re in trouble.<\/p>\n<p style=\"padding-left: 30px;\"><span style=\"font-weight: bold;\">ISO 9001:2015 applicability:<\/span> the requirement <span style=\"font-weight: bold; font-style: italic;\">would not <\/span>stand under ISO \u00a09001:2015, which now requires <span style=\"font-weight: bold; font-style: italic;\">both <\/span>&#8220;<span style=\"font-style: italic;\">review <span style=\"text-decoration: underline;\">and<\/span> approval for suitability and adequacy<\/span>.&#8221;<\/p>\n<p><span style=\"font-weight: bold;\">5.) You do <span style=\"text-decoration: underline;\">not<\/span> have to retain records of inspection of purchased product. (TC 176 RFI # 115)<\/span><\/p>\n<p style=\"padding-left: 30px;\"><span style=\"font-weight: bold;\">Ruling<\/span>: Maybe it was an oversight, but under ISO 9001:2008 clause 7.4.3, TC 176 only required companies to &#8220;<span style=\"font-style: italic;\">establish and implement the inspection or other activities necessary for ensuring that purchased product meets specified purchase requirements<\/span>&#8221; and never actually required any records of it. Most companies keep &#8220;receiving inspection&#8221; records anyway, but it is\u00a0entirely optional.<\/p>\n<p style=\"padding-left: 30px;\"><span style=\"font-weight: bold;\">ISO 9001:2015 applicability:<\/span>\u00a0it&#8217;s <span style=\"font-weight: bold; font-style: italic;\">not clear<\/span> how this ruling would apply under the new standard, since the clause\u00a08.4 &#8220;Control of Externally Provided Processes, Products and Services&#8221; is badly written, the result of trying to do too many things in one clause. Technically clause 8.4.1 &#8220;General&#8221; says that company must &#8220;<span style=\"font-style: italic;\">determine the controls to be applied to externally provided processes, products and services<\/span>&#8221; and then &#8220;<span style=\"font-style: italic;\">retain documented information of these activities and any necessary actions arising from the evaluations<\/span>&#8220;; but this language appears to be a re-phrasing of ISO 9001:2008 language related to the controls over the supplier, which would mean it deals with supplier audits, surveys, flowdown of requirements, etc. &#8211; and thus <span style=\"font-style: italic; font-weight: bold;\">not <\/span>inspection of incoming purchased materials. This is reinforced by the fact that the next clause, 8.4.2 &#8220;Type and Extent of Control,&#8221; goes on to discuss &#8220;<span style=\"font-style: italic;\">verification, or other activities, necessary to ensure that the externally provided processes, products and services meet requirements<\/span>,&#8221; which clearly addresses incoming product inspection. That clause, however, does <span style=\"font-style: italic; font-weight: bold;\">not <\/span>require any records.<\/p>\n<p style=\"padding-left: 30px;\"><span style=\"font-weight: bold;\">Note<\/span>: We will need a new RFI ruling on this one, as clauses 8.4.1 and 8.4.2 seem to contradict each other, or at least do not compliment each other.<\/p>\n<p>Want to request an official TC 176 interpretation of ISO 9001:2015? Grab the proper request form <a href=\"http:\/\/isotc.iso.org\/livelink\/livelink?func=ll&amp;objId=10443984&amp;objAction=Open&amp;nexturl=%2Flivelink%2Flivelink%2Ffetch%2F2000%2F2122%2F%2D8835176%2F%2D8835848%2F8835872%2F8835883%2Fcustomview%2Ehtml%3Ffunc%3Dll%26objId%3D8835883%26objAction%3Dbrowse%26sort%3Dname\">here<\/a>, and send it to your nation&#8217;s official TC 176\u00a0member body. The list of member bodies can be found <a href=\"http:\/\/www.iso.org\/iso\/home\/standards_development\/list_of_iso_technical_committees\/iso_technical_committee_participation.htm?commid=53882\">here<\/a>. Then sit back and wait, because it can take up to a year or more for TC 176 to process and vote on it. Yes, I know they haven&#8217;t updated the RFI form to reflect ISO 9001:2015, but fill it out anyway. I&#8217;ve alerted Charles Corrie at TC 176 to update the form, but I am sure that will take at least a decade to actually happen.<\/p>\n<p>&nbsp;<\/p>","protected":false},"excerpt":{"rendered":"<p>ISO TC 176 publishes official &#8220;interpretations&#8221; on confusing ISO 9001 clauses. Here are five you probably didn&#8217;t know existed.<\/p>","protected":false},"author":2,"featured_media":7260,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_et_pb_use_builder":"","_et_pb_old_content":"","_et_gb_content_width":"","mc4wp_mailchimp_campaign":[],"footnotes":""},"categories":[4,5],"tags":[504,43,14,29,116,506,505,42],"class_list":["post-7258","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-guidance","category-opinion","tag-interpretations","tag-iso","tag-iso-9001","tag-iso-90012008","tag-iso-90012015","tag-requests-for-interpretation","tag-rfi","tag-tc-176","et-has-post-format-content","et_post_format-et-post-format-standard"],"_links":{"self":[{"href":"https:\/\/www.oxebridge.com\/emma\/wp-json\/wp\/v2\/posts\/7258","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.oxebridge.com\/emma\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.oxebridge.com\/emma\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.oxebridge.com\/emma\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.oxebridge.com\/emma\/wp-json\/wp\/v2\/comments?post=7258"}],"version-history":[{"count":5,"href":"https:\/\/www.oxebridge.com\/emma\/wp-json\/wp\/v2\/posts\/7258\/revisions"}],"predecessor-version":[{"id":7264,"href":"https:\/\/www.oxebridge.com\/emma\/wp-json\/wp\/v2\/posts\/7258\/revisions\/7264"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.oxebridge.com\/emma\/wp-json\/wp\/v2\/media\/7260"}],"wp:attachment":[{"href":"https:\/\/www.oxebridge.com\/emma\/wp-json\/wp\/v2\/media?parent=7258"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.oxebridge.com\/emma\/wp-json\/wp\/v2\/categories?post=7258"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.oxebridge.com\/emma\/wp-json\/wp\/v2\/tags?post=7258"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}