{"id":18,"date":"2015-04-01T14:26:45","date_gmt":"2015-04-01T14:26:45","guid":{"rendered":"http:\/\/www.pinnacleeg.com\/iso\/2009\/08\/25\/iso-9001-myth-1-documentation-glut\/"},"modified":"2015-04-08T12:38:28","modified_gmt":"2015-04-08T12:38:28","slug":"iso-9001-myth-1-documentation-glut","status":"publish","type":"post","link":"http:\/\/www.pinnacleeg.com\/iso\/iso-9001-myth-1-documentation-glut\/","title":{"rendered":"ISO 9001 Myth #1 – Documentation Glut"},"content":{"rendered":"

Welcome to the first part of the ISO 9001 Myth series of articles that will attempt to dispel some common misconceptions about ISO 9001.\u00a0 In this first installment, I will address the misperception of ISO 9001 as a documentation glut.<\/p>\n

ISO 9001 certification<\/a> has become almost synonymous with a bureaucratic documentation glut.\u00a0 Most companies seeking ISO 9001 certification<\/a> view it as a necessary evil for gaining access to key customers or markets.\u00a0 The resulting quality management system (QMS) is viewed and functions as overhead.\u00a0 Most companies never realize any actual intended benefit beyond a pretty certificate on a wall and access to a new customer or market.\u00a0 Why is this so?\u00a0 One reason is the all too common misconception of ISO 9001 as a set of documentation requirements.\u00a0 While it is true that ISO 9001 stipulates certain documents and records, the intent and focus of the standard is not documentation.\u00a0 In fact, very few documents are specifically required by ISO 9001.\u00a0 Following is a list of all ISO 9001 required documents and records<\/a>:<\/p>\n

 <\/p>\n\n\n\n\n\n\n\n\n\n
ISO 9001 Require Documented Procedures<\/strong><\/td>\n<\/tr>\n
1.<\/td>\n4.2.3<\/td>\nDocument Control<\/td>\n<\/tr>\n
2.<\/td>\n4.2.4<\/td>\nRecord Control<\/td>\n<\/tr>\n
3.<\/td>\n8.2.2<\/td>\nInternal Audits<\/td>\n<\/tr>\n
4.<\/td>\n8.3<\/td>\nControl of Non-Conforming Product (or Service)<\/td>\n<\/tr>\n
5.<\/td>\n8.5.2<\/td>\nCorrective Action<\/td>\n<\/tr>\n
6.<\/td>\n8.5.3<\/td>\nPreventive Action<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

 <\/p>\n

 <\/p>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n
ISO 9001 Required Records<\/strong><\/td>\n<\/tr>\n
1.<\/td>\n5.6.1<\/td>\nManagement reviews<\/td>\n<\/tr>\n
2.<\/td>\n6.2.2 (e)<\/td>\nEducation, training, skills and experience<\/td>\n<\/tr>\n
3.<\/td>\n7.1 (d)<\/td>\nEvidence that the realization processes and resulting product fulfill requirements<\/td>\n<\/tr>\n
4.<\/td>\n7.2.2<\/td>\nResults of the review of requirements related to the product and actions arising from the review<\/td>\n<\/tr>\n
5.<\/td>\n7.3.2<\/td>\nDesign and development inputs relating to product requirements<\/td>\n<\/tr>\n
6.<\/td>\n7.3.4<\/td>\nResults of design and development reviews and any necessary actions<\/td>\n<\/tr>\n
7.<\/td>\n7.3.5<\/td>\nResults of design and development verification and any necessary actions<\/td>\n<\/tr>\n
8.<\/td>\n7.3.6<\/td>\nResults of design and development validation and any necessary actions<\/td>\n<\/tr>\n
9.<\/td>\n7.3.7<\/td>\nResults of the review of design and development changes and any necessary actions<\/td>\n<\/tr>\n
10.<\/td>\n7.4.1<\/td>\nResults of supplier evaluations and any necessary actions arising from the evaluations<\/td>\n<\/tr>\n
11.<\/td>\n7.5.2 (d)<\/td>\nAs required by the organization to demonstrate the validation of processes where the resulting output cannot be verified by subsequent monitoring or measurement<\/td>\n<\/tr>\n
12.<\/td>\n7.5.3<\/td>\nThe unique identification of the product, where traceability is a requirement<\/td>\n<\/tr>\n
13.<\/td>\n7.5.4<\/td>\nCustomer property that is lost, damaged or otherwise found to be unsuitable for use<\/td>\n<\/tr>\n
14.<\/td>\n7.6 (a)<\/td>\nBasis used for calibration or verification of measuring equipment where no international or national measurement standards exist<\/td>\n<\/tr>\n
15.<\/td>\n7.6<\/td>\nValidity of the previous measuring results when the measuring equipment is found not to conform to requirements<\/td>\n<\/tr>\n
16.<\/td>\n7.6<\/td>\nResults of calibration and verification of measuring equipment<\/td>\n<\/tr>\n
17.<\/td>\n8.2.2<\/td>\nInternal audit results and follow-up actions<\/td>\n<\/tr>\n
18.<\/td>\n8.2.4<\/td>\nIndication of the person(s) authorizing release of product.<\/td>\n<\/tr>\n
19.<\/td>\n8.3<\/td>\nNature of the product nonconformities and any subsequent actions taken, including concessions obtained<\/td>\n<\/tr>\n
20.<\/td>\n8.5.2<\/td>\nResults of corrective action<\/td>\n<\/tr>\n
21.<\/td>\n8.5.3<\/td>\nResults of preventive action<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

If you consider the required documented procedures carefully, you will agree that requiring six documents does not seem particularly bureaucratic.\u00a0 Furthermore, it is certainly reasonable for any company to have a defined and consistent method for controlling its key documents and records.\u00a0 Surely conducting self assessments (internal audits) to gauge how consistent, efficient, and effective an organization is at following its own business practices seems like common sense and good business practice.\u00a0 And having a consistent process for dealing with nonconforming products or services should already be part of any business.\u00a0 Finally, systematically taking action to correct or prevent problems hardly seems impractical and is not new to anyone.\u00a0 It would appear that you should be doing these things already.\u00a0 In fact, you probably are.\u00a0 Furthermore, you are probably doing all of the things that ISO 9001 describes.\u00a0 So, why is the intent of ISO 9001 so misunderstood and misapplied?<\/p>\n

A major reason is that early interpreters and adopters of ISO 9001 were military and defense contractor quality folks.\u00a0 They used the early 1950’s military approach to quality standards because they recognized some vestiges of MIL-Q-9858, which is an early ancestor of ISO 9001.\u00a0 Bureaucracy and a documentation glut is what they knew.\u00a0 The result was that the intent and requirements of ISO 9001 were interpreted through the lens of military and defense contractors.\u00a0 This resulted in the following documentation-centric paradigm that still persists today:<\/p>\n

\"QMS<\/p>\n

While this paradigm may be appropriate for describing a documentation structure for a government or military agency, commercial enterprises rarely operate in this way.\u00a0 In fact, this paradigm is typically the cause of over documentation.\u00a0 The resulting paperwork glut quickly becomes “shelf-ware” and a burden to a business.<\/p>\n

The fact is that ISO 9001 does not stipulate this pyramid of documentation.\u00a0 Nor does it make any suggestion regarding the form and structure of QMS documentation<\/a>.\u00a0 ISO 9001 simply describes the minimal<\/span><\/em> elements or components that a basic quality management system should have.\u00a0 It is simply a platform and structural framework for a quality management system, not a set of documentation requirements.\u00a0 As I mentioned above, you are probably doing these things already.\u00a0 If so, your ISO 9001 quality management system<\/a> documentation should support your current business practices.\u00a0 ISO 9001 gives you the freedom to structure your documentation to suit your particular organizational needs.<\/p>\n

As an antidote to the pyramid paradigm above, I utilize the following documentation hierarchy:<\/p>\n

 <\/p>\n

\"QMS<\/a><\/p>\n

This structure gives a business the flexibility to structure its documentation in any way that makes sense for the company.\u00a0 For example, when a well designed form provides all of the instructions and work flow necessary to complete a particular function, as well as collect any required information, then there may be no need for a procedure and\/or a work instruction.\u00a0 Nothing in ISO 9001 prevents you from doing this.\u00a0 On the other hand, if you determine that you need to have multiple layers of documentation, you have the freedom to do so too.\u00a0 In fact, both scenarios can exist in the same ISO 9001 compliant quality management system.\u00a0 This documentation hierarchy does not force you to create non-value-added documents when and where they are not needed.<\/p>\n

 <\/p>\n

There are many methods for eliminating the “documentation glut” and improving the value of the ISO 9001 quality management system documentation. \u00a0 One example is the replacement of the traditional 50-100 page Quality Manual with a more modern 1-3 page version, like the Lean QMS<\/em>\u00ae<\/sup><\/em> Map<\/em><\/a> that I utilize.\u00a0 I wrote about this approach in “The Modern Quality Manual<\/em><\/a>.”\u00a0 The result can be an up to 80% reduction in the volume of ISO 9001 documentation.\u00a0 More importantly, however, the remaining 20% will have at least 80% more value to your business.\u00a0 Look for the next installment in this ISO 9001 Myth series:\u00a0 “ISO 9001 Myth #2 – “Say What You Do & Do What You Say<\/a>.”<\/em><\/p>\n

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

Welcome to the first part of the ISO 9001 Myth series of articles that will attempt to dispel some common misconceptions about ISO 9001.\u00a0 In this first installment, I will address the misperception of ISO 9001 as a documentation glut. ISO 9001 certification has become almost synonymous with a bureaucratic documentation glut.\u00a0 Most companies seeking […]<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[3,4,5,7,10,12,13,14],"tags":[],"class_list":["post-18","post","type-post","status-publish","format-standard","hentry","category-as9100","category-continual-improvement","category-iso13485","category-iso9001","category-pinnacle-enterprise-group","category-quality-management-system","category-tl9000","category-ts16949"],"_links":{"self":[{"href":"http:\/\/www.pinnacleeg.com\/iso\/wp-json\/wp\/v2\/posts\/18","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=18"}],"version-history":[{"count":2,"href":"http:\/\/www.pinnacleeg.com\/iso\/wp-json\/wp\/v2\/posts\/18\/revisions"}],"predecessor-version":[{"id":42,"href":"http:\/\/www.pinnacleeg.com\/iso\/wp-json\/wp\/v2\/posts\/18\/revisions\/42"}],"wp:attachment":[{"href":"http:\/\/www.pinnacleeg.com\/iso\/wp-json\/wp\/v2\/media?parent=18"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"http:\/\/www.pinnacleeg.com\/iso\/wp-json\/wp\/v2\/categories?post=18"},{"taxonomy":"post_tag","embeddable":true,"href":"http:\/\/www.pinnacleeg.com\/iso\/wp-json\/wp\/v2\/tags?post=18"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}