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2015 Edition, December 3, 2015

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Software Engineering Process Technology - Evidence Product Checklist For Standard ISO 9001:2015 Quality management systems – Requirements

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Product Details:

  • Revision: 2015 Edition, December 3, 2015
  • Published Date: December 3, 2015
  • Status: Active, Most Current
  • Document Language: English
  • Published By: Software Engineering Process Technology (SEPT)
  • Page Count: 178
  • ANSI Approved: No
  • DoD Adopted: No

Description / Abstract:

 The purpose of this checklist is to ensure that an organization does not overlook any facet of physical evidence that is called out or implied in ISO9001:2015.  In total there are 77 required artefacts and 433 suggested artefacts included in the SEPT checklist.                                                                                                                                                                                                          The process of defining what is necessary for compliance with a quality management process standard such as “ISO Standard 9001:2015” is often confusing and laborious because the directions contained in the standards are unclear or ambiguous.  To aid in determining what is actually “required” by the document in the way of physical evidence of compliance, the experts at SEPT have produced this checklist.  This checklist is constructed around a classification scheme of physical evidence comprised of policies, procedures, plans, records, documents, audits, and reviews.  There must be an accompanying record of some type when an audit or review has been accomplished.  This record would define the findings of the review or audit and any corrective action to be taken.  For the sake of brevity this checklist does not call out a separate record for each review or audit.  All procedures should be reviewed but the checklist does not call out a review for each procedure, unless the standard calls out the procedure review.  In this checklist “manuals, reports, scripts and specifications” are included in the document category.  When the subject standard references another standard for physical evidence, the checklist does not call out the requirements of the referenced standard.  The Author has carefully reviewed the document “ISO Standard 9001:2015 Quality management systems – Requirements" and defined the physical evidence required based upon this classification scheme.  SEPT has conducted a second review of the complete list to ensure that the documents’ producers did not leave out a physical piece of evidence that a “reasonable person” would expect to find.  It could certainly be argued that if the document did not call it out then it is not required; however if the standard was used by an organization to improve its process, then it would make sense to recognize missing documents.  Therefore, there are documents specified in this checklist that are implied by the standard, though not specifically called out in the document, and they are designated by an asterisk (*) throughout this checklist.  If a document is called out more than one time, only the first reference is stipulated.