ISO 9001:2015 ''Quality Management Systems - Requirements 2015 Edition''

Purpose and Objectives of the Checklist

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. Below is a table showing the required artifacts by type.

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.

There are occasional situations in which a procedure or document is not necessarily separate and could be contained within another document. For example, the "Design and Development Verification Plan" could be a part of the "Design and Development Plan". The Author has called out these individual items separately to ensure that the organization does not overlook any facet of physical evidence. If the organization does not require a separate document, and an item can be a subset of another document or record, then this fact should be denoted in the detail section of the checklist for that item. This should be done in the form of a statement reflecting that the information for this document may be found in section XX of Document XYZ. If the organizational requirements do not call for this physical evidence for a particular project, this should also be denoted with a statement reflecting that this physical evidence is not required and why. The reasons for the evidence not being required should be clearly presented in this statement. Further details on this step are provided in the Detail Steps section of the introduction. The size of these documents could vary from paragraphs to volumes depending upon the size and complexity of the project or business requirements.

General Principles of SEPT Checklist for the ISO Standard 9001:2015 Quality management systems - Requirements

This checklist was prepared by analyzing each clause of this document for the key words that signify a:

• Policy
• Procedure
• Plan
• Records
• Document ( Including Manuals, Reports, and Specifications)
• Audit
• Review

This checklist specifies evidence that is unique. After reviewing the completed document, the second review was conducted from a common sense “reasonable man” approach. If a document or other piece of evidence appeared to be a required artefact, but was not called out in the document, then it is added with an asterisk (* - suggested artefacts) after its notation in the checklist. The information was transferred into checklist tables, based on the type of product or evidence.

The checklist will allow the organization to divide the compliance activity into manageable work packages such as procedures, plans, documents etc.

The checklist is available in PDF or word format. The latter format allows you to tailor the document to your business case or the media that your organization wants to use the checklist in such as excel web page format or any other end product type in order to meet compliance with the standard in the most efficient way possible. The checklist comes with 4 hours of free consultation, from experts that have firsthand knowledge of the underlying standard, to answer questions on the standards and checklists and is valid for 60 days after purchase of the product.

This product supports these Software Engineering processes

• Documentation
• Testing
• Quality
• Life Cycle

Customers of this product:

• Acme Monaco
• Adelong Engineering & Constructions P/L, Australia
• Aero Mechanical Services Ltd., Canada
• Airflow Laboratory Services
• APICAL INDUSTRIES
• Archinoetics LLC
• Arnot Ogden Medical Center
• Barnes Group Inc.
• Bean Tool & Die Inc.
• Behm Quartz Industries
• Berk Matics, Inc.
• Beta International
• BiosPacific, Inc.
• Bodenheim
• CaP Biomaterials, LLC
• Cardio Medics, Inc.
• Center Inc
• Chemtura
• CIBA Vision Corporation
• CMC Impact Metals
• Concepts NREC
• Cornerstone Machining
• Corrprot NDT
• DCMA - DENVER
• Deep Flex Inc.
• DORMA ARCHITECTURAL HARDWARE
• Electro Polishing Systems, Inc.
• Falcon Sheet Metal
• Frank Henry Equipment, Canada
• Fullco General Machine
• GKN Armstrong Wheels
• Greenford Energy USA, Inc
• Gulf Steel Works
• Hager Companies
• Harbor Plastics Manufacturing
• Health Management
• Hi-tech plastics
• Independence Tube Corporation
• Indium Corporation
• Industrial Metals Int'l Ltd
• Instrumented sensor technology, Inc.
• Interfast Inc., Canada
• Jrenegadeeng
• Ke-Burgmann EJS
• Key Corporation
• Kenosha achievement
• Kidder Inc
• L-3 communications
• M.R. welding ltd
• Machine services Inc
• MAS of Monterrey
• Mcneilus truck & manufacturing Inc.
• NAC-MI
• Nebraska state patrol
• Nelsen steel company
• Northrop Grumman
• Ocean works international
• Omni Air International
• Penn Machine Inc.
• Phillips Precision
• Pride Industries
• Quality Coatings, Inc.
• Quality Energy
• ReelWell
• Rubb, Inc.
• Sauter, Bachmann AG
• Seneca Foundry
• SKYRIDERS, South Africa
• SOUTHERN MACHINERY REPAIR, INC.
• Spectrum Microwave
• Sulzer Pumps (US) Inc.
• Supreme Group (USA) LLC
• Thomas & Betts
• Trans Gas Limited
• Tri-Gon Precision, Inc.
• TY VALVE ITALY SRL, Italy
• Vasogen Inc.
• Veyance Technologies
• Vital Few Consulting
• W.C. Caribbean Instruments, Corp.
• WCF-DMI
• Xunlight Corporation

Note: “International Standards (ISO) define the best of practices for Medical Device and Software firms in producing a quality product. This checklist that SEPT produces will ensure that all of the best of practices are adhered to.”