本产品提供4小时免费咨询。SEPT将在购买后60天内回答有关标准或检查表的任何问题。新订购“自解压文件格式”选项，以在可编辑的Microsoft Word文档中获取此产品！本检查表的目的是确保组织不会忽视ISO 9001:2015中提出或暗示的物证的任何方面。9月清单中总共有77件必需的文物和433件建议的文物。下表按类型显示了所需的工件。所需工件程序计划记录文件SAUDITSREEVIEWSTOTAL15381321877定义符合质量管理过程标准（如“ISO标准9001:2015”）所需内容的过程经常令人困惑和费劲，因为标准中包含的说明不清楚或模棱两可。 为了帮助确定文件中实际“需要”的合规性实物证据，9月的专家编制了这份清单。该检查表是围绕一个物理证据的分类方案构建的，包括政策、程序、计划、记录、文件、审计和审查。审计或审查完成后，必须有某种类型的附带记录。该记录将定义审查或审计的结果以及要采取的任何纠正措施。为简洁起见，本检查表并未为每次审查或审计单独列出记录。应审查所有程序，但检查表不要求对每个程序进行审查，除非标准要求进行程序审查。在本清单中，“手册、报告、脚本和规范”包含在文件类别中。 当主体标准参考另一个物证标准时，检查表不要求参考标准的要求。作者仔细审查了文件“ISO标准9001:2015质量管理体系-要求”，并根据该分类方案定义了所需的实物证据。SEPT已经对完整的清单进行了第二次审查，以确保文件的制作人不会遗漏“通情达理的人”希望找到的实物证据。可以肯定地说，如果文件没有提出，那么就没有必要这样做；然而，如果一个组织使用该标准来改进其流程，那么识别缺失的文档是有意义的。因此，本标准暗示了本检查表中规定的一些文件，尽管在本文件中没有明确指出，但它们在本检查表中用星号（*）表示。 如果一份文件被多次调用，则只规定第一次引用。有时，一个程序或文件不一定是单独的，可以包含在另一个文件中。例如，“设计和开发验证计划”可以是“设计和开发计划”的一部分。作者单独列出了这些项目，以确保该组织不会忽视物证的任何方面。如果组织不需要单独的文件，并且一个项目可以是另一个文件或记录的子集，那么这个事实应该在该项目清单的详细部分中指出。这应以声明的形式进行，以反映本文件的信息可在文件XYZ的第XX节中找到。如果组织要求不要求为特定项目提供这种物证，还应该用一份声明来表示，说明不需要这种物证以及原因。 本声明中应明确说明不需要证据的原因。介绍的详细步骤部分提供了有关此步骤的更多详细信息。根据项目或业务需求的大小和复杂性，这些文件的大小可能因段落和卷而异。ISO标准9001:2015《质量管理体系-要求》9月检查表的一般原则该检查表是通过分析本文件的每一条款中的关键词来编制的:政策程序重新记录文件（包括手册、报告和规范）审核该检查表规定了独特的证据。在审查完完整的文件后，第二次审查是从常识“理性人”的角度进行的。如果一份文件或其他证据似乎是必需的人工制品，但没有在文件中显示出来，则会添加星号（*- 建议的人工制品）在清单中的符号之后。根据产品或证据的类型，信息被转移到检查表中。该清单将允许组织将合规活动划分为可管理的工作包，如程序、计划、文件等。该清单以PDF或word格式提供。后一种格式允许您根据您的商业案例或您的组织希望使用清单的媒体（如excel网页格式或任何其他最终产品类型）定制文档，以尽可能高效地符合标准。 该清单提供4小时的免费咨询，由对基本标准有第一手知识的专家提供，以回答有关标准和清单的问题，并在购买产品后60天内有效。

This product comes with 4 hours of free consultation. SEPT will answer any question concerning the standard or Checklist for 60 days after purchase.New! Order the "Self-Extracting File Format" option to get this product in an editable Microsoft Word document!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 ISO 9001:2015. 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.Required ArtifactsProceduresPlansRecordsDocumentsAuditsReviewsTotal15381321877The 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 evicence 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 - RequirementsThis checklist was prepared by analyzing each clause of this document for the key words that signify a:PolicyProcedurePlanRecordsDocument ( Including Manuals, Reports, and Specifications)AuditReviewThis 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.