Revision of standards

ISO 9001 - New version 2015

ISO 9001:2015 was published on 15.09.2015, the German translation DIN EN ISO 9001 is available from Beuth Verlag since 23.10.2015.

The formal change certification procedure is now possible at VdS Schadenverhütung.

The formal change certification procedure will be possible at VdS Schadenverhütung from the publication of ISO 9001:2015. The order forms required for this will be made available on this website as an appendix to the VdS 2343 guidelines as of 2015-09. A document check and an audit are required to convert the certification to the new status. In accordance with ISO, a transition period of three years from the publication of ISO 9001:2015 is provided for this purpose. Certifications in accordance with ISO 9001:2008 will become invalid at the latest after this transition period. The changeover should ideally take place during a regularly scheduled re-audit, but can also be carried out during one of the surveillance audits or, with additional effort, at any time by means of a so-called delta audit. The German Accreditation Body (DAkkS) has set a binding minimum time requirement for a conversion audit of at least 10%/0.25 audit days for a re-audit and 20%/0.5 audit days for a surveillance audit.

In the following, we will only inform you about the most important changes that need to be taken into account for the changeover as a whole. Sections shown in italics represent newly added requirements or those that require an adaptation of the existing QMS documentation based on ISO 9001:2008 or whose adaptation is strongly recommended:

  • The sequence of sections has been changed to comply with the basic structure for management system standards ("High Level Structure") defined in the ISO directives.
  • A section has been included in which the principles of quality management are presented.
  • The uniform basic text defined in the ISO directives has been adopted. The following three points are particularly new in this context:

 

  • A section has been added to define the context of the organisation, including the identification of interested parties and their requirements relevant to the quality management system.
  • The "risk-based approach" has been highlighted.
  • "Documented information" was introduced as a new collective term for the previously known "documented procedures" and "records", the requirement for Quality management manual is no longer necessary. However, this does not mean that an existing and introduced manual has to be removed.
  • The formulation of requirements makes the previous option of excluding certain requirements as "not applicable" superfluous.
  • Instead of "products", which previously included "services", the term "products and services" is now explicitly used.
  • In connection with roles, responsibilities and authorities in the organisation, the "representative of the top management" for the quality management system is no longer explicitly required. This does not mean, however, that the function of an existing QMB must be removed.
  • Specifications for planning and implementing changes to the quality management system have been added.
  • The "knowledge of the organisation" is explicitly included as a resource.
  • The process-oriented approach was strengthened and new requirements were formulated (risk analysis). The management is now obliged to promote risk-based and process-oriented thinking in the organisation.
  • A section on the applicability of the process environment to production and service organisations has been added.
  • New requirements to avoid human error in the control of production and service provision were formulated.
  • Specifications on activities after delivery of the product or provision of the service were added.
  • An overview of the ISO 10000 series standards that can help organisations to introduce or improve their quality management systems has been added to Annex C.

The standard provides various implementation guidance in its Annex A. Detailed information and practical examples of implementation are provided in our ISO 9001:2015 training courses.

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