September 24th, 2015
The latest edition of the ISO 9001 quality management systems standard has just been published. This concludes over three years of revision work by experts from nearly 95 participating and observing countries to bring the standard up to date with modern needs.
ISO 9001 helps organizations demonstrate to customers that they can offer products and services of consistently good quality. It also acts as a tool to streamline processes and make them more efficient. ISO 9001:2015 replaces previous editions and certification bodies will have up to three years to migrate certificates to the new version.
ISO 14001:2015 Environmental Management System Published
ISO 14001:2015 specifies the requirements for an environmental management system that an organization can use to enhance its environmental performance. ISO 14001:2015 is intended for use by an organization seeking to manage its environmental responsibilities in a systematic manner that contributes to the environmental pillar of sustainability.
ISO 14001:2015 is applicable to any organization, regardless of size, type and nature, and applies to the environmental aspects of its activities, products and services that the organization determines it can either control or influence considering a life cycle perspective.
Purchase these standards at www.iso.org / www.asq.org / www.techstreet.com
August 18th, 2015
The final draft international standard (FDIS) of ISO 9001:2015 has been released in July, and the revised standard is slated for publication in September. Based on Annex SL of the “Consolidated ISO Supplement,” some elements of the standard will be restructured to allow for easier integration of multiple management systems.
Integrated management systems generally refers to integrated processes that result in one management system to implement such as ISO 9001, ISO 14001, and OHSAS 18001.
Annex SL consists of 9 clauses and 3 appendices. This annex has been developed primarily with ISO technical committees who develop management system standards. The impact of Appendix 2 of Annex SL will be felt by all users of management system standards in the future.
Appendix 2 is in three parts:
* high level structure,
* identical core text,
* common terms and core definitions.
Future management system standards will need to have these elements. In addition, there will be less confusion and inconsistency because common terms will all have the same definition and there will be common requirements across all the management system standards, for example the requirement to establish, implement, maintain and continually improve the management system.
High level structure
The major clause numbers and titles of all management system standards will be identical They are:
- Normative references
- Terms and definitions
- Context of the organization
- Performance evaluation
All future ISO MSS should be consistent and compatible, and will have the same look and feel. At this time, it is questionable whether ISO 13485 Medical Devices Standard will utilize Annex SL. We are hoping that this could be the beginning of the end of the conflicts, duplication, and misunderstanding arising from precisely different requirements across the various MSS.
July 14th, 2015
On July 9th 2015, the ISO/FDIS 9001:2015 was issued in 28 pages, the last stage in the ISO 9001 revision process. This is the last formal draft before final publication scheduled on September 23, 2015. ISO member countries have about 2 months to vote on the latest draft of the standard before the September 9, 2015 deadline.
ISO/FDIS 9001:2015 positions the new version of the standard as an integral part of an organization’s efforts with leadership enhancement for development, and promotes it as a tool for improving an organization’s overall performance. It drives more internal and external stakeholder focus as part of the adoption of a risk-based approach to quality management and emphasizes the importance of adopting a quality management system as a strategic direction for the organization.
In addition to renaming and repositioning some QMS activities, other significant new requirements have been introduced.
Based on our review of the FDIS, and compared to the DIS, changes are relatively minor. The most extensive ones have been to the Introduction and Graphic Figures, which have been simplified, with explanations being moved to an informative Annex. The terms and definitions have now been removed from the standard and added to ISO 9000.
Organizations that are already certified to ISO 9001:2008 will have three years from formal publication of ISO 9001:2015 in September to transfer to the new version of the standard. The transition period will end in September 2018.
If interested, you can purchase the ISO/FDIS 9001:2015 at the ASQ Website. FYI: The ISO 14001:2015 Environmental Management System Standard FDIS has also been released for voting.
June 12th, 2015
The members of the International Automotive Task Force (IATF) are the authors of ISO/TS16949 Automotive Quality Management System. The IATF has announced that they have begun the task of revising the automotive industry’s quality management system (QMS) standard to align with the High Level Structure of FDIS ISO 9001:2015.
The IATF wants a piece of your mind!
The IATF is requesting that each stakeholder organization (whether OEM, supplier of any tier, or CB) provide a single response to this survey. Please complete all parts of Section I and Section II of the survey. In Section III, it is not necessary to provide input on every clause. You are encouraged to provide input on any clause where you have identified opportunities for improvement. For each response in Section III, it is necessary to complete all three columns (restatement of the current requirement, identified issue with the current requirement, and proposal for new wording for the requirement) for the input to be considered in the analysis.
The survey will be open from June 1, 2015 to July 10th, 2015. Only responses received during this period will be included in the analysis. The survey is available at the following link – HERE.
This survey is a very important opportunity to improve the future QMS standard for the automotive industry. The IATF is requesting you promote participation from your company. Your responses to this survey will identify key opportunities for improvement in the ISO/TS16949 requirements and in the ISO/TS audit process to the IATF.