Communication, Aviation & Automotive - ISO 9001 & Beyond
John DiMaria, Global Product Champion, BSI, Herndon, VA, USA
Keywords: Qualtiy, Certification, Transition
With over one million certified organizations, ISO 9001 is the most widely recognized quality management standard in the world. The changes recently created by the 2015 revision is reverberating across a broad swath of industries, affecting the widest range of products and services.
For example, the Aviation, Space and Defense (ASD) series of standards, known collectively as the AS9100-series, were published late last year and directly align with the new ISO 9001 revision and include enhancements that deal with ASD-specific concerns, like product safety, counterfeit parts and obsolescence.
The new Automotive standard, IATF 16949:2016, replaces ISO/TS 16949. While it is no longer an ISO standard; it has been written to be a complement and supplement to ISO 9001:2015.
TL 9000:2016 also incorporates ISO 9001:2015 in its latest Requirements Handbook.
All of these industry specific standards require completing the transition to the new version by September 15, 2018. So, there is very little time to make the changes necessary to successfully transition.
With ISO 9001 and quality as the foundation for these and other sector-specific standards, it is important to understand its structure and fundamentals before moving on to the more rigorous elements the supplemental industry requirements impose.
One of the biggest changes to ISO 9001 is its structure. The International Organization of Standardization, known as ISO, developed Annex SL or the High Level Structure to be the blueprint for all new and revised management system standards. This generic framework allows for rapid integration of multiple standards without the duplication of efforts that has proven to be so frustrating and costly in the past. While ISO 9001 was not the first standard to use this structure, it is certainly the most far-reaching.
This revised ISO 9001 calls for increased management engagement, consideration of suppliers and the context of the organization, an intensified focus on risk management, analysis of the process approach as well as increased communication and awareness. The new standard also has less prescriptive requirements; for example, there is now no specific direction to maintain a quality manual.
This session will cover a breakdown of the ISO high-level structure, the intended outcomes organizations should be striving for and the issues assessors find during audits. This session will also provide statistics on where organizations struggle through identified nonconformities along with the relevant sections in the various quality standards.