ISO Quality Management Systems
Based on the requirements of ISO 9001:2008, for the establishment of QMS or Quality Management System, an organization should be able to consistently produce products that meet requirements from its customers and applicable regulatory standards. It aims to improve customer satisfaction through effective implementation and application of the QMS. This includes creation or enhancement of procedures for continual improvement of the system and compliance to customer demands and regulatory requirements.
But as the requirements of ISO 9001:2008 are universal as intended, the standards are not applicable to some organizations due to its nature and product. There have been exemptions made for conformity to ISO 9001:2008. However, despite the exemptions, it seemed inadequate because these exclusions should be limited to requirements within Clause 7 (Product Realization), and that these exemptions do not affect the organization’s capability to provide product that meets their market’s demands and applicable regulatory compliance.
ISO 9001 is currently being revised which is referred to an ISO 9001:2015. Web-based surveys in 122 countries, participation in the targeted high-level structures for development, studies of terminologies, directives, and the latest QMS trends including new concepts for integration into the revision of ISO 9001 has been completed in 2012.
Conclusive to these activities, along with the systematized review of ISO 9001, indicated the need to revise the standard to relevantly reflect the changes in its environment and continuously deliver the organization’s credibility in providing products that meets customers’ expectations and necessary regulatory requirements.
Based on the draft design, the revised ISO 9001:2015 should deliver a stable set of requisites as its core for the next 10 years and above. It should remain generic and sustain focus on process management for desirable outcomes. Changes will be monitored in QMS routines and technology from the last revision so to mirror these changes in the highly dynamic environments the organizations operate. It will also utilize Annex SL in part of ISO Directives in alignment with other ISO system standards. It also includes facilitating the implementation and assessment by first, second and third parties; and applies the latest High Level Management System Standard (MSS) Structure developed by ISO’s Joint Technical Coordination Group (JTCG), requiring usage of standard terms, simple language and writing formats for better understanding and interpretations of its requirements.
The revisions are expected to be published in September 2015 as entailed in the December 2012 approval of working draft. The transition period from 2008 standard to 2015 standard is expected to be three years since there are over 1 million 9001 certificated to be transitioned. Current ISO 9001 users can look forward to this positively as they will be able upgrade their systems without major impacts.
Changes in ISO 9001 Quality Management Standard
QSE Consultants from Atlanta, Georgia has been successfully helping organizations to achieve ISO 9001 certification through their 10 Step Approach. This program was developed based on 20 years of experience and expertise in utilizing lean management tools, tested and proven to achieve operational excellence and compliance to ISO standards. To find out more about the changes in ISO 9001, contact a QSE consultant by visiting their website.