Since its first publication ISO 9001 went through several revisions to keep it up-to-date and to consider the changing environment and stakeholder expectations. It was first published in 1987, containing a set of requirements grouped in 20 elements for quality assurance systems. The first revision followed in 1994, introducing some minor changes like the distinction between corrective and preventive action. The revision in the year 2000 introduced a completely new concept, abandoning the element-based requirements and introducing a Quality Management Model based on a process approach. Again a revision followed in 2008 with very few changes without adding or changing requirements.
ISO 9001 is the most successful standard for management systems in the world. While in 1995 only 127,000 organizations have been certified according to ISO 9001, this number increased in 2013 to more than 1,100,000 certificates in 180 countries.
Despite the innumerous benefits obtained through an implemented quality management system based on ISO 9001 (e.g. error prevention, reduced costs through improved and more efficient processes, minimization of business risks, increased customer satisfaction, trust and reputation), a new revision of the standard was necessary again to assure that the standard is still relevant and adequate in an always faster changing world. The increasing diversity of ISO 9001 users had to be considered, not having any longer only manufacturing industries but more and more service industries and other kinds of organizations. It was also necessary to verify the impact of new developments in knowledge and technologies which changed during the last years, as well as broader user interests and changes in industry. In 2010 and 2011, ISO conducted an extensive web-based user survey, asking about the need for a revision and the future needs and interests of the standard users. The answers have been evaluated and the majority asked for changes and a review of ISO 9001.
The Revision Process
In 2011 the responsible ISO committee, the Technical Committee 176, started the systematic review and decided in March 2012 to revise the standard. The revision process went through several internal draft stages and is now expected to be concluded in September 2015 with the publication of ISO 9001:2015, based on a new common structure for all ISO Management System Standards and introducing several new concepts, the most important being the so called “risk based thinking”.
High Level Structure
- Normative reference
- Terms and definitions
- Context of the organizations
- Performance evaluation
In June 2014 the most recent step was concluded and the DIS (Draft of International Standard) was published for public consultation.
New content and structure:
Even keeping in mind that the final version may still introduce some minor adjustments, now the main changes and concepts are already defined:
- It is already known that ISO 9001:2015 will have a complete new structure and core text from the so called “High Level Structure” as defined in the Annex SL of the “Consolidated ISO Supplement” of the ISO/IEC Directives.
- As one of the main content changes, the new standard will increase the requirements for top management commitment and involvement.
- Another significant change will be the introduction of the concept of “risk based thinking”. While the concept of risk has always been implicit in ISO 9001, the revised standard makes it more explicit and builds it into the whole management system. Annex SL includes a specific requirement that organizations determine the risks that need to be addressed to ensure that their management system can achieve its intended outcomes, prevent or reduce undesired effects and achieve continual improvement. Each management system standard can define risk in terms that are relevant to their specific discipline; so the revised version of ISO 9001 will do so in relation to product or service conformity and customer satisfaction. Risk based thinking will make preventive action part of the routine and it will not any longer be necessary to keep a specific requirement for preventive action.
- The revised standard will also give increased emphasis on achieving value for the organization and its customers. Important are the results, in other words “output matters”.
- ISO 9001:2015 will require the need to understand the context of the organization and the needs and expectations of interested parties like for example direct clients or customers, end users, suppliers or regulators. The advance of modern media will be recognized by an increased flexibility on the use of documentation and the terms “document” and “record” probably will be substituted by the term “documented information”.
- The process approach introduced in the year 2000 as the desired model for quality management systems will become an explicit requirement in ISO 9001:2015.
- Preventive action will disappear as explicit requirement and the whole wording of the revised standard will make it more readily applicable and usable by “service” type organizations.
- Recognizing the importance of competent people within any kind of organization there will be also more emphasis on requirements for competence of personnel. In that context, competence means being able to apply knowledge and skill to achieve intended results.
- As an annex of the standard we will also find the revised quality management principles, now reduced from eight to seven principles, combining the former process and system approach.
Impact for certified organizations:
First of all it is important that there is no formal requirement to start any activity before the publication of ISO 9001. However, as the DIS, the Draft of International Standard, is now published, we already have a clear picture how the revised standard will look like and it may make sense to start some preparation activities. So far we recommend the monitoring of the revision process and making yourself aware of the new structure and the new requirements as soon as possible. After the final publication of ISO 9001:2015, certified organizations will need the transition to the revised standard. That means that processes and system documentation will have to be revised and be aligned with the new requirements.
ISO and the International Accreditation Forum IAF already agreed about a period of three years for the transition from the ISO 9001:2008 to the new ISO 9001:2015.
DQS will support its clients and other interested organizations aby different means, among others by:
- Publicly available information
- Recorded webinars in several languages
- Seminars and training
- Gap audits