ISO 9001:2015 has replaced ISO 9001:2008 and the revised edition certainly differs from the 2008 version in many respects. Some of the main developments are noted below. We strongly recommend ISO 9001:2015 changes training of your personnel to give them the knowledge for proper implementation of the 2015 version, in order to ensure compliance with the requirements of the revised standard.
Increased Focus on Risk Management
The new version increasingly focuses on risk management, which includes early identification of risks, the qualification thereof and management of such risks. With effective management of the risks, the organisation benefits from improvement in quality that can be sustained over the long term. This, in turn, implies consistency in quality and ongoing improvement, since actions taken to correct problem areas and to minimise risks lead to improvement, in order to prevent any occurrences of the risks.
Focus on Leadership
Another focus area of ISO 9001 of 2015 is that of leadership. You will notice that the management representative is no longer mentioned and the quality policy forms an integral part of the company’s strategic plans. The implementation of a quality management system in compliance with the 2015 version must be done in such a manner so as to ensure full merging with the organisation’s business processes.
Changes in Layout
The ISO 9001:2015 version is written in accordance with High Level Structure requirements with all the chapters and sub-chapter titles changed, in addition to extensive changes in the various clauses. However, this layout restructuring doesn’t affect any of the requirements that you must meet. It is well worth going through the standard and to receive ISO 9001:2015 changes training in the requirements for implementation, in order to ensure that you and your personnel are familiar with the revised standard, as well as its layout and structure.
The reasoning behind the restructuring of content is to ensure seamless integration of the various parts of the organisational management systems. The structure is consistent with that of other new and revised standard layouts, such as ISO 14001 and ISO 55001.
More Applicability for Service-Focused Organisations
The 2008 version featured many terms that were mainly relevant to the manufacturing sectors for which the ISO 9001 was originally developed. Since quality in all industries is essential, the standard has been widely adopted across all business sectors. This has necessitated changes in the standard to ensure applicability to the service sector as well. The vocabulary of the revised edition has been adapted to ensure universal application.
Speculation Regarding the Future of the Quality Manual
Although many people have speculated that the quality manual may disappear from the scene altogether, it still forms an important part of Quality Management Systems. It thus stays in place, but one of the noteworthy changes is that ISO 9001:2015 certified enterprises will not have to keep current quality manuals. That being said, the quality management documentation requirements are still part of the requirements of the new version.
Enterprises must still document and maintain their quality information. The setting up and maintaining of a quality manual is thus implied as one way of meeting the requirement. The new standard has taken into consideration that the way information is collected, retrieved, managed and distributed has changed considerably over the years. Paper is no longer the base medium for such and the new standard thus allows for more flexibility regarding the way in which the information is collected, organised, maintained and distributed. If the basic principles are followed, then the requirement is met.
Knowledge is a Manageable Resource
Another one of the ISO 9001: 2015 changes to note and for which training in the requirements of the new version will be beneficial is that of knowledge management. The new standard acknowledges that knowledge is a resource that can be managed to ensure quality. For this, the organisation is required to identify the knowledge needed to perform specific activities in order to ensure compliance with the enterprise quality management system.
The enterprise must maintain, safeguard and make the knowledge available where relevant and needed. In addition, it is important to foresee knowledge needs changing and to manage risks regarding failure to get the required knowledge when needed.
Context of Operation
New clauses have been added to the standard regarding the context within which the organisation operates, as well as the identification of the relevant stakeholders. More focus is applied regarding this context with proper stakeholder identification, insight regarding the stakeholder expectations and analysis of the context of the enterprise.
Where to Start
ISO 9001: 2015 changes training is now offered by us at WWISE, in addition to our training on internal auditing, introduction to ISO 9001 and making the transition from the 2008 to the 2015 version.