ISO 9001:2015 standard is now arrived and it is one more step towards revolution in the QMS implementation. Actually there are many transformations in the ISO 9001 standard since 1987. Just have a glance.
When ISO 9001:2000 was introduced, the standard has changed the attitude towards the QMS. This new standard was more proactive, having focus on continual improvement. Now ISO 9001:2015 is a step forward to that. It is totally based on risk based thinking and it makes the business and QMS go hand in hand.
In ISO 9001:2015, role of Top Management is very important. Until now, the role of top Management was limited to defining the Quality Policy, Objectives, roles and responsibilities and providing resources. Now Top Management is completely accountable for implementation and effectiveness of Quality Management System. As there is no role of Management Representative (MR) now, Top Management is accountable for QMS. The responsibility of QMS can be shared by others, but this new standard demands some activities to be done by Top Management itself like-
- Taking accountability for the effectiveness of Quality Management System
- Promoting the use of process approach and risk based thinking
- Communicating the importance of effective quality management and conforming to the Quality Management System requirements
- Promoting improvement
- Supporting the other relevant management roles to demonstrate the leadership as it applies to their area of responsibility.
It is also expected that there should be different levels of leadership in the organization. Due to this, involvement of leadership at all levels of the organization will be increased towards establishment and implementation of QMS, and all processes will be more aligned towards the organization’s business goals.
Management Review meetings will be now Business Review meetings- Until now, the organization’s business and QMS were two separate aspects. MRM used to be conducted just to review the QMS implementation with audit NCs, process performance, customer feedbacks, etc. The business discussion was limited to client feedbacks and complaints. But now Context of the organization is one more very important aspect, in which the organization is supposed to identify the internal and external issues, risks, opportunities, etc. These issues and risks will now be discussed in MRM as part of its agenda. Actually in most of the organizations, the issues and risks are discussed in the business planning meetings, but they are not reviewed or monitored after that.
Business oriented Quality Policy- Quality Policy will not be just a statement now. Now the requirement of standard is that, Quality Policy shall be appropriate to the context of the organization and support its strategic direction. So now the Quality Policy will be mirror image of the organization and more business focused.
Now we can say that if Quality Management System is effectively implemented as per ISO 9001:2015, then it will definitely be a Business Management System.