ISO/DIS 9001 - PLANNING FOR THE QUALITY MANAGEMENT SYSTEM - Actions to address risks and opportunities
Keshav Ram Singhal
Clause 6 of ISO/DIS 9001 deals with the requirements related to planning for the quality management system. ISO/DIS 9001 broadly follows the PDCA cycle and this clause is the part of its first action 'plan.'
The relevant sub-clauses are as under:
6.1 Actions to address risks and opportunities
6.2 Quality objectives and planning to achieve them
6.3 Planning of changes
Actions to address risks and opportunities
This is a new clause in ISO/DIS 9001, which is not a part of ISO 9001:2008 QMS standard. As per requirements of ISO/DIS 9001, the organization is required to consider (i) issues related to the understanding the organization and its context, and (ii)requirements related to the understanding the needs and expectations of interested parties. In this connection, please refer to the relevant portion of the previous article 'ISO/DIS 9001 - Context of the organization'. The organization needs to determine the risks and opportunities, that (i) provide assurance of quality management system achieving intended results, (ii) prevent/reduce undesired effects (happenings), and (iii) achieve continual improvement.
The organization is required to plan:
- actions to address determined risks and opportunities,
- procedures to integrate and implement actions into the processes of the quality management system, and
- procedures to evaluate the effectiveness of the actions taken.
Actions, to address risks and opportunities taken by the organization, must be proportionate to the potential impact on the conformity of products and services.
There can be various options to address risks and opportunities and that can include:
- avoiding risk
- converting the risk into an opportunity
- eliminating the risk source
- changing the likelihood or consequences
- sharing the risk
- retaining risk by informed decision
While going through the recent changes in ISO/DIS 9001, we should note that these new requirements will influence organizations worldwide. A risk-based approach to the quality management system will now influence the success of the quality management system of an organization. Risk-based approach will now assist an organization in building and operating safety margins within its quality management system. Understanding organizational context and risks is helpful for an organization for its preparation t pursue, retain or take the amount and type of risk. It is very important to understand risk sources. A risk source is an element, which alone or in combination of other risk source(s), has the intrinsic potential to give rise to risk, where 'risk' is 'uncertainty in achieving objectives'. A risk source in an organization could vary and affect organization's objectives.
In a manufacturing organization considering an objective related to conformity of product quality, the typical examples of risk sources could be purchasing process, manufacturing process, measurement process, competence of people, technology, methods, machines, work environment etc.