Quality objectives have a strategic role of carrying out the quality policy and its implementation through a quality management system and provide a means to assess whether the QMS achieves its goals. The effectiveness of a QMS depends on the extent to which quality objectives have been achieved. In other words, quality objectives report the status of the effectiveness of the QMS. Without quality objectives, the organization cannot promote some of the ISO 13485 Standard basic goals: meeting customer and regulatory requirements, achieving the improvement of the QMS and its products, and enhancing customer satisfaction. This statement is valid to all areas in the organization.
Consistence with the strategy of the organization
I would like to point out the strong relation between quality objectives and the strategies of the organization. Quality objectives are strategic as well as operational steps that the organization defines. On achieving these objectives, quality goals are reached and the strategies of the organization are executed. The type and hierarchy of the objectives are to be planned in order to accomplish the strategies of the organization, and the quality objectives are determined according to the organizational goals and should support the achievement of the goals. It begins at setting strategic objectives and continues with defining operational objectives. The quality objectives are derived from:
- The context of the organization—quality objectives adjust the organization to its relevant business and environmental conditions
- Needs and expectations of interested parties—through the achievement of the quality objectives, aspects related to the needs and expectations of interested parties of the organization are ensured
- QMS requirements—quality objectives support the promotion of quality management requirements
Reference to applicable regulatory requirements
When requirements are part of the QMS and demand the achievement of certain goals, quality objectives shall refer to those goals. In other words, specific quality objectives shall be planned in order to enable the organization to better meet regulatory requirements. In my book; ISO 13485:2016: A Complete Guide to Quality Management in the Medical Device Industry (Second Edition) I specify the types of applicable regulatory requirements and explain how the quality objectives must refer to them.
Consistence with quality policy
The determined quality policy represents the general guidelines, intentions, and goals of the organization referring to its quality intentions. The policy demonstrates what quality signifies to the organization and defines the areas and scopes in which the quality is active and valid. Quality objectives are to be developed for those areas and scopes. Quality objectives are a result of the quality policy; quality goals are to be analyzed and operational measurable steps that assist in achieving them are to be planned as objectives. Those objectives must relate to operational and practical activities. Practical quality objectives should lead the organization to achieve more high-level objectives until strategic destinations are achieved. For example, if the quality objective is to enhance customer satisfaction and you know that customers are complaining about the packaging of the product, the operational quality objective should relate to those activities and quality elements that handle the packaging of the product (directly or indirectly). In other words, the strategic goals and the quality policy are to be broken down into specific steps.
Comments are closed.