,Context, Quality Policy and Objectives
The ISO 9001:2015 Standard puts a strong focus on strategic management. What this means is a closer connection in the interrelationships between business policy, objectives and results.
Interpreting ISO 9001:2015, we can relate to 3 key areas of Business Strategy:
If we consider the literal definition of Context, we arrive at the term "circumstance". Therefore, we can consider our Context to be those circumstances that affect our ability to provide a product or service. In order to comprehend those circumstances, we must understand our business. What are our strengths and weaknesses (internal factors) and what opportunities and threats must we consider (external factors)? What requirements must we satisfy and how to we intend to achieve these results?
A common misconception is that ISO 9001:2015 requires quality objectives to be based on the company's quality policy; however, the actual requirement is that they are consistent with this policy. To be effective, quality objectives do not require line-by-line linkage to the quality policy, only align with it's intent. Quality objectives must take into account those strategic issues arising from an analysis of current business performance and opportunities.
Most quality policies cite improvement, customer satisfaction and quality. Many however, fall short on the commitment to satisfy applicable requirements. Meeting customer requirements is one piece of the whole; however, with a heightened focus on internal and external factors, interested parties and their requirements as part of determining the context of the organization, the quality policy needs to take these other requirements into consideration.
Per ISO 9001:2015, there are 4 key components that a Quality Policy must encompass:
The Quality Management System (QMS) must be aligned with the Business Strategy. If the organization has strategic initiatives in place, they must connect with the Quality Policy. There must be linkage between the QMS and the Business. The Quality Policy must reflect the strategic direction of the company.
Can you connect the dots between your organization's strategic direction, quality objectives and quality policy?
Quality Objectives and planning to achieve them (6.2)
Excerpt from ISO 9001:2015 below. Also attached is a worksheet that we use for this purpose. Hope this helps.
6.2.1 The organization shall establish quality objectives at relevant functions, levels and processes needed for the quality management system.
The quality objectives shall:
a) be consistent with the quality policy;
b) be measurable;
c) take into account applicable requirements;
d) be relevant to conformity of products and services and to enhancement of customer satisfaction;
e) be monitored;
f) be communicated;
g) be updated as appropriate.
6.2.2 When planning how to achieve its quality objectives, the organization shall determine:
a) what will be done;
b) what resources will be required;
c) who will be responsible;
d) when it will be completed;
e) how the results will be evaluated.
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