Why Manage Quality?
While this may seem like a silly question, is it possible that the organization may not fully grasp the real benefits of establishing an effective system to manage their business and quality processes?
When the rationale is to achieve a certification for marketing purposes, we believe that the true benefit of establishing an effective quality system will most likely be missed, resulting in product and/or service safety, effectiveness and performance problems.
Understand the Business
Most companies will use an ISO 9001 like model, or equivalent, as the fundamental set of requirements upon which to structure their business system to manage quality processes. The revisions in the 2015 version of ISO 9001 require the organization to identify external and internal issues (clause 4.1) and identify interested parties and understand their needs and expectations (clause 4.2). These are critical first steps in order to develop a comprehensive system to manage an effective business.
A few key steps to consider:
- Identify and understand all reasonable factors, concerns, influences and issues affecting the organization.
- Identify and map major processes.
- Understand the interactions of these processes, and who controls them.
- Identify controllable inputs to and measurable outputs from these processes.
- Apply risk-based approach to all processes: What can go wrong, what are the consequences, how do you reduce or eliminate the likelihood of occurrence.
- Know the needs and requirements of all internal “customers”.
- Identify clear and measurable objectives.
Identify Context and Objectives
Determining the context in which the organization exists is critical to ensure all reasonable factors have been considered that will enable or inhibit business success.
- Context is the combination of internal and external factors and conditions that can have an effect on the organization’s approach to products, services, investments and relevant interested parties.
Establishing appropriate objectives (we call them Critical Performance Measures [CPMs]) are essential to ensuring controllable processes deliver expected and planned results.
- These CPMs need to be focused, reviewed regularly, and actionable.
The Plan-Do-Check-Act cycle, as shown below, can be applied to all processes and to the quality management system as a whole. The numbers in parenthesis represent the ISO 9001:2015 clause references. [Reference: ISO 9001, 5th edition, 2015-09-15, clause 0.3.2 Plan-Do-Check-Act cycle]