|Provide a structured, practical approach to quality management systems development, including the establishment of critical quality systems procedures, as needed.|
|Review effectiveness of existing quality and business management systems with respect to compliance to business and regulatory requirements and internal quality system documentation.|
|Facilitate identification and evaluation of business context to ensure all critical factors, i.e., internal, external, environmental, legal, regulatory, and social are being considered, including the identification of interested parties and their requirements.|
|Perform pre-certification or transitional quality management system upgrade certification preparatory audits. Ensure quality and business management systems are certification ready to ISO 9001:2015, ISO 13485:2016 and/or EU MDR requirements.|
|Facilitate the application of risk-based concepts as they apply to inter-related processes.|
During a recent client quality system audit to ISO 13485:2016, it was discovered that the client had instituted two separate quality systems: one to ISO 9001:2015 and the other to ISO 13485:2016. Recognizing that they had redundant processes in place, it was suggested by Ron that they could reduce the likelihood of noncompliance issues by integrating both requirements into a single system.
A recent project led by Ron involved successfully consolidating thirteen (13) diverse, product development processes of an internationally recognized, Fortune 500 medical device and pharmaceutical company, into a single, harmonized system. Using Microsoft SharePoint, and leading globally diverse teams, Ron employed creative mapping techniques to facilitate this effort.
“I have worked closely with Ron for several years. He is a complete professional. Ron is an expert in establishing and maintaining quality systems. He is extremely well-organized and works rapidly. Ron works well as a team player and typically offers multiple solutions and approaches to challenges. He is adaptable and works well in a consulting capacity.”
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]