Implementing ISO 13485 as an Integrated Management System
Since the publication of Annex SL - the standard that defines the high-level structure for all ISO management systems standards - all ISO management systems must be developed following this structure:
- Scope
- Normative references
- Terms and definitions
- Context of the organization
- Leadership
- Planning
- Support
- Operation
- Performance evaluation
- Improvement
So, if your company have already a management system implemented don’t forget that clauses 4, 5, 7, 9, and 10, have a similar text, so it can be unified without compromising the individual standards. It is the beginning of integration!
What is ISO 9000?
ISO 9000 is defined as a set of international standards on quality management and quality assurance developed to help companies effectively document the quality system elements needed to maintain an efficient quality system.
The ISO 9000 family of standards lays out the fundamentals and provides terminology, requirements and guidance for implementing, maintaining and improving an effective quality management system, that can be applied to all type of organizations with any size.
Benefits of an Optimized Quality Management System
ISO 9000 is a quality management standard that presents guidelines intended to increase business efficiency and customer satisfaction. Based on ISO 9001, the goal of ISO 13485 is to embed a quality management system within an organization, increasing productivity, reducing unnecessary costs, and ensuring quality of processes and products.
What are the 7 quality management principles?
Seven Quality Management Principles behind ISO9001 requirements:
- Customer Focus - The whole goal of a company is to provide products or services to customers, by with knowing your customer and their requirements, ensuring there is communication with customers throughout the process, and measuring the satisfaction of your customer as a way of measuring if the requirements have been met.
- Leadership Importance of Top Management - More involvement of top levels of management in the Quality Management System, ensures greater chance of success, and better end result.
- Engagement of People - QMS must focus on the competence of people to help them become engaged in the processes to build value in them. By having empowered and engaged people in the organization, this will become a driving force behind meeting the goals defined.
- The Process Approach - By looking at the overall system as smaller interrelated processes you can focus your efforts toward more consistent and predictable results on the individual processes of the system. Controlling and improving the individual processes will be much easier and more effective way to control and improve the entire system.
- Improvement - Continuous Improvement are key for organizations to drive down cost and maintain market share. This allows the company to react to changes in internal or external conditions to create new opportunities.
- Evidence-based decision making - To understand a process effectiveness we need adequate data, and in order to plan and assess improvements this data is even more important. Therefore, maintaining good records becomes crucial to have an efficient decision-making process.
- Relationship Management - The interaction with interested parties such as customers, partners, employees and suppliers can influence the performance of an organization, so it is critical to manage these relationships. Successful companies see these relationships as partnerships rather than strictly customer/supplier interactions.
