Location
602, 6th Floor, Ceaser’s Tower Karachi
+92 300 8270988
+92 300 8218041
Monday – Saturday
9:00am – 06:00pm
602, 6th Floor, Ceaser’s Tower Karachi
+92 300 8270988
+92 300 8218041
9:00am – 06:00pm
ISO 13485:2016 is an international standard for medical devices. Medical devices — Quality management systems — Requirement for regulatory purposes specifies the requirements for a quality management system in situations where an organization must demonstrate its ability to provide medical devices and related services that consistently meet customer requirements as well as regulatory requirements applicable to medical devices and related services. Medical devices — Quality management systems — Requirement for regulatory purposes.
International Organization for Standardization (ISO) 13485: 2016 applies to companies that are at any stage of the medical device manufacturing process, according to the organization’s website. This includes the sourcing of raw materials, distribution, design, and sterilization, among other functions in the manufacturing life cycle, as well as the design and development of new products. The general requirements for a quality management system, management’s responsibilities, documentation standards, and product realization are just a few of the topics covered by ISO 13485. The ISO certification process can be completed by an organization that can demonstrate compliance with the elements of the quality management system.
Have a question or need consultation in regards to ISO 13485:2016? Contact a consultant below.
Efficient Cycles
Customer satisfaction is increased through quality and process excellence initiatives that employ statistical process control, waste reduction, and systems thinking techniques. A common result of implementing a quality management system is that cycle times in the supply chain and on the production floor are reduced. This is due to the fact that when quality management is integrated into an organization’s culture, products, processes, and systems are constantly being reviewed and redesigned. Quality can lead to faster cycle times and better service in a variety of areas, including administration, accounting, and purchasing.
Waste Reduction:
Waste reduction in all aspects of the manufacturing process is a direct effect of establishing an ISO-compliant organisation. Overproduction, waiting, extra inventory, flaws, and scrap are just a few of the advantages of using a quality management system. Internal machinery problems are also down, as are customer returns. As a result of all of this, production costs are lower and profit margins are better. Labor hour reductions enable for cost savings and resource reallocation to value-added activities.
Improved systematic processes
While it is the responsibility of employees at all levels of an organisation to improve operational efficiency and effectiveness, it is difficult to do so without a common vocabulary to identify inefficiencies and process improvements. A quality management system not only establishes effective communication channels for expressing flaws, but it also provides systematic procedures for process improvement using six sigma and lean methodologies. Systematic improvement is an advantage of ISO 13485 certification, whether it’s through quality auditing or corrective action requests.
Customer Satisfaction
Quality management techniques lower the cost of nonconforming items while also improving customer satisfaction. This is true for raw material providers and other supply chain actors, and it can lead to better customer experiences. There is minimal space for error or customer returns when it comes to medical gadgets, which have such a profound impact on people’s lives. Statistical process control, for example, can aid in the removal of special cause variation from the machining process, resulting in a product that rarely deviates from design tolerances. Medical devices can survive environmental stresses and deliver on their intended function, which can improve people’s lives in the long run.
Feel free to contact one of our representatives.
Ace Management System Consultants is an ISO 9001 certified organization that provides customization consulting, training, auditing, and certification services that reduce risks and save time for organizations while educating, empowering, and enabling leadership to implement, improve and integrate management systems and strategic initiatives.
All rights reserved – Copyrights © Ace Management System Consultants
Designed & Developed by Tech Vision
