ISO 13485 specifies requirements for a quality management system where an organization is required to demonstrate its ability to provide medical products and related services that consistently meet consumer and applicable regulatory requirements. ISO 13485 Certification in Malaysia  helps determine the actual position and health of current QMS and processes. The purpose of the quality audit is to ensure that manufacturing, development, and related control facilities meet the current manufacturing process, as well as conform to the commitment of ISO 13485 standard.

ISO 13485 standard is to be used by organizations involved in the design, production, installation, and servicing of medical products and other related services. It can be used in internal and also external parties, such as certification bodies to help them with their audit processes. 

ISO 13485 applies to all types and sizes of organization ,except where explicitly stated otherwise. ISO 13485 essential for any organization operating the medical products and pharmaceutical supply chain, including design, production,installation, storage development, and other services.

Benefits of ISO 13485 Certification:

The advantages of ISO 13485 cannot be overstated. Organizations of all sizes have realized significant savings in cost and time, and other improvements that an efficient Quality management system naturally brings about.

Overview of ISO 13485:

ISO 13485 applies to the organization in one or more stages of medical products. This includes the sourcing of material, distribution, design and sterilization among other functions in the manufacturing life cycle. Generally quality management system requirements, management responsibility documentation standard and product realization are among the subjects covered in ISO 13485. 

Faster cycle times:

Quality and process excellence initiatives utilize statistical process control, waste reduction and system thinking to improve consumers satisfaction. A common result of Quality management system deployment is faster cycle time in the supply chain and on the production facility floor.

Less waste:

Waste reduction in all stages of the production is a direct result of building a company to conform to ISO 13485 Registration in Singapore. Identification and removal of overproduction, waiting, over inventory, defects, and scrap are among the advantages  of quality management system deployment. There are also fewer internal machinery failures and fewer consumer returns. 

Systematic process improvement:

Although it's the responsibility of staff at all  stages of a company to enhance the efficiency and effectiveness of operation, it is hard to do so without having a common  language to describe inefficiencies and process improvements. 

Higher customer satisfaction:

Quality management systems decrease  the cost of non conforming goods, enhancing consumer satisfaction. This is true for supplier raw material and other entities in the supply chain and it can lead to consumer experience.

Higher prestige :

Meeting ISO requirements enable organizations in the medical device industry to better market their product and services. While creating their business that meets quality management system standards is not a simple process, it is well worth the effort and investing the time and  energy.

Our Advice:

If you’re looking for ISO 13485 Certification. .You can write to us at contact@certvalue.com or visit our official website as we are ISO Certification Consultant Companies in Australia, Sri Lanka, Singapore, India, Malaysia. Certvalue provides your contact details so that one of our certification experts shall contact you at the earliest to understand your requirements better and provide the best available service in the market.