Specifies the requirements for the quality management where a company needs to prove its ability to provide medical equipments and services that regularly meets the customer requirements.It provides guidelines regarding the design , development , production , storage and transportation , service and installation of the medical devices.It is also applicable to suppliers and wholesalers who deal with medical equipment.Certification to this standard shows the clients and customers that the company takes quality very seriously and has a system to maintain the quality of the products on a regular basis.It focuses on customer satisfaction and also increases the brand value.Ensuring customer satisfaction helps to sustain in the business for a long time and helps in retaining the customers.Using the process requirements in the ISO ISO 13485 Certification in iraq focuses on increasing the efficiency of the product by reducing the mistakes and errors.It also aims to reduce the wastage costs and minimize the production cost.It makes sure the decisions are taken based on the facts and the data to ensure the long term goals of the organization are met.It also focuses on regular documentation and internal audit of the process and procedure.It creates a foundation for continuos growth and improvement of quality management.It focuses on minimizing the errors and taking the necessary actions required to prevent and reduce mistakes.Risk management is also a part of iso 13485 certification ,the team does a comprehensive and a detailed analysis of the process and the product.Low quality is the main cause of high risk.So low quality products are rejected and eliminated. Low quality products are a threat to the brand value and can cause legal troubles and hefty fines.It includes the elimination of the potential risks and threat to organisation. It includes distribution of the management responsibility because clear communication is a key to the success of the company. Distribution of the roles and responsibilities of the team must be unambiguous and employees have a sense of responsibilities.Training should be provided to the employees on a regular basis to improve the quality parameters.Skill enhancement should be done on a regular basis.Training sessions should be conducted every six months.Cleanliness should be maintained in the workplace and the tools and machinery should be kept in a particular place.Machines should be calibrated and maintained regularly to monitor the quality of the products.Updated and well maintained equipments ensure the safety of the workers.Advanced techniques like robotics and softwares should be implemented to ensure high quality products are produced on a regular basis.Medical devices should be designed and developed using the latest techniques to obtain precise results on a regular basis .
Our Advice:
If you’re looking for ISO 13485 Audit in South africa You can write to us at contact@certvalue.com or visit our official website as we are ISO Certification Consultant Companies in South Africa.Certvalue and provide 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.
