ISO 13485: Medcical Device QMS
ISO 13485 Certificate is important for medical device organizations to wish to demonstrate applicable regulatory requirements.
Medical device quality management system, which is often referred to as an MD-QMS, is a collection of policies, processes, documented procedures, and records to be followed by an organization in-line with a set of internal rules tailored to organizational needs or product or service you provide to customers and patients.
ISO 13485 certification is the world’s most accepted and followed international QMS standard by the medical device industries.
Benefits of EN ISO 13485 Certificate
The organizations that have certified to ISO 13485 will have better control over their processes and the continual improvement possible in all areas of the organization.
The ISO 13485 Certification enables the organization for establishing the QMS in all phases of product realization including design & development, production, installation, and post-market surveillance. The benefits of being an ISO 13485 certified organization are the following
- Manages quality throughout the life-cycle of a medical device
- Continuous improvement of the product realization processes of medical devices
- Ensures safety in medical devices and continuous improvement of the devices
- Reduces operational cost and increases the market share
- Enhances customer satisfaction
- Helps in CE Marking of Medical and In-vitro devices.
Steps of certification
- Formation of Team for ISO Certification.
- Preparation of documentation including Quality Manual, SOP , Procedure Manual , Policy , Risk management Manual
- Training to team
- Implementation of ISO System
- Internal Audit
- NC AND CCA Management
- Certification Audit with Certification Body of Clients’ Choice
Good Manufacturing Practice (GMP)
Good manufacturing practices (GMP) are the practices required in order to conform to the guidelines recommended by agencies that control the authorization and licensing of the manufacture and sale of food and beverages, cosmetics, pharmaceutical products, dietary supplements, and medical devices.GMP is a certification of proof of maintaining consistency in the production of goods as per the quality standards. It helps in minimizing the risks in any stage of the production that cannot be eliminated through testing the final product.
The GMP Certification provides a framework for manufacturing, testing, and assuring the quality and safety of food and other products. There are many countries that have put forward legislation according to which the food, pharmaceutical, and medical device manufacturers should follow GMP procedures and create their own guidelines in order to be compliant with the legislation.
The common basic principles of all guidelines are as follows:
- Manufacturing facilities must maintain a clean and hygienic manufacturing area.
- Prevention of cross-contamination of food or drugs from adulterants by maintaining controlled environmental conditions.
- A clear, defined, and controlled manufacturing process. Manufacturing processes are clearly defined and controlled. Validation of all critical processes are done to ensure consistency and compliance.
- Operators must be trained to carry out and document procedures
- Clarity and unambiguity in written instructions and procedures.
- Training of operators to carry out the procedures and document them.
- Any distribution of products must minimize any risk to their quality
- A system must be in place for recalling any batch from sale or supply.
- Either manual or instrumental records are made during the manufacture to demonstrate that the right steps were taken in order to ensure the quality and quantity of the products as per the expectation. Any deviation is investigated and documented.
- Manufacturing and distribution records should be maintained in order to ensure the traceability of the product or batch
- Evaluation of changes in the manufacturing processes that are kept under control.
- Minimizing the risk to the quality of products when they are distributed.
- There should be an availability of a system to recall any batch from sale or supply.
Benefits of GMP Certification
- It demonstrates the organization’s credibility in ensuring Safe Product Quality.
- Reduction of safety risk
- Timely problems solving approach which leads to reduction in cost.
- Better understanding and compliance with the relevant regulations
- Improvement in customers’ satisfaction .