How ISO Certification will help your Medical device companies’ business.
For medical device manufacturers seeking ingress to new markets, conformity with statutory and regulatory requirements is most often a prerequisite. Those who want to compete effectively and efficiently also should have a properly established, implemented, Improved and maintained quality management system QMS. To satisfy these conformity and quality management system needs, many manufacturers are discovering the benefits of working with a third-party auditing company.
Your management system’s conformity with ISO 9001, ISO 13485, ISO 14971, or ISO 14001 can help your company open doors to untapped domestic and international business opportunities, and reap the benefits of:
- Promotes best practices—ISO and other standards give you access to internationally recognized best practices across your business. Standards exist for everything from quality management to environmental performance, information security, food safety, risk management, and health, Medical Device and safety.
- Helps you become more productive—Adhering to standards requires you to clearly define, document and monitor your business processes. You also need to set objectives for your company and measure your progress.
- Reduced cost of sales– Your certification establishes your company’s credibility and commitment to quality. Because the task of explaining the specifics and demonstrating the effectiveness of your quality system is more straightforward, it takes less time to earn your prospective customers’ trust and confidence.
- Expanded market access – National regulatory authorities require or strongly prefer that manufacturers marketing medical products in their countries have a third-party audited and certified management system in place. Investing in such a system speeds access into those countries that require it, and expedites market entry into the others.
- Fosters team commitment—Meeting ISO standards can help you foster a more engaged and productive workforce. Certified businesses report better job satisfaction, turnover, absenteeism, employee motivation and manager-employee communication.
- Improved performance – Based on a uniform and widely-accepted system of process control, your company’s certified management system helps you improve your products and processes. This can foster improved relationships with your suppliers, business partners, and customers, and give you a real advantage in the marketplace.
- Keeps customers happy—Standards help keep customers satisfied by improving complaint management, quality control and client satisfaction monitoring. Research indicates one of the top benefits from certification is reduced customer complaints.
Which ISO Certifications are best for your industry?
ISO 13485: design and manufacture of medical devices
ISO 13485 is a quality management system standard designed for medical device companies. Being ISO 13485 compliant shows a commitment to the safety and quality of your medical devices.
- Establish a risk based approach to product development and realization
- Complete the validation of processes
- Ensure compliance with regulatory requirements
- Implement effective product traceability and recall systems
ISO 14971: medical device risk management
ISO 14971 specifies a process for medical device manufacturers to identify the hazards, or risks, that are associated with their products and to create the necessary controls to monitor them. Assess the essential performance of your medical device.
- Identify potential hazards
- Estimate the severity and likelihood of the hazards
- Create controls to minimize the risks
ISO 9001: quality management for medical device manufacturing
ISO 9001 specifies the requirements for a quality management system for companies that need to demonstrate their ability to provide a product and Services that meets interested parties, Statutory and regulatory requirements.
- Implement a Quality Management System
- Better process integration
- Improve your evidence for decision making
- Create a continual improvement culture
- Improvement of your credibility and image
How can SIS Certifications help you to get certified?
We are a leading global management system certifications body for quality management systems, environmental management system etc. including management systems applicable in the manufacture of medical devices. And our technical professionals have contiguous knowledge and in-depth expertise with all types of medical devices. Each audit team incorporate of experts with the effective skills and expertise needed to accurately appraise the compliance of your management system, and is headed by a lead auditor who will oversee the audit and any required management change notices. Finally, our on-site or off-site Technical Documentation appraisal will provide you with the information you need to understand your exposure to non-compliance issues. This unique combination of experience makes SIS Certifications ideally suited to address the needs of medical device manufacturers seeking to achieve or maintain ISO 13485 certification.