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ISO Pros is a major ISO consultancy, auditing organization committed to assisting facilities to achieve approval to most of the ISO certifications and accreditations. ISO Pros has since assisted many organizations in receiving their ISO certifications. Our team of experts has many years of experience in providing business solutions, quality assurance, ISO consulting, auditing, and training. Our team of trained and experienced experts supports businesses to obtain ISO certifications and other certifications
ISO 13485 certification is essential for medical device organizations wishing to demonstrate relevant regulatory specifications. MD-QMS-compliant medical device entities should be given an ISO 13485 certificate by the Informed Institution and certain entities by the Approval Institution after an on-site audit
Medical Device Quality Management System (MD-QMS) is a list of protocols, methods, recorded practices and documents to be implemented by an entity with a series of functional guidelines customized to the operational requirements of clients and patients or the product or service you offer.
ISO 13485 Recognition by the medical device industry is the most recognized and practiced universal QMS requirement worldwide. The new corresponding edition of the specification is (EN) ISO 13485:2016 which was released on 1 March 2016.
Why you need to get a free instant quote
ISO 13485 Compliance Program is designed to enable producers to concentrate on their framework and improve and enhance their commitment and risk control and satisfy regulatory requirements. Compliance with ISO 13485 through your company network will help your business expand the doors to unexploited markets for the national and foreign markets. You’ll also reap a whole range of perks, such as:
Expanded exposure to business
National Regulatory authorities in most developed countries prefer manufacturers or suppliers that have an audited third party and an ISO certified management system. Investment in a professional company accelerates the opportunity to supply products to other countries that need it. In simple words, ISO 13485 certification can accelerate your market entry to other countries.
Reduced sales costs
A manufacturer has to expend resources not just on the production cycle but also on advertising and marketing when it comes to selling medical equipment. You don’t have the need for ads when you sell ISO approved goods. The ISO mark tells you everything about the product. While such a marketing method will reduce selling and promotion costs.
What’s required to get the certification? You need a well-developed management framework focused on a standardized process control method which is agreed globally. This certified system allows you to improve both your production process and the quality of your products. It helps foster a strong bond with your suppliers, business associates, and clients. You should consider the overall market results which are enhanced as a result.
When we do your quality management – these are our do’s and don’ts
The most relevant factors for success are:
- Commitment from management
- The aspiration to change and not only undergo an audit
- Common approach: Each process proprietor describes the processes themselves
- Smart people with common sense
- Risk-management understanding
- Awareness that a system of quality management is (forever) alive
We try and discourage:
- Keeping historical record retrospectively
- Re-using templates which are not quite in accordance with your (desired) way of behaving
- Assigning accountability (exclusively) for the QM program to the Deputy for Quality Control
- Top-down management e.g. dictating SOPs