ISO 13485:2016 Medical Devices Quality Management System (MDQMS)
The most extensively used and most preferred Quality Management System in the medical industry.
What is ISO 13485?
ISO 13485:2016 is the most extensively used and most preferred Quality Management System in the medical industry. The standard helps introduce improvements in a company by identification, evaluation and prioritisation of threats.
ISO 13485:2016 requires companies to define requirements and budgets, perform design reviews, risk analysis, verification protocols and more.
The standard is considered as a dynamic tool because it gives a framework that is compatible with every business yet is flexible to the unique characteristics of each business.
Why is ISO 13485 necessary?
- A medical device is any instrument that is intended for medical purposes such as diagnosing and treating patients, helping them to treat illnesses or disease. There are potential hazards connected with the use of medical devices and so these products must be shown to be safe and effective with regulations
- It makes company staff document information about each product; for example, a device's function, performance, etc. By tracking and documenting each feature, performance and so forth, you are made to completely think about every element of your product
Who Can Obtain ISO 13485 Certification?
ISO 13485:2016 sets prerequisites, policies and instructions for any business that designs, manufactures, assembles, stores, installs, distributes or services medical devices. This includes agencies that provide related assistance or components at any stage which incorporates technical support, distributors and external third parties.
The rewards of implementing ISO 13485 can't be under rated. Companies of all sizes have gained huge savings in expenses and time, in addition to other enhancements that an effective Quality Management System naturally brings. Medical device businesses that market their products internationally will benefit the most as it reduces trade barriers to enter the international market.
What Are the Benefits of ISO 13485 Certification?
- Certain countries such as the UK, USA, Australia, Japan, Canada, Europe demand that medical devices must be ISO certified. Working to ISO 13485 standard is a requirement for medical businesses seeking access to new markets.
- The standard satisfies potential customers & stakeholders with the fact that a product has been produced with compliance to an internationally recognised standard. It boosts your customer's trust in your business as a safe choice.
- Improved documentation and control of processes lead to stability in performance, and less scrap and rework. Implementing the standard helps minimise production loss rate, operational expenses and hazards. You can identify and eliminate waste in between processes and avoid errors.
- Have complete insight in your overall processes, and any improvements that are achieved.
- ISO 13485:2016 highlights audit activities, management reviews and fine-tuning of processes based on collected information. After analysing facts, improvements are planned and implemented carefully. This makes sure that the best decisions are drafted for your business, resulting in better operations, performance and profitability.
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