Requirements and Importance of ISO 13485 in Organization

ISO 13485:2016 certain requirements for a quality management system where an organization needs to prove its ability to provide medical devices and associated services that constantly meet customer and applicable monitoring requirements. Such organizations can be required in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities.

What is a Medical Device?

A medical device is a product, such as an instrument, machine, implant or in vitro reagent, that is intended for use in the analysis, prevention and treatment of diseases and other medical conditions.

What is ISO 13485 Standard?

ISO 13485 is designed to be used by organizations contain in the design, production, installation and servicing of medical devices and associated services. It can also be used by internal and external parties, such as certification, to help them with their auditing procedures.

The Importance of ISO 13485 Standard:

ISO 13485 is important to designers, manufacturers, and suppliers of medical devices. In addition, suppliers and service providers can improve an organization's marketability as more and more manufacturers necessitate certification in order to do business with a seller.

The worth of ISO 13485 is not just in the execution, but also in providing a tool for a thorough audit to test the efficiency of the system. certificate of registration it offers the manufacturer with a higher level of confidence in the capability to consistently achieve and maintain compliance with regulatory requirements.

What are the Requirements of ISO 13485 Standard?

ISO 13485:2016 specifies conditions for a Quality Management System to produce ISO medical devices and associated services that constantly meet customer and applicable regulatory necessities. Requirements of ISO 13485:2016 are valid to organizations regardless of their size and irrespective of their type, except where obviously stated. Wherever requirements are specific as applying to medical devices, the requirements apply equally to associated services supplied by the organization. ISO 13485 Lead Auditor training provide knowledge about the QMS and ISO 13485 requirements as the ISO 13485 lead auditor.

General Requirements:

In evaluation of any ISO standard, there are a few systematic requirements that are the driving force for establishment and implementation of a Quality Management System. The requirements specific to ISO 13485 include the following:

• Have written procedures in place and ensure the effectiveness of the system that organization implement.
• Consider the risk factors in all activities in the organization.
• Introduce steps to minimize the risks identified and aim to not cause catastrophic events.
• Identify how things should be done to generate your medical device and stick to those processes.
• Determine ways to track your activities, correct any process failures or oversights, and generate records to show all the activities are being done.
• Determine the requirements that you are legally bound to, and follow them!
• Even when outsourcing work, ensure you maintain responsibility for that work.
• Any systems used in your manufacturing processes should be confirmed to ensure they work as intended and don’t negatively affect your processes.

Source:

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As ISO Consultant profession since last many years Charles has rich experience in preparing such certification documents within ISO guideline to his global clients to acquire better ISO Certification Solution to their Organization.