ISO13485 is the standard for medical devices. ISO13485 was first released in 2003. It took ISO 9001 as the base of the standard then added the additional requirements for medical devices but unlike the other standards, it did not include all the sections. Then when ISO9001 was updated in 2015 ISO13485 did not follow the updates instead it stayed with the old format of ISO9001. So, ISO 13485 has the old numbering platform where all the other standards took the new numbering system. The ISO13485 standard is not government-related and too has developed standards to ensure the quality, safety, and efficiency of products, services, and processes but the FDA does have a medical device standard, 21 CFR Part 820.
Implementing an effective and robust ISO13485 quality management system will help your company focus on the important areas of your business and improve efficiency. The processes implemented by the company will provide a solid foundation, leading to increased productivity and profit. ISO 13485 provides guidelines intended to increase business efficiency and customer satisfaction. The goal of ISO13485 is to embed a quality management system into your company, increasing productivity, reducing costs, and ensuring quality processes and products for the aerospace industry.
ISO13485 Requirements
One of the requirements of ISO13485 is for the company to do an internal audit on their system this is where Audits4U comes in. You can train your employees to be internal auditors which is costly and what usually happens is the employee doesn’t like being an auditor or they get the experience then leave your company to go somewhere else. Audits4U will do an internal audit for your company. Don’t have time to do your supplier audits, Audits4U will audit your suppliers.
To be ISO 13485 certified means to certify a company’s management system, manufacturing process and documentation meet the requirements of ISO13485.
Steps to certification are:
- Implement the type of quality management system (ISO9001, AS9100, ISO13485, or IATF16949) into your company.
- One of the requirements is to do an internal audit of your system, Audits4U can help you.
- Once you have implemented all the requirements of the quality management system (ISO9001, AS9100, ISO13485, or IATF16949) you need to choose an accredited registrar. You can search for an accredited registrar also known as a certification body under ANAB (ANSI National Accreditation Board) which ensures impartiality and competence. ANAB performs your 3rd party audit.