What is the difference between ISO 13485 and EN ISO 13485?

What is the difference between ISO 13485 and EN ISO 13485?

With respect to ISO 13485:2016, there is no difference in the main text between EN ISO 13485 and ISO 13485. The only difference is the addition of the Z annexes. So, if you have ISO 13485, and can preview the Z-annexes (at link above, or through iso/bsi, etc. webstores), you don't need to purchase the EN version.

What is ISO 13485 certified?

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

What is the current version of ISO 13485?

ISO 13485:2016 The current version is ISO 13485:2016, which was published in March of 2016 (thus the: 2016). It is NOT a standard for products. It does not define product quality. This is a process-based standard: you use it to control your processes, then your end product should meet the desired results.

How many sections does ISO 13485 have?

eight sections How is ISO 13485 Structured? The ISO 13485 standard is organized into the following eight sections.

Who needs ISO 13485 certification?

Any company involved in the supply chain of medical devices needs ISO 13485 certification. This is particularly true for those that design, develop, manufacture, and distribute these types of products. Even local regulations in various countries require businesses to gain certification.

Why is ISO 13485 important?

ISO 13485 was written to support medical device manufacturers in designing quality management systems that establish and maintain the effectiveness of their processes. It ensures the consistent design, development, production, installation, and delivery of medical devices that are safe for their intended purpose.

What is ISO 13485 in plain English?

ISO 13485 Medical devices -- Quality management systems -- Requirements for regulatory purposes is an International Organization for Standardization (ISO) standard published for the first time in 1996; it represents the requirements for a comprehensive quality management system for the design and manufacture of medical ...

How much does it cost to get ISO 13485?

Registration to ISO13485 by an accredited registrar for a small company would be between 5k and 10k (very rough numbers). This is the cost paid to the registrar only. It depends how much you want to do yourself, what experience and what skills you have in-house and how much time you have available.

What ISO means?

International Organization for Standardization ISO (International Organization for Standardization) is a worldwide federation of national standards bodies. ... Member organizations collaborate in the development and promotion of international standards for technology, scientific testing processes, working conditions, societal issues and more.

How long does it take to get ISO 13485 certification?

How long does it take to achieve ISO 13485 certification if we have no system in place? Implementation usually takes 4-6 months for companies with fewer than 50 employees.

What is medical ISO?

• ISO 13485 Medical devices -- Quality management systems -- Requirements for regulatory purposes is an International Organization for Standardization (ISO) standard published for the first time in 1996; it represents the requirements for a comprehensive quality management system for the design and manufacture of medical devices.

What is ISO documentation?

• Documentation. According to the ISO, the required quality management system documentation includes a quality policy and quality objectives; a quality manual, specifies procedures and documents the organization needs for effective planning, operation and control of its processes and specified records.

What is ISO document control?

• The term document control in ISO 9001 refers to the control of documented information that is required by the standards and guidelines. Along with putting these standards in place, the documents themselves should be controlled to fit the specified requirements.