ISO 13485 PDF FREE HOW TO
No matter if you are new or experienced in the field, this book gives you everything you will ever need to learn on how to handle ISO documents. In this book Dejan Kosutic, an author and experienced ISO consultant, is giving away his practical know-how on managing documentation. No matter if you are new or experienced in the field, this book gives you everything you will ever need to learn more about certification audits. See our product tour or contact our main ISO expert who is here to assist you in your implementation. ISO is an international quality management standard for medical devices. SGS is currently making arrangements with the appropriate accreditation authorities to confirm the plan to start the certification service for ISO and will soon communicate accordingly. SGS will soon provide materials, services and courses to help make the transition in the best possible conditions.
![iso 13485 pdf free iso 13485 pdf free](https://pecb.com/article_docs/images/71F6376464ED9104DE5C98B5566EC1D7.jpg)
Some of the key changes between the and version include. The new ISO focuses on how companies should manage risk-based decisions related to purchasing, design, development, manufacturing, production control activities and other aspects of the quality management system.
![iso 13485 pdf free iso 13485 pdf free](https://easymedicaldevice.com/wp-content/uploads/2018/07/ISO-13485-2016-Doc-Requ.png)
The new edition of the ISO standard was published on March 1, concluding almost five years of intense discussion and development by experts around the world to improve and update the standard with new European requirements and other international regulatory changes, implemented since its previous revision in Organizations complying with this standard, such as medical devices manufacturers, as well as suppliers and external parties that provide products or services to manufacturers, will be able to demonstrate compliance with regulatory requirements, manage risk, ensure best practice for quality and safety, improve processes and provide confidence to patients and users.