Iso 13485 standard free download

For full functionality of this site it is necessary to enable JavaScript. Here are the instructions how to enable JavaScript in your web browser. Liza Horielikova April 14, Tags: ISO , standards supporting biological evaluation of medical devices , standards supporting protective clothing used in health care settings. Upcoming free webinar. Presenter Kristina Zvonar Brkic. Thursday — December 2, Suggested reading.

The manufacturing, design, or supply of any product or service needs an infrastructure Most medical devices interact with the human body during the surgical process; just You have successfully subscribed! You'll receive the next newsletter in a week or two. This short presentation, intended for employees, shows what ISO is all about.

This white paper is intended for medical device manufacturers that seek approval from the regulatory bodies. The paper describes the key differences between requirements of the U. The paper describes the suggested steps in the transition process.

The paper is intended for companies planning to sell or distribute medical devices in the European Union and want to know exactly what the regulation requires before you start. This white paper is intended for companies that need to perform an internal audit as part of their ISO management system. Learn how ISO can help you, and read about principles of auditing, auditor characteristics, and steps for internal auditing according to this standard.

This white paper is intended for quality managers, decision makers, consultants and other employees in companies planning to implement ISO This helpful document gives an overview of benefits that the implementation of the ISO can bring to your company, and explains how does this standard fit with small enterprises.

This white paper is intended for quality managers, CEOs, and consultants in companies which already implemented quality standard s and need guidance on what to expect at the ISO certification audit. Implementing a project like ISO can be costly if you do not budget in advance.

This white paper aims to help you budget effectively, and prevent any unnecessary expenses from occurring. Not only will you learn budgeting benefits and tips, but also how different implementation options can impact your overall budget. Deciding which method to follow when implementing ISO can be difficult and confusing. This white paper outlines the pros and cons of both going it alone, and hiring a consultant. It offers detail on both techniques, as well as what to look for in a good online solution, helping you make an informed decision on the best approach for your business.

This matrix shows the relationships between the requirements of ISO and the new ISO , while providing an overview of requirements common to both versions. It also offers tips on how to make the transition to the new version with as little stress as possible. This white paper is intended for companies that have implemented the ISO standard, and are planning to transition to the revision.

Short presentation intended for quality managers, project managers, and other employees. This presentation will help clearly define the objectives of the medical devices Quality Management System implementation project, documents to be written, deadlines, and roles and responsibilities in the project. Templates 2 Template MS Word. Implementing a project like ISO is easier with the support of management.

Use our project proposal template to help achieve the approval and commitment necessary from top management to progress. Template MS Word. Checklists 4 Checklist MS Word. Before deciding which ISO expert to engage for the implementation, consider asking these questions to help you determine whether this is the right option for your company. This list contains prepared questions that are relevant to helping you find the best possible consultant for your business.

Checklist MS Word. With so many different companies to choose from, finding the right ISO certification body to work with can be confusing.