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. Take a look at our pricing plans and request an estimate that works for your business. Want to see what MasterControl has done for great organizations?
Explore our many case studies. We are growing fast and looking for innovative and creative people to join the team. Learn about the variety of partnerships and strategic benefits available in our partner network. ISO is an international quality management standard for medical devices. Systemic requirements. Management requirements. See our product tour or contact our main ISO expert who is here to assist you in your implementation.
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. 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!
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