![]() ![]() ISO 13485:2016 requires your quality manual to cover four key elements:ĭescribe the scope of your QMS. What are ISO 13485 quality manual requirements? Here’s how:īONUS RESOURCE: Click here to download a free template you can use to outline all documented procedures in your quality manual. Your quality manual should also communicate your company’s purpose and objectives for the QMS as well as establish the roles and responsibilities for maintaining the system and performing quality activities.Īs such, it’s important that you create a quality manual that complies with the applicable requirements from ISO 13485:2016 and is both informative and easy to navigate. ![]() The purpose of a quality manual is to help you, your team, and any stakeholders or auditors navigate your QMS. Think of a quality manual as the user’s guide to your QMS. ![]() An excellent quality management system (QMS) is one of the keys to bringing a safe and effective medical device to market.Īnd in order for your QMS to fall into that category, you’ll want to follow guidelines from ISO 13485:2016-the international standard for medical device quality management systems-which include the need for a quality manual. ![]()
0 Comments
Leave a Reply. |
AuthorWrite something about yourself. No need to be fancy, just an overview. ArchivesCategories |