123ArticleOnline Logo
Welcome to 123ArticleOnline.com!
ALL >> Business >> View Article

What An Iso 13485 Quality Manual For Medical Devices Should Look Like

Profile Picture
By Author: Global Manager Group
Total Articles: 50
Comment this article
Facebook ShareTwitter ShareGoogle+ ShareTwitter Share

This ISO13485 manual describes the Quality Management System, delineates authorities, inter relationships and responsibilities of the personnel responsible for performing within the system. The manual also provides procedures or references for all activities comprising the Quality Management System to ensure compliance to the necessary requirements of the ISO 13485:2016 standard.

This manual is used externally to introduce our Quality Management System to our customers and other external organizations or individuals. The ISO 13485 manual is used to familiarize them with the controls that have been implemented and to assure them that the integrity of the Quality Management System is maintained and focused on customer satisfaction and continuous improvement.

Medical devices - Quality management systems - Requirements for regulatory purposes represent the requirements that the medical device manufacturers must incorporate into their management systems. These ISO 13485 manual requirements are becoming popular among the medical devices' manufacturers.

The ISO 13485 quality manual for medical devices manufacturers ...
... is a primary document required for ISO 1348:2016, a quality management system designed for medical device manufacturers. If you are manufacturing medical devices, your organization will need to prove compliance with FDA regulations. Demonstrating compliance with ISO 13485 is required for manufacturing medical devices which will be distributed internationally.

ISO 13485:2016 total documentation for quality management system for the design and manufacture of medical devices is designed and sell online by Global Manager Group. So far many companies globally have taken such readymade documentation kit and successfully developed quality management system. Many quality management system (QMS) consultants use it to guide medical device manufacturing companies on system implementation, documentation and training process, and help them establish effective and good quality system and get quick certification.


Quality guidelines are designed to capture the requirements for the quality management system and practices at the organization in a single, comprehensive document. ISO 13485 requirements for the quality manual include:

• Describe the scope of the QMS, including any exclusions
• List or reference QMS standard operating procedures (SOPs)
• Describe interactions between QMS processes
• Provide an outline of QMS documentation structure

ISO 13485 provides flexibility in how organizations choose to structure the quality manual. Procedures, work instructions, and forms can be included in the quality guidelines to satisfy these requirements. Specific characteristics hold true for a practical 13485 quality manual at any organization. Regardless of how large or mature your company is, a high-value set of quality guidelines should be a streamlined guide, carefully controlled, readily accessible, and follow a set structure. It should also address any regulations which your organization is not required to comply with and clear justification.

Total Views: 48Word Count: 423See All articles From Author

Add Comment

Business Articles

1. 7 Signs You Need To Restore Your Sash Windows
Author: Sash Windows

2. How Can You Scale & Automate Your E-commerce Business?
Author: simplysolved

3. Uae Anti-money Laundering Legislation – What You Should Know
Author: Haroon Juma

4. Acetonitrile Uses, Storage, And More 101
Author: Magan Bhadani

5. 5 Tips On How To Prepare Your Home For Air Conditioning Installation
Author: Air Conditioning

6. 6 Reasons Why You Should Hire A Professional Food Photographer
Author: kanika panchal

7. How To Get Your Sa302 Tax Calculation & Tax Overview
Author: Holland Emery is a professional tax accountant.

8. Management By Exception: A Path Towards Touchless Procurement For Manufacturers
Author: conver gentis

9. Always Outsource The Trusted Book Keeping Services
Author: Adam Jones

10. Ever Green Scope Of Translation Services
Author: Steve Smith

11. Spot Welding Nickel Strips
Author: Amit Shah

12. Stainless Steel Seamless Pipes Manufacturers In India
Author: Ashwin Bhansali

13. Why You Require Feeralloys As A Steelmaking Company
Author: Anindya Bhaumik

14. Attractive Features Of Refractories And Their Manufacturers
Author: Anindya Bhaumik

15. Branding Without A Website Is Basically No Branding At All
Author: Arun Kumar

Login To Account
Login Email:
Forgot Password?
New User?
Sign Up Newsletter
Email Address: