qmsWrapper Blog

How to define the hierarchy, functions, role, and relations in your company – easy to follow, by qmsWrapper.

The quality policy is a document where you should state your commitment to your improvement. Learn more about how to establish it and maintaining it.

Leadership is like the steering wheel of the company and commitment is the key to success. All that you need to know about the 5.1 clauses of ISO 9001 Standard.

It’s the ISO 9001 requirement and it explains how to maintain your internal and external issues in your company. qmsWrapper made it easy to understand.

Find out what is the core of the ISO 9001 standard. qmsWrapper explained it all in simple terms, for QMS beginners. Learn more.

qmsWrapper brought the library folder to its full potential. The easy-access place to put what you need to find easily and much more. Find out here.

Find out if and when you need to perform a GAP analysis for implementing your ISO 9001 or ISO 13485. Learn more about GAP analysis activities.

qmsWrapper has prepared an eye-catching infographic of implementing ISO 13485 standard for you. It includes all the benefits and more. Learn more here.

it’s time for improvement through corrective and preventive action – with qmsWrapper ISO 13485 compliance is easy.

Learn about strategy for identifying the data for analysis because the ISO 13485 requires collecting data from all processes and activities.

A nonconformity is any failure to meet a requirement. Learn how to control it according to ISO13485.

Monitoring and measuring activities of products are the necessary controls to ensure the medical device performs as intended – simplified ISO 13485, by qmsWrapper.

In this lesson learn how to inspect product quality, determine the quality of your in-house processes, continuously improving methods of measuring customer satisfaction…

Control of monitoring and measuring medical devices are one of the most important parts of the ISO 13485. Learn from qmsWrapper.

This section of ISO 13485 covers the different elements and resources that combine the realization processes to ensure conformance to medical device specifications.

Recognizing the client's needs and their specific requirements, somehow it just imposes for qmsWrapper to expand its capacities and dominate ISO 9001:2015 market.

ISO 13485 requires you to document your purchasing procedure to ensure purchased products adheres to stated purchasing information. What does that mean? Find out here.

D&D as one of the most important sections of the ISO 13485 standard, explained to prevent the failure because if your medical device fails to meet regulatory design requirements, it won’t be able to reach the market.

qmsWrapper explains how and why is important for you to keep to a high standard of your medical device or service that you offer to customers. About requirements and it’s a review of the way of communication.

Planning is part of success. And it refers to all phases of the life-cycle of your medical device. qmsWrapper guides you through the chapter of product realization of ISO 13485.

Work environment and contamination control are important and critical for effective and compliant medical device business run. qmsWrapper explains it all.

Learn why ISO 13485 focuses on the improvement of Human Resources - the importance of the connection between qualified employees, the implementation of QMS, and maintenance of its effectiveness.

How important is management review input and output while you build your medical device, read in this explained chapter of ISO 13485 – all about management review.

In every medical device company, there must be an organizational structure. In this article, you will learn about responsibility, internal communication and management representative according to ISO 13485.

You will learn why without planning it’s impossible to build quality into your medical device and company since the start. Find out more about key elements of Quality Planning.