qmsWrapper Blog
Take Back Compliance
The Art of Managing Through Quality
Organizational Roles, Responsibilities, and Authorities – Lecture 5
Lecture summary:
Top Management is by definition a person or group of people who instruct and control an organization at the highest level (within the scope of the quality management system)
The requirements on responsibility and authority are divided into two parts: one general and the other relating to people with particular roles
Each person responsible for elements...
Policy: establishing and communicating the quality policy – Lecture 4
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 and commitment – Lecture 3
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.
Understanding the organization and its context – Lecture 2
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.
Introduction (Scope, normative references, terms, and definitions) – Lecture 1
Find out what is the core of the ISO 9001 standard. qmsWrapper explained it all in simple terms, for QMS beginners. Learn more.
The library – feature for the rest of the company
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.
Gap analysis in QMS
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.
How To establish an ISO 13485:2016?
qmsWrapper has prepared an eye-catching infographic of implementing ISO 13485 standard for you. It includes all the benefits and more. Learn more here.
Improvement through corrective and preventive action – Lesson 20
it’s time for improvement through corrective and preventive action – with qmsWrapper ISO 13485 compliance is easy.
What ISO 13485 considers under - Analysis of data? – Lesson 19
Learn about strategy for identifying the data for analysis because the ISO 13485 requires collecting data from all processes and activities.
Control of nonconforming products in ISO 13485 – Lesson 18
A nonconformity is any failure to meet a requirement. Learn how to control it according to ISO13485.
Monitoring and measurement according to ISO 13485 – Lesson 17
Monitoring and measuring activities of products are the necessary controls to ensure the medical device performs as intended – simplified ISO 13485, by qmsWrapper.
How ISO 13485 explains Measurement, analysis, and improvement – Lesson 16
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 equipment in the medical device industry – Lesson 15
Control of monitoring and measuring medical devices are one of the most important parts of the ISO 13485. Learn from qmsWrapper.
Medical device Production and service provision in ISO 13485 - Lesson 14
This section of ISO 13485 covers the different elements and resources that combine the realization processes to ensure conformance to medical device specifications.
qmsWrapper now covers and supports ISO 9001:2015
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.
What is Purchasing process in design and development in ISO 13485 – Lesson 13
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.
From A to Z about Design and Development of medical device ISO 13485:2016 – Lesson 12
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.
Customer-related processes – Lesson 11
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.
What is considered by the planning of your product realization as per ISO 13485 – Lesson 10
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 according to ISO 13485 – Lesson 9
Work environment and contamination control are important and critical for effective and compliant medical device business run. qmsWrapper explains it all.
What is Resource Management in the medical device world – Lesson 8
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.
All about Management Review in ISO 13485 – Lesson 7
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.
Responsibility, authority, and communication in ISO 13485 – Lesson 6
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.
What is considered by QMS planning in ISO 13485 – Lesson 5
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.