Awareness of support in ISO 9001 – Lecture 11
Awareness of the QMS increases the motivation and devotion of employees in your company – emphasizes ISO 9001, clarifies qmsWrapper.
Top 5 trends in the MedDev industry for 2021
Follow trends related to MedDev industry with qmsWrapper. 5 fields are innovative and impactful as technology and healthcare are developing daily.
Competence in Support of ISO 9001 – Lecture 10
Employees' competency is crucial for your successfully produced product or service. Importance of training, education, qualification explained by qmsWrapper team.
Resources of Support – Lecture 9
They are critical zones and should be support for achieving your QMS goals, aligned with the objectives – how, why, when – more here in lectures by qmsWrapper.
Planning of changes – Lecture 8
Understanding the purpose of the change is critical for the planning of the change – ISO 9001 - now easy to understand by qmsWrapper.
Quality objectives and planning to achieve them – Lecture 7
Quality objectives are measurable goals relevant to enhancing customer satisfaction. Learn how to establish objectives throughout your company.
Planning: Actions to address risks and opportunities – Lecture 6
Risk-based thinking will guide your top management to make better decisions. Find out more about actions on how to address risk.
Organizational Roles, Responsibilities, and Authorities – Lecture 5
How to define the hierarchy, functions, role, and relations in your company – easy to follow, by qmsWrapper.
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.