qmsWrapper Blog
![Quality objectives and planning to achieve them – Lecture 7 Quality objectives and planning to achieve them – Lecture 7](/files/Pictures/blog/ISO_9001_seria/7_ISO_9001/Quality_objectives_and_planning-_cover_small.png)
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 Planning: Actions to address risks and opportunities – Lecture 6](/files/Pictures/blog/ISO_9001_seria/6_ISO_9001/planning_iso9001_cover_small.jpg)
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 Organizational Roles, Responsibilities, and Authorities – Lecture 5](/files/Pictures/blog/ISO_9001_seria/5_ISO_9001/Organizational_Roles_iso9001_cover_small.jpg)
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 Policy: establishing and communicating the quality policy – Lecture 4](/files/Pictures/blog/ISO_9001_seria/4_ISO_9001/Policy_iso9001_cover_small.jpg)
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 and commitment – Lecture 3](/files/Pictures/blog/ISO_9001_seria/3_ISO_9001/Leadership_and_commitment_iso9001_cover_small.jpg)
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 Understanding the organization and its context – Lecture 2](/files/Pictures/blog/ISO_9001_seria/2_ISO_9001/Understanding_the_organization_iso9001_cover_small.jpg)
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 Introduction (Scope, normative references, terms, and definitions) – Lecture 1](/files/Pictures/blog/ISO_9001_seria/1_ISO_9001/Introduction_iso9001_cover_small.jpg)
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 The library – feature for the rest of the company](/files/Pictures/blog/library/library_cover_small.jpg)
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 Gap analysis in QMS](/files/Pictures/blog/ISO_13485/Gap_analysis/GAP_analysis_cover_small.jpg)
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? How To establish an ISO 13485:2016?](/files/Pictures/blog/ISO_13485/How_to_establish_ios13485/How_to_establish_iso13485_cover_small.jpg)
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 Improvement through corrective and preventive action – Lesson 20](/files/Pictures/blog/ISO_13485/iso_13485_20/ISO13485_lesson20_cover_small.jpg)
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 What ISO 13485 considers under - Analysis of data? – Lesson 19](/files/Pictures/blog/ISO_13485/iso_13485_19/ISO13485_lesson19_cover_small.jpg)
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 Control of nonconforming products in ISO 13485 – Lesson 18](/files/Pictures/blog/ISO_13485/iso_13485_18/ISO13485_lesson18_cover_small.jpg)
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 measurement according to ISO 13485 – Lesson 17](/files/Pictures/blog/ISO_13485/iso_13485_17/ISO13485_lesson17_cover_small.jpg)
Monitoring and measurement according to ISO 13485 – Lesson 17
Monitoring and measuring activities of products are the necessary controls to ensure the meddev performs as intended – simplified ISO 13485, by qmsWrapper.
![How ISO 13485 explains Measurement, analysis, and improvement – Lesson 16 How ISO 13485 explains Measurement, analysis, and improvement – Lesson 16](/files/Pictures/blog/ISO_13485/iso_13485_16/ISO13485_lesson16_cover_small.jpg)
How ISO 13485 explains Measurement, analysis, and improvement – Lesson 16
How to inspect product quality, determine the quality of your in-house processes, continuously improve methods of measuring customer satisfaction…
![Control of monitoring and measuring equipment in the medical device industry – Lesson 15 Control of monitoring and measuring equipment in the medical device industry – Lesson 15](/files/Pictures/blog/ISO_13485/ISO_13485_15/ISO13485_lesson15_cover_small.jpg)
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 Medical device Production and service provision in ISO 13485 - Lesson 14](/files/Pictures/blog/ISO_13485/iso_13485_14/ISO13485_lesson14_cover_small.jpg)
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 meddev specifications.
![What is Purchasing process in design and development in ISO 13485 – Lesson 13 What is Purchasing process in design and development in ISO 13485 – Lesson 13](/files/Pictures/blog/ISO_13485/iso_13485_13/ISO13485_lesson13_cover_small.jpg)
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 adhere to the stated purchasing information. What does that mean?
![From A to Z about Design and Development of medical device ISO 13485:2016 – Lesson 12 From A to Z about Design and Development of medical device ISO 13485:2016 – Lesson 12](/files/Pictures/blog/ISO_13485/iso_13485_12/ISO13485_lesson12_cover_small.jpg)
From A to Z about Design and Development of medical device ISO 13485:2016 – Lesson 12
D&D is explained to prevent failure because if your meddev fails to meet regulatory design requirements, it won’t be able to reach the market.
![Customer-related processes – Lesson 11 Customer-related processes – Lesson 11](/files/Pictures/blog/ISO_13485/iso_13485_11/ISO13485_lesson11_cover_small.jpg)
Customer-related processes – Lesson 11
What is important when determining requirements, when it's time to review, and how to communicate with your customers?
![What is considered by the planning of your product realization as per ISO 13485 – Lesson 10 What is considered by the planning of your product realization as per ISO 13485 – Lesson 10](/files/Pictures/blog/ISO_13485/iso_13485_10/ISO13485_lesson10_cover_small.jpg)
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 meddev. Chapter of product realization of ISO 13485.
![Work environment and contamination control according to ISO 13485 – Lesson 9 Work environment and contamination control according to ISO 13485 – Lesson 9](/files/Pictures/blog/ISO_13485/iso_13485_9/ISO13485_lesson9_cover_small.jpg)
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 What is Resource Management in the medical device world – Lesson 8](/files/Pictures/blog/ISO_13485/iso_13485_8/ISO13485_lesson8_cover_small.jpg)
What is Resource Management in the medical device world – Lesson 8
The importance of the connection between qualified employees, the implementation of QMS, and the maintenance of its effectiveness.
![All about Management Review in ISO 13485 – Lesson 7 All about Management Review in ISO 13485 – Lesson 7](/files/Pictures/blog/ISO_13485/iso_13485_7/ISO13485_lesson7_cover_small.jpg)
All about Management Review in ISO 13485 – Lesson 7
How important is management review input and output while you build your meddev, read this explained chapter of ISO 13485 – all about management review.
![Responsibility, authority, and communication in ISO 13485 – Lesson 6 Responsibility, authority, and communication in ISO 13485 – Lesson 6](/files/Pictures/blog/ISO_13485/iso_13485_6/ISO13485_lesson6_cover_small.jpg)
Responsibility, authority, and communication in ISO 13485 – Lesson 6
In every meddev company, there must be an organizational structure. Learn about responsibility, internal communication, and management representative.