Beginners guide through
ISO 13485

Learn everything about the ISO 13485 standard
through a series of articles that explain each part in detail.

ISO 13485 is an international standard for establishing quality management in the medical device industry. Implementing a QMS is a strategic, long-term decision that guides a medical device company to consistently meet standards, improve overall performance, and support sustainable development initiatives. A QMS also reassures customers that quality requirements are being met.

I've observed a lack of clear interpretation of ISO 13485 requirements within the industry, so I've written this guide to translate these requirements into plain English.

The best practice in the industry is to implement electronic quality management (eQMS). An eQMS is easy to maintain, makes all information readily accessible for audits, and quickly communicates recent changes to all staff members. qmsWrapper is a ready-to-use eQMS for medical device companies, providing interconnected Quality Management software tailored to regulatory and quality requirements.

Tajana Vasilic, qmsWrapper expert
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“Beginners guide through ISO 13485”

The following lessons are designed
to turn you into an ISO 13485 expert

5 FAQs about ISO 13485

What are 5 the most frequently asked questions about ISO 13485? Check the questions, but find out all answers.
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Lesson 1: Understand ISO 13485

ISO 13485 for everyone - Simplified, explained, chapter by chapter - quality management system for medical devices! Start with lesson 1.
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Lesson 2: What are the General requirements in ISO 13485

Get familiar with the technical terms and general requirements of ISO 13485. qmsWrapper has adjusted it and simplified, so everyone can understand it. QMS establishment, structure clarification, etc. – all explained.
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Lesson 3: Essentials of Documentation requirements in ISO13485

What is quality manual, a medical device file, or document control – learn in lesson 3 that qmsWrapper have prepared for everyone who begins in the medical device world.
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Lesson 4: What are the Management Responsibilities according to ISO 13485

Find out who and how supposed to be responsible in the amazing world of Quality management system for medical devices. Learn about Quality Policy, and much more.
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Lesson 5: What is considered by QMS planning in 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.
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Lesson 6: Responsibility, authority, and communication in ISO 13485

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.
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Lesson 7: All about Management Review in ISO 13485

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.
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Lesson 8: What is Resource Management in the medical device world

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.
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Lesson 9: Work environment and contamination control according to ISO 13485

Work environment and contamination control are important and critical for effective and compliant medical device business run. qmsWrapper explains it all.
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Lesson 10: What is considered by the planning of your product realization as per
ISO 13485

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.
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Lesson 11: Customer-related processes

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.
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Lesson 12: From A to Z about Design and Development of medical device
ISO 13485:2016

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.
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Lesson 13: What is Purchasing process in design and development in ISO 13485

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.
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Lesson 14: Medical device Production and service provision in ISO 13485

This section of ISO 13485 covers the different elements and resources that combine the realization processes to ensure conformance to medical device specifications.
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Lesson 15: Control of monitoring and measuring equipment in the medical device industry

Control of monitoring and measuring medical devices are one of the most important parts of the ISO 13485. Learn from qmsWrapper
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Lesson 16: How ISO 13485 explains Measurement, analysis, and improvement

In this lesson learn how to inspect product quality, determine the quality of your in-house processes, continuously improving methods of measuring customer satisfaction…
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Lesson 17: Monitoring and measurement according to ISO 13485

Monitoring and measuring activities of products are the necessary controls to ensure the medical device performs as intended – simplified ISO13485, by qmsWrapper.
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Lesson 18: Control of nonconforming products in ISO 13485

A nonconformity is any failure to meet a requirement. Learn how to control it according to ISO13485.
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Lesson19: What ISO 13485 considers under - Analysis of data?

Learn about strategy for identifying the data for analysis because the ISO 13485 requires collecting data from all processes and activities.
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Lesson 20: Improvement through corrective and preventive action

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

Understanding standards can be a challenging task. That's why, as a company specializing in QMS software for medical device companies, we take it upon ourselves to simplify the process of implementing and interpreting the ISO 13485 standard. To make implementation even smoother, quicker, and more reliable, embrace digital QMS:

 

   

 

qmsWrapper empowers teams to collaborate effectively by integrating Quality Management, Documentation and Risk, Design Controls, and Team Communication. Whether you're a startup, a well-established organization, or a quality-focused team, qmsWrapper offers the ideal solution for achieving compliance effortlessly.

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