Learning Guides

Unlock practical knowledge with qmsWrapper Learning Guides, crafted to simplify compliance with ISO 13485 and ISO 9001 standards.

Explore 24 in-depth lessons on ISO 9001 and 20 detailed guides on ISO 13485, designed to help you interpret requirements correctly and apply them in practice.

Step-by-step guidance ensures your team gains confidence in implementing quality management processes, reducing errors and improving efficiency.

Start learning today and master the art of compliance with our free, expert Learning Guides.

Beginners guide through ISO 13485

Lesson 1: Understand ISO 13485

Lesson 2: What are the General requirements in ISO 13485

Lesson 3: Essentials of Documentation requirements in ISO13485

Lesson 4: What are the Management Responsibilities according to ISO 13485

Lesson 5: What is considered by QMS planning in ISO 13485

Lesson 6: Responsibility, authority, and communication in ISO 13485

Lesson 7: All about Management Review in ISO 13485

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

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

Lesson 10: What is considered by the planning of your product realization as per ISO 13485

Lesson 11: Customer-related processes

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

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

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

Lesson 15: Control of monitoring and measuring equipment in the medical device industry

Lesson 16: How ISO 13485 explains Measurement, analysis, and improvement

Lesson 17: Monitoring and measurement according to ISO 13485

Lesson 18: Control of nonconforming products in ISO 13485

Lesson19: What ISO 13485 considers under - Analysis of data?

Lesson 20: Improvement through corrective and preventive action

Beginners guide through ISO 9001

Lecture 1: Introduction (Scope, normative references, terms, and definitions)

Lecture 2: Understanding the organization and its context

Lecture 3: Leadership and commitment

Lecture 4: Policy: establishing and communicating the quality policy

Lecture 5: Organizational Roles, Responsibilities, and Authorities

Lecture 6: Planning: Actions to address risks and opportunities

Lecture 7: Quality objectives and planning to achieve them

Lecture 8: Planning of changes

Lecture 9: Resources of Support

Lecture 10: Competence in Support of ISO 9001

Lecture 11: Awareness of support in ISO 9001

Lecture 12: Communication of support

Lecture 13: Documented information

Lecture 14: Operational planning and control

Lecture 15: Requirements for products and services

Lecture 16: Design and Development of products and services

Lecture 17: Control of externally provided processes, products, and services

Lecture 18: Production and service provision

Lecture 19: Release of products and services

Lecture 20: Control of Nonconforming Outputs

Lecture 21: Monitoring measurement, analysis, and evaluation

Lecture 22: Internal audit

Lecture 23: Management review

Lecture 24: Continual Improvement and Nonconformity and corrective action

Learning Guides

Unlock practical knowledge with qmsWrapper Learning Guides, crafted to simplify compliance with ISO 13485 and ISO 9001 standards.

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Beginners guide through ISO 13485

Beginners guide through ISO 9001

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