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Learning Guides

Your guidebook of standards and more; carefully crafted by the qmsWrapper team
to help you understand the ease of being compliant.

Beginners guide through ISO 13485

(20 lessons)
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
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Beginners guide through ISO 9001

(24 lessons)
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
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