Beginners guide through
a series of articles explaining each part of this standard.
ISO 13485 is an international standard for establishing quality management in the medical device industry. The practice of implementing a QMS is a long-term tactical decision that, once in place, works to guide the medical device company to meet standards constantly, improve general performance, and to provide a basis for maintainable development initiatives. A QMS also gives assurance to customers that the requirements for quality have been met. I’ve noticed that the medical device industry is missing an obvious interpretation of the ISO 13485 requirements, so I’ve written this guide and translate the requirements into plain English.
The industry’s best-practice is implementing electronic quality management. eQMS is a system that is very easy to maintain, it makes all information available online to audit easily, and any recent changes can be communicated quickly to all staff members. qmsWrapper is a ready-to-use eQMS for medical device companies. It is interconnected Quality Management software for companies focused on regulatory issues, and quality requirements specific to these companies.
The following lessons are here to turn you into
a ISO 13485 expert.
5 FAQs about 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
Lesson 11: Customer-related processes
Lesson 12: From A to Z about Design and Development of medical device
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
It is not easy to fully understand the standards, which is why we, as a company that produces QMS software for medical devices companies, considered ourselves responsible to facilitate the path to implementation and interpret the ISO 13485 standard. For an even easier, faster, more reliable implementation, start using digital QMS:
qmsWrapper provides the means for teams to work effectively together, integrating Quality Management, Documentation and Risk, Design Controls, and Team Communication. Startups, mature organizations, and quality-oriented teams will find qmsWrapper the right approach to achieving painless compliance.
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