ISO 13485: Quality Management Systems for Medical Devices
Course duration: Allow 2 to 4 hours to complete this course.
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GMP education topic: ISO 13485:2016 QMS requirements
ISO 13495 and Quality Management Systems for Medical Devices
QMS requirements for Medical Devices
This self-paced online training presentation for ISO13485 compliance will help you understand what’s required for your Quality Management System (QMS) including documentation.
QMS requirements discussed in this course include but are not limited to the following:
- Medical Device QMS – Quality Policy
- Quality Objectives
- Quality Manual
- Personnel competency assessments and training programs
- Resource Management
- Management Reviews
- Risk Management Strategies
- Comparison of ISO 13485 vs MDSAP
- Common audit findings relating to Medical Device QMS deficiencies
Medical Devices& ISO 13485 QMS requirements
Preparing your team to comply with ISO Quality Management System (QMS) requirements for Medical Devices.
- This online ISO13485 compliance training course is suitable for any business that:
- Manufactures, services, imports, exports and/or distributes a Medical Device
- Including medical software products and healthcare software programs
- It’s available in an entirely self-paced format via the internet
- It is a Certificate Training Course (training certificates/records meet GMP requirements for personnel files/training program recordkeeping)
Once you pass the Final Assessment for this ISO 13485:2016 training course, you will gain a Certificate of Completion for your personnel files and company GMP training program records. You can also attach the Certificate to your CV/resume, when applying for job openings in the Medical Device Manufacturing industry.
Who will benefit from taking this ISO13485 course?
This training course covering ISO 13485 QMS standards, is suitable for a wide range of personnel.
It is generally suitable for the following Managers, Product Developers, Quality Management Professionals, & Operations/Manufacturing personnel including but not limited to:
- Founders/CEOs of medical device companies
- Quality Managers
- Quality Associates in Medical Device Sectors
- Personnel and Contractors
- Medical Device Service Providers including maintenance workers/validation teams
- Medical device designers and engineers
- Purchasing teams and Operational team members
- Medical device software designers and software update support personnel
- QMS documentation specialists
ISO 13485: QMS standards for Medical Device Manufacturers, Service Providers, & Distributors
Completing this Certificate Course for this ISO compliance topic will help your team understand what’s required in terms of:
- Quality Management System Documentation
- QMS documents including procedures/SOPs
- Management review meeting documentation
- Personnel Competency Assessments
- Corrective and preventive actions
- Auditing schedules and more
- Quality Risk Management (QRM) principles
- Risk-based decision-making requirements (refer to ISO 14971:2019)
- Rules for exceptions to ISO 13485 requirements (documented justifications)
- Product Risk Classes (Product Risk Classifications)
- How ISO 13485 compares with MDSAP and other standards such as ISO 9001
- Importance of Root cause analysis and CAPA documentation
This online GMP training course will answer frequently asked questions (FAQs) relating to ISO 13485 requirements for your Quality Management System (QMS). It can help personnel understand what Regulatory Authorities generally expect from medical device companies and their management teams, employees, and suppliers.
Medical Device Products: Quality Control Requirements
FAQs by medical device manufacturers/distributors, which are answered in this course, include the following:
- What are the regulatory requirements for establishing an effective Quality Management System (QMS)?
- What procedures and documentation controls are required to ensure compliance with ISO13485 (ISO 13485:2016)?
- What personnel training is required in relation to medical device quality assurance?
- How do self-inspections, regulatory compliance audits, and management reviews assist with quality control?
- How should documents be controlled in order to avoid the use of obsolete documents?
- What change control measures need to be in place?
- Which procedures need to be validated?
- How does ISO 13485 compare to MDSAP requirements?
- What is the difference between ISO 13485 and ISO 9001?
- How does ISO 14971 (Risk Management) relate to QMS requirements?
Learn about ISO 13485:2016 QMS requirements for medical devices.
This fully online Certificate GMP training course is suitable for a global audience and for any type of regulated medical device.
To order, simply scroll up and “add to cart”, complete your purchase, and then check your email system for an email with your log-in details (search all mailboxes).
This course includes examples of QMS requirements from Regulatory Authorities such as:
- EU EMA
- US FDA
- Australian TGA (UPRTG)
- UK MHRA
Purchase this course online, and start your training today! Be sure to read the FAQs so you know what to expect.
The content for this regulatory compliance course is based on publications from ISO, the FDA, TGA, MHRA, and other regulators as well as insights from our team of regulatory compliance experts for medical device businesses.
- It includes information on MDSAP vs ISO 13485 requirements.
- If you develop, design, manufacture, import, service, repair, distribute, update, or are otherwise involved with Medical Devices, this course will be a great addition to your best-practice Regulatory Compliance Training program.
This ISO 13485 QMS course is suitable for a worldwide audience.
Regional examples of QMS requirements in different regions:
- The course includes examples of globally accepted standards for establishing and maintaining an effective Quality Management System).
- It also includes references to QMS guidance that is specific to certain regions/Regulatory Authorities, e.g.
- The US (FDA QMS guidance in CFR 21 Part 820)
- Australia (TGA guidance for medical devices and IVDs), and
- Other regulators
Earn your GMP training certificate in “ISO 13485” to add to other GMP education topics including management of deviations, complaints management, and CAPA!
- ISO 13485:2016 compliance training (Medical Device QMS Guidelines/Medical Device Regulations) is ideal to complete along with the Complaints Management course, the Deviations and Non-Conformances management course, and the CAPA systems training course.
- Subsequent to completing ISO 13485, learners should complete the ISO 14971 – Medical Device Risk Management training course.
GMP industry and ISO 13485 compliance training experts
- This is one of our many GMP education topics eLearning courses available 24/7.
- Click here for a list of face-to-face courses delivered via Zoom (onsite training of large groups of personnel may also be available, where feasible).
Training Program Recommendation:
- Combine this ISO QMS standards course with ISO 14971 training for the Application of Risk Management Principles for Medical Devices/Medical Device Manufacturers.
- If your product includes software, be sure you consider Annex 11 and SaMD regulatory compliance courses – visit the GMP online training page for self-paced GMP education topics.
- You can purchase a single course or just a few of the courses you need for just-in-time learning.
- Note: one learner, one cGMP course completion Certificate per course purchase.
- The learner will have 12 months’ access to the course and a downloadable online CAPA training certificate of completion.
Note: All course prices are in US dollars.
Bundled training options let you ‘mix and match’ standard courses and/or assign courses to different employees when required (enabling ‘just in time’ GMP training). All successfully completed courses provide learners with a time-dated GMP Training Certificate for successful completion of that particular GMP education topic.
Get your Course Certificate for ISO 13485 training
- Completion of any of our online GMP courses will enable you to print your GMP topic Course Certificate — and earn a Credly badge for your social media channels.
- You can also attach your Certificate of Completion to your CV when applying for jobs in the pharmaceutical sector.
How to complete this course.
- Add the course to your basket and complete your purchase.
- Remember, the course fees are listed in US Dollars.
- Check your emails (all folders) for log-in instructions approximately 5 to 10 minutes after your order is finalised.
- Be sure to search for/add the following domains to your safe sender’s list: “@onlinegmptraining.com” and @pharmout.net”.
One user/per licence purchase (12 months’ access)
- This ISO 13485 (regulatory compliance) education course is available online, one user per licence.
- Course completion provides learners with a foundational understanding of planning and implementing an effective QMS for medical devices and medical device servicing, including medical device software updates and post-marketing surveillance.
Allow 2 to 4 hours to complete this ISO 13485 QMS (Medical Devices) eLearning training course including the online Final Assessment.
Other recommended courses include:
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Are your SOPs for deviation management out of date?
- Click here for Deviation Management examples and templates.
- Technical writers for SOPs are also available as PQS/QMS consultants/writers.