This ISO 13485 quality plan webinar will teach you how to create a quality plan step-by-step for compliance with ISO 13485:2016.
When is the ISO 13485 Quality Plan webinar?
The ISO 13485 quality plan webinar will be hosted as a live webinar on June 16, 2020, 8:30 am EDT. When you purchase this webinar, you will receive an invitation to participate in the live webinar. Everyone that registers for the webinar will receive a link to download the recording if you are unable to attend the live webinar.
Description of ISO 13485 quality plan webinar
If you aren’t sure what is ISO 13485? please visit our 2-part training webinar on the topic. If you’re planning to implement an ISO 13485:2016 quality system at your company or thinking about it. Maybe you are a medical device company with an existing quality management system that needs to implement ISO 13485:2016 in order to expand into export markets, such as Canada, Europe, Japan, or Australia. Maybe you are a supplier to the medical device sector who is required to implement ISO 13485:2016 to retain a customer or to attract new ones. Whatever external factors are driving you toward ISO 13485:2016 certification, you also have the opportunity to build a quality system that will be a source of competitive advantage to your company.
In the ISO 13458 quality plan webinar, you will learn how to develop a quality plan for implementing ISO 13485:2016 in your organization, how to resource and implement that plan, and then achieve ISO 13485:2016 certification in a timeframe that works for your company. You will also learn how to:
- Choose a certification body and schedule audits
- Build a simple, logical document structure
- Analyze which documents must be written or modified
- Integrate the ISO 13485:2016 quality system with other systems already in place
- Identify the records that must be maintained
- Plan the rollout and the training that is required
- Consider the change management aspects of the project
Who should attend the ISO 13485 quality plan webinar?
- Supplier quality
- Quality assurance
- Lead auditors
- Audit program managers
- Senior management
Additional Resources Related to Quality Plans
The following blogs include additional information related to creating quality plans:
- MDR Quality Plan – for EU Regulation 2017/745 Compliance
- How to write a quality system plan template (free download)
- How to implement a new ISO 13485 quality system plan in 2016
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About Your Instructor
Robert Packard is a regulatory consultant with 30 years of experience in the medical device, pharmaceutical, and biotechnology industries. He is a graduate of UConn in Chemical Engineering. Robert was a senior manager at several medical device companies—including President/CEO of a laparoscopic imaging company. His Quality Management System expertise covers all aspects of developing, training, implementing, and maintaining ISO 13485 and ISO 14971 certification. From 2009-2012, he was a lead auditor and instructor for one of the largest Notified Bodies. Robert’s specialty is regulatory submissions for high-risk medical devices, such as implants and drug/device combination products for CE marking applications, Canadian medical device applications, and 510(k) submissions. The most favorite part of his job is training others. Specialties: CE Marking, Canadian Medical Device Applications, Post-Marketing Activities, Supplier Quality, CAPA, Risk Management, Auditing, Sterilization Validation, Lean Manufacturing, Silicone Chemistry, Extrusion, Bioprocess Engineering, and Strategy. He can be reached via phone 802.258.1881 or email. You can also follow him on Google+, LinkedIn or Twitter.