ISO 13485 school training courses in Cambridge, MA (public, in-house or online)

This four-hour interactive program introduces participants to the ISO 13485:2003 quality management system (QMS) standard for medical device manufacturers.. The program including discussions of when compliance or registration is required or desirable, how to document and design an effective QMS, what the new requirements mean for the worldwide medical device industry, and what auditors are looking for and finding. Also covered are the steps and potential benefits of registration, such as increas...

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Learn to develop and implement an internal quality system that meets the requirements of ISO 9001:2008 and ISO 13485. This course will help you prepare for an audit and effectively manage your resources. You’ll understand how to close out an audit and conduct follow-up surveillances.

This training course satisfies the requirement for RABQSA’s QMS Internal Auditor Registration Scheme. Learn the necessary background to develop, implement, and audit an internal quality system that meets the ...

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Understand the elements that constitute a quality system, and the audit evidence necessary to comply with ISO 13485 requirements. The course includes hands-on workshops that allow you to replicate the working environment of the medical device industry. The curriculum will reinforce key topics critical to your success in this field.

This training course is an RABQSA-certified course and meets the training requirements for certification of individual QMS auditors, QMS senior auditors, and Q...

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ISO 13485:2003 is a quality management system for an organization making medical devices and related services that consistently meet customer (and regulatory) requirements applicable to medical devices and related services. This standard includes unique clauses for medical devices and excludes some of the requirements of ISO 9001 that are not applicable. Therefore, conformance to ISO 9001 does not imply conformance to 13485 and vice versa. They must be independently certified.

ISO 13485 i...

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Day One
•Terminology and Definitions
•Background, History and Rationale for Quality Assurance
•Introduction to the ISO Family of Documents
•Analysis of the Contents of ISO 13485
•Audit of Active Medical (Audit #1)

Day Two
•Quality System Requirements
•Analyzing Findings
•Audit of Active Medical to ISO 13485 (Audit #2)
•RABQSA and U.S. Certification System
•Auditor Qualifications
•Roles and Responsibility of Auditors
•Creation of Effective Audit Checklis...

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