ISO 13485:2016 Internal Auditor Course – Medical Devices

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ISO 13485:2016 Internal Auditor Course – Medical Devices

ISO 13485:2016 Medical Device QMS Internal Auditor Training Course

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Medical Devices are critical for the effective treatment of human health-related issues. Patients undergoing any form of treatment should not be adversely affected by medical devices that are used during a treatment which could result in adverse impacts. Medical Devices are therefore regulated by governments through laws and controls. The Medical Devices Rules: 2017, have been notified by the Central Government (Government of India) and have been in effect since 2018. The rules are harmonized with international regulatory practices.

Medical Devices have a classification based on the Risk they may pose on the patient due to the device. The lowest risk devices are classified as A, then B, C, and the most severe risk devices as D. For risk categories A and B, CDSCO has recognized Quality Austria Central Asia as a Notified Body under the Medical Device Rules: 2017. Notified Bodies are nominated by the State Governments to conduct Audits on behalf of the State Licencing Authority, of a particular Medical Device manufacturer and to submit their report and based on the report, the State Government Licencing Authority would issue a certificate. For risk categories C and D, the Central Licencing Authority is responsible, and they do not nominate Notified Bodies to conduct the audit on their behalf. The Notified Bodies would audit the manufacturing covering the following

Technical review of respective documents as prescribed
On-site audit of the manufacturer’s quality management system as laid in the fifth schedule of the Medical Device Rules:2017
Establish conformity by examination and provision of objective evidence
To the essential principles laid down by the Central Government from time to time
Establish design conformity by reviewing the design documents during
Assessment of medical devices to ensure their quality, safety, and performance
Quality Austria Central Asia is recognized as a “Semi Regulator” or a Notified Body by CDSCO
We are approved via Notification related to MD-2 ie we can grant licenses for the Manufacturing, Sales, Storage, Distribution, and Exhibition of Medical Devices for Class A and Class B
Quality Austria Central Asia will grant a license as per Schedule 4(Plant Medical File ie MD-5) and Schedule 4(as per ISO 13485)
Non-measurable and Non-Sterile Devices, No Audit is required(Notified dated 14/10/2022); clients can directly register on the CDSCO Portal and they are granted Licenses.

Risk Criteria	Classification	Licensing Responsibility	Examples	Audit responsibility
Low	Class A	State Licensing Authority	Surgical Dressing(Dressing Pads, Alcohol swabs)	Notified Bodies
Low Moderate	Class B	State Licensing Authority	Intravenous Catheter, IV Cannula, Disinfectant	Notified Bodies
Moderate High	Class C	Central Licensing Authority	Bone Cement, Bifurcation Stent	Central Authority
High	Class D	Central Licensing Authority	Heart Valves, Copper T, Coronary Patches, Coronary Stent	Central Authority

The objective of the ISO 13485:2016 internal auditor training course is to help you learn how to audit the processes of an ISO 13485:2016 Quality Management System (QMS). This course provides guidance and practical experience in planning, executing, reporting, and auditing follow-up of an internal audit while maintaining the effectiveness and conformity of an ISO 13485:2016 compliant QMS. In the course, we will cover the general principles of ISO 13485:2016 auditing and walk through all the clauses in this standard, to provide a holistic picture of how audits can be performed.

What You Will Learn?
The ISO 13485:2016 Internal Auditor Training will help you:

Know ISO 13485:2016 structure and scope, as well as how it pertains to organizations seeking regulatory compliance.
Recognize essential auditing principles and auditor responsibilities.
Plan for an internal audit.
Know about general concepts and principles of auditing.
Post-audit activities and CAPA planning.

What You Will Gain Through This Course?

Know the ISO 13485:2016 requirements and the quality system requirements of Directives 93/42/EEC and 98/79/EC.
Have a good understanding of how to conduct internal quality system audits.
Plan and prepare for an internal audit by understanding the function of internal audits in the maintenance and enhancement of management systems.
Collecting information through observation, questioning, and sampling.
Conduct a thorough audit based on identifying, sampling, and questioning processes.
Check to see if corrective action has been taken effectively.

Who Can Attend the ISO 13485:2016 Internal Auditor Training course?

Internal auditors
Consultants
Individuals interested in performing first-party or second-party audits
Management representatives
Medical device quality professionals with expertise in quality management systems and ISO 13485:2016

Pre Requisite
You should have an understanding of the Plan-Do-Check-Act cycle and the process used in the quality cycle management.

For any queries or further information related to our services, please feel free to contact us at info@qacamail.com or call us at +919599619392. We are here to assist you!

Frequently Asked Questions

The ISO 13485:2016 Internal Auditor Training Course is designed to help participants understand and audit Medical Device Quality Management Systems (MDQMS) in accordance with ISO 13485:2016 requirements and applicable regulatory standards for medical devices.

This course is ideal for internal auditors, quality managers, medical device professionals, consultants, management representatives and individuals involved in maintaining or auditing quality management systems within the medical device industry.

ISO 13485 helps medical device manufacturers establish consistent quality processes, improve product safety, meet regulatory requirements, reduce risks and enhance customer confidence in medical devices and related services.

The training covers ISO 13485:2016 requirements, audit planning, audit execution, CAPA processes, risk-based thinking, ISO 19011 auditing guidelines, audit reporting and practical internal auditing techniques for medical device quality systems.

Participants should have a basic understanding of the Plan-Do-Check-Act (PDCA) cycle and quality management principles. Familiarity with medical device regulations and ISO 13485 concepts can be beneficial.

The ISO 13485 Internal Auditor course is typically conducted over 2 days and is available in online training mode with practical audit-based learning sessions.

ISO 13485 Internal Auditor certification helps professionals build expertise in medical device quality systems, improve auditing skills, support regulatory compliance activities and pursue career opportunities in medical device manufacturing, healthcare and compliance management.