ISO 13485:2016 Medical Devices Documentation

Increase your competence in ISO 13485:2016 Documented information Control System for Medical Devices.

Course

2 Dates available

Certificate of Attendance

Virtual learning

8 Lessons

Available online

Seminar Number: PH-C05-ISO13485-Doc-VC

ISO 13485:2016 is the globally recognized standard for establishing a Quality Management System (QMS) dedicated to the medical devices industry. This training is designed to equip participants with a deep understanding of the standard's requirements, focusing on the creation, management, and control of documented information essential for meeting customer needs and regulatory compliance.

Embark on this essential training to master the documentation controls of ISO 13485:2016 and enhance the quality management of medical devices within your organization.

Benefits

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At the end of the seminar, participants should be able to:

Enhanced Compliance: Understand and implement the necessary practices to meet the standards of ISO 13485:2016.
Risk Reduction: Learn to manage documentation effectively to avoid misunderstandings and losses in business operations.
Improved Efficiency: Standardize operations and enhance the control of documents and records.
Knowledge Application: Gain the ability to not only follow but also improve documentation processes within your organization.

Target group

This course is tailored for professionals involved in the quality management and documentation of medical devices, including:

Quality Assurance Managers
Regulatory Affairs Specialists
Document Controllers
Process Engineers
Compliance Officers

Requirements

To fully benefit from this training, participants should have:

A foundational understanding of ISO 9001:2015 Quality Management Systems.
Some experience auditing practices is recommended but not mandatory.

No advanced technical skills are required, making this training accessible to anyone looking to enhance their auditing capabilities within the ISO 13485:2016 environment.

Training outline

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General Understanding of Management Systems

Purpose and Objective

Why Documentation is Critical

Role of Documents
Using Documents to Control Process Outcomes

Document Management System Effectiveness

Structure and Compliance
Naming Conventions and Documentation Standards

Detailed Examination of ISO 13485 Clauses

Clause 4: General Requirements and Documentation Information
Clause 5: Implementation and Control of Documentation

Document Master List & Inventory

Document Workflow and Change Management

Scope of ISO 10013:2021 Documentation Standard

Normative References, Terms, and Definitions

Annex A: Additional Insights

Other information

For payment details and inquiries, please contact academy@phl.tuv.com. Our team will guide you through the payment process and answer any questions about schedules, content, or logistics.

ADDITIONAL INFORMATION

Training fees include materials and a certificate.
Unless stated otherwise, fees are subject to 12% VAT.
A 50% down payment is required before the first day of training. The balance is due on or before the last day.
We accept various payment methods; please reach out for instructions.
For Classroom Trainings, there will be an additional ₱ 1,000 for ancillary costs.

CANCELLATION POLICY

TÜV Rheinland Philippines reserves the right to postpone or cancel public courses due to valid reasons.
Unless cancelled by TÜV Rheinland Philippines, all fees are non-refundable once registration is confirmed.
Cancellations made five days or fewer before the training date are non-refundable; full fees will be charged.
You may nominate a substitute delegate at no extra cost. Please provide their details at least three business days beforehand.

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