ISO 13485:2016 Quality Management Lead Auditor Training
The QualCert ISO 13485:2016 – Quality Management Systems for Medical Devices Lead Auditor Course is designed to provide professionals with the knowledge and skills required to audit, assess, and certify quality management systems (QMS) specific to the medical device industry. The QualCert ISO 13485:2016 – Quality Management Systems for Medical Devices Lead Auditor Course follows internationally recognized auditing principles and best practices to ensure compliance with ISO 13485:2016, the globally accepted standard for medical device QMS.
The QualCert ISO 13485:2016 – Quality Management Systems for Medical Devices Lead Auditor Course covers audit planning, execution, non-conformity reporting, and corrective actions, preparing learners to lead internal and third-party audits effectively. With a focus on regulatory compliance, risk management, and continuous improvement, this course is ideal for quality professionals, auditors, and medical device manufacturers aiming for ISO 13485 certification.
By completing this QualCert ISO 13485:2016 – Quality Management Systems for Medical Devices Lead Auditor Course, participants will be equipped to enhance product quality, patient safety, and regulatory compliance, ensuring the highest standards within the medical device industry. The QualCert ISO 13485:2016 – Quality Management Systems for Medical Devices Lead Auditor Course is a comprehensive training program designed to develop expertise in auditing and assessing medical device quality management systems (QMS) in accordance with ISO 13485:2016.
Program Framework
The QualCert ISO 13485:2016 – Quality Management Systems for Medical Devices Lead Auditor Course offers 30 Credits, requiring a Total Qualification Time (TQT) of 180 hours, including 120 Guided Learning Hours (GLH).
| Unit Ref# | Unit Title | Credit | GLH | TQT |
| QC17004-1 | Introduction to ISO 13485:2016 and Medical Device QMS | 5 | 20 | 30 |
| QC17004-2 | Regulatory Requirements for Medical Devices | 5 | 20 | 30 |
| QC17004-3 | Audit Planning, Preparation, and Risk Management | 5 | 20 | 30 |
| QC17004-4 | Conducting QMS Audits for Medical Devices | 5 | 20 | 30 |
| QC17004-5 | Non-Conformity Identification, Reporting, and CAPA | 5 | 20 | 30 |
| QC17004-6 | Certification Process and Auditor Responsibilities | 5 | 20 | 30 |
Eligibility Criteria
To enrol in the QualCert ISO 13485:2016 – Quality Management Systems for Medical Devices Lead Auditor Course, candidates are expected to meet the following entry requirements to ensure they can fully benefit from the program:
- Minimum Age: 18 years old at the time of enrollment.
- Educational Background: Secondary education or equivalent is required; prior study in medical devices, engineering, life sciences, healthcare, or quality management is recommended.
- Work Experience: No formal auditing experience is mandatory; however, prior exposure to quality management systems, medical device manufacturing, regulatory compliance, or internal auditing is highly beneficial.
- Language Proficiency: Proficiency in English is required to understand ISO standards, technical documentation, audit procedures, and assessment requirements.cation.
Core Achievements
Introduction to Quality Management Systems (QMS)
- Understand the fundamental principles of quality management and their importance in the medical device industry.
- Explain the purpose and benefits of an effective ISO 13485:2016 QMS.
ISO 13485:2016 Standard and Requirements
- Identify key ISO 13485:2016 clauses and their application in medical device manufacturing.
- Demonstrate knowledge of regulatory requirements related to medical devices (e.g., FDA, EU MDR).
Audit Fundamentals and Principles
- Explain the principles of auditing, including integrity, fair presentation, confidentiality, and due professional care.
- Recognize the role of an ISO 13485 lead auditor in ensuring compliance and continual improvement.
Audit Planning and Preparation
- Develop an audit plan, including defining objectives, scope, and criteria for an ISO 13485 audit.
- Apply risk-based thinking to prioritize critical audit areas in medical device QMS.
Conducting an ISO 13485:2016 Audit
- Perform on-site and remote audits using standard auditing techniques.
- Assess compliance with ISO 13485:2016 requirements and identify areas for improvement.
Non-Conformity Identification and Reporting
- Detect and document non-conformities using standardized methods and reporting structures.
- Provide corrective and preventive action (CAPA) recommendations to enhance QMS compliance and effectiveness.
The QualCert ISO 13485:2016 – Quality Management Systems for Medical Devices Lead Auditor Course is designed for professionals involved in medical device quality management, auditing, and regulatory compliance. This course is ideal for:
- Quality Assurance (QA) and Quality Control (QC) Professionals – Individuals responsible for maintaining and improving quality management systems in medical device manufacturing.
- Internal and Lead Auditors – Professionals conducting first-party (internal), second-party (supplier), or third-party (certification) audits within the medical device industry.
- Regulatory Affairs Specialists – Those working with global medical device regulations, ensuring compliance with FDA, EU MDR, and other international standards.
- Medical Device Manufacturers and Suppliers – Organizations seeking to achieve or maintain ISO 13485:2016 certification to ensure product quality and patient safety.
- Consultants and Compliance Officers – Experts advising medical device companies on ISO 13485 implementation, auditing, and regulatory requirements.
- Engineers and Production Managers – Individuals responsible for ensuring manufacturing processes comply with ISO 13485:2016 quality and safety requirements.
This course is suitable for professionals seeking to develop in-depth auditing skills, enhance regulatory compliance, and improve overall quality management in the medical device industry.
Assessment and Verification
Assessment Framework :
This qualification consists of 6 mandatory assignments designed to assess the learner’s understanding and practical application of the required skills and knowledge. The key elements of the assessment framework include:
- Comprehensive Assignment Structure:
The assignments are designed to cover a range of topics within the qualification, ensuring that learners demonstrate their competence across all essential areas. - Pass Requirement:
Learners must successfully complete all 6 assignments to meet the requirements for certification. Each assignment must meet the specified criteria and demonstrate sufficient understanding and application of the subject matter. - Assessment Process:
Each assignment is reviewed and marked by a qualified assessor, with feedback provided to support learner development. - Final Completion Criteria:
The successful completion of all assignments is necessary for certification. Only learners who meet the required standards across all assignments will be awarded the qualification.
Quality Assurance & Verification:
QualCert applies a rigorous, multi-layered quality assurance system to ensure the reliability, consistency, and integrity of all assessments and results.
1. Internal Quality Assurance (IQA)
Conducted by the approved training centre:
- Assignment Evaluation:
Centre-approved Assessors and Internal Quality Assurers (IQAs) review the assignments to ensure they meet the assessment criteria and learning outcomes. - Standardisation:
Regular standardisation sessions are held to maintain consistency in assessment and marking practices across all centre staff. - Feedback & Support:
IQAs ensure that learners receive constructive feedback to aid their progress and improve future submissions.
2. External Quality Assurance (EQA)
Conducted by QualCert:
- Independent Verification:
QualCert’s External Quality Assurers (EQAs) verify the completed assignments and assess the quality and fairness of the marking process. - Centre Audits:
EQAs audit the centre’s compliance with QualCert’s quality assurance standards, reviewing assessment practices, learner records, and overall delivery. - Final Certification:
After satisfying the EQA’s verification process, QualCert will officially issue the certification to the learner.
QualCert delivers all qualifications exclusively through its network of officially approved training centres.
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