ISO 13485 Internal Auditor Training

Introduction to ISO 13485 Internal Auditor Training

ISO 13485 Internal Auditor trainingInzinc Consulting India Pvt. Ltd. (formerly Inzinc Products and Services) offers ISO 13485 Internal Auditor Training in Bangalore, Chennai, Mumbai, Delhi, and other Indian cities. ISO 13485 is the Quality Management System standard for Medical Devices (QMS-MD). This training really helps an Organization who are in the process of implementing the ISO 13485:2016 QMS-MD Standard. By enrolling to this training, their personnel will acquire the basic knowledge and develop competency to conduct ISO 13485:2016 internal Audits in their Organization. We conduct this training both through online and on-premise training modes for the convenience of our Customers.

Learning objectives of the ISO 13485 Internal Auditor training

The ISO 13485 Internal Auditor Training is conducted with the following learning objectives to achieve post training:

  • Understanding the basics of Medical Devices Quality Management System and ISO
  • Learn the ISO 13485:2016 Clauses 
  • Learn Internal audit process, auditing techniques and other audit basics
  • Develop the ability to conduct ISO 13485:2016 Internal Audits in the Organization

Audience for the ISO 13485 Internal Auditor Training

Following are the type of personnel who would be the right audience to take this training:

  • Medical Device Management representative
  • Process Owners or Departmental Heads of the Organisation
  • Top Management

Brief topics covered in the training

Following topics are covered in the ISO 13485 Internal Auditor Training session:

  • Basic Medical Device, Quality definitions and concepts
  • About ISO and its brief history 
  • What is ISO 13485 ?
  • Benefits of ISO 13485 standard implementation
  • The PDCA Cycle
  • Understanding the essence of each of the ISO 13485 Clauses
  • Learn basic audit definitions and concepts from ISO 19011
  • Types of audits
  • Auditing principles
  • Audit techniques
  • Qualities required in an auditor
  • Internal Audit process / phases of an audit
  • Understand Non-conformity and its types
  • Learn to write non-conformity, correction and corrective actions
  • Learn about reporting of Internal audit results

Highlights of the Course

  • Classroom learning
  • Illustrative examples wherever required
  • Case studies
  • Exercises
  • Role play for a bigger audience

Duration of the training

The duration of training is 3 days with minimum of 21 hours of training

Mode of the training

We conduct training through two modes:

  • On-premise training at our Customer’s premises or our training centers
  • Remote online training with live Presentation through video-conferencing

Faculty for the training

Experienced tutor with Industry and auditing experience who is also an ISO 13485 Auditor

Trainee Evaluation

Trainees will be given a simple test on the training topics. These may be mostly objective based with few descriptive questions. 

Evaluation and Certification

Candidates will be awarded soft copy certificates within 1 working day after the course subjected to passing the test on training topics. Hard copies will be couriered post training session within a working week.

Study Material

Candidates will be provided with hard copy slide notes on the above topic. For trainees enrolled into the online training mode, we will provide them with the soft copy slide notes for their reference.

Fill up the training registration form below and submit the details to enable us to provide you with an offer.

Pre-requisite for training

Though we put our best efforts to train personnel in limited time, as a pre-requisite it helps trainees immensely if they have glanced through the ISO 13485 standard at least once before attending the training session. By this, their level of correlating and understanding the concepts and clauses is enhanced.

Online ISO 13485 Internal Auditor Training

Apart from On-premise training, Inzinc Consulting India Pvt. Ltd. conducts Online ISO 13485 Internal Auditor training in Bangalore (Bengaluru) and other places like Bagalkot, Belgaum (Belagavi), Bellary, Bidar, Bijapur, Chamarajanagar, Chikmagalur, Chitradurga, Coorg, Dakshina Kannada, Davanagere, Dharwad, Gadag, Gulbarga, Hassan, Haveri, Honnavar, Hospet, Hubli (Hubballi), Kolar, Koppal, Mandya, Mangalore (Mangaluru), Manipal, Mysore, Nanjangud, Raichur, Ramanagaram, Ranibennur (Ranebennuru), Shimoga (Shivamogga), Tiptur, Tumkur, Udupi, Uttara Kannada, Yadgir, and other cities in Karnataka.

Inzinc Consulting India Pvt. Ltd. also conducts Online ISO 13485 Internal Auditors Training in Chennai, Coimbatore, Hyderabad, Amravati, Vizag, Vishakapatnam, Trivandrum (Thiruvananthapuram), Kochi, Panjim (Goa), Pune, Mumbai, Nashik, Gandhinagar, Vadodara (Baroda), Ahmedabad, Jaipur, Johpur, Chandigarh, Delhi, Kolkata, Bhopal, Baddi, Gurugram (Gurgaon), Noida, Gwalior, Indore, Haridwar, Dehradun, Jamshedpur, Durgapur, Bhubaneswar, Raipur and other cities in India.

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