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Certified Internal Auditor for ISO 13485:2016 | Medical Devices Management System

Certificate Course

WhatsApp Number: +919599619392

Email Address: info@qacamail.com

Description

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 audit 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's 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

 

Course Pre-requisites

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

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Offline Price: 5200.00 INR

Online Price: 0.00 INR

Duration: 5

Study Method: Online/Offline

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The objective of Understanding Core Tools (APQP/PPAP, FMEA, SPC, and MSA) Following the AIAG FMEA 4th Edition, the methodology provides the basics tools that are the building blocks for creating and managing a quality management system in a company. Individuals pursuing IATF 16949 certification will understand the main tools to provide continuous improvement while focusing on defect avoidance, supply chain variation, and waste reduction.

What You Will Learn?

The Understanding Core Tools (APQP/PPAP, FMEA, SPC, and MSA) Following the AIAG FMEA 4th Edition Methodology training course will help you:

  • • Learn OEMs tools made necessary in the automotive sector.
  • • Find Connection to IATF 16949:2016.
  • • Understand FMEA revisions and new standards.
  • • Develop understanding utilizing the 7-step FMEA technique and new tables, such as the table for Action Priority.

What You Will Gain Through This Course?

  • • A thorough understanding of the various parts of the IATF 16949: 2016 QMS and processes.
  • • Efficiently generate and assess PPAP documents in order to improve the efficiency of the product, process, and development operations.
  • • Effectively review vendors' PPAP.
  • • You will be able to develop appropriate PROCESS FLOW, DFMEA, PFMEA, and CONTROL PLAN.
  • • Effectively contribute to the internal audit and supplier audit processes.
  • • Utilization of SPC to improve quality in the organization.
  • • Perform effective MSA for variable and attribute measurements.
  • • Practice the APQP process in order to fulfil the customer's deadline.
  • • Gain a working knowledge of the bulk material industry.

Who Can Attend the Understanding Core Tools (APQP/PPAP, FMEA, SPC, and MSA) Following the AIAG FMEA 4th Edition Methodology Training course?

  • Managers
  • Engineering
  • Quality
  • Production
  • Process Engineering
  • PPC Supplier Development
  • All IATF 16949 internal auditor

Course Pre-requisites

A degree / diploma in science / engineering / technology.

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The objective of the IATF 16949:2016 Awareness & Internal Auditor Course is to help you conduct internal audits of Automotive Quality Management Systems (QMS) using the process approach to verify compliance with IATF 16949:2016. The course also helps you gain knowledge of the key terms, definitions, and requirements of IATF 16949:2016. In addition, you will learn how the standard can help your organization better meet automotive customer needs. This IATF 16949:2016 Awareness & Internal Auditor Course is designed to give representatives from key functional areas involved in the organization's QMS the skills and experience to help their company achieve the best standards.

 

What You Will Learn?

The IATF 16949:2016 Awareness & Internal Auditor Course will assist you in the following areas:

  • •  Understand the differences between ISO/TS 16949 and IATF 16949:2016 regulations.
  • •  Understand how to use quality management principles in the ISO 9001 and IATF 16949 frameworks.
  • •  Connect the quality management system to the firm's products, services, activities, and operational processes.
  • •  Assist with IATF 16949:2016 implementation.
  • •  Meet the IATF revisions' internal and third-party auditor requirements.
  • •  Understand how to use auditing principles, methods, and techniques.
  • •  Understand how to conduct a successful audit in the context of the auditee's organization.

 

What You Will Gain Through This Course?

  • •  Determine the benefits and requirements of an IATF 16949:2016 audit and put them into practice.
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  • •  Prepare factually accurate audit reports and aid with corrective action.
  • •  How to use a checklist for auditing an IATF 16949 Quality Management System for value addition in the organization.
  • •  Understanding essential elements of IATF rules, queries and SIs followed by certification agency external auditors..
  • •  Identify and fix any shortcomings in implementing the IATF 16949 Quality Management System.
  • •  IATF 16949:2016 audit actions should be planned, carried out, and followed.
  • •  For efficient application in the organization, a thorough understanding of the IATF 16949 Clauses is required..

 

Who Can Attend the IATF 16949:2016 Awareness & Internal Auditor Course?

  • • Quality executives/managers in Automotive Supply Chain
  • • Management representatives
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Course Pre-requisites

You should have an understanding of both ISO 9001 and IATF 16949 requirements or may have a work experience in IATF 16949. If not, you can enroll in our ISO 9001 and IATF 16949 requirement courses to transition to a higher course.

Training batches


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