ISO 13485 LEAD AUDITOR

ISO 13485 LEAD AUDITOR
May 16, 2023 No Comments » ISO, PECB adminweb

ISO 13485 LEAD AUDITOR

Master the Audit of Medical Devices Quality Management Systems (MDQMS)

based on ISO 13485

*International Certification by Professional Evaluation and Certification Board (PECB)*

Background ISO 13485 LEAD AUDITOR

ISO 13485 Lead Auditor training enables you to develop the necessary expertise to perform a Medical Devices Quality Management System (MDQMS) audit by applying widely recognized audit principles, procedures and techniques. During this training course, you will acquire the necessary knowledge and skills to plan and carry out internal and external audits in compliance with ISO 19011 and the certification process according to ISO/IEC 17021-1.

Based on practical exercises, you will be able to master audit techniques and become competent to manage an audit program, audit team, communication with customers, and conflict resolution.

After acquiring the necessary expertise to perform this audit, you can sit for the exam and apply for a “PECB Certified ISO 13485 Lead Auditor” credential. By holding a PECB Lead Auditor Certificate, you will demonstrate that you have the capabilities and competencies to audit organizations based on best practices.

 

Objectives ISO 13485 LEAD AUDITOR

  • Understand the operations of a Medical Devices Quality Management System based on ISO 13485
  • Acknowledge the correlation between ISO 13485 and other standards and regulatory frameworks
  • Understand an auditor’s role to: plan, lead and follow-up on a management system audit in accordance with ISO 19011
  • Learn how to lead an audit and audit team
  • Learn how to interpret the requirements of ISO 13485 in the context of a MDQMS audit
  • Acquire the competencies of an auditor to: plan an audit, lead an audit, draft reports, and follow-up on an audit in compliance with ISO 19011

 

Contents

  1. Introduction to Medical Devices Quality Management Systems (MDQMS) and ISO 13485
  • Course objectives and structure
  • Standards and regulatory frameworks
  • Certification process
  • Fundamental principles of Medical Devices Quality Management Systems
  • Medical Devices Quality Management System (QMS)
  1. Audit principles, preparation and launching of an audit
  • Fundamental audit concepts and principles
  • Audit approach based on evidence and risk
  • Initiating the audit
  • Stage 1 audit
  • Preparing the stage 2 audit (on-site audit)
  • Stage 2 audit (Part 1)
  1. On-site audit activities
  • Stage 2 audit (Part 2)
  • Communication during the audit
  • Audit procedures
  • Creating audit test plans
  • Drafting audit findings and non-conformity reports
  1. Closing the audit
  • Documentation of the audit and its review
  • Closing the audit
  • Evaluating action plans by the auditor
  • Beyond the initial audit
  • Managing an internal audit programme
  • Competence and evaluation of auditors
  • Closing the training
  1. Certification exam

 

Examination

  • Domain 1 : Fundamental principles and concepts of a Medical Devices Quality Management System (MDQMS)
  • Domain 2 : Medical Devices Quality Management System (MDQMS)
  • Domain 3 : Fundamental audit concepts and principles
  • Domain 4 : Preparation of an ISO 13485 audit
  • Domain 5 : Conducting an ISO 13485 audit
  • Domain 6 : Closing an ISO 13485 audit
  • Domain 7 : Managing an ISO 13485 audit program

 

 

 

 

 

 

 

 

 

Certification

 

Metode

Metode pelatihan dapat dilakukan dengan tiga metode dimana Peserta dapat memilih metode yang sesuai. Metode tersebut adalah :

  1. Metode Peserta Belajar Online Mandiri (Asinkron) yaitu:
  • Peserta belajar secara mandiri melalui website yang disediakan setelah mendapatkan akun untuk mengakses materi.
  • Apabila diperlukan peserta dapat diskusi atau konsultasi terkait dengan materi yang akan difasilitasi  oleh konsultan/trainer dari PT Expertindo melalui berbagai media seperti Google Meet, Zoom, Microsoft Teams, Team link, atau WhatsApp sesuai dengan kesepakatan
  1. Metode Live Online Training(Sinkron) yaitu :
  • Instruktur mengajar secara LIVE dengan durasi 4 jam perhari selama 3 hari secara terjadwal
  • Media Live training dapat menggunakan Google Meet, Zoom, Microsoft Teams atau Team link.
  1. Metode Offline Training(Classroom) yaitu:
  • Instruktur mengajar secara tatap muka dengan durasi 8 jam perhari selama 3 hari secara terjadwal
  • Teknik yang digunakan: presentasi, diskusi, tanya jawab, studi kasus, brainstorming.

Ketentuan  Online  Training

Persiapan Peserta

  • Dianjurkan menggunakan laptop, bukan smartphone.
  • Koneksi internet yang stabil.
  • Buku dan alat tulis.
  • Peserta menginstall aplikasi sesuai yang akan digunakan, sebelum jadwal training berlangsung. Untuk yang mempunyai kesulitan, bisa menghubungi staff kami sebelum jadwal training berlangsung

Platform yang digunakan

  • Beberapa alternative platform Zoom, Google Meet, Hang Out,  Team link atau Webex untuk conference live training
  • Google Classroom untuk memuat materi, tugas dan dokumen lain yang dapat diakses peserta dengan link dan kode kelas yang akan diberikan oleh penyelenggara sebelum pelaksanaan training.

Cara masuk ke video conference

  • Penyelenggara akan memberikan undangan berupa link.
  • Klik linktersebut, ikuti arahan selanjutnya.
  • Anda akan dibawa masuk ke dalam video conference.

 

 

Metode Pelaksanaan Harga & Fasilitas
Opsi 1 –

Pelatihan Online

●               Training Online Rp 6.900.000 per peserta

●               Sertfikasi $600

●               Minimal kuota 1 peserta dan bisa request tanggal

●               Pelaksanaan training selama 3 hari half day (08.00 – 12.00 WIB atau 13.00 – 17.00 WIB)

●               Menggunakan aplikasi Zoom, Google Meet, atau Ms Teams

●               Fasilitas : Sertifikat Training Softfile & Hardfile, Pengiriman Sertifikat ke Alamat Peserta, Softfile Materi

●               Biaya belum termasuk PPN 11%

Opsi 2 –

Pelatihan Offline di Yogyakarta

●               Training Offline Rp 9.900.000 per peserta

●               Sertfikasi $600

●               Minimal kuota 1 peserta dan bisa request tanggal

●               Pelaksanaan training selama 3 hari full day (08.00 – 16.00 WIB)

●               Tempat pelaksanaan di Hotel Ibis Malioboro, Yogyakarta

●               Fasilitas : Meeting Room, Modul Training, Sertifikat Training, Training Kits, Lunch, Coffee Break

●               Biaya belum termasuk PPN 11%

Opsi 3 –

Pelatihan Offline Luar Yogyakarta (Jakarta, Bandung, Surabaya, dll)

●               Training Offline Rp 10.900.000 per peserta

●               Sertfikasi $600

●               Minimal kuota 2 peserta dan bisa request tanggal

●               Pelaksanaan training selama 3 hari full day (08.00 – 16.00 WIB)

●               Pilihan Tempat pelaksanaan :

●               Hotel Grand Tebu, Bandung

●               Hotel Santika Pandegiling, Surabaya

●               Hotel Asyana Kemayoran, Jakarta

●               Hotel Ibis Simpang Lima, Semarang

●               Hotel Ibis, Solo

●               dll

●               Fasilitas : Meeting Room, Modul Training, Sertifikat Training, Training Kits, Lunch, Coffee Break

●               Biaya belum termasuk PPN 11%

Opsi 4 –

Pelatihan Offline Luar Pulau Jawa (Lombok, Bali, Balikpapan, dll)

●               Training Offline Rp 11.900.000 per peserta

●               Sertifikasi $600

●               Minimal kuota 2 peserta dan bisa request tanggal

●               Pelaksanaan training selama 3 hari full day (08.00 – 16.00 WIB)

●               Pilihan Tempat pelaksanaan :

✔            Hotel Santika Kuta,Bali

✔            Hotel Nagoya Plaza, Batam

✔            Hotel Fave, Balikpapan

✔            Hotel Aston, Manado

✔            Hotel Lombok Raya, Mataram

✔            dll

●               Fasilitas : Meeting Room, Modul Training, Sertifikat Training, Training Kits, Lunch, Coffee Break

●               Biaya belum termasuk PPN 11%

 

 

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