ISO 13485 LEAD IMPLEMENTER

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

ISO 13485 LEAD IMPLEMENTER

Master the implementation and management of Medical Devices Quality

Management Systems (MDQMS) based on ISO 13485

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

Background ISO 13485 LEAD IMPLEMENTER

ISO 13485 Lead Implementer training enables you to develop the necessary expertise to support an organization in establishing, implementing, managing and maintaining a Medical Devices Quality Management System (MDQMS) based on ISO 13485. During this training course, you will also gain a thorough understanding of the best practices of Medical Devices Quality Management Systems and be able to improve an organization’s overall performance by consistently providing safe and qualitative medical devices.

After mastering all the necessary concepts of Medical Devices Quality Management Systems, you can sit for the exam and apply for a “PECB Certified ISO 13485 Lead Implementer” credential. By holding a PECB Lead Implementer Certificate, you will be able to demonstrate that you have the practical knowledge and professional capabilities to implement ISO 13485 in an organization.

 

Objectives ISO 13485 LEAD IMPLEMENTER

By the end of this training course, the participant will be able to:

  • Acknowledge the correlation between ISO 13485 and other standards and regulatory frameworks
  • Master the concepts, approaches, methods and techniques used for the implementation and effective management of a MDQMS
  • Learn how to interpret the ISO 13485 requirements in the specific context of an organization
  • Learn how to support an organization to effectively plan, implement, manage, monitor and maintain a MDQMS
  • Acquire the expertise to advise an organization in implementing Medical Devices Quality Management System best practices

 

Contents

  1. Introduction to ISO 13485 and initiation of a MDQMS
  • Course objectives and structure
  • Standard and regulatory framework
  • Medical Devices Quality Management System (MDQMS)
  • Fundamental principles of quality and medical devices
  • Initiating the MDQMS implementation
  1. Plan the implementation of the MDQMS
  • Understanding the organization and clarifying the quality objectives
  • Analysis of the existing management system
  • Leadership and approval of the MDQMS project
  • MDQMS scope
  • Quality Policy
  • Definition of the organizational structure
  1. Implementation of a MDQMS
  • Definition of the document management process
  • Design of controls and drafting procedures
  • Communication plan
  • Training and awareness plan
  • Product Realization
  • Operations Management
  1. MDQMS monitoring, measurement, continuous improvement and preparation for a certification audit
  • Monitoring, measurement, analysis and evaluation
  • Internal audit
  • Management review
  • Treatment of problems and non-conformities
  • Improvement
  • Preparing for the certification audit
  • Competence and evaluation of implementers
  • 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: Planning a MDQMS implementation based on ISO 13485
  • Domain 4: Implementing a MDQMS based on ISO 13485
  • Domain 5: Performance evaluation, monitoring and measurement of a MDQMS based on ISO 13485
  • Domain 6: Continual improvement of a MDQMS based on ISO 13485
  • Domain 7: Preparing for a MDQMS certification audit

 

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.

 

Investasi dan Fasilitas

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%

 

 

Lead Instructor

PECB Consultant Team
Formulir Permintaan Informasi Lanjutan / Pra-Pendaftaran Public Training
    INFORMATION OPTIONS
    1. (required)
    2. (required)
    PERSONAL DATA
    1. (required)
    2. (required)
    3. (required)
    4. (valid email required)
    5. (required)
    6. (required)
    PRE REGISTRATION DATA (Tidak Mengikat)
    1. (required)
    MESSAGE FOR TRAINING PROVIDER
     

    In House Training lainnya yang beritanya dapat dilihat di link berikut => In House Training.

    Untuk judul dan informasi online training, kunjungi juga website PT Expertindo lainnya di alamat www.e-trainingonline.com

    Tags
    About The Author

    Leave a reply

    Your email address will not be published. Required fields are marked *

    Open chat
    Butuh Bantuan? Chat Dengan Kami
    PT Expertindo Training
    Dengan Expertindo-Training.com, ada yang bisa Kami bantu?