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ISO 13485 Course Description

ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. Such organizations can be involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities (e.g. technical support). ISO 13485:2016 can also be used by suppliers or external parties that provide product, including quality management system-related services to such organizations.

Course Overview

Aims & Objectives

  • Memahami kaitan persyaratan dari ISO 13485:2016 – Sistem Manajemen Perangkat medis
  • Memahami mengenai penerapan system ISO 13485 : 2016 di perusahaan
  • Memahami tanggung jawab berkaitan dengan implementasi Sistem Manajemen Perangkat Medis
  • Improvement system & mensupport kelulusan Audit

Learning Outcome

  • Setiap organisasi mampu menerapkan system ISO 13485 : 2016
  • Kepuasan pelanggan melalui pengiriman produk yang secara konsisten memenuhi persyaratan pelanggan termasuk kendali mutu, keamanan dan kepatuhan hukum
  • Peningkatan terhadap pengendalian manajemen resiko dengan konsistensi secara sungguh-sungguh dan kemampu-telusuran produk yang diproduksi
  • Lulus audit badan sertifikasi sehingga perusahaan mempunyai nilai jual ataupun pengakuan dari customer-nya

Who Should Attend

  • Quality executives/managers
  • Tim Quality perusahaan
  • Top management / management representatives
  • Fresh graduates 
  • Dan semua pihak yang terlibat secara langsung maupun tidak terkait dengan sistem manajemen perusahaan

COURSE OUTLINE 

  • Pengenalan ISO 13485 : 2016
  • Pemahaman persyaratan dari ISO 13485 : 2016
  • Pemahaman mengenai contoh implementasi dokumen dari ISO 13485 : 2016 
  • Pemahaman mengenai teknis audit internal di perusahaan (opening, pelaksanaan dan closing)
  • Pemahaman mengenai kompetensi dan evaluasi auditor

LEARNING AND TEACHING 

Teaching Methods

  • Detail materi seminar (bisa didownload)
  • Istilah dan Definisi
  • Jumlah slide : 88

Study time allocation

Efektif belajar mandiri : 4 Jam 

Jam kontak trainer : Office hour (08.00 – 17.00 WIB)