This training is designed to give delegates the knowledge and skills needed to undertake an unbiased and constructive Quality System audit in line with the Generic Guidelines laid down in ISO 19011. D

Neville Clarke (Singapore) Pte Ltd
Singapore, Singapore

Course Format: Classroom | E-learning | Virtual Class | Online | On-site | Blended | Self-paced

Course Description:

'' The primary objective of the course is to equip delegates with the skills and knowledge to understand the benefits, requirements and pocess for implementing a QMS based on the requirements of the ISO 13485:2002 Standard.

Programme Outline

Brief Background of ISO 13485
what is a Medical Device
Who need to be Certified
Requirement of Different Countries on Medical Devices
ISO 13485 Requirements
Management Responsibility
Resource Management
Product and/or Service Realisation
Measurement, Analysis and Improvement
The Implementation & Certification Process
Who Must Attend

This training designed for senior management, steering committe and all personnel involved in the implementation of ISO 13485 Quality System.
...''

Phone:65 6291 8983

School Address:



Jobs & Resumes: Singapore
Houses & Roommates: Singapore

ISO/TS 16949 Series of Standards
ISO/TS 16949 Core Tools for Internal Auditors
ISO/TS 16949 Internal Auditor
ISO/TS 16949:2002 Supplier Auditor Certificate
Measurement System Analysis (MSA)
Statistical Process Control (SPC)
Advanced Environmental Management Systems Auditor Training (IEMA Approved) (SDF & SDU Points)
Internal Environmental Management Systems Auditor Training (SDF & SDU Points)
Understanding, Implementing an ISO 14001:2004 Environmental Management System (SDF & SDU Points)
ISO 13485:2003 Internal Auditor
Advanced QMS Auditor
Internal QMS Auditor
Quality Management Representative Skills Development (QMR)
ISO 9000:2000 Series Auditor/Lead Auditor
ISO 9001:2000 - A Process Approach
ISO 9001:2000 - An Analysis
ISO 9001:2000 - Effective Document Development and Control
Internal OHSAS 18001/SS506:Part 1 Auditor Training (SDF Approved & SDU Points
OHSAS 18001 Lead Auditor

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