ISO 13485:2003

ISO 13485:2003
Internal Auditing

Available Dates:
September 23rd & 24th, 2010
November 22nd & 23rd, 2010

Costs: ($579 members / $629 non-members)

Location: QSG Training Center, Peabody, MA

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Date(s) Attending

Name of Attendee(s)

2- DAY, WORKSHOP ON:

ISO 13485:2003 INTERNAL AUDITING

Internal Auditing is critical to compliance!

Learn the necessary background to assess compliance, develop, implement and audit an internal quality system that meets the requirements of ISO 13485. This QMS internal auditor course includes workshops tailored to meet the medical device industry and discussions of ISO 13485 medical devices-quality management systems requirements for regulatory purposes. Hands-on workshops reinforce the methods and techniques discussed.

Learn the steps to develop, implement, and audit an internal quality system that
efficiently and effectively meets the requirements of ISO 13485:2003 and ISO
9001:2000. Get your training from the industry leaders! Quality Support Group has
been the first choice for internal auditor in New England. This version of our internal
auditor course includes workshops tailored to the changing medical device industry and
discussions of ISO 13485:2003.

Seminar Content

ISO 13485 is a Quality Management Standard for Medical Devices. Many medical device companies are utilizing ISO 13485:2003 as a platform to build their business management systems because of its benefits or because it is a necessary step to market their products and services in certain regions. For many companies, registration to ISO 13485 is a key to securing and maintaining global business. This course meets the training portion of the requirements for certification of individual internal auditors. The seminar will include an explanation of ISO 13485:2003 and audit systems, the auditing process and audit instruments; documentation process, how to conduct an audit, how to write the audit report, and take corrective action; auditing case studies to develop skills for identifying nonconformance.

Who Should Attend

Quality Assurance Managers, ISO 13485:2003 Implementation Team Members, Management Representatives should attend this seminar.

Seminar Materials

Seminar manual with case study and guide for auditing the standard will be provided to participants.

Seminar Goals

Understand the ISO 13485:2003 auditing and registration process
Understand each element of ISO 13485:2003
Prepare, perform and complete an audit

Seminar Outline
Day 1

Introduction and Welcome
The Challenge for Top Management
Eight Quality Management Principles
The ISO Standard Explained
Family of Standards
Overview of ISO 13485:2003 Requirements
Exclusions
Overview of ISO 13485:2003 Requirements: Clause 4
Overview of ISO 13485:2003 Requirements: Clause 5
Overview of ISO 13485:2003 Requirements: Clause 6
Overview of ISO 13485:2003 Requirements: Clause 7
Overview of ISO 13485:2003 Requirements: Clause 8

Day 2

Introduction to ISO 13485:2003 Audit Trails
Documentation for ISO 13485:2003
The audit cycle and ISO 19011
Introduction to Quality Audits
Management of Audit Programs
Audit Planning and Preparation
Scope and Objectives
Audit Plan
Performing the Audit
Opening Meeting
Quality Audits
Conducting the Audit
Writing Nonconformity Statements
Writing Nonconformities (using CARs)
Closing Meeting
Summary Statement and Closing Meeting
Completing the Audit Report
Corrective Action and Close Out (using CARs)
Verification and Close Out

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