ISO 13485 Training : Introduction for Management Training

ISO 13485 Training Introduction for Management provides the information management needs to determine the method that will be used to implement an ISO 13485 quality management system for medical devices.

ISO 13485:2003
The full name of this standard is ISO 13485:2003 Quality management systems – Medical Devices – System requirements for regulatory purposes.

ISO 13485 specifies requirements for quality management systems for medical device manufacturers who must must comply with regulatory requirements. Implementing this international standard can help medical device manufacturers place their products into the international market.

ISO 13485 uses the ISO 9001:2000 format, structure, and process approach and specifies additional requirements. It differs from ISO 9001 in that it does not include requirements for customer satisfaction and continual improvement.

The requirements in ISO 13485 are in line with those required by the U.S. Food and Drug Administration (FDA) in 21CFR 820 (the cGMP).

Who should attend:
Typically, this is a 2 to 3 hour presentation attended by senior management. Senior management often invites other personnel to attend part of the presentation.

Location: Premises of your organization
Time required: 2 to 3 hours
Fee: $600.00 (number of attendees does not affect the cost)
Date: To be determined

Objective
The objective is for management to understand what must be done to achieve ISO 13485 certification, the approximate time required, and the resources that are needed to complete the project.

Part 1 – A Preview of ISO 13485:2003

Topic
Purpose
Background on the ISO 13485 Standard
Understand how the standard relates to ISO 9001. ISO 13485 focuses on meeting customer and regulatory requirements and ensuring that the system is maintained, suitable and effective.
Structure of ISO 13485:2003
An overview of the main topics of the Standard.
Perceptions of the potential impact of the new system are obtained from a Brainstorming Session.
Information learned from this session determines the the approach the organization wants to use based on the time and resources available.

Part 2 – Planning for ISO 13485:2003 Certification

Topic
Purpose
ISO 13485:2003 is a process-based management system.
To understand ISO 13485:2003, it is necessary to agree to the requirements of managing through processes. This segment describes this approach.
A review of the Clauses of the Standard and the requirements for their implementation and use.
The Standard must be understood before it can be implemented. This segment provides a brief introduction to the main Clauses (topics) of ISO 13485. Click here to print out the Clauses (topics) in the Standard.
The requirements for achieving ISO 13485 certification.
To create a successful certification plan, it is necessary to understand the strategic requirements for certification. This segment addresses this need.
Implementing ISO 13485
This segment describes a proven first-time certification method. Senior management often invites those who will work closely with the standard to attend this segment.
Establish plan for certification
Management are now conversant with the requirements and a proven successful method for certifying to ISO 13485:2003. This awareness enables a draft transition plan to be established.

Input from senior management defines the implementation approach best suited to the needs of the organization.

Fee includes introduction materials.

Inquiries
For more information about ISO 13485 Training, or to make arrangements for ISO 13485 Introduction training at your location, contact:

Jane Birkenstock
Phone: (408) 371-9995
Email: Jane Birkenstock <janebirk@qrccentral.com>

Registration Information
Company name:
Street Address:
City/State/Zip:
Organization contact person:
Title:
Email:
Phone:
Fax:

First calendar date choice:
Second calendar date choice:
Any number may attend.

Your purchasing department will require the following information.

Payment:
Purchase Order Terms: Payment due upon completion of training
Company check preferred.
Credit cards accepted: Visa, MasterCard, American Express, and Discover

Travel Expenses: Expenses are charged at cost when travel (beyond 50 miles) to your location is required.

Make checks payable to: Quality Resource Center, Inc.

Accounting office – Mailing address for purchase orders and payment:
Quality Resource Center, Inc.
1448 Oak Grove Drive
Roseville, CA 95747

Accounting office contact information:
Phone/Fax: (800)244-5409
Email: Ken McCann <KenMcCann@aol.com>

Main Office
Quality Resource Center, Inc.
1250 Oakmead Parkway, Suite 210
Sunnyvale, CA 94085
Phone: (408) 371-9995
Fax: (800) 244-5409