A Practical Field Guide for ISO 13485: 2016: Medical Devices--Quality Management Systems--Requirements for Regulatory Purposes

The purpose of this expanded field guide is to assist organizations, step-by-step, in implementing a quality management...
$181.20 AUD
$181.20 AUD
SKU: 9781636941325
Product Type: Books
Please hurry! Only 384 left in stock
Author: Erik V. Myhrberg
Format: Paperback
Language: English
Subtotal: $181.20
10 customers are viewing this product
A Practical Field Guide for ISO 13485: 2016: Medical Devices--Quality Management Systems--Requirements for Regulatory Purposes by Myhrberg, Erik V.

A Practical Field Guide for ISO 13485: 2016: Medical Devices--Quality Management Systems--Requirements for Regulatory Purposes

$181.20

A Practical Field Guide for ISO 13485: 2016: Medical Devices--Quality Management Systems--Requirements for Regulatory Purposes

$181.20
Author: Erik V. Myhrberg
Format: Paperback
Language: English
The purpose of this expanded field guide is to assist organizations, step-by-step, in implementing a quality management system (QMS) in conformance with ISO 13485:2016, whether "from scratch" or by transitioning from variations of the ISO 13485 family. In keeping with ISO 9000:2015's definition of quality as the "degree to which a set of inherent characteristics fulfills requirements," Myhrberg, Raciti, and Myhrberg have identified the requirements and inherent characteristics (distinguishing features) for this expanded field guide. Within the guide, each subclause containing requirements is the focus of a two-page visual spread that consistently presents features that fulfill the requirements listed below. This guide will: Provide a user-friendly guide to ISO 13485:2016's requirements for implementation purposes -Identify the documents/documentation required, along with recommendations on what to consider retaining/adding to a QMS during ISO 13485:2016 implementation -Guide internal auditor(s) regarding what to ask to verify that a conforming and effective QMS exists -Direct management on what it must do and should consider to satisfy ISO 13485:2016's enhanced requirements, as well as on the responsibilities for top management -Depict step-by-step in flowchart form what must occur to create an effective, conforming QMS

Author: Erik V. Myhrberg, Joseph A. Raciti
Publisher: ASQ Quality Press
Published: 11/06/2019
Pages: 158
Binding Type: Paperback
Weight: 0.84lbs
Size: 11.00h x 8.50w x 0.34d
ISBN: 9781636941325

This title is not returnable

Returns Policy

You may return most new, unopened items within 30 days of delivery for a full refund. We'll also pay the return shipping costs if the return is a result of our error (you received an incorrect or defective item, etc.).

You should expect to receive your refund within four weeks of giving your package to the return shipper, however, in many cases you will receive a refund more quickly. This time period includes the transit time for us to receive your return from the shipper (5 to 10 business days), the time it takes us to process your return once we receive it (3 to 5 business days), and the time it takes your bank to process our refund request (5 to 10 business days).

If you need to return an item, simply login to your account, view the order using the "Complete Orders" link under the My Account menu and click the Return Item(s) button. We'll notify you via e-mail of your refund once we've received and processed the returned item.

Shipping

We can ship to virtually any address in the world. Note that there are restrictions on some products, and some products cannot be shipped to international destinations.

When you place an order, we will estimate shipping and delivery dates for you based on the availability of your items and the shipping options you choose. Depending on the shipping provider you choose, shipping date estimates may appear on the shipping quotes page.

Please also note that the shipping rates for many items we sell are weight-based. The weight of any such item can be found on its detail page. To reflect the policies of the shipping companies we use, all weights will be rounded up to the next full pound.

Related Products

Recently Viewed Products