Name: Devine Guidance for Complying with Japan's Quality System Regulation: MHLW Ministerial Ordinance 169 (en Inglés)
Price: 40.12 USD
Availability: InStock
Author: Devine, Christopher Jospeh
ISBN: 9781490927770

portada Devine Guidance for Complying with Japan's Quality System Regulation: MHLW Ministerial Ordinance 169 (en Inglés)

Formato

Libro Físico

Autor

Christopher Jospeh Devine

Editorial

Createspace Independent Publishing Platform

Idioma

Inglés

N° páginas

296

Encuadernación

Tapa Blanda

Dimensiones

28.0 x 21.6 x 1.6 cm

Peso

0.69 kg.

ISBN13

9781490927770

Categorías

Garantía y gestión de la calidad empresarial

Devine Guidance for Complying with Japan's Quality System Regulation: MHLW Ministerial Ordinance 169 (en Inglés)

Christopher Jospeh Devine (Autor) · Createspace Independent Publishing Platform · Tapa Blanda

Libro Físico

$ 40.12

$ 61.72

Ahorras: $ 21.60

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Origen: Estados Unidos (Costos de importación incluídos en el precio)

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Reseña del libro "Devine Guidance for Complying with Japan's Quality System Regulation: MHLW Ministerial Ordinance 169 (en Inglés)"

The purpose of Dr. D's fourth book is to breakdown and analyze the requirements depicted in Ministerial Ordinance 169 (MO 169). The good news for the readers is that the Japanese regulation steals shamelessly from ISO 13485. If your organization has an approved ISO 13485 Quality Management System certificate, issued by a notified body, then compliance to MO 169 should be that proverbial cakewalk. However, there are some quirky nuances specific to doing business in Japan. In this book, the doctor will breakdown and provide guidance on the responsibilities of MHLW, PMDA, JPAL, JIS, and the MAH. Enough acronyms for you? Dr. D has also added some lessons in Japanese, while expanding on the importance of the Chief Impalable Officer (the Senior RA/QA individual) that will be required to fall on the sword if quality and regulatory issues arise. I hope you find value in this book as the doctor's intent is to not only teach but entertain as well. After all, books on quality and regulatory compliance are notoriously boring, so Dr. D has taken some liberty and injected some of his infamous dry humor into his fourth book.