SKU/Artículo: AMZ-0873899172
How to Establish a Document Control System for Compliance with ISO 9001:2015, ISO 13485:2016, and FDA Requirements
Format:
Hardcover
Detalles del producto
Disponibilidad:
En stock
En stock
Peso con empaque:
0.49 kg
0.49 kg
Devolución:
No
No
Condición
Nuevo
Nuevo
Producto de:
Amazon
Amazon
Viaja desde
USA
USA
Sobre este producto
- This book explains the requirements for compliance with FDA regulations and ISO standards (9001/13485) for documented information controls, and presents a methodology for compliance. The document control system (DCS), or documented information control system (DICS), is the foundation of a quality management system. It is the first quality system element that must be implemented because the establishment and control of documented processes and information in a quality-controlled environment is dependent on the ability to proactively manage access to documents and the movement of documents through the document life cycle. A well-developed document control system benefits business by: Improving knowledge retention and knowledge transfer within and across business units Improving access to knowledge-based information Improving employee performance by providing standardized processes and communicating clear expectations Improving customer communication and satisfaction by providing documented information from which common understanding can be achieved Providing traceability of activities and documentation throughout the organization Improving organization of and access to documents and data Sample documents are included in the appendixes of this book to help clarify explanations. This book provides a process-based approach that can be used for controlling all forms of documented information that are required to be managed under the quality management system.
AR$155.613
49% OFF
AR$79.800
IMPORT EASILY
By purchasing this product you can deduct VAT with your RUT number
AR$155.613
49% OFF
AR$79.800
10% OFF con cupon ANIVERSARIO10
Pagá fácil y rápido con Mercado Pago o MODO
Llega en 18 a 28 días hábiles
con envío
Tienes garantía de entrega
Este producto viaja
de USA ![]()
a tus manos en
![]()
a tus manos en
Compra protegida
Disfruta de una experiencia de compra segura y confiable
Tarjetas de Crédito y Débito
Visa
Mastercard
American Express
Pagos a través de PayPal
Compra procesada en dólares con dinero en cuenta o tarjetas internacionales.
Paypal
Pagos a través de MODO
Compra procesada en pesos desde la App de tu banco.
PayPal
