Document Control Policy
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How to Establish a Document Control System for Compliance with ISO 9001:2015, ISO 13485:2016, and FDA Requirements
Author: Stephanie L. Skipper
language: en
Publisher: Quality Press
Release Date: 2015-10-12
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.
Internal Controls Policies and Procedures
Drawing on her many years as a consultant to numerous companies big and small, author Rose Hightower infuses Internal Controls Policies and Procedures with her wealth of experience and knowledge. Instead of reinventing the wheel, your company can use this useful how-to manual to quickly and effectively put a successful program of internal controls in place. Complete with flowcharts and checklists, this essential desktop reference is a best practices model for establishing and enhancing your organization's control framework. These manuals are favorites for organizations and companies that need a foundation and grounding to ensure an internal control posture of integrity, credibility, method, process and process: or a reminder of its importance. URLs were included when first published to encourage the dissemination and distribution of relevant chapters to those interested and in charge of the specific departments. Although times have changed, the principles professed are sound and solid for today’s accounting and business environment. Implementing these cornerstones will produce a principled manageable approach. These manuals can be used by accounting individuals, finance departments, sole proprietor businesses, large corporations, accounting / auditing students and any others interested in specific topics or general disciplines. The discipline for the oversight processes and procedures are important when introducing or implementing auditing practices whether in accounting or throughout the organization. These manuals should be used together to provide the basics when setting up a department or specific process discipline, for learning about the strengths, weaknesses and opportunities within the specific focus areas.