How To Establish A Document Control System For Compliance With Iso 9001 2015 Iso 13485 2016 And Fda Requirements
Download How To Establish A Document Control System For Compliance With Iso 9001 2015 Iso 13485 2016 And Fda Requirements PDF/ePub or read online books in Mobi eBooks. Click Download or Read Online button to get How To Establish A Document Control System For Compliance With Iso 9001 2015 Iso 13485 2016 And Fda Requirements book now. This website allows unlimited access to, at the time of writing, more than 1.5 million titles, including hundreds of thousands of titles in various foreign languages.
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: 2015-10-14
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, and a full set of formatted procedures and document templates are available for download to get you off to an even faster start. 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.
How to Audit ISO 9001:2015
ISO 9001:2015 includes many changes that not only affect the companies aiming to achieve certification to it, but also auditors. This book is the resource auditors need to fully understand ISO 9001:2015 and help them perform audits to it. This book integrates two different types of audit strategies, conformance audits and performance audits, into one process approach audit. Conformance audits confirm that the organization is meeting the requirements of the standard, while performance audits confirm that the QMS is achieving its intended results. The book includes: An introduction to ISO 9001:2015 An auditing strategy for ISO 9001:2015 How to conduct a Stage 1 audit for ISO 9001:2015 How to conduct a Stage 2 on-site audit for ISO 9001:2015 Appendices include an introduction to process focus, an assessment report template for Stage 1 audits, a confidential assessment report template for Stage 2 audits, and an example of the format for an ISO 9001:2015 conformance checklist.
A Practical Field Guide for ISO 9001:2015
The intent of this field guide is to assist organizations, step by step, in implementing a QMS in conformance with ISO 9001:2015, whether from scratch or by transitioning from ISO 9001:2008. Within the guide each sub-clause containing requirements is the focus of a two-page spread that consistently presents features that fulfill the requirements listed below. This book examines each sub-clause of clauses 410 of ISO 9001:2015, which contain the requirements, with a visual representation provided in flowchart format on the facing page. This field guide will: - Provide a user-friendly guide to ISO 9001:2015s requirements for implementation purposes - Identify the documents/documentation required, along with recommendations on what to consider retaining/adding to a QMS during ISO 9001:2015 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 9001:2015s enhanced requirements and responsibilities for top management - Depict step by step what must occur to create an effective, conforming QMS What separates this field guide from most other books on ISO 9001:2015 and its implementation are the flowcharts showing the steps to be taken in implementing a QMS to meet a sub-clauses requirements. As the flowcharts themselves can be overwhelming when you first look at them, a text box appears with each flow chart that explains pertinent facts and/or what the flowchart represents and how it is to be used.