The ISO 9001:2015 Implementation Handbook

1 The ISO 9001:2015 ImplementationHandbookUsing the Process Approach to Build aQuality Management SystemMilton P. DentchASQ Quality PressMilwaukee, WisconsinAmerican Society for Quality, Quality Press, Milwaukee 53203 2017 by ASQ. Printed in 2016 All rights of Congress Cataloging-in-Publication DataNames: Dentch, Milton P., 1942 : The ISO 9001:2015 Implementation Handbook : using the process approachto build a quality management system / Milton P. : Milwaukee, Wisconsin : ASQ Quality Press, [2016] | Includesbibliographical references and : LCCN 2016023938 | ISBN 9780873899383 (hardcover : alk. paper)Subjects: LCSH: ISO 9001 Standard Handbooks, manuals, etc. | Newproducts Quality control standards Handbooks, manuals, etc. |Industrial management standards Handbooks, manuals, : LCC D46 2016 | DDC record available at part of this book may be reproduced in any form or by any means, electronic, mechanical, photocopying, recording, orotherwise, without the prior written permission of the : Seiche SandersAcquisitions Editor: Matt MeinholzManaging Editor: Paul Daniel O MaraProduction Administrator: Randall BensonASQ Mission: The American Society for Quality advances individual, organizational, and community excellence worldwidethrough learning, quality improvement, and knowledge Bookstores, Wholesalers, Schools, and Corporations.

2 ASQ Quality Press books, video, audio, and software areavailable at quantity discounts with bulk purchases for business, educational, or instructional use. For information, please contactASQ Quality Press at 800-248-1946, or write to ASQ Quality Press, Box 3005, Milwaukee, WI 53201 place orders or to request a free copy of the ASQ Quality Press Publications Catalog, visit our website first experience with ISO occurred around 1992. I was employed as the director ofmaterials for worldwide film manufacturing at the Polaroid Corporation in Waltham,Massachusetts. The company was experiencing a big challenge: Polaroid s instant filmproducts would no longer be sold in European hospitals unless the film was produced in anISO 9001 certified plant.

3 Since several million packs of instant film per year, plus many X-ray camera devices, were sold to hospitals in Europe, Polaroid needed to act quickly andwe did. Several engineers and managers were reassigned from their regular jobs to assistthe film assembly plants in obtaining certification to ISO 9001. The film assembly plantsachieved this goal in about a year, and instant film sales continued uninterrupted at theEuropean than maintaining European film sales, what impact did the ISO certification have onthe quality of Polaroid film? Judging from my observations, I would say very little to folks assigned to implement the ISO certification were not part of the day-to-dayoperations in the plants; they attacked each of the 20 elements and attendant requirements ofISO 9001 as a short-term project with goals and milestones.

4 Employees attended awarenesssessions to be trained on how to answer questions from the ISO auditor: What isPolaroid s quality policy? Where do you find instructions on how to make film? What stepsdo you take when film you made does not meet specifications? The employees learned theanswers in a somewhat rote fashion, and the auditors from Denmark were sufficientlyimpressed during their weeklong series of interviews and investigations to recommend theplant be certified to ISO 9001. While many nonconformances were brought up during theaudit, the ISO team convinced the auditors that the film plant had addressed the issues withdiligence and that Polaroid customers could be assured the film produced at these plantswas of consistent reality, Polaroid instant film, before and after ISO certification, was plagued withconsistent quality problems stemming from its extremely complex scientific andmanufacturing challenges.

5 Customer experience with Polaroid instant film products overtheir entire 75-year life cycle indicated that one in four instant pictures was of poor , the perceived value of the instant experience was so great that customerspurchased well over 100 million packs of Polaroid instant film every year until the late1990s, when the advent of digital imaging essentially obsoleted the ISO audit in 1992, managers such as myself were instructed by the ISO team tostay out of the way perhaps take some vacation time as we had not attended theawareness (indoctrination) training. As materials director, I was responsible forcoordinating the manufacturing planning and scheduling with Polaroid s sales and marketingdivisions. In ISO terms, this process was referred to as contract review or sales-manufacturing forecast.

6 Like many other publicly traded consumer product companies in the1990s, Polaroid adjusted its film sales demand to satisfy Wall Street analysts for thequarter, with little connection to actual consumer sales demand. If the ISO auditor had askedme to explain the contract review process, Polaroid might never have been certified toISO 9001! The ISO team selected lower-level employees to answer the auditor s questions,using professionally presented spreadsheets indicating a strong link between sales opinion of the value of ISO 9001 certification was shaped by this first experience andcontinued as I observed suppliers to Polaroid becoming certified to ISO without anyobvious uptick in quality or delivery performance.

7 There was a joke circulating in the1990s that went something like this: An ISO 9001 certified company manufactured lifepreservers to size specifications using precise instructions and tight , the technical department had selected cement as the material of choice, so thelife preservers were useless. The ISO 9001 revision in 2000 addressed the cement lifepreserver issue by placing more emphasis on results and customer leaving Polaroid in 1996 to provide materials consulting, I found a new entry intothe ISO world by way of a graduate program I attended on total quality management. One ofthe monthly modules in the program at the National Graduate School of Quality Managementwas Introduction to ISO Auditing. To complete the course I had to pass the RegistrarAccreditation Board (RAB) exam for ISO 9001 quality auditors.

8 I passed the exam, andafter a year of trial audits, I became certified as an RAB lead auditor. Over the next20 years I completed over 500 audits for large and small companies in the United States,Mexico, Canada, Europe, and Brazil. While conducting these audits and providing dozensof auditor training classes, I continued to observe the many flaws in the ISO process I hadfirst observed at Polaroid but I also saw how the discipline of the ISO approach couldprovide value when properly implemented and audited. Through my work with a very widespectrum of manufacturing and service organizations, combined with my previous workexperiences, I have accumulated a reservoir of best practices what works, what to avoid and an ability to explain the sometimes convoluted requirements and intentions ofstandards issued by the International Organization for Standardization (ISO).

9 I wrote the ISO 9001:2015 Implementation Handbook with the following goals in mind:Provide guidance to organizations (both manufacturing and service) seekingcertification to ISO 9001:2015 Assist currently certified ISO 9001 organizations in upgrading to ISO 9001:2015 ,while improving their present quality management system (QMS)Provide guidance for internal auditorsProvide guidance on interpreting ISO 9001:2015 requirementsSuggest improvements on the formatting of the ISO 9001 standardFor organizations obtaining ISO 9001 certification for the first time, I suggest you viewISO as a tool to support your business processes the linchpin for consistency andstandardization. The Handbook is structured to guide your organization through the processnecessary to connect your practices to the requirements of ISO 9001:2015 .

10 Fororganizations that are already certified to ISO 9001, with a voluminous quality manual anddozens of seldom-used procedures, I suggest you consider the upgrade to ISO 9001:2015 asan opportunity to rebuild your QMS into a helpful asset in managing your business. TheHandbook will guide you through the steps in creating a solid QMS in support of the end of each section describing the requirements for the clauses of ISO 9001:2015 ,I ve included audit questions related to the defined clauses. In addressing these questions,the reader can evaluate the organization s conformance to ISO 9001:2015 contents of ISO 9001:2015 have been paraphrased in this book. Paraphrased text by itsvery nature can introduce differences in understanding and interpretation. This book shouldbe used in conjunction with ASQ/ANSI/ISO 9001:2015 Quality management systems Requirements with guidance for use.