Discover ISO 9001:2015 Through Practical Examples

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Discover ISO 9001:2015Through PracticalExamples1

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Carlos Pereira da CruzDiscover ISO 9001:2015Through PracticalExamplesA Straightforward Way to Adapt a QMS to YourOwn BusinessAdvisera Expert Solutions LtdZagreb, Croatia3

Copyright 2017 by Carlos Manuel Gonçalves Pereira da CruzAll rights reserved. No part of this book may be reproduced, stored ina retrieval system, or transmitted in any form or by any means,electronic, mechanical, photocopying, recording, or otherwise,without written permission from the author, except for the inclusionof brief quotations in a review.Limit of Liability / Disclaimer of Warranty: While the publisher andauthor have used their best efforts in preparing this book, they makeno representation or warranties with respect to the accuracy orcompleteness of the contents of this book and specifically disclaim anyimplied warranties of merchantability or fitness for a particularpurpose. This book does not contain all information available on thesubject. This book has not been created to be specific to anyindividual’s or organization’s situation or needs. You should consultwith a professional where appropriate. The author and publisher shallhave no liability or responsibility to any person or entity regarding anyloss or damage incurred, or alleged to have been incurred, directly orindirectly, by the information contained in this book.First published by Advisera Expert Solutions LtdZavizanska 12, 10000 ZagrebCroatiaEuropean Unionhttp://advisera.com/Editor: Dejan KosuticISBN: 978-953-8155-15-4First Edition, 20174

ABOUT THE AUTHORCarlos Pereira da Cruz is the author of several books aboutstrategy, the balanced scorecard, ISO 9001, and ISO 14001. Hehas 30 years of experience helping various organizationsincluding industrial, healthcare, and service companies in theimplementation of management systems. He holds numerouscertificates, among them ISO 9001 Lead Auditor and ISO 14001Lead Auditor.5

TABLE OF CONTENTSAbout the Author. 5List of figures . 71. The reason for this book . 102. Why is ISO 9001 usually implemented the wrong way? . 123. Altix: An introduction to the case study . 144. Analyzing the Altix strategy . 155. Linking the strategic side with ISO 9001: 2015 . 276. How ISO 9001:2015 helps the company strategy . 337. The strategic side of management review inISO 9001: 2015 . 358. Analyzing Altix’s operations . 379. How do we map a process?. 4210. From a process to a group of interacting processes . 5911. Using processes to model the way Altix operates . 6112. Relating processes and strategy . 6413. Describing a process . 6914. Competences of people in a process . 7315. What infrastructure is needed to operate a process? . 7716. What should we expect from a process? . 8017. Identify the risks associated with the process . 8118. Assess the risks associated with a process . 8319. What to improve in a process, and how . 8820. Monitoring the process. 9121. Initial corrections . 9322. Improvements after the corrections . 9823. Relating the operational side of the company withISO 9001: 2015 . 10224. Relating strategic and operational aspectssimultaneously . 11225. A word about internal audits . 11426. ISO 9001 is an opportunity, not a burden . 1186

Bibliography . 119Index . 120LIST OF FIGURESFigure 1 : The company Altix as a black box . 14Figure 2: The ecosystem of interested parties around Altix . 17Figure 3: The requirements of a relevant interested party (Altixcustomers) . 19Figure 4: The Altix strategy map . 20Figure 5: A SWOT analysis for Altix . 23Figure 6: Different results in the future must come from adifferent organization in the future . 24Figure 7: Example of monitoring plan . 25Figure 8: The Plan-Do-Check-Act cycle . 27Figure 9: Linking good business practices at the strategic levelwith ISO 9001:2015 clauses . 32Figure 10: How ISO 9001:2015 can be used as a source of ideasabout requirements to follow when developing the strategicside of a company . 34Figure 11: Altix as a converter of inputs into outputs . 37Figure 12: Using the organizational chart to show how acompany works . 38Figure 13: Organizational charts easily generate organizationalsilos . 39Figure 14: The flow of work in a vertical organization . 40Figure 15: The flow of work in a horizontal organization . 40Figure 16: Repairs R Us – A black box. 43Figure 17: Repairs R Us – Main input and output . 43Figure 18: Flowchart of activities . 45Figure 19: Extra work, extra cost, damaged reputation . 477

Figure 20: Flowchart of activities and objects . 49Figure 21: Flowchart of activities, objects, and participants(part I) . 51Figure 22: Flowchart of activities, objects, and participants(part II) . 52Figure 23: Flowchart of activities, objects, and participants(part III) . 53Figure 24: Flowchart of activities, objects, participants, andrelevant documents . 54Figure 25: Alternative routes for making decisions . 55Figure 26: Simplifying the flowchart of verbs . 56Figure 27: A simplified flowchart for the core process of a carrepair shop . 57Figure 28: Interaction of processes with other processes . 59Figure 29: Flowchart of the main activities of Altix . 62Figure 30: Legend to read the flowchart of the main activities ofAltix . 62Figure 31: Main processes of Altix . 63Figure 32: Objectives produced from the black box . 64Figure 33: Objectives produced from the main processes . 64Figure 34: Altix as a set of processes producing objectives . 65Figure 35: Objectives as a function of processes . 65Figure 36: Relationship between processes and strategicobjectives . 66Figure 37: Relationship between strategic objectives, processes,and strategic projects . 68Figure 38: Inputs and providers table . 70Figure 39: Outputs and receivers table . 70Figure 40: Flowchart of process 4 (Send orders to factories) . 71Figure 41: Monitoring plan for process 4 (Send orders tofactories) . 718

Figure 42: The Commercial Assistant job description for process4 (Send orders to factories) . 74Figure 43: The infrastructures in the context of process 4(Send orders to factories) . 77Figure 44: The infrastructures in the context of a process (Buyraw materials – reception phase) . 78Figure 45: Risk evaluation matrix . 84Figure 46: Process 4 (Send orders to factories) - risksassessment . 85Figure 47: Process 4 (Send orders to factories) – decisions aboutrisks . 87Figure 48: Risks, process and improvement project . 90Figure 49: Balancing two cycles: control and improvement . 94Figure 50: Linking monitoring, correction, and improvement . 96Figure 51: The “5 Why’s” technique . 99Figure 52: Example of chart using sparklines . 100Figure 53: Linking good business practices at the operationallevel with ISO 9001:2015 clauses . 108Figure 54: Cross check between ISO 9001:2015 clauses and theoperational side of Altix . 109Figure 55: Linking Altix processes and ISO 9001:2015 clausesfrom section 8 . 110Figure 56: Linking ISO 9001:2015 and the strategic andoperational sides of a company . 112Figure 57: Internal audit diagram . 114Figure 58: Audits as a process . 1169

1. THE REASON FOR THIS BOOKI believe with greater and greater conviction that the mostpractical way to understand the implementation of ISO 9001requires a company to look at the standard as if they have neverhad a Quality Management System, with no knowledge ofprevious ISO 9001 versions, and with the least amount ofbaggage.Unfortunately, most companies that look at the standard toprepare to meet its requirements have a way of thinking thathas been introduced by consultants since the first version, in1987.So, let’s try to look at the 2015 version as if we were ignorant.A person who is ignorant of ISO 9001, in the truest sense of theword: doesn’t think of conformity (compliance) – he thinksabout performance doesn’t think of complying with the standard’srequirements – he thinks of reaching objectives whileavoiding constraints and potentially negative situationsHave you worked with ISO 9001 in the past?Which was your experience: comply with the standard, orimprove performance?While I write these lines, I am preparing to audit a smallcompany that had been certified for seven years, but in 2010, asa result of the economic crisis, decided to let the certificationand the company’s quality system expire, because theyconcluded that the investment didn’t pay off. At this moment,10

The reason for this bookbecause a multi-national company (a potential new customer)demands it, the company decided to relaunch theimplementation of the quality system and certify it. This auditwill serve to take a snapshot of the current situation, and it willbe the basis for designing a realistic project to re-implement theQuality Management System.To prepare an audit, the auditor must know its objective andmust prepare a checklist. That’s why I have studied the companydocumentation in order to prepare the audit. The SME alsoprovided me with a folder that I read with a mixed feeling ofcuriosity and disappointment, where I found the internal andexternal audits carried out over the course of eight years. Therewas not a single note about benchmarks, objectives, or targets –rather, I saw many reports of non-conformities in documents,and more documents, and still more documents.That is what I see too often: Quality Management Systems withtoo few or too many documents, but concentrated on listingtasks that people must perform. And people perform their tasks,and companies remain certified, but nothing else happens. No,don’t blame the external auditors. Their client, the registrar(certification body), asks them: “Does the company comply withISO 9001?” Very rarely do they ask: “Is the system effective? Isit useful? Is the system the driving force of development?”11

2. Why is ISO 9001 usually implementedthe wrong way?This book is about how to build a Quality Management Systemfrom scratch without looking at ISO 9001; the standard willnaturally come afterwards when we show the relationshipbetween sound management practices and ISO 9001 clauses (asyou will see in chapters 4 and 22). However, I have to invite thereader for a previous reflection about a definition of ISO9000:2015, the definition of management system:A management system is a “set of interrelated or interactingelements of an organization to establish policies and objectivesand processes to achieve those objectives.”Have you ever looked at the definition of management system?My interpretation is that a management system is not a set ofpapers, nor is it a list of activities. A management system isaction in order to achieve the desired results. First, anorganization must define its overall guidelines (policies, though Iprefer the word “strategy”). Objectives and targets arise fromthese guidelines, and the reason for the management system toexist is to transform itself and change the company in order toachieve these objectives and targets in a sustainable way.Thus, a management system must be seen, above everything, asa tool to achieve a portfolio of objectives and targets alignedwith the strategy of the organization. And, that is what islacking in many management systems. Most of the consultants“were born” for the job in a time when there was an ISOstandard about vocabulary: ISO 8402; or, they “were taught” bythe good practices of other consultants of that time. With ISO12

Why is ISO 9001 usually implemented the wrong way?8402 (please, grasp your chairs!) the definition of managementsystem was:“It is the structure, the responsibilities, the procedures, theprocesses and the resources that an organization needs toimplement the quality management in order to achieve theobjectives established in the Quality Policy.”Compare the two definitions – the second one is really prehistorical. It’s no wonder that many quality systems concentratesolely on compliance. As a matter of fact, I learned this througha quote from Napoleon: "To understand someone, you have tounderstand what the world looked like when they weretwenty."There are no such things as hazards and coincidences.Management systems produce what was introduced in theirDNA at the time they were generated. If what was indoctrinatedwas exclusively “We want a certification!”, then they will becertified – but don’t wait for anything else, because a systemcannot generate something it was not designed for.The approach of this book intends to demonstrate how to builda Quality Management System focused on producing results,and which can be certified, this certification being a by-productrather than the main objective (without any negativeconnotation).13

3. ALTIX: AN INTRODUCTION TO THECASE STUDYLet’s begin by choosing one company to serve as an example.We choose Altix, a company that designs and develops its ownshoe models, with its own brands, which they present atinternational tradeshows. Its clients choose the models, andthen order samples to show in their shops or in shops they workwith. After that, Altix receives the orders, processes them, andsends them to factories where the production is outsourced.Altix does not own factories. The orders are dispatched from itswarehouse or from the warehouses of the outsourced factories.Let’s represent Altix as a black box:Figure 1 : The company Altix as a black boxWhy a black box?That’s a metaphor: a black box because, to begin with, we arenot interested in what is done inside Altix in detail. In this firststage, we are only interested in the results generated by Altix.Altix, like any other company, has two sides: the strategic oneand the operational. Let’s focus first on the strategic side.14

4. ANALYZING THE ALTIX STRATEGYThe strategic side deals with profound questions, topics wellabove the day-to-day business: What is Altix, and what is its business? Why does Altix exist? What makes it different? What is its competitiveadvantage? What business objectives does it pursue, and whattargets does it want to achieve? What is it going to do to achieve them? How will it monitor its journey toward the desired future,a place where it will be meeting the targets?Put yourself in the shoes of the top management team: Whatdo they want for Altix? They want the company to besuccessful. How do you begin building a successful company?NOTE: The following numbers at the beginning of the sentencesare a sort of GPS you can use later on to relate each sentencewith parts of ISO 9001:2015.15

Discover ISO 9001:2015 Through Practical Examples1Choose the right purpose, its reason for being. What isAltix’s business? What does it really offer to the market? Acompany never sells the product or the service that is in itscatalogue; it sells the results that those products and servicesprovide to its clients.Purpose: Comfortable footwear for demanding seniorcustomers.2Formulate a strategic orientation for the company sothat it may stand out, so that it may differentiate itself and gaina competitive advantage. What makes it different? In whataspect does it intend to make the difference?Comfortable footwear, for demanding senior customers.Not the traditional older generation customer, but one thatis looking for something that is outside the box, with abolder design, that meets the needs of those who livedthrough the turbulence and cultural revolution during the1960s as a young adult, and who cannot stand the boringfootwear their parents and grandparents wore when theywere the same age. Comfortable footwear for shops andretail nets that serve this kind of consumer, and that wantexclusivity, small series, quick repositions, and a reliablepartner.3When formulating a strategic orientation, the Altix topmanagement must identify which relevant interested parties andwhich relevant requirements it wants to focus on, which formthe basis to build what may be called “the ecosystem where thecompany operates.”16

Analyzing the Altix strategyAltix identified three relevant interested parties: consumers (Altix does not deal directly withconsumers, but it must know them in order to meettheir needs and provide value. In the end, theconsumer is king.)shops and retail nets (These are Altix’s customers. Thecompany considered the market segment they workin – medium-high price, their geographic situation,size, and credit insurance – as selection criteria.)outsourced factories (Despite being providers, Altixdecided to consider them as relevant interestedparties, because it intends to develop long-

strategy, the balanced scorecard, ISO 9001, and ISO 14001. He has 30 years of experience helping various organizations including industrial, healthcare, and service companies in the implementation of management systems. He holds numerous certificates, among them ISO 9001 Lead Auditor and ISO 14001 Lead Auditor.

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