Discover ISO 9001:2015 Through Practical Examples

A Straightforward Way to Adapt a QMS to Your Own Business

Carlos Pereira da Cruz

• Publisher: Advisera Expert Solutions Ltd
• eBook ISBN: 9789538155154
• Topic: Business
• Subtopic: Operations
• Index: Business

Author and experienced quality management consultant Carlos Pereira da Cruz has written this book with one goal in mind: to offer you a practical and straightforward way to adapt your quality management system to your business, while meeting the requirements of ISO 9001:2015.

Discover ISO 9001:2015Through Practical Examples is primarily for beginners in quality management systems, and for people with moderate knowledge of ISO 9001. However, if you are an experienced quality practitioner, but are disappointed with bureaucratic side of the standard, this book will show you a practical and relevant method of applying ISO 9001 to your business rather instead of blindly following policies and procedures.

The main focus of the book is author's desire to show you a different approach to the QMS. As he says at the beginning of the book, "What I see too often is Quality Management Systems with too few or too many documents, but concentrated on listing tasks that people must perform. And people perform their tasks, and companies remain certified, but nothing else happens." Rather than looking at the standard that way, da Cruz says, "This book is about how to build a Quality Management System from scratch without looking at ISO 9001; the standard will naturally come afterwards when we show the relationship between sound management practices and ISO 9001 clauses."

Even though this book is written to be short and simple, it has more than 50 case studies, charts, diagrams and tables to help you develop your own QMS. Some of them include:

• The ecosystem of interested parties around Altix
  
• Example of monitoring plan
  
• Flowchart of activities, objects, and participants
  
• Objectives produced from the main processes
  
• Risk evaluation matrix
  
• Risks, process and improvement project

Da Cruz has written the book using plain English, which is easy to understand for beginners. Using practical examples to help you understand the relationship between your regular business operations and ISO 9001:2015, he shows you that you're not just implementing the standard to prove compliance, you're doing it to improve the business.

1. THE REASON FOR THIS BOOK

 

I believe with greater and greater conviction that the most practical way to understand the implementation of ISO 9001 requires a company to look at the standard as if they have never had a Quality Management System, with no knowledge of previous ISO 9001 versions, and with the least amount of baggage.

Unfortunately, most companies that look at the standard to prepare to meet its requirements have a way of thinking that has been introduced by consultants since the first version, in 1987.

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 the word:

• doesn’t think of conformity (compliance) – he thinks about performance
• doesn’t think of complying with the standard’s requirements – he thinks of reaching objectives while avoiding constraints and potentially negative situations

Have you worked with ISO 9001 in the past?

Which was your experience: comply with the standard, or improve performance?

While I write these lines, I am preparing to audit a small company that had been certified for seven years, but in 2010, as a result of the economic crisis, decided to let the certification and the company’s quality system expire, because they concluded that the investment didn’t pay off. At this moment, because a multi-national company (a potential new customer) demands it, the company decided to relaunch the implementation of the quality system and certify it. This audit will serve to take a snapshot of the current situation, and it will be the basis for designing a realistic project to re-implement the Quality Management System.

To prepare an audit, the auditor must know its objective and must prepare a checklist. That’s why I have studied the company documentation in order to prepare the audit. The SME also provided me with a folder that I read with a mixed feeling of curiosity and disappointment, where I found the internal and external audits carried out over the course of eight years. There was 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 with too few or too many documents, but concentrated on listing tasks 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 with ISO 9001?” Very rarely do they ask: “Is the system effective? Is it useful? Is the system the driving force of development?”

 

 

2. WHY IS ISO 9001 USUALLY IMPLEMENTED THE WRONG WAY?

 

This book is about how to build a Quality Management System from scratch without looking at ISO 9001; the standard will naturally come afterwards when we show the relationship between sound management practices and ISO 9001 clauses (as you will see in chapters 4 and 22). However, I have to invite the reader for a previous reflection about a definition of ISO 9000:2015, the definition of management system:

A management system is a “set of interrelated or interacting elements of an organization to establish policies and objectives and 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 of papers, nor is it a list of activities. A management system is action in order to achieve the desired results. First, an organization must define its overall guidelines (policies, though I prefer the word “strategy”). Objectives and targets arise from these guidelines, and the reason for the management system to exist is to transform itself and change the company in order to achieve these objectives and targets in a sustainable way.

Thus, a management system must be seen, above everything, as a tool to achieve a portfolio of objectives and targets aligned with the strategy of the organization. And, that is what is lacking in many management systems. Most of the consultants “were born” for the job in a time when there was an ISO standard about vocabulary: ISO 8402; or, they “were taught” by the good practices of other consultants of that time. With ISO 8402 (please, grasp your chairs!) the definition of management system was:

“It is the structure, the responsibilities, the procedures, the processes and the resources that an organization needs to implement the quality management in order to achieve the objectives established in the Quality Policy.”

Compare the two definitions – the second one is really pre-historical. It’s no wonder that many quality systems concentrate solely on compliance. As a matter of fact, I learned this through a quote from Napoleon: "To understand someone, you have to understand what the world looked like when they were twenty."

There are no such things as hazards and coincidences.

Management systems produce what was introduced in their DNA at the time they were generated. If what was indoctrinated was exclusively “We want a certification!”, then they will be certified – but don’t wait for anything else, because a system cannot generate something it was not designed for.

The approach of this book intends to demonstrate how to build a Quality Management System focused on producing results, and which can be certified, this certification being a by-product rather than the main objective (without any negative connotation).

3. ALTIX: AN INTRODUCTION TOTHE CASE STUDY

 

Let’s begin by choosing one company to serve as an example. We choose Altix, a company that designs and develops its own shoe models, with its own brands, which they present at international tradeshows. Its clients choose the models, and then order samples to show in their shops or in shops they work with. After that, Altix receives the orders, processes them, and sends them to factories where the production is outsourced.

Altix does not own factories. The orders are dispatched from its warehouse or from the warehouses of the outsourced factories.

Let’s represent Altix as a black box:

Figure 1 : The company Altix as a black box

Why a black box?

That’s a metaphor: a black box because, to begin with, we are not interested in what is done inside Altix in detail. In this first stage, we are only interested in the results generated by Altix.

Altix, like any other company, has two sides: the strategic one and the operational. Let’s focus first on the strategic side.

4. ANALYZING THE ALTIX STRATEGY

The strategic side deals with profound questions, topics well above the day-to-day business:

• What is Altix, and what is its business?
• Why does Altix exist?
• What makes it different? What is its competitive advantage?
• What business objectives does it pursue, and what targets 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: What do they want for Altix? They want the company to be successful. How do you begin building a successful company?

NOTE: The following numbers at the beginning of the sentences are a sort of GPS you can use later on to relate each sentence with parts of ISO 9001:2015.

1 Choose the right purpose, its reason for being. What is Altix’s business? What does it really offer to the market? A company never sells the product or the service that is in its catalogue; it sells the results that those products...

Table of contents

• ABOUT THE AUTHOR
• TABLE OF CONTENTS
• 1. THE REASON FOR THIS BOOK
• 2. WHY IS ISO 9001 USUALLY IMPLEMENTED THE WRONG WAY?
• 3. ALTIX: AN INTRODUCTION TOTHE CASE STUDY
• 4. ANALYZING THE ALTIX STRATEGY
• 5. LINKING THE STRATEGIC SIDE WITH ISO 9001: 2015
• 6. HOW ISO 9001:2015 HELPS THE COMPANY STRATEGY
• 7. THE STRATEGIC SIDE OF MANAGEMENT REVIEW IN ISO 9001: 2015
• 8. ANALYZING ALTIX’S OPERATIONS
• 9. HOW DO WE MAP A PROCESS?
• 10. FROM A PROCESS TO A GROUP OF INTERACTING PROCESSES
• 11. USING PROCESSES TO MODEL THE WAY ALTIX OPERATES
• 12. RELATING PROCESSES AND STRATEGY
• 13. DESCRIBING A PROCESS
• 14. COMPETENCES OF PEOPLE IN A PROCESS
• 15. WHAT INFRASTRUCTURE IS NEEDED TO OPERATE A PROCESS?
• 16. WHAT SHOULD WE EXPECT FROM A PROCESS?
• 17. IDENTIFY THE RISKS ASSOCIATED WITH THE PROCESS
• 18. ASSESS THE RISKS ASSOCIATED WITH A PROCESS
• 19. WHAT TO IMPROVE IN A PROCESS, AND HOW
• 20. MONITORING THE PROCESS
• 21. INITIAL CORRECTIONS
• 22. IMPROVEMENTS AFTER THE CORRECTIONS
• 23. RELATING THE OPERATIONAL SIDE OF THE COMPANY WITH ISO 9001: 2015
• 24. RELATING STRATEGIC AND OPERATIONAL ASPECTS SIMULTANEOUSLY
• 25. A WORD ABOUT INTERNAL AUDITS
• 26. ISO 9001 IS AN OPPORTUNITY, NOT A BURDEN
• BIBLIOGRAPHY