ISO 9001:2015

A Pocket Guide

Steve Watkins, Nick Orchiston

• Publisher: IT Governance Publishing
• Year: 2016
• eBook ISBN: 9781849288132
• Topic: Computer Science
• Subtopic: Operations
• Index: Computer Science

Quality management principles to ensure business success

The success – or failure – of all businesses largely depends on the quality of the products and services they supply. This, in turn, depends on finding the right balance between investment and returns. Develop goods and services that are of too low a standard and no one will buy them; put too much into creating high-quality products and services and you may price yourself out of the market in an attempt to recover your costs. This is where quality management comes in.

A quality management system (QMS) establishes process-driven methods of producing and delivering products and services with consistent results. Assuming your QMS processes are effective, your products and services will meet the expected quality levels every time, giving you greater control over production costs and increasing customer satisfaction.

Currently used by more than 1.1 million organisations worldwide, the international standard ISO 9001: 2015 is the world's most established quality framework. It specifies the best-practice requirements for a QMS that organisations can use to:

• demonstrate their ability to consistently provide products and services that meet customer and applicable regulatory requirements;
• enhance customer satisfaction;
• manage costs and improve efficiency.

An ISO 9001-compliant QMS is adaptable, continually improves to meet organisational and market requirements, and includes processes for the assurance of conformity and applicable regulatory requirements.

Product overview

ISO 9001: 2015 – A Pocket Guide is a handy reference book that provides an overview of the ISO 9001 quality management standard. It includes:

• a brief history of quality management and ISO 9001;
• useful definitions of ISO 9001 terminology;
• a discussion of the requirements of the Standard, including an in-depth examination of clauses 4 to 10 of ISO 9001, which specify the requirements for a QMS; and
• some of the myths about ISO 9001 certification.

This is the perfect introduction to the Standard, and will help ensure the quality of your products and services, increase customer satisfaction, and enhance your business's efficiency.

About the authors

Steve G Watkins has been working with quality management standards since the days of BS 5750, first applying it in a leisure centre and then other service sector environments. In addition to quality, his experience includes environment, health and safety, information security, business continuity, and IT service management systems, working with the relevant British and international standards. Steve sits on a number of UK technical committees that contribute to ISO's work developing and revising standards in the areas of risk, information security and service management. He also contracts to UKAS as a technical assessor, giving him a strong understanding of accredited certification.

Nick Orchiston is a management systems consultant with more than 20 years' experience encompassing quality (ISO 9001), health & safety (OHSAS 18001), environmental (ISO 14001), IT service management (ITIL/ISO 20000) and information security (ISO 27001) management systems. He has successfully supported a wide variety of organisations, from SMEs to global corporations, through to accredited certification to all of these standards. Nick also created the IT Governance Toolkits for ISO 9001, ISO 14001, ISO 16001, ISO 50001, and OHSAS 18001 standards, used across the globe by project implementers.

Buy your copy of ISO 9001: 2015 – A Pocket Guide now to learn how an ISO 9001: 2015-compliant QMS will help your business thrive.

CHAPTER 1: WHAT IS A QUALITY MANAGEMENT SYSTEM?

Although it would be simple to describe a quality management system (QMS) as a system for managing quality, that’s not a useful definition (and would be justly rejected by any dictionary). More usefully, a QMS is a set of interacting policies, objectives and processes designed to make sure that quality requirements for products and services are met.¹ These requirements can be set either internally (the organisation’s criteria) or externally (customers’, and others’, requirements). Crucially, it should be seen as including an organisational structure – including appropriate authorities, responsibilities and accountabilities, along with the required competences for each – rather than a set of simple processes and requirements.

It is also important to remember that a QMS can be applied to both products and services. For businesses that focus on only products or services, this may appear to be a redundant point, but it’s important to recall that many businesses provide both, even if they don’t realise it. A company that sells products online, for instance, is implicitly offering their webshop as a service. The customer isn’t buying the webshop, but it has an inherent value reflected in repeat customers, multiple purchases and so on.

Quality management should be a primary focus for any organisation. Regardless of the level of investment actually put into the product or service, ensuring a minimum ‘rejection’ level is simply good business. Although almost every organisation recognises this, approaches to quality management can be incredibly varied. In its simplest form, the product or service is subject to quality control – someone looks at the product or service and assesses whether it meets the organisation’s established criteria. For some products, there may not even be established quality criteria beyond ‘it does not break’. An equivalent criterion for services might be ‘it isn’t awful to work with’.

This is reactive quality management (also called quality control): the product or service has already been produced before it is checked for conformance. The problem with reactive quality management is that you might produce thousands of widgets before passing a sample to quality control, only to discover that a significant proportion aren’t up to scratch and hundreds of widgets require rework – or worse – disposal. It’s better than no quality management at all, but it doesn’t give the organisation significant benefits.

Proactive quality management, on the other hand, establishes methods of designing, producing and delivering products and services so that results are consistent. Assuming your processes are effective, your products and services will meet the expected standards. This is much like a machine in a factory being set to achieve the required output from the outset: the machine performs a series of actions that result in converting one object into another object, repeatedly and consistently to meet requirements.

Obviously, some part of quality management must be reactive – it would be foolish to rely on proactive measures to get everything right and simply send out your widgets without checking that the processes worked as intended, no matter how confident you are in your quality assurance arrangements. Equally, following the factory machine analogy, some maintenance is required: the machine must be cleaned, blades sharpened, parts replaced and so on, and the processes must also be re-examined, tidied and improved.

And, of course, all of this relies on people following the defined processes. The path of least resistance is always the most appealing, and this often means cutting corners, fudging complexities and generally finding easier ways to do things. Although it would be nice if we could come up with processes that are immune to this (although assembly line methodologies are intended to be), in many cases this will not be possible because of the demands of the product or service.

So, an effective QMS uses proactive processes to determine how each stage of a product or service’s production cycle is performed, and reactive processes to check that this was done correctly. The two approaches complement each other to improve efficiency and quality.

Aside from ensuring that investments make it through to delivery, quality correlates with customer satisfaction. The importance of customer satisfaction cannot be understated, especially regarding the QMS.

Satisfaction is based on the product or service meeting the customer’s needs, not necessarily the simple fact that it does what you design it to do – it’s even possible that the product or service meets a need that it wasn’t intended for. Because quality and satisfaction are so closely related, satisfaction essentially becomes an important metric of quality.

This relationship can operate as a feedback loop: rather than designing the product or service to meet arbitrary quality objectives, it can be designed to meet customers’ needs. This may seem obvious – after all, who doesn’t design their products and services to meet their customers’ requirements? Despite this apparent truism, it’s important to keep in mind, as that objective can be lost when you’re too familiar with your products and services. Just as we’re all aware that products and services should meet customers’ needs, we’ve all also heard internal complaints that customers “don’t know what they want” and that “they’re using [the product or service] wrong!”

Applying a standard

Although most organisations will have their own processes for ensuring the quality of their products and services, it can be useful to look for external guidance to make sure that your QMS is the best it can be. As mentioned earlier, this is true of many business disciplines.

ISO standards provide a set of generic requirements for the organisation, which allows you to get all the key processes in place, as well as defining their relationships. This makes sure the organisation as a whole is on board and understands the management system’s importance, and can be independently verified to assure partners, suppliers and customers of your organisation’s credentials.

Furthermore, because ISO standards are based on tried and tested good practice, they essentially provide the collected wisdom of thousands of practitioners garnered over decades of experience. This is distilled into a few pages and sold for a relative pittance.

ISO 9001, like other ISO management system standards, specifies a management system that incorporates continual improvement, which ensures its ongoing value for the organisation. This way, even if the Standard isn’t updated for several years – and it is unlikely to be – the organisation is in a position to adapt to changes such as manufacturing improvements, technologies and so on.

This is an important feature of the Standard, as it makes sure the QMS is flexible and adaptable, rather than imposing a rigid structure that might have been ideal for the organisation at a single moment in time. Establishing the QMS so that it can change with the nature of the business environment is essential.

 

¹ See ISO 9000:2015, 3.5.3 and 3.5.4 for the formal ISO definitions.

CHAPTER 2: A BRIEF HISTORY OF QUALITY MANAGEMENT AND ISO 9001

The pursuit of quality and consistency goes back a long time – probably as long as trade has existed. A craftsman or merchant in the traditional mould wants their product to be the best fit to requirements that it can be so they can minimise costly reworking and ensure ongoing demand/funding. In pre-industrial societies, produ...

Table of contents

• Cover
• Title
• Copyright
• Contents
• Introduction
• Chapter 1: What is a Quality Management System?
• Chapter 2: A Brief History of Quality Management and ISO 9001
• Chapter 3: Useful Definitions
• Chapter 4: Requirements of ISO 9001:2015
• Chapter 5: Context of the organization
• Chapter 6: Certification
• ISO 9001 Resources
• ITG Resources