ISO 9001:2015 for Small Businesses

Ray Tricker

• Publisher: Routledge
• Year: 2016
• ISBN:
  9781317685678
• Edition: 6
• Topic: Commerce
• Subtopic: Petite entreprise

Small businesses face many challenges today, including the increasing demand by larger companies for ISO 9001compliance, a challenging task for any organisation and in particular for a small business without quality assurance experts on its payroll. Ray Tricker has already guided hundreds of businesses through to ISO accreditation, and this sixth edition of his life-saving ISO guide provides all you need to meet the new 2015 standards.

ISO 9001: 2015 for Small Businesses helps you understand what the new standard is all about and how to achieve compliance in a cost effective way. Covering all the major changes to the standards, this book provides direct, accessible and straightforward guidance. This edition includes:

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• down-to-earth explanations to help you determine what you need to enable you to work in compliance with and/or achieve certification to ISO 9001: 2015;
• a contextual explanation of ISO 9001 within the structure of ISO 9000 family of standards;
• a detailed description of the structure of ISO 9001: 2015 and its compliance with Annex SL;
• coverage of the new requirements for Risk Management and Risk Analysis;
• a guide to the costs involved in implementing ISO 9001: 2015 and advice on how to control costs;
• an example of a complete, generic Quality Management System consisting of a Quality Manual plus a whole host of Quality Processes, Quality Procedures and Word Instructions; and
• access to a free, software copy of these generic QMS files to give you a starting point from which to develop your own documentation.

This book is also supported with a complete bibliography containing abbreviations and acronyms as well as a glossary of terms. This comprehensive text will provide you and your small business with a complete guide on your way to ISO compliance.

Chapter 1

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What is the importance of quality to small businesses?

Author’s Start Note

The aim of this short chapter is to introduce the reader to the requirements and benefits of quality, Quality Control and Quality Assurance.

The significance and the types of specification are explained, supplier’s and purchaser’s responsibilities are defined and a thorough review of quality during a product’s life cycle enables the reader to appreciate the costs and associated benefits of quality.

This particular edition has been rewritten to cover the changes made in the latest 2015 edition of ISO 9001, particularly ISO’s requirement (as detailed in Appendix 3 of ISO/IEC Directives, Part 1 Annex SL) that all future revisions to Management System Standards will have to be written to the same high level structure, with identical core text, as well as common terms and definitions (where suitable) with the overall aim of making them easier to read and understand and thus, easier to integrate more than one standard into an overall business management process.

Although I have written Chapter 1 primarily from the point of view of a manufactured product (bearing in mind that 41 per cent of all small businesses are actually manufacturers), it is equally applicable to the design of any type of products and services, be they hardware or piece of software, the production of a document or, indeed, any other form of deliverable.

I consider this part of the book to be essential reading, regardless of the type of business you are involved in.

1.1 WHY MANAGE QUALITY?

The Chartered Quality Institute (CQI) have carried out extensive research on this point and have advised that the effective management of quality not only creates value for an organisation and its stakeholders but also manages its exposure to risk and can make the difference between success and failure.

A properly implemented and effective business management system identifies and manages organisational risks to ensure that:

• the organisation consistently delivers the products and services that customers want, when they want them and to the quality they expect;

• customer satisfaction and loyalty is improved;

• organisational goals and objectives are achieved;

• organisational risk is identified and effectively managed;

• products and services, and the processes that deliver them to customers are continually improved through innovation;

• waste throughout the organisation is identified and eliminated; and

• partnerships and the supply chain deliver value to the parties involved.

1.2 THE IMPORTANCE OF QUALITY

First of all, what is meant by the word ‘quality’?!

Basically, the quality of a products and services refers to the degree to which they meet, and continues to meet, customer expectations.

In business, there are many meanings of quality, such as:

• ‘A product or service free of deficiencies’ (Deming);

• ‘Conformance to requirements’ (Cosby);

• ‘Fitness for use’ (Juran);

• ‘Meeting or exceeding customer expectations’ (Juran);

• ‘The characteristics of a product or service that bear on its ability to satisfy stated or implied needs’ (American Society for Quality);

• ‘The degree of excellence of something’ (Oxford Dictionary);

• ‘The number of defects per million opportunities’ (Six Sigma);

• ‘The result of care’ (Page);

• ‘The standard of something as measured against other things of a similar kind’ (Oxford Dictionary);

• ‘Uniformity around a target value’ (Kano);

• ‘The loss a product imposes on society after it is shipped’ (Taguchi);

• ‘Value to some person’ (Weinburg); and even

• ‘Quality in a product or service is not what the supplier puts in – it is what the customer gets out and is willing to pay for’ (Drucker).

But today’s internationally accepted definition of quality (i.e. as defined in ISO 9000) is that:

‘Quality is the degree to which a set of inherent characteristics fulfils requirements’.

However, quality has no specific meaning unless related to a specific function and/or object. Quality is a perceptual, conditional and somewhat subjective attribute.

FIGURE 1.1Quality

Quality (particularly with respect to ISO 9001:2015) is a reference to a set of predetermined, well-organised actions that can be used by any organisation whether they are large or small and regardless of whether they are designers, manufacturers, producers, suppliers or end users. It is a method of ensuring that all of these organisations get standard quality products and services that satisfy their individual and collective needs.

Quality consists of two separate yet connected activities, Quality Control (QC) and Quality Assurance (QA) as shown on page 4.

1.3 QUALITY – THE FUNDAMENTALS

• Business process management – delivering results through business processes to increase efficiency.

• Customer focus – delivering customer value while anticipating future needs and potential markets.

• Fact-based decision making – ensuring good decision making by using accurate data and facts.

• Improvement – making performance improvement a perpetual objective.

• Leadership – providing vision and direction, gaining commitment and achieving collective results.

• People and organisational culture – delivering maximum value through development and involvement of individuals working in – and to – a productive organisational culture.

• Suppliers and partners – maintaining mutually beneficial relationships to enable value creation.

• Systems thinking – managing interrelated processes with an integrated approach.

Quality Control	Quality Assurance
Is a procedure (or set of procedures) to make sure that all products and services adhere to required quality standards.	Confirms the degree of excellence of products and services measured against its defined purpose.
Is a regulating process through which actual quality performance can be measured and compared to quality standards.	Ensures that a set of activities are ca...