Mini guide to ISO 9001, part 1

07 February 2017

A couple of weeks ago we had our ISO 9001 stage two audit and gained our accreditation! This is our second ISO accreditation, the other being the 27001, which we’ve maintained for three years now.

In both cases, 27001 and 9001, we used the certification body British Assessment Bureau. They supplied us with a toolkit; generic documentation which you need to adapt and apply to your business. This was the first ISO management system I have implemented. At first it was quite daunting, but once I’d written the Quality Management System Manual, the main document for for the 9001, the rest fell into place. The toolkit is really helpful. I suggest anyone undergoing any of the ISO’s start with a toolkit. It doesn’t answer all your questions, but provides an excellent foundation.

Because the ISO can be applied to any type of business, large or small, some of the information can be vague and open to interpretation. The nonspecific nature of the resources available left me questioning my own interpretation. Maybe I was asking for too much, but I wanted a simple outline of each clause. Below is a brief overview of our Quality Management System Manual, clauses 1 to 4. I’ll cover the other 6 over the next two posts. I hope this proves to be helpful to anyone preparing for their ISO 9001:

1. Introduction

1.1. The Purpose of this Document

Here we introduce the document, its purpose within the business and how it is designed to meet the requirements of the ISO 9001

1.2. Plan-Do-Check-Act

ISO requires you to adopt the plan-do-check-act process and risk-based approach. Illustrate your understanding of these processes and how they apply to your business. For example, what are the process steps, and what do you need to consider to achieve them.

1.3. Quality Policy

The quality policy is what you promise to do to ensure quality in all areas of the business, and for the benefit of all interested parties.

2. Overview of the Organisation

Basic facts about the business, for example: when was the company established; what services/products do you provide/manufacturer; what specific area of your industry do you specialise?   

2.1. Scope of Registration

I struggled with this one a bit. In actual fact it is simple, but you may feel that you are repeating yourself. You need to state the services you provide. You may also want to state how this relates to your QMS. For example, we provide digital services, design, development etc, and our manual represents the scope of the QMS, which identifies the relationship between the procedures, processes and outputs.

3. Quality Objectives

I would advise writing these when you write your quality policy, or at least refer back to your quality policy. Here we’ve listed a number of objectives and how we plan to measure them. Try to write SMART objectives.

4. Context of the Organisation

4.1. Understanding the Organisation and its context

I don’t think it’s compulsory, but I found it helpful to start by listing internal issues and external issues. For example, social and political factors, and performance and resource issues. I found listing these useful when sourcing legislation, and determining interested parties (4.2) and the scope of the QMs (4.3).

You must list all legal and regulatory legislation applicable to your business. Use

From this you should be able to form a pretty good understanding of all the areas of the business, and how they relate to each other. This should make the rest of clause 4 pretty straight forward.

4.2. Understanding the Needs and Expectation of Interested Parties

List all the interested parties. For example, clients, directors and employees. Then alongside, list their needs and expectations. For example, quality, growth and job security.

4.3. Determining the Scope of the Quality Management System

Take into account all these aspects; issues, context and interested parties etc, and state how the QMS applies, thus setting its boundaries. We set out the business functions, management systems and processes/procedures, which would be controlled by the QMS.

4.4. Quality Management and its Processes

This one can take the form of a flow chart. Chart the areas of the business, and the processes that links them, and google ‘flow charts’, just for some presentation ideas.

I’ll leave it here for this week. Next post I will look at clauses 5 - 7; Leadership, planning of the QMS, and support.