How to Implement a QMS and Achieve ISO 9001 Certification: Clauses 0.1, 0.2, 0.3 ,1, 2 and 3

Posted by Craig Thornton

Part 9: Clauses 0.1, 0.2, 0.3, 1, 2 and 3 of ISO 9001:2015

I know what you’re thinking – who on earth takes any notice of clauses 0.1 to 0.3 and 1 to 3 in ISO 9001:2015?  Surely they’re just unnecessary padding, like the foreword to a book or the editorial in a magazine?  Shouldn’t I just fast-forward to where the real action begins, at clause 4?

Sure, you could do that – and certainly in my experience most people do – but overlooking clauses 0.1 to 0.3 and 1 to 3 is not like merely skipping the opening credits to a movie.  It’s more like missing the first third of a movie.  The first third of the movie is where all the necessary, important stuff is.  It’s where the fundamentals of the story are laid out, where all the characters are introduced, and where all the groundwork is laid.  Movies are structured like this so that you will understand what is going on when the actions heats up.  ISO is just the same.

How to Implement a QMS and Achieve ISO 9001 Certification  Part 9.jpg

 Read all of the clauses prior to 4.  Then re-read them.  Think about them till you really get it (a good way to know if you’ve really got it is to try and explain the gist to someone else in your own words.  Better buy that person a coffee and a muffin before doing this, though).  Understanding these clauses is going to give you a rock-solid basis from which to manage the whole certification process.  Believe me, it will not be time wasted.  I’ll wait here while you do that.

Done?  You really gave it a lot of time and considerable thought?  Excellent!  Now here are a few more things that may or may not have occurred to you while reading those clauses.

 

Clause 0.1 General

This clause contains an overview of the strategic decision to implement a quality management system (QMS), the benefits of a QMS and the fact that the standard can be used by both internal and external parties. 

Get sign off - here at Mango we have made this a strategic decision at Board level.  If you are seeking ISO 9001 you should get sign-off from your Board or from the senior management team (SMT).  As part of this decision-making process you’ll need to discuss (and perhaps argue) the benefits of a QMS with the Board or SMT. 

Incorporating other business management systems - in developing our QMS we have decided to incorporate some business management systems too.  Other non-traditional quality systems like financial systems, governance systems and sales and marketing systems can easily be added into the QMS.  We highly recommend that you seriously consider doing this.  After all, why invent another two or three ways of doing things when you have your QMS ready and able to handle it?  It’ll keep everything chugging away nicely, within a proven, sturdy structure.

Uniformity - the standard doesn’t imply that there should be “uniformity in quality systems”.  This isn’t a cookie-cutter situation.  I strongly suggest that your QMS is unique to your business and not just copied from another system.  There is no other business exactly like your business.  Let your QMS reflect this.

Numbering your documentation - the standard says that that you don’t have to align your “documentation to the clause structure of this International Standard”.  So don’t feel that you have to make your documented QMS numbering match that of the standard.  Having said that, however, this new ISO 9001 seems to be better structured than previous editions, so here at Mango we’ll be using the ISO 9001 clause numbering in our Quality Manual.

Terminology - the standard also says that you don’t have to adopt the terminology used in ISO 9001 within your organisation.  Some ISO 9001 language can be very confusing to those who are new to the concepts.  Unfamiliar language puts a significant barrier between staff and the QMS.  At Mango we want clarity for every one – we don’t want our staff having to translate unfamiliar terms before taking action.  So at Mango we will use our own terminology.  For example, instead of “design review”, we will use “input review”, “code review” and “MRS review”.  These are the terms we use every day in our business, so it makes sense to use them in our QMS. 

Products versus services - the standard is complementary to both products and services.  In the standard, products and services mean the same thing, so if you see the word “product” and you provide a service, then just replace the word “product” for “service”.

Sales and marketing - at Mango we will use our certification to ISO 9001 in all of our sales and marketing efforts, and you should too.  The ISO 9001 logo should be in every staff member’s email signature, on letterheads, on every page of your website (actually there should also be an entire page dedicated to ISO 9001 on your website), it should appear in all of your quotations, and on any tenders or Requests for Proposals that you put forward.  It should also appear on any ISO 9001-related resources that you give away, like forms and checklists, policies and procedures.

 

Clause 0.2 Quality Management Principles

These have been covered in my previous 7 blogs.  See the takeaways of those blogs for tips in customer focus, leadership, engagement of people, process approach, improvement, evidence-based decision making and relationship management.

 

Clause 0.3 Process Approach

Next the standard suggests that a process approach should be adopted.  This will include the plan-do-check-act (PDCA) cycle and the risk-based thinking approach.  I’ve previously discussed this in a blog about the process approach.

When developing our QMS we will incorporate the PDCA cycle into our thinking.  At the same time we must make sure that we have enough resources to do the job, and that opportunities to improve are encouraged and fostered. 

We’ll also ensure that risk-based thinking is well managed.  We need to ensure that both negative risk and positive opportunities are considered equally (it’s so easy to focus on what could go horribly wrong, and allow those positive opportunities to drift on by).

The standard then discusses the need to “adopt various forms of improvement ..., such as breakthrough change, innovation and re-organization”.  This has been built into our philosophy from the beginning anyway.

This clause finishes off with some important definitions:

  • “shall” indicates a requirement;
  • “should” indicates a recommendation;
  • “may” indicates a permission;
  • “can” indicates a possibility or a capability.

These are very important to understand when reading the standard.  Every time these words are mentioned, we’ll refer to these definitions to make sure we’re on the right track.

 

Clause 1.0 Scope

This is the scope of the standard, not the scope of your business.  This scope is for a quality management system only.  I repeat, it’s not for all business management systems but only for the quality management system.  It is also for organisations that need to demonstrate their ability to consistently provide products that meet customers’ requirements and applicable standards or regulations.  Plus it aims to enhance customer satisfaction. 

As Mango grows, more and more customers are requiring conformance to different standards such as cyber-security, IT security and high up-time.  Being ISO 9001 certified will give customers some level of assurance that we will provide them consistent products and service and continually improve that overtime.

Clauses 2 and 3 are around reference to ISO 9000:2015.  You should buy this standard too because it provides many useful tips and tricks for your newly created QMS.

In the end though, all of these tips and hints will get you only so far.  If you haven’t got your foundation right – clearly understanding those early clauses 0.1 to 0.3 and 1 through 3 – then you’ll be building on shaky ground.  You need to have a deep appreciation for the big picture before getting into all of the details.  Do it right the first time.

 

Integrated_Management_System_manuel.jpg

To view previous blogs in this series "How to Implement a QMS and Achieve ISO 9001 Certification":

How to Implement a QMS and Achieve ISO 9001 Certification - Part 1: Introduction

How to Implement a QMS and Achieve ISO 9001 Certification - Part 2: Customer Focus

How to Implement a QMS and Achieve ISO 9001 Certification - Part 3: Leadership

How to Implement a QMS and Achieve ISO 9001 Certification - Part 4: Engagement of People

How to Implement a QMS and Achieve ISO 9001 Certification - Part 5: Process Approach

How to Implement a QMS and Achieve ISO 9001 Certification - Part 6: Improvement

How to Implement a QMS and Achieve ISO 9001 Certification - Part 7: Evidence Based Decision Making 

How to Implement a QMS and Achieve ISO 9001 Certification - Part 8: Relationship Management

 

Tags: Quality Management, ISO 9001, ISO 9001 certification, ISO 9001 accreditation