Featured Book of the Month:

Title: The Quality Audit for ISO 9001: 2000: A Practical Guide

Author: David Wealleans

Publisher: Gower Pub Co

Notes: This book aims to teach the entire process of auditing without any of the dogmatism so common in quality management. It is comprehensive yet flexible so that it is of use to novices and beginners. The approach, especially for internal audits, is geared towards improvement and assessing objectives, which now fits in well with the philosophy of the 2000 version of ISO 9001.

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You can order this book from internal-auditor.com at: http://www.internal-auditor.com/books.htm

Auditing To The 8 Quality Management Principles 

It has been said that ISO 9001:2000 changes the entire structure of the Quality Management System. We must move away from a focus on the standard, to a focus on the business needs. We do this through auditing the processes, not just the compliance to the standard. We also accomplish this by auditing to the Eight Quality Management Principles. This is taking ISO 9001 beyond ensuring the product is conforming to ensuring the entire process is conforming. 

These Quality Management Principles can be found in the Introduction part of ISO 9000:2000. They are:

1. Customer Focus
2. Leadership
3. Involvement of People
4. Process Approach
5. System Approach to Management
6. Continual Improvement
7. Factual Approach to Decision Making
8. Mutually Beneficial Supplier Relationships

It is important to note that ISO 9000:2000 is not an auditable standard. It does however, form the basis for ISO 9001:2000. For that reason, it is important for an auditor to know and understand how these principles affect the auditable standard. Let's examine each one in detail to determine how we can audit them for maximum impact.

Customer Focus

"Organizations depend on their customers and therefore should understand current and future customer needs, should meet customer requirements and strive to exceed customer expectations."

There are several specific requirements in ISO 9001:2000 that align with this principle. The goal here is for you to understand your customer and your customer's needs. It is also expected you will try to meet those needs in such a manner that satisfies the customer to the point where the customer is satisfied, not just with the product, but with the transaction as a whole. Auditing Customer Focus is performed primarily through auditing the sections that deal specifically with this topic [5.1, 5.3, 5.2, 5.4, 5.5, 5.6, 8.2.1, 8.4, 8.5.1, 8.5.2, 8.5.3]

Leadership

"Leaders establish unity of purpose and direction of the organization. They should create and maintain the internal environment in which people can become fully involved in achieving the organization's objectives."

ISO 9001:2000 begins with stressing "Top Management". As you can imagine, this is no accident. Upper management need to be much more involved than just to say "let's do it". Too many times the top management drops the entire process on the quality manager's desk with direction to get the organization registered. It then becomes "quality's" thing. Auditing Leadership is a bit more challenging, if nothing more than a lot of leadership is based on, and demonstrated though intangible processes. It is expressed in ISO 9001 through the entire standard. Probably the best barometer would be the management review process.

Involvement of People

"People at all levels are the essence of an organization and their full involvement enables their abilities to be used for the organization's benefit"

Processes work best when the process 'doers' feel like they are also process 'owners'. True involvement includes real empowerment and deployment of decisions to the lowest possible level. It also means that top management must use greater care in selecting process operators. Empowerment must be coupled with ability and competence. This should include professionalism, attitude and motivation. Clause 6 give the best choice for auditing involvement, although Clause 5 in involved as well. 

Process Approach

"A desired result is achieved more efficiently when activities and related resources are managed as a process."

This is a new thing for many companies. QS 9000 companies have had to deal with processes for a while and have a slight advantage. ISO 9001 forces us to look at and examine our processes. We must also determine how the various processes interact. Probably the best way to do this is to map our processes. There is no requirement to 'map' the processes, but it the most common and is quite effective (if done correctly). Auditing the process approach is reflected in 4.1, but do not neglect 8.2.3 and 8.4 as well.

System Approach to Management

"Identifying, understanding and managing interrelated processes as a system contributes to the organization's effectiveness and efficiency in achieving its objectives."

This is a natural extension of the Process Approach. Whereas the Process Approach focuses on the process, this focuses on how top management manages the processes. Auditing will be similar to above, but with added emphasis on Clause 5.

Continual Improvement

"Continual improvement of the organization's overall performance should be a permanent objective of the organization."

I entered manufacturing back in 1978. The rate of change I've experienced since then is staggering. What is even more astonishing is the fact the each year the rate of change increases. Continual Improvement was a good thing back in the 70's, now it is a necessity! Continual Improvement is required by ISO 9001 and can be audited using primarily Clauses 5.6, 8.5.1 and 8.5.3.

Factual Approach to Decision Making

"Effective decisions are based on the analysis of data and information."

Clause 8 of ISO 9001 is full of factual and data requirements. Making decisions based on fact and logic is far superior to making 'gut' decisions and guesses. This can also be hard to audit because of lack of clarity on what data should be collected and how to interpret such data. The primary clauses here are 5.6 and the whole of Clause 8.

Mutually Beneficial Supplier Relationships

"An organization and its suppliers are interdependent and a mutually beneficial relationship enhances the ability of both to create value."

This is without a doubt the hardest to audit. From an organizational standpoint, there are two parts to this. First is how we deal with our suppliers, and second is how we deal with our customer. Where do we fit in the supply chain, and how can we best impact the entire chain? Most organizations don't ask how they can assist their customers and suppliers in gaining market share and increase everyone's profit margin. Yet, this is exactly what we should do. Auditing this principle is a matter of auditing the Customer Focus listed earlier and also 7.4.

Summary:

It is important to note that although ISO 9000 is not an auditable standard, it has many components that are addressed in ISO 9001. The framers intentionally built the eight quality management principles into ISO 9001. An understanding of these principles, and their application could very well lead to more effective auditing and organizational performance.

As always...Good Auditing!

ISO 9000 Translated into Plain English is a site that makes sense of the language of ISO. If you are unsure of what a particular part of the standard means, then this is the ideal resource! [Finally...we have some hope! Also, ISO 10011, and ISO 10013... And there's more... They also have internal audit training programs.] You can visit them at:

http://praxiom.com/

Q – What requirements are there for the trainers of internal auditors?

A – In order to answer that, we must first look at the requirements for the internal auditors. Internal auditors must be competent to audit to the requirements. There are no special requirements for this. Applying this to the internal auditor trainers will lead us to only one possible answer. The trainer must be able to provide the auditor with the necessary competence. If that means the trainer must be a RAB-certified Lead Auditor and have 10 years experience, then that is what it takes. If the trainer has only on-the-job training, but can lead a auditor trainee through the on-the-job process then that is good enough. 

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ISO 9001:2000 Clause 5.2 Customer Focus

"Top management shall ensure that customer requirements are determined and met with the aim of enhancing customer satisfaction."

Organizations must do more than just meet customer requirements. How many times have you engaged in a business transaction and even though you received what you paid for and might be happy with the product, you still did not like the transaction? Doing business is more than just selling a service or product. Top management must look at the entire business with the understanding of what it is like from the customer's eyes to do business with them. Only then, can they attempt to enhance customer satisfaction.

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September 2001's question: 

You are a newly appointed auditor. You are auditing your company’s Corrective Action procedure. You notice a considerable of corrective actions from the previous audit of document control, just last month. Each of them involved a failure to review documents under their control every three months. The procedure cited is for Document Review. Most of the corrective actions have been closed, but there are two still open. You decide to look at the Document Review procedure. To your amazement, you find the procedure was removed six months ago. All of the corrective actions written during the last internal audit were to a non-existent procedure.

The answer: 

This problem could be an embarrassment to the internal audit team. If the procedure was removed, it should not have been audited, and provided the actions listed on the corrective actions were not in violation of an alternate procedure, they should not have been written. But they were. Now the question raises that if the corrective actions were closed, does that mean the removed procedure was in fact valid? Another question is raised about the closed corrective actions. Are they now in violation of an alternate procedure? This situation requires all parties involved to reach an understanding about the original corrective actions and the closed actions taken. If there should have been no corrective actions, then the organization must determine if the corrective actions taken are still valid. The nonconformance in this scenario could be in the internal audit department.

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Do we really need a standard to tell us we must focus on the customer? On one hand common sense would tell us no, but then again I think we have all experienced what is called 'buyer's remorse'. In many cases, buyer's remorse stems from the seller talking us into something we really didn't want. Other times it stems not from the product, but from the transaction. ISO is not so much telling us how to run our business, as much is it is telling us to listen to our customer and see our business the way the customer does. And that ain't all bad!

Dave

...Good auditing!

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Because this site uses information from many different sources, it must be pointed out that any advice, tips, information, etc., provided should be regarded as opinion and not fact! What works well for one company may be a disaster for another. Also, what one registrar, or auditor may allow, another may not. As always, reflect on what you read, see if it fits into your own quality system, and if it conflicts with your auditor...you've got to make a decision