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Quality Manuals

ISO 9001 ISO 13485 ISO 14001
Manual Review Checklists

Designing Checklists

By Mark Kaganov

This is an updated and modified version of the article originally published under the title Checklists – A Perfect Tool to Tune-up Your Quality Manual in Quality Progress magazine in the October 2000 issue.

Abstract

This paper offers practical methods to create and use checklists to verify compliance of a quality manual with the requirements of various international and national standards such as ISO 9001, ISO 14001, ISO 13485 or any other. The author analyzes the advantages of using single and multi-standard checklists. The various examples shown in the paper illustrate a practical approach to developing a simple yet very helpful tool to ensure that your quality manual addresses all the requirements of the applicable standards.

Introduction

Did you ever arrive at your campsite and realize that you forgot your fishing rod or charcoal for the grill? Did you ever arrive at a hotel on a business trip to find that your lap top power adapter is still on your desk in the office? Most likely at one time or another each of us have found ourselves in situations where we were so busy preparing for an event that we forgot something important. The same thing happens when writing quality manuals – very often some of the requirements of the standards are forgotten and not addressed in the quality manual that per the requirement of ISO 9001:1994, element 4.2.1, shall cover all “…the requirements of this International Standard.”

The problem of forgetting to address some requirements in a quality manual is not just hypothetical. Through my work in the registration business with dozens of companies around the world, I have witnessed the implementation of numerous quality systems. What seemed to be a simple task of creating a quality manual and documenting a company’s commitment to a particular standard can create significant difficulties for businesses of various sizes, in diverse industries, in different countries. During my career in the registration business, I have not yet seen a quality manual that addressed all the requirements of an applicable standard on initial review.

Fortunately, there is a simple solution – use a checklist. Going back to the example of the forgotten fishing rod, most camping books contain checklists of what you need to take on fishing, climbing or camping trip. Not long ago, I found a book that listed what business travelers need to take on a business trip.

A quality manual for ISO 9001, ISO 13485 or any other standard or regulation, if we follow the rule to cover “…the requirements of this International Standard,“ can be a somewhat complicated document. Since we are human beings, it is not unusual that some of these requirements may be missed and not addressed in the quality manual. Using a checklist will help you remember to address all the requirements. This is why many registrars use quality manual review checklists on initial assessments.

Creating checklists

Checklists are widely used by companies in various industries for documenting test results, equipment maintenance procedures, internal audits and other activities. Surprisingly, not many companies use checklists to verify the quality manual. If you are in the process of developing a quality system for registration, or reviewing your existing quality manual, you might ask your registrar for a checklist.

Actually, creating a checklist for a standard is a relatively simple task. Based on the premise that a quality manual should cover all the requirements of a standard, you simply need to condense the standard into a set of requirements. For example, the simplest checklist for the ISO 90012000 standard is a list of its 5 elements documenting requirements. A checklist in this format would look like the one shown in Figure below: 

Checklists Figure 1 - ISO 9001 Quality manual Checklista

Using a checklist is simple. It prompts you to note where the answer to a particular requirement is located in your manual or quality system. For example, Figure 1, clause 4, requires establishment of of a quality management system. The entry in the “Response location” column indicates that it is defined in the Quality Manual (QM), section 4. The “y” in the next “A” column indicates that this requirement is adequately addressed.

The simple checklist shown in Figure 1 may help you to verify if all major clauses of the standard are addressed in your quality manual. However, it most likely will not be sufficient for your quality system or your registrar, since there are more requirements within each of the clauses. To continue enhancing the checklist in Figure 1, you may consider including the requirements of sub-clauses of the standard. In this case, the checklist will be transformed into the list shown in Figure below:

Manual Checklistss Figure 2 - ISO 9001 ISO 13485 Quality manual Checklists

This expanded checklist includes requirements of both the elements and sub-elements of the standard and most likely will satisfy most quality systems and registrars. Depending on how detailed you want to be covering all “…the requirements of this International Standard,” there are still ways to continue enhancing your checklist. For example, element 4.1, General requirements, contains such specific requirements as a), b), etc. If you wish to include this level of detail in your manual, you can add these specifics to your checklist. In this case the checklist would look like the one shown in Figure below:

Manual Checklists Figure 3

This version of the checklist is much more detailed than the original example in Figure 1. Using this approach of increasing level of hoe detailed your checklist is, you will be able to create a checklist that meets needs of your organization.

So far we spoke about a checklist for one standard. What if your company has an integrated manual, let’s say, for ISO 9001 and ISO 14001? To be sure your manual is complete; you may use multiple checklists, such as those shown in Figures 4 for each standard.

Another approach is to develop one checklist covering the requirements of all standards applicable to your management system. If your manual addresses requirements of more than one standard, you can identify all the requirements in a common checklist. If, for example, you combine the requirements of ISO 9001 and ISO 14001 standards into one checklist, you may have a checklist similar to the one shown in Figure below:

Manual CHecklists Figure 4 - ISO 9001 ISO 14001 Integrated Manual Checklists

When working with checklists for more than one standard, it is a good idea to include symbols identifying which requirements belong to what standard. The green dot () in Figure 7 is used to identify requirements of the environmental ISO 14001 standard. The same approach may be used for standards that include text of the ISO 9001 standard, such as ISO 13485 and others.

Afterward

I hope this review helped you realize that checklists can be a very useful tool in creating and maintaining a quality manual that addresses the requirements of applicable standards and regulations. I also hope that you now have enough ideas to create your own checklist for your specific needs. Now that you know how to make your own checklist with sufficient detail, but perhaps do not have time to put it together, check our Products page to see how our publication can help you developing and implementing your management system

About the author

Mark Kaganov is a Director of Operations with Quality Works. He is an IRCA certified QMS lead auditor and RAB certified EMS lead auditor. He earned a master’s degree in design and technology of electronic equipment from Moscow University of Radio-Electronics and Automation. Learn more about the author here

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