Our 5-Step Approach

Simplify your ISO 9001 implementation with our 5-Step Approach!  Follow the five steps below and you will be surprised how simple your ISO 9001 implementation can be. Note that our Complete Package contains our Guide to ISO 9001 Compliance which explains each step in detail; in addition, the Complete Package contains numerous materials that support each implementation step.

Step 1: Preparation

This step is the preparation for your ISO 9001 implementation. It’s not difficult but it’s important and should not be missed.

Get an Understanding of ISO 9001:2008

ISO 9001:2008 is a world-wide accepted standard for quality management requirements. As such, ISO 9001:2008 focuses on a large variety of business activities – not merely on quality testing! Implementing ISO 9001:2008 will affect virtually all business processes.

Note: "ISO 9000", "ISO 9001" and "ISO 9001:2008" all mean the same: the ISO 9001:2008 standard.  click for explanation

For a good overview, please review the following:

• Our Important Startup Documents (which come with the Complete Package) contain a good summary and overview of ISO 9001:2008.

• http://www.iso.ch

• In addition, we recommend that you obtain the actual ISO 9001:2008 standard (see our Resources section) and review it.

ISO 9001 Management Representative

First, appoint the ISO 9001 “Management Representative”. This is typically a quality manager or senior manager of your company; it needs to be somebody who has sufficient authority to change the way that the company works. This person is responsible for the ISO 9001 implementation.

A “Role Description” for the Management Representative is included in our Important Startup Documents (which come with the Complete Package). We wrote this short guide as if you, the reader, will be the Management Representative.

Larger companies may appoint a Management Representative for each physical location or for each business unit; a corporate Management Representative would then coordinate among all local Management Representatives. Note that our Quality Manuals are based on a system of local and corporate Management Representatives (which can very easily be modified to a single Management Representative).

Training

Next, the Management Representative needs to get some training. A Training Plan for Management Representatives is included with our Forms Collection.

Please see our Resources section for training videos, training classes and good books for self-study.

Also, studying a sample of good ISO 9001 documentation is an excellent training tool. For this purpose, we highly recommend you carefully review our Implementation Manual (which includes many explanations) and the detailed customization instructions that are included.

Get Buy-In

Further, you should ensure that the company executives completely support the ISO 9001 effort. You may need to explain to them the advantages, requirements and costs. See our Resources section for useful information.

Finally, you should inform all employees. It’s important that the employees don’t feel threatened by ISO 9001. In our Important Startup Documents (which come with the Complete Package) you’ll find a brief Employee Intro To ISO 9001, as well as an ISO 9001 Summary; also our Resources section contains useful information.

Step 2: Quality Manual, Quality Policy and Procedures

Developing the various documents required by ISO 9001:2008 is for most companies the most difficult part of the ISO 9001 implementation. The main reasons are that these documents have to meet the rather hard-to-understand requirements of the ISO 9001:2008 standard, and that writing these documents is at the beginning of the ISO 9001 implementation thus presenting a big initial hurdle.

However, we make it easy for you!

Use our Implementation Manual (or our Streamlining Manual if your company already has some form of quality management system in place) and the many useful forms included in our Forms Collection as templates and you can complete this crucial step quickly and at minimal cost!  (Note: our Complete Package contains both, the Implementation Manual and the Streamlining Manual.)

Which Documents are required?

(1) Quality Manual

(2) Six Quality Procedures

(3) Quality Policy

(4) Quality Objectives

(5) Process Flowchart

In addition, ISO 9001:2008 indirectly requires the following:

(6) Work Instructions
Work Instructions are detailed step by step instructions on how to perform a particular work process. ISO 9001:2008 does not include an absolute requirement for Work Instructions; however, section 7.5.1 requires Work Instructions where they add value to the company.

(7) Forms
ISO 9001:2008 does not specifically require forms but they can be considered both work instructions (before they are filled in) and records (after they are filled in). For this reason, good forms save time and provide many more benefits.

Choose the right Documentation Template

The secret to easy ISO 9001 implementation is the use of good templates. Good templates will not only help you develop a business-friendly ISO 9001 quality management system, they will also make the development of all required documentation a rather easy task.

Both our Implementation Manual and our Streamlining Manual contain and fully integrate the following documents: Quality Manual, Six Quality Procedures, Quality Policy, Quality Objectives, Process Flowchart.  In addition, many Work Instructions and additional Procedures are included.

Both our Implementation Manual and our Streamlining Manual come with comprehensive customization instructions that make it really easy to develop the required documentation.

Please use our product pages to chose the ideal manual for you (for first time ISO 9001:2008 implementation you will likely choose the Implementation Manual - either alone or packaged in our Complete Package).

Easy Documentation Development

It is particularly easy to develop the entire documentation required by ISO 9001:2008 if you customize the Implementation Manual or the Streamlining Manual using the included detailed customization instructions.  Just follow them step by step, and you will achieve your own, complete ISO 9001 documentation quickly and easily.

Once done, get your new ISO 9001 documentation approved by the president of your company.

Step 3: Implementation, Training and Work Instructions

Now it’s time to implement your ISO 9001 quality management system. During this phase you introduce the new requirements included in our Implementation Manual, you train employees, and you get them to adjust their way of working to any new requirements. This step will be much easier if you did a good job in Step 1!

One Step at a Time

Take one step at a time in your implementation process. You may want to start with the section on Document Control. Explain the requirements in a meeting or memo, or have the appropriate department managers explain to their staff.

Training and Work Instructions go Hand in Hand

As you implement your ISO 9001 quality management system, virtually all employees have to change the way they work at least to some extent. At the same time, ISO 9001:2008 calls for standardization and for work instructions. Our Implementation Manual and Streamlining Manual point out where work instructions are required. We recommend that you assign the writing of work instructions to those who actually do the work. Instruct them to write up the best way of doing the work. If your Quality Manual calls for a change in their work, introduce those new requirements and make the employees incorporate them into their work instructions. Review the work instructions to make sure that they meet the requirements of your Quality Manual.

Step 4: Internal Audits

Internal audits are performed by somebody within your company (or by a subcontractor). The job of the auditor is to verify that your company meets the requirements of ISO 9001:2008 as they are described in your Implementation Manual or Streamlining Manual.

The Auditor

In most cases the ISO 9001 Management Representative is also responsible for internal audits. In this case, the Management Representative audits the entire company except his/her own work, and another employee audits the work of the Management Representative. Our Forms Collection contains an invaluable Audit Checklist.

Larger companies often appoint and train several internal auditors. This is an excellent opportunity for cross-training and for staff of different departments to learn what other departments are doing.

Audits as Training Tool

We recommend that you start Step 4 even before Step 3 is complete. Audits are an excellent way of training; they will help with your implementation efforts!

Once you have performed a complete internal audit that didn’t uncover any significant problems, you are probably ready for the certification audit!

Step 5: Certification

Now it’s time to select your registrar! There are many companies offering certification services but be careful: some are not accredited! Start your search on the Internet and compare the different registrars. Our Forms Collection contains a Registrar Evaluation Form; our Important Startup Documents (which come with the Complete Package) also contain very valuable Audit Preparation Tips.

Reaping the Marketing Benefits

Once you successfully passed the certification audit, you should leverage your new ISO 9001 certification in marketing. You may want to prepare a press release, send notification cards to your customers, print your certification mark on business cards and letterhead, add your ISO 9001 certification mark to your advertisement, display a banner outside your office building and last but not least, recognize your employees for the hard work they put into this effort. Our Important Startup Documents include valuable ISO 9001 Marketing Tips.

Maintaining Certification

Remember, ISO 9001 certification is not the end, and your ISO 9001 registrar will perform a surveillance audit once or twice a year to verify continued ISO 9001 compliance. Your ISO 9001 system is designed to continually improve itself. Make sure it remains implemented, continue your internal audits, and we are convinced you’ll see your company’s performance improvements at the bottom line!

In section 8.5.1, ISO 9001:2008 requires to "continually improve the effectiveness of the quality management system". Most auditors would expect you to revise your ISO 9001 Quality & Procedures Manual as your ISO 9001 quality management system matures and the detailed explanations of the initial Quality & Procedures Manual are no longer needed.  The Streamlining Manual is ideal to meet this improvement requirement. In addition, the Streamlining Manual will provide you with even more streamlined and efficient processes.

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