The 9000 Resource

ISO Survey

The latest edition (2006 data) of The ISO Survey highlights the combination of ISO 9001 and ISO 14001. It compares the status at the end of 3 years post-implementation, and outlines how the service sectors are using the standards effectively. 

Certificates issued to industries has skyrocketed to 35% over the previous year and 64% over 2000, which demonstrates the acceptance of global standards. Although Certification is not required, it gives customers more confidence in their suppliers.

Note: The ISO survey provides the basic results free-of-charge as a public information service. www.iso.org

What's the big deal with ISO 9001:2008?

ISO 9001:2000 is finally changing after 8 years. ISO 9001:2008 is available as a draft document with an expected approval by Q408.  You can buy a copy by clicking here http://www.techstreet.com/cgi-bin/joint.cgi/210223/cgi-bin/detail?product_id=1516270, and you can compare the proposed changes for yourself. 

So what is the big deal?  In my opinion: not much.  I hate to critique it since many people spent many hours on it, but it's hard to believe that after 8 years the changes are mostly grammatical.  It is almost the equivalent of bringing your car into the shop and getting it back 8 years later with new air in the tires. 

Behind the scenes there are some things happening which will allow the integration of ISO 9001 & ISO 14001 for easier dual certification. And there are some genuine clarifications to ensure that people understand that the focus of ISO 9000 is to exceed customer expectations. But on the surface it really won't change anybody's QMS - except in the technicalities. You can read more about it here: http://www.the9000store.com/iso-9001-2008.aspx.  But I wouldn't worry about having to make too many changes in your QMS just yet...

Procedures, Processes and Work Instructions...what's the difference?

There are three terms often confused: Procedure, process, and work instruction.  Here's a quick snapshot of the differences between them.

Procedures describe a process such as "Purchasing". They describe an overall process, where as work instructions would describe a more detailed portion of the procedure such as "Completing a

PO

" or "Ordering supplies". Procedures are used for all of the Quality System Processes. You are required to have a procedure wherever it is dictated in the standard to ensure that the process is performed correctly and consistently.

Document Control Software

There are some posts on this blog about documentation, and our site (www.the9000store.com) gives some information on document control, but I've never felt comfortable enought to recommend a software package for electronic document control.  We've looked at several software solutions, but none seemed to match our expectations of user friendliness, cost-effectiveness, and flexibility.

Then we found a little gem called Clearaudit - and they meet all our criteria: Simple and Intuitive, Flexible and User Friendly, Cost Effective (less than three dollars per day.) while being Scalable. We've played around with it, and can recommend this product 100% without any hesitation...See for yourself. I know some people who have bought it already and love it.

Some of the features and benefits of Clearaudit:

• Custom folders allow you to take complete control over your document library
• Approval functionality enables collaboration: Track approvals to ensure no one is left out of the loop
• Trace document distributions to avoid lost copies of obsolete manuals
• Improve productivity by sharing approved quality policies, work instructions, and processes with employees
• Ensure compliance with ISO quality requirements with minimal pain and cost

Since Clearaudit is pure web-based software you have nothing to install and can get started right away. No IT involvement is needed. It has all of the elements of a *full-featured quality management system* for ISO Certification:

• Non-Conformances
• Calibration Records
• Customer Complaints
• Supplier Quality
• Audit Management
• Corrective & Preventive Actions
• Training & Employees
• Document Management, and more

I'll let them (Clearaudit) give you the details, but i recommend signing up for a free demo to see for yourself.

If you were a baker...ISO 9000 as applied to making cookies

Sometimes to understand the impact ISO 9001 has on a company, it's helpful to think about a simple and common example anyone can relate to.  So let's say you wanted to bake cookies.

ISO 9001 doesn't determine the quality of the cookie, your customers have already determined that they like them.  ISO 9001 just helps you deliver consistent product to your customers. The market decides if they like them soft and chewy or crisp and crunchy, you just choose your recipe and try to repeat it exactly every time so customers can count on the consistency.  Continuous improvement helps ensure that your recipe can adapt with the customers' needs (low fat, etc.)

ISO 9001 DOES enforce these types of items:

• Do you always use the same ingredients?
• Do you always measure them the same way?
• Is your oven always the same temperature?
• Do you calibrate your ovens to ensure this?
• Are employees trained to ensure consistent performance?

ISO 9001 DOESN'T try to tell you:

• Crispy or chewy?
• Oatmeal or Chocolate Chip?
• How should you inspect: 100% or Random Sample?

For a further look at how ISO 9001 would impact a common cookie recipe, please download the attached document.  Download cookies_and_iso_9001.pdf  I have picked apart the entire recipe for a deeper look.  If nothing else, it gives you a good recipe for chocolate chip cookies.

What will an auditor look for?

ISO 9001 is often summarized as "Say what you do, and do what you say". (See 12/5/07 post: "Explaining your project...) Auditors are looking to make sure that you are doing what you say. Everyone should be on the same page so that an auditor can walk into your facility and ask anyone"WHY they are doing a particular task, and HOW they know to do it this way".

An employee should be able to say: I was trained on this procedure/task/work instruction (and there should be a record of it) on 4/11/06 (for example) I have a document (that the employee can quickly reference) that outlines the procedure/task/work instruction next to me/in my filing cabinet/on my PC

And, the procedure should be clearly marked with the current revision when compared to the master list in the QMS.  These may seem nit picky, but it takes complete alignment to keep your company working as a system of interlinked processes.

ISO 9001 is also about being consistent – if your processes are designed to meet certain goals/objectives, then if followed they should meet them every time. By making sure everyone is following the same recipe each time, then the company will realize consistent results.  This is what an auditor will look for.

Explaining your Project to Co-workers...in simple terms

It is important to have people on your side as you implement the project, and there is a balance between not enough info and too much when you’re informing employees.  Anxiety is often caused by a lack of knowing (“will my job be affected?”) yet too many details can confuse them.  So as you prepare to implement ISO 9000:2000, try to get people engaged without giving them the nitty-gritty details. We’ve all seen an ISO implementation broken down into any number of steps, our site even gives some examples. But depending on the context of the conversation it may be too much. Here is a simple look which may help translate the project into very concise terms that anyone can understand:

1. Documentation = Say what you do – document your processes/procedures
2. Implementation = Do what you say – follow procedures as documented
3. Training – Ensure that everyone knows how to perform their procedures/tasks.
4. Improve – Continually look for ways to improve your processes. 

And all of the above must be customer driven…you must be meeting or exceeding customer expectations.  This is the big advantage of ISO 9001:2000 over the 1994 version.  You could follow #1-4 above, but it is said that if you are designing CONCRETE life jackets you won’t have many customers, even though you are making them consistently to the specification.

Everyone needs to be informed. So keeping it in simple terms might just help you win some employees and keep them from becoming cynical detractors.

ISO 9001 for small business on a budget

Many people in small business wonder if ISO 9001 is for them: can they afford it? will it be worthwhile? Yes and yes! Here's why:

The benefits of ISO apply to any size company. Small ones benefit from improvement just as much if not more than the big ones. Those benefits include improving the bottom line through increased productivity and increased customer satisfaction.

All of this leads to financial rewards, your reward for your hard work and investment in the Quality Management System.

When ISO 9001:2000 is implemented in an organization:

• Well defined and documented procedures improve the consistency of output
• Quality is constantly measured
• Procedures ensure corrective action is taken whenever defects occur
• Defect rates decrease
• Defects are caught earlier and are corrected at a lower cost
• Defining procedures identifies current practices that are obsolete or inefficient
• Documented procedures are easier for new employees to follow
• Organizations retain or increase market share, increasing sales or revenues

What will ISO 9001:2000 do for my organization?

A well designed and implemented Quality Management System, based on ISO 9001:2000 has been shown to provide organizations with the following benefits:

Reduced costs are obtained through:

• Improved product reliability
• Better process control and flow
• Better documentation of processes,
• Greater employee quality awareness
• Reductions in product scrap, rewords and rejections

ISO 9001 on a small business budget

To implement ISO 9001 on a shoestring budget is definitely possible and not difficult. You can do it using the resources within the company without having to hire an outside consultant. The 9000 Store offers a Small Busines Package specifically designed for the small business do-it-yourselfer.

$797 buys you training for your project leader, ready-to-edit quality manual, procedures & forms, gap analysis checklist and internal audit checklist along with an implementation guide. It is all very easy to use so you probably won't have any questions, but if you do, phone and email support is free throughout your project!

In a nutshell this is how it works:

1. Your ISO project manager takes an online implementation course which explains the whole process and ISO 9001 requirements in detail.
2. There is a detailed PowerPoint presentation you can use to train the rest of the company on ISO 9001.
3. The next step is the gap analysis which is like a mini-audit that shows you what you have in place now compared to what ISO 9001 requires. So the gap between the two becomes the basis of your implementation plan.
4. Then you begin to document your system using the ready-to-edit quality manual and procedures.
5. Once you have that in place you will begin to have internal audits to show how well your system is working and how you might tweak it for improvements.
6. Then, you hire a Registrar to come in and perform the Registration Audit.

ISO 9001 Book Recommendations

How long does ISO 9001 Registration Take?

Getting ready for registration involves building your Quality Management System, documenting that system, and implementing it throughout your organization. The time that it takes a company to complete these tasks depends on several factors:

• Do you have a Quality Management System or parts of a system in place?
• How much time can personnel devote to working on the Quality Management System development each week?
• What tools or assistance will you use?
• As you plan your project you will need to think about those questions. You can measure your current Quality Management System against the ISO 9001 System by performing a Gap Analysis.

A Gap Analysis is an audit you perform to see what parts of the ISO 9001 Standard you already are complying with. It is useful information for planning a timeline for your project.

You will also want to determine how much time will be spent on the project by internal people. Will they be able to spend 5 hours a week on the project? One hour a week? Answer this question so you know what internal resources are available.

Look for tools or assistance to help make your project efficient and effective. A professionally designed and documented ISO 9001 Quality Management System will save you a tremendous amount of time spent designing your system by trial and error and documenting the system.

By using a professional system you will have a system of procedures that are designed to give you running head start at a well designed, time tested Quality Management System. Our system has been used in thousands of companies from a variety of industries, all over the globe.

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