ISO 9001 - 2000 -- Implement Your Quality Management System With Minimum Headaches

If you have been unlucky enough to have been saddled with the onerous task of achieving ISO 9001:2000 compliance for your company, this article may prove to be your big break. At the very least it will put you on a minimum fuss path to ISO 9001 certification. It may very well also rescue your career, because--as you already know--as a great deal is riding on your success.

ISO, of course, stands for the International Organization of Standardization, a worldwide organization responsible for the development of many different kinds of standards. ISO 9001:2000 is the most recent version of their Quality Management System Standard. It consists of a collection of documentation that describes how a company should implement their quality management system.

To achieve certification, a company must produce both a Quality Manual and a Quality Procedures Manual. This is no light undertaking. These manuals must be audited by a registrar for compliancy, and renewed at the end of each 3 year period. The larger and more complex your company, the more difficult the process will be.

So why would a company chose to conform to an ISO 9001 profile? Rarely is it because it seems like a good idea. Many companies are filled with bright people who can develop their own quality management system. The primary motivating force is market pressure. Your quality management system may well be up to scratch, but who is to say?

A potential customer surveying the marketplace, and presented with two or more competing companies he might choose to do business with, needs to feel good about his final choice. If the decision comes down to who has the best quality management system in place, common sense suggests he go with the company that has gone through the ISO 9001 certification process.

In the long run, an organization that implements an ISO 9001 system is likely to discover the company runs better, with improved performance and higher profitability. But for a company just getting started, such considerations are often seen as "ideals" that get short shrift as managers race to make the company profitable in the shortest amount of time. It therefore takes commitment and foresight, as well as an acute understanding of market vision in order to get to the ISO 9001 finish line.

If your company already has a decent quality management system in place, your main task will be to redesign the system so that it addresses all the sticking points of the ISO 9001 documentation. If your company is large, this may prove to be some not insignificant undertaking.

You might be tempted to hire ISO 9001 consultants. This will be expensive, and may not in fact lead to the desired result, which is a streamlined version of the Quality Manual and Quality Procedures Manual that you must submit for certification.

The reason for this is that consultants never fully appreciate the scope and depth of your company, and cannot be expected to share the urgency of your plight to get it right the first time. For this reason, choosing the right in-house person to head the job may be the best option for your company. Perhaps, even, that person is you. If so, you definitely have your work cut out for you, particularly if you work for a company of any real size.

The benefit, and it is a big one, of having been tasked with preparation for ISO 9001 certification is that your personal value to the company is going to be cemented--no, it will be cast in iron--by a successful conclusion to certification.

The trick then, is to find a way to achieve the desired result WITHOUT saddling yourself with all the headaches this job can provide. If you have already peeked at the ISO 9001:2000 documentation you can be forgiven for thinking that you may have bit off more than you can chew. Going from zero to sixty on this task can seem like a formidable proposition.

But it need not. If it seems like you are destined to begin dreaming that you personally will be taking the ISO 9001 certification test, night after restless night, instead of your quality management system, take heart. Because there is a way to get a jump start on the process, and avoid so much of the hassle that you have taken on.

To find out how to leverage the ISO 9001 proficiency of an already successfully certified company, and dramatically cut your expected ISO 9001 development costs by slashing the time it takes to achieve certification, get across to my Squidoo lens on Isom's Quality Handbook For ISO 9001 Certification. This may prove to be the best decision you have made this year!

ASA - ISO Ambient Light Rule

If you have been taking photographs for years or just now starting there is one quick rule of thumb that is key to understanding how cameras work. I call it the Ambient Light Rule. There are two standard agencies that regulate camera speeds; in the old days film used ASA (American Standards Association) now film cameras and digital cameras use ISO (International Standards Organization) with both the higher the ASA or ISO number the faster the film or computer chip will accept light therefore allowing the camera to manipulate shutter speed and aperture opening.

Ambient Light Rule is quickly this, the faster the shutter speed (stop motion) the lower the aperture opening (depth of field). This can be changed by using a higher or lower ASA or ISO. This all depends on what kind of picture you want to take. Automatic cameras make it easy to take pictures they will adjust the shutter speed and aperture without you needing to know the Ambient Light Rule.

However sometimes it is necessary to go off automatic mode for the shot you want to take. For example, say you go to a Nascar race and you want a picture of your favorite Nascar Driver going over 200 miles per hour. In this case you may want to take your film or digital camera off auto and go with shutter preferred and choose a fast stutter speed probably at least 1/500th of a second. The faster the better, but this setting does effect how clear the items are in the foreground and background.

Another situation is when you want to take a close up and want as clear of shot that is possible. Here you may want to go with aperture preferred. In this case the higher the aperture (means the smaller the light source kind of like squinting your eyes to see better) means that you will get a sharper photograph. But the higher the aperture the slower the shutter speed. You either need more light or you may want to use a tripod.

Today with all the advancements in computers photography has been made quite a bit simpler. Adobe Photoshop CS2 is a photographer’s dream program. It has made darkroom manipulations obsolete. You can now lighten, darken, sharpen, unsharpen, as well as erase or add to your photos with easy. If you are serious about photography I would definitely suggest purchasing Adobe Photoshop. Plus I would recommend that you take courses on the program. Two that I have used in the past are from Lynda.com and Total Training both are excellent!

For more information www.bestdigicamsite.com

Bob has been a photograher since the 1960's from a Kodak Instamatic to Minolta, Canon, Nikon, and now a Fuji Digital Camera.

ISO 9001 What Records Does My Business Need To Keep?

Which documents must I keep for ISO 9001?

In addition to the legislative requirement for your business to keep certain records ISO 9001 2000 requires your business to retain other records to demonstrate compliance with its various clauses.

From an ISO 9001 2000 viewpoint records are documents generated whilst operating your Quality Management System. Typical examples are records of management reviews, purchase orders, sales orders, test results and internal quality system audits.

An ISO 9001 2000 consultant can be very helpful to your business in deciding which records are required and those that are not.

The standard is not specific about how long your business must retain each record but in order not to fall foul of your own Quality Management System, or the law, you might like to consider the following.

If your business offers a period of (x) years guarantee with its product you must keep associated records for at least (x) years.

If your business sells products that have legislative requirements for product testing you must keep associated records for the life of the product and sometimes longer.

Any legislative requirement for you to keep records associated with your product or service.

Records can be in many formats including computer generated records such as those maintained by the Easy ISO 9001 2000® software package.

It would be wise to remember when keeping computer based records for long periods (say 10 - 30 years) the medium upon which the data is stored will deteriorate and therefore you must periodically validate its integrity. Another factor to consider with long term data storage is will a device still be available in 30 years time to read the media upon which the data is stored? I still have computer programs on punch tape but I no longer have a punch tape reader! If you do not know what I am talking about here take it as validation of this advice. (Punch tape was a medium for storing computer programs and data in the 1960's and 1970's)

The following table identifies the specific records required by ISO 9001 2000. The list does not include records that your business might choose to retain voluntarily or those required by legislative requirements for your product or service.

Clause Document to retain, (Record)

5.6.1 Minutes from your Quality Management Review meetings, including any actions raised.

6.2.2 Education, training, skills and experience.(Sub clause-e)

7.1 Evidence that the realization processes and resulting product fulfill requirements. (Sub clause-d)

7.2.2 Results of the review of the requirements relating to the product and actions arising from the review.

7.3.2 Design and development inputs.

7.3.4 Results of design and development reviews and any necessary action.

7.3.5 Results of design and development verification and any necessary action.

7.3.6 Results of design and development validation and any necessary action.

7.3.7 Results of the review of design and development changes and any necessary action.

7.4.1 Results of supplier evaluations and actions arising from evaluations.

7.5.2 As required by the organization to demonstrate the validation of processes where the resulting output cannot be verified by subsequent monitoring and measurement. (Sub clause-d)

7.5.3 The unique identification of the product, where traceability is a requirement.

7.5.4 Customer property that is lost, damaged or otherwise found to be unsuitable for use.

7.6 Standards used for calibration or verification of measuring equipment where no international or national measurement standards exist. (Sub clause-a)

7.6 Validity of previous results when measuring equipment is found not to conform with its requirements.

7.6 Results of calibration or verification of measuring equipment.

8.2.2 Internal audit results.

8.2.4 Evidence of product conformity with the acceptance criteria and indication of the authority responsible for the release of the product.

8.3 Nature of the product non-conformities and any subsequent actions taken, including concessions obtained.

8.5.2 Results of corrective actions.

8.5.3 Results of preventive actions.

Driso provide ISO 9001 2000 consultancy, auditing, software, and training Services. They also supply Easy ISO 9001 2000® software for initially setting up an ISO 9001 2000 compliant Quality Management System or improving upon an existing one. To contact Driso Consultancy Services visit the web site below and see what they can do for you and your business. Contact: http://www.driso.co.uk for more details.

ISO 9001 Registration - 8 Steps for Success

 

You’ve made the plans, built the quality system and conducted the audit. So how do you register your company as ISO 9001 conformant? And how can you be sure you’re getting the most value for your investment? Here’s how the process works.

Certifying Your Company and Quality System

After your company's ISO 9001 audit, you will want to register your company's quality system to show that you've met the requirements. And to do this effectively, you will need to follow eight essential steps.

1. Finding a Registrar

You’ll need to begin searching for an ISO registrar during the 2 to 3 months your company is still building its quality system. You can search the Registrar Accreditation Board (RAB) at http://www.rabnet.com to select the registrar right for you.

2. Selecting a Registrar

Select a registrar that has experience within the scope category of your specific industry, which you can also find on the RAB site. Keep in mind accreditation, scheduling issues, fees and comfort level when selecting the registrar right for you.

3. Creating an Application

A company and a registrar will agree on the application, contract. This defines the rights and obligations of both parties, and includes liability issues, confidentiality and access rights.

4. Conducting a Document Review

The registrar will require a copy of your quality manual and procedures to verify that all the requirements of the standard are addressed. Allow 2-4 weeks in advance for the registrar to fully review all of the necessary documents.

5. Determining Preassessment

Though optional, this 2-4 week initial review of the system identifies any significant omissions or weaknesses. It saves time and allows the registrar to assess any issues and resolve logistics before the actual assessment audit.

6. Issuing an Assessment

During the audit, or physical onsite inspection of procedures in action, the auditors will issue findings if they assess anything that doesn’t meet requirements, or nonconformities. The length of this step will depend on the scope of the audit and the size your organization.

7. Completing ISO Registration

After all of the findings are put into the audit report and nonconformities are addressed, your company has the option to register as ISO 9001 conformant. You will receive a certificate and can also be listed in a register, which the company can use to publicize its registration and use in advertising.

8. Checking with Surveillances

To ensure that the system is maintained and that changes don’t result in deficiencies in the system, registrars perform regular surveillances of the system. Over the three-year period of your certificate, auditors will perform one full and two partial checks of your system.

Considerations in Planning

The Document Review and Preassessment typically require 2-4 weeks each. However, the number of registrars and the number of days for each stage of the registration audit depends on the size and complexity of your organization. So set target dates accordingly to allow both you and the registrar time to fully prepare.

Strong Return on Your Internal Audit Investment

Always keep in mind, registration should provide you with valuable feedback to improve your system. So make sure to seek the appropriate registrar, and take full advantage of the entire audit process. After all, it’s your company, it’s your registration, and so make sure you get a strong return on YOUR investment.

Chris Anderson has over 18 years of sales, marketing and business management experience working with business process design, software and systems engineering. He is also co-author of policies and procedures manual products, producing the layout, process design and implementation to increase performance. He is currently the Managing Director of Bizmanualz, Inc. Visit: Bizmanualz, Inc.