The difference between ISO 9000, ISO 9001, ISO 9001:2008 and ISO

All terms are usually used interchangeably though there are some technical differences:

- ISO 9001 is the standard the consists of the requirements for a quality management system. This is the standard to which a company can get certified.

- ISO 9001:2008 is the current revision of the ISO 9001 standard; it was published in the year 2008 and supersedes the old ISO 9001:2000 (published in 2000). People who want to be precise or who want to distinguish between other revisions call it "ISO 9001:2008" instead of simply "ISO 9001".

- ISO 9000 is the family of standards which includes ISO 9001. It is also a set of guidelines that help with the implementation of ISO 9001. Usually when people refer to "ISO 9000", they refer to ISO 9001.

- ISO is the short name of the International Organization for Standardization (it's not an acronym but the Greek word for "equal"). Since ISO 9001 is the most famous of the countless standards published by ISO, many people refer to ISO 9001 simply as "ISO".
 

The relationship between ISO 9001, ISO 9002, ISO 9003 and ISO 9004

Prior to December 2000, there used to be an ISO 9001, an ISO 9002 and an ISO 9003 standard. However, in December 2000, the International Organization for Standardization (ISO) merged ISO 9001, ISO 9002, and ISO 9003 into a revised ISO 9001 standard, then referred to as ISO 9001:2000.

ISO 9004, on the other hand, is a set of guidelines that exceeds the requirements of ISO 9001. You cannot get certified to ISO 9004 but if you look for further improvement ideas beyond ISO 9001, take a look at ISO 9004.
 

Who wrote the ISO 9001 standard?

The ISO 9000 standard was created by the International Organization for Standardization, a Switzerland based organization consisting of representatives of about 145 nations worldwide. For more information, visit www.iso.ch.

There are many benefits in implementing ISO 9000

1) Improvement: ISO 9000 is an excellent tool to develop a strong foundation of good business processes and systems. Good processes and systems are essential for the performance and expansion of any company. Quality improvements come along with this. Remember, ISO 9000 was developed as a real tool to improve companies.

2) Marketing: The ISO 9000 certification is a powerful marketing tool as it is a well-recognized standard for quality. It shows our customers that we take quality seriously, that we are proactive and that we put our customers' satisfaction first.

3) Customer requirements: more and more corporate customers implement ISO 9000, and many of them either prefer or outright require that their vendors are ISO 9000 certified as well. In order to do business with these companies, we have to be ISO 9000 certified.

What is Document Control?

Document control means that the right persons have the current version of the documents they need, while unauthorized persons are prevented from use.

We all handle many documents every day. These documents include forms that we fill out, instructions that we follow, invoices that we enter into the computer system, holiday schedules that we check for the next day off, rate sheets that we use to bill our customers, and many more.

An error on any of these documents could lead to problems. Using an outdated version could lead to problems. Not knowing if we have the latest version or not could lead to problems. And so on.

ISO 9001 gives us tools (also referred to as 'requirements') that help us control our documents.

Which of our documents are "ISO 9000 documents"?

There are no ISO 9000 documents that need to be controlled, and 'non ISO 9000 documents' that don't need control. The ISO 9000 system affects our entire company, and all business related documents must be controlled. Only documents that don't have an impact on our products, services or company don't need to be controlled - all others need control. This means, basically, that any business related document must be controlled.

However, how much control you apply really depends on the document.

▪ The extent of your approval record, for example, may vary with the importance of the document (remember, documents are approved before they are published for use).
▪ The Quality Policy, an important corporate policy document, shows the signatures of the top executives.
▪ Work instructions often have merely a note in the footer indicating approval by the department manager.
▪ No approval record is needed for a document that does not need separate approval if the person who prepared it is also responsible for the content (e.g., the Quality Manager prepares instructions for his auditors).
▪ On the other hand, identifying a document with a revision date, source and title is basic. It really should be done as a good habit for any document we create.

Please note that documents could be in any format: hardcopy or electronic.

Who controls documents?

Document control is the responsibility of all employees. It is important that all employees understand the purpose of document control and the requirements.

Please be aware that if you copy a document or print one out from the Intranet and then distribute it, you are responsible for controlling the distribution! The original author won't know that you distributed more of his documents, so the original author can't control that distribution.

Using the automatic date function

ISO 9000 requires us to show on every document when it was created or last updated. Many of us thought about using the automatic date function in MS Word for this, but...
Should we use the automatic date field on documents?

Generally not. If you enter the automatic date field into a document, the field will automatically be updated to always show the current date, no matter when you actually created or updated the document.

Example:
For example, if you use the automatic date field in a fax and you save the fax on your computer for future reference, you won't be able to tell when you wrote the fax: when you open the fax, it will only show the current date.

Another example:
Another example is entering the automatic date field in the footer of a document that you frequently change and then print. You may have used the automatic date field as an easy way to see on your printouts when they were printed; the idea here was that the document with the latest date is the most current printout. However, you may make one printout today and another tomorrow without having made any changes to the document. Though both printouts are identical, they now show different dates. This will inevitably lead to confusion.

Document control requires us to show on any document when it was created or last updated. The automatic date field is not suitable for this. Therefore, as a general rule, don't use the automatic date field to identify revision status.

Continuous Improvement

Implementing ISO 9001 :2008 is not a one-time benefit to our company. ISO 9001 :2008 actually provides us with the tools (and the requirement) to continuously improve ourselves. This is a very important aspect because companies that don't continue to improve are soon overtaken by the competition.

Do forms need to be controlled?

Yes, forms must be controlled as long as the form has an impact on our services or our company.

Blank forms are similar to instructions as they guide the user to provide certain information. If the form is outdated or incomplete, the user will not be prompted to supply all the necessary information. It is, therefore, important to control blank forms like any other document.

Once a form is filled out, however, it has become a record. At this point, we need to be concerned with filing, storage, archiving and eventually destruction. Our Record Retention Guide specifies how long records must be kept and how we can get rid of them (e.g., do we need to shred them or is the recycle bin sufficient?).

How is our ISO 9001 quality management system documented?

The following documents make up our ISO 9001 quality management system:

- Quality Manual

- Quality Procedures

- Quality Policy

- Work Instructions

- Records

What do audits cover?

ISO 9001 audits are typically more challenging for management than for workers. ISO 9001 is a quality MANAGEMENT system and provides many requirements on activities of managers and executives; in many cases, ISO 9001 directly affects how the company is managed.

All audits may cover any or all sections of the ISO 9001 quality manual. As a general rule, all audits cover Goals & Objectives, Customer Feedback, Management Reviews, Audits (especially if nonconformities from prior audits have been properly corrected), and Corrective Action.

Flowcharts

Flowcharts are great ways to describe the interaction of processes. Flowcharts are often used to show how the key processes (or activities) in an office or at a production facility work together; flowcharts are also often used as work instructions and procedures.

The following shapes are sufficient for most flowcharts (the arrows are used to connect the different shapes in the correct order):

 

This is the shape used to describe a process (or activity). In this example, the process is called Check invoice.

This is the shape used to describe a decision. A decision in a flowchart has usually two possible outcomes. In this example, the decision is Is the invoice correct? and the two possible outputs are yes and no.

Some decisions have three possible outcomes: the decision From which supplier is the invoice? could have either of the outcomes Supplier A, Supplier B, or Supplier C.

This shape describes a document. In this example, the document is called Invoice. See example below on how this shape is used.

Example using all three shapes:

Microsoft Visio is an excellent program to create flowcharts; also Microsoft Word and PowerPoint can be used for some basic flowcharting.

Whichever tool you use, please keep it simple for the user. Some sophisticated shapes might make much sense to you, but most users will be confused as they won't understand the subtle differences.