The 9000 Resource

ISO is Consistency: Say what you do, do what you say, etc.

Please keep in mind that ISO 9000 doesn’t really care about HOW it is documented, just that it is clearly documented and all parties “sing form the same songbook”.  If you want to call your department Procedures a Quality Manual, then you may do so – it really doesn’t matter. ISO 9000 just wants a few simple things:

1. Say what you do. (document your processes = procedures)
2. Do what you say. (follow procedures)
3. Be consistent – if your processes are designed to meet certain goals/objectives, then if followed they should meet them every time.  Like a recipe for cookies.
4. Ensure that everyone knows their role and what is expected of them. (people are trained on processes and have been tested to ensure the training was effective)

And all of the above must be customer driven…you must be meeting or exceeding customer expectations. You could follow #1-4 above, but if you are designing CONCRETE life jackets your customer will be disappointed, even though you are making them consistently to the specification.

I should be able to 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
• The procedure is the current revision

Remember, this isn't rocket science - it's just good business practice.

Flowcharting Software

When you document your system, you will need to make an organizational chart as well as a flowchart of your processes. We like to use the flowcharting software from SmartDraw.com.

We have found Smartdraw the easiest software to use for creating ISO 9000 models and flowcharts. SmartDraw has over 60,000 professionally designed symbols and over 1,200 industry specific templates to use in your drawings.

View ISO 9000 chart samples

Download a free  7 day trial version

Step 5 Document your System

Implementation of Section 4 should take place early on in your project. It may be assigned to management or even your project steering team.

A. General Requirements
Have the team review the requirements in section 4.1, notice that many are very general and will be a natural outcome of building your Quality Management System(QMS). However, this team must identify the processes that will make up the QMS and outline these processes to show how they interrelate.

Identifying Processes

1. Start by outlining broad categories or by listing your departments. For example:
2. Purchasing, Receiving, Production Control, Sales and Marketing, Customer Service, Production (or Service), Quality Control, Shipping,
3. You will need to show how these processes relate to each other, by use of a flow chart or diagram. A simple way of diagramming is to chart the processes. Download free trial of flow charting software
4. Once you have listed the categories or departments, have management in those departments add the detail. You will want to include all the QMS processes, and all production, service and administrative processes that affect the quality of your product or service. The chart or flow chart that you come up with should be included in your Quality Manual.

B. Documentation Requirements

• As you review the requirements for QMS documentation, pay particular attention to the requirement for your organization to identify documents that are needed for your quality system and production or service processes. You will need to have a method to identify what processes must be documented. Remember that as you add new processes, products or services to your organization in the future you will need a method of identifying when documentation is required.
• During implementation, set guidelines for identifying processes that need documentation as part of their control. Have management identify the processes that need documentation as they identify the processes to be included in the QMS.
• After implementation, include the identification of documentation requirements as part of your quality planning for new processes and changes. The "Planning of Product Realization Procedure" from the The 9000 Store covers this step for you.

C. Quality Manual & Procedures

• A complete quality manual and procedures package, with text to help you customize the manual for your organization, is available at The 9000 Store. It will definitely save you money over the hours you would spend developing one from scratch. It is designed with the same approach to the QMS as we follow in these sessions, so you will find it very compatible with this approach.

D. Document and Records Control

• You must have a procedure for control of documents and control of quality records. This task should be on your task list and assigned to a team or individual for completion.

Step 6: Training

ISO 9001:2000 Documentation Requirements

There are 2 types of requirements for procedures and work instructions.

I. Specific procedures required by the standard.
These are the procedures that the standard says you must have documented. They include:

• Document Control
• Control of Quality Records
• Internal Audits
• Control of Nonconforming Product
• Corrective Action
• Preventive Action

II. Procedures, work instructions, quality plans and related documentation required to ensure control of your processes.

Your organization is responsible for determining the other documentation you need to have to control your processes. A guideline used for determining where documentation is a necessary control is to ask several different people how they perform the process. If the answers are different, you need more control and documentation is one way of getting that control. If the people answer the same, you may not need a procedure.

Other documentation required by the standard:

• Quality Manual
• Quality Policy
• Quality Objectives
• Quality Records

We finished our documentation, now what?

Congratulations on completing your QMS design and documentation! This is a good time to celebrate, and to communicate appreciation and kudos to everyone involved!

The next step in your project is to use and improve your QMS:

Follow documented procedures and work instructions

Everyone in your organization should be performing processes following your documented procedures and work instructions, complying with the QMS requirements.

Make improvements to the processes
Many of these procedures may be new to your organization, or have changed significantly during your ISO 9001 project. Now that they are actually in use, you will most likely find areas that can be improved. Make improvements using the Corrective and Preventive Action process and the document revision process.

Conduct Internal Audits
Schedule internal audits to cover all areas of the organization before your Registration Audit. Allow time to take corrective action on any findings. A robust and effective internal audit program is one of the best tools to finding and correcting shortcomings in the QMS before your Registration Audit. You willll need to train a team of internal auditors. Internal Auditor Training Materials Package allows you to do that yourself, in-house.

Hold frequent Management Review meetings
Management Review is another key factor in getting the new QMS ready for a Registration Audit. Review information from Internal Audits, Corrective and Preventive Action and results of measuring and monitoring of the QMS. Initiate corrective actions and preventive actions to fix problems and make improvements to the QMS.

Keep records
During the Registration Audit, the auditor will be looking for evidence that you are complying with the requirements of ISO 9001 and of your QMS. This evidence is in the form of records that you generate as you run your QMS. Be sure that you are following all of the records requirements that you set up in the QMS. Run your system for several months before your Registration Audit so there are sufficient records for the auditor to evaluate.

Controlling the Quality Policy and Objectives

When you are working on document control, make sure that you include your quality policy and quality objectives. They must be controlled. Control them by:

Making them part of a procedure

Making them their own numbered, controlled document

Making them part of the quality manual

You may want to handle the quality policy and quality objectives separately. The quality objectives might change more frequently than the quality policy. This may mean you do not want the objectives in the quality manual.

What is a quality plan?

A quality plan is a "document specifying the quality management system elements and the resources to be applied in a specific case". The “case” may be a product, project, process or even a specific contract.
The quality plan can consist of production paperwork, a formal plan, a table of requirements, or other form of document that specifies what needs to be done for operation, control, monitoring and measuring of the process, project or product.

What does it mean to design and document your system?

When we talk about designing and documenting the system, we are talking about establishing the processes that will become the backbone of the Quality System, the processes that will fulfill the requirements of the standard. I suggest establishing teams for each section of the standard. These teams are made up of employees and managers that will be responsible for a particular process.

For example, purchasing staff would make up a team that will establish the process for meeting the purchasing requirements of the standard. Groups of 3 to 7 people work well for a team; the team size should be kept to a minimum but be appropriate for the size and complexity of the department. The approach this team will take is to evaluate the current process against the requirements of the standard. If you have performed a Gap Analysis, that information would be used for this step.

Once the team identifies what ISO 9001:2000 requirements are not being met by the current process, they will identify how the process will be changed to address the requirements. Flow charting, interviewing employees and brainstorming ideas can all be used to come up with a new proposed process.

Another useful tool are the procedures from The 9000 Store. These procedures provide an example process and guidance for the team to use. Instead of starting from a blank slate, the team can review the procedure, compare it to the current process, modify the process to meet the standard and edit the procedure.

Once the team has a procedure prepared, they submit that to the ISO Steering team for approval. This gives the project a centralized review process so one group can see all the procedures and make sure that they will work well together.

The 9000 Store has procedures available, as well as a Quality Manual to help you get off to a great start on your ISO 9001:2000 Quality Management System. The Procedures, Quality Manual and Forms are available as a package.

Control of Production and Service

In section 7.1 you are asked to plan for all of your product realization processes, including processes that do not result in the product or service that is delivered to the customer (customer-related processes, design and development and purchasing). Planning included identifying things like:

Documentation Requirements

Resources

Measuring and monitoring activities

Inspection and test activities

Product criteria

Records required

In 7.5.1 the requirements focus on the processes that actually create your hardware or your service that is delivered to your customers. You are required to follow the plan that you created based on requirements in 7.1

A written procedure for this section will be useful in defining how you are meeting these requirements. By clearly documenting the way that you are satisfying the requirements of 7.5.1 you will ensure that the requirement are understood and followed consistently.

Most organizations will also need documentation in the form of work instructions to control these processes. Your planning in 7.1 will determine where these are needed; to meet the requirements of 7.5.1 these must be in place, available to employees performing the process. Instructions can take many different forms: written steps, pictures, drawings, prints, travelers or flow charts are some of the methods used. Specify in your procedure what documents are necessary for the control of your processes.

The procedure should also state how you ensure that suitable equipment is used, and how release, delivery and post-delivery activities are controlled.

Do we need to control our forms?

One of our frequently answered questions has to do with the control of Forms. Why do forms have to be controlled, and how in the world can we control them all?

Well, forms are designed to make sure that you collect the data that is required. Forms often are also acting as work instructions, indicating steps and order of steps for a process, telling what data to collect and specifying the acceptable limits for that data. If a change is made, it is important to get that change out to everyone using the form.

But how can an organization control the forms, and still make them available to everyone who needs to use them?

Assign individual numbers and revisions to the forms and list them on the master list on their own worksheet or page. Keep a record of approval, either on the original copy of the form or on an approval list. All of this can be handled the same or very similar to your other documents.

But then forms will be printed in large quantities and distributed to the point of use or points of use. That is where you will need to take a look at specific measures to control the forms themselves. Indicate on the master list where the blank forms are distributed so that when a revision is made the old version can be collected and destroyed. Many companies have a designated area in each department where blank forms are kept, minimizing the number of distribution places for forms.

Forms play an important role in controlling processes and in collecting data for analysis and for records. For more detail on controlling your forms check the “Document Control Procedure” available from the The 9000 Store.

For prepared forms for ISO 9001:2000 procedures check out the documentation package. The9000Store is there to help make your project efficient and effective! Make use of those professional tools, save time and resources, and design a great system.