The 9000 Resource

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.

How to handle customer related processes

Does your organization have processes in place to determine customer requirements? What about a process to review those requirements and make sure that you can meet those requirements?

Determination of Requirements
Your goal here is to set up a process to make sure that however an order is accepted, all the requirements for that order are determined. Every organization will have different types of requirements, so you must do some planning up front to identify what information you need to get from the customer.

The use of order forms that prompt personnel to ask the right questions is a good tool to use here. You may also use a similar technique to make sure that the customer fills in all the relevant information. Good up front planning while you set up your process will identify all of the types of information you may need to collect.

Review of requirements
Your process must include a step for reviewing the requirements, and making sure that you can meet those requirements. You must understand your process and know at what point you are accepting the order, saying yes you can meet requirements. You will need a record of this review and acceptance.

You will also need to consider how you handle changes to orders, you must review the changes to ensure that you can meet the new requirements.

Customer Communication
Evaluate the ways you use to communicate with customers. Do you have customer service that takes orders? A catalogue that communicates what you have to offer? Are your methods achieving planned results- that is are they effective? If so, would you benefit from formalizing them as a procedure, or is training sufficient to make sure that communication is effective and consistent?

Facing the Challenge of Documenting your ISO System

There are several challenges your organization will face as you start to document procedures and work instructions. According to feedback, the two hardest things for employees involved in documenting the procedures has been:

1. Starting with a blank page
2. Making the different QMS Procedures work together

How can you help employees with these challenges? There are several options to helping employees produce good documentation.

Technical Writing Services

Many technical writers and technical writing firms specialize in ISO 9000 documentation. This approach is often used in large companies, with large amounts of documentation to prepare. A common approach taken is to have the tech writer interview people responsible for the process, and document the process. This approach must be combined with incorporating any changes to the process that are being made to comply with ISO 9000:2000. Involving the tech writer in meetings as you plan the changes will help with coordinating the changes and the documentation.

Benefits of this approach can be:

Clear, concise documentation with a professional look

Good coordination of documentation if the writer is involved in the project meetings.

Drawbacks can include:

Cost

Lack of a feeling of ownership for the documentation from the employees

Prepared Templates or Documents

Templates prepared by your organization or an outside organization can be very helpful to employees.

To prepare your own templates, develop a standard format that you want to use for procedures and a format for work instructions. You may also want to write a work instruction for "Writing a Procedure" and "Writing a Work Instruction". Useful items to include are:

Definitions for common items such as Records, Forms and Attachments.

Definitions for Procedures and Work Instructions

General writing guidelines. For example, "Start sentences with an action word", "Include the job title of the person responsible for the action "

Providing clear definitions will help employees create documents that are consistent with other employees' documents and prevent the need for a lot of editing towards the end of your project.

Using a prepared Documentation System can save a tremendous amount of time and effort if it is well prepared. The 9000 Store has a complete documentation system available. It has been prepared by ISO 9000 Professionals (registered Lead Assessors) that provide the information for our site, and answer your technical questions. If you are familiar with the quality of information on our site, you can be confident in the Documentation System that they provide. The 9000 Store also offers a satisfaction guarantee on their products. We have based the following information on that system.

To use a Prepared set of Procedures and Related Quality Manual and Forms:

Purchase a system from a reliable source that will provide professionals to answer your questions as you use their product.
(The system referenced here is available at www.the9000store.com)

Give each procedure to the team or individual responsible for that section of the standard.

Have the team or individual review the procedure and compare it to the Task List.

The procedure documents how the requirements can be met. Evaluate this approach to determine if any changes need to be made to the documented process to make it work for your organization.

Determine what changes need to be made to your organizations practices to meet the requirements.

Edit the documentation as needed, and train employees on changes to previous processes or practices.

Implement the new procedure, collect records on the forms provided.
Ask questions along the way from the Documentation System supplier.

Benefits:

Procedures and Quality Manual have been designed to work together to address the requirements of the ISO 9001:2000 requirements. This saves time and effort in determining what procedures to have for your QMS, designing the QMS system, coordinating the procedures, determining how to address the requirements and document the procedures.

Technical support is available for your questions.

Documentation is professional in presentation.

Employees do not have to face a blank page to fill.

Effectiveness of Training Must be Evaluated

The biggest change in the training requirements is the requirement to evaluate the effectiveness of training. Don't forget to include a process in your procedure.

Examples of evaluating training effectiveness include:

• Written test after group training
• Certificates from outside training, If the certificate is issued based on performance
• Grades from outside training
• On-the-job evaluation by supervisor or peer at a specified timeframe after the training is completed
• Monitoring results of performance against specified criteria

The training programs available at the9000store.com all meet the requirements of the standard for showing the effectiveness of training. Records are provided after the training and after the student has shown understanding of the content. These records go into your quality records and can be readily seen by an auditor to show that this requirement has been met. ISO 9001 Employee Training

ISO 9001 Internal Audit Tips

Internal Audits are a Quality Management System’s best friend. Audit findings lead to great improvement in the effectiveness and efficiency of the system. How can you make your internal audit program work for your organization? Here are some tips to help get the most from your internal audits.

*Make sure the authority of the audit team is established. This will increase the cooperation from auditees.
*Decide what areas of the company will be audited and the frequency of the audits. Prepare a yearly audit schedule and distribute.
*Develop an audit plan. Decide what other audit resources are needed - checklists, other auditors?
*Determine the purpose of the audit - is it an overview of the area being audited or is it to concentrate on a specific system within the area?
*Determine the purpose of the audit - is it to comply with government regulations, quality standards, internal procedures and system?
*Hold a meeting with the auditors to discuss the plan, purpose, and scope of the audit.
*Read the documents you will be auditing against. Know what they say. Develop questions to ask the auditees.
*Conduct an opening meeting with the auditees.

During an Audit

*Be professional at all times. Avoid being judgmental.
*Follow safety procedures, clean room procedures, and all other required procedures.
*Explain the purpose of the audit to the auditees.
*Answer questions or discuss compliance problems brought to your attention by auditees.
*Be flexible - if you find a potential problem not within the scope of the audit - evaluate the potential risks of the problem if left unaddressed.
*Encourage honesty with the auditees.

After the Audit

*Hold an auditors meeting to discuss the closing meeting content.
*Hold a closing meeting with all auditees involved with the audit. First, point what was done well. Second, address the nonconformances and ensure the auditees understand the nonconformance and what part of the standard is not met.
*Issue the audit report in a timely manner.
*Encourage auditees to decide on the corrective actions. Allowing auditees to have input will give them ownership in implementing changes.
*Assist those responsible for completing the corrective actions with setting reasonable deadlines. The correct action deadlines may vary depending on the severity of the noncompliance.
*Be available and willing to help the auditees.
*Ask for feedback on how you and your audit team were perceived - adjust your approach if necessary.
One last tip: Involve people!

Use audits as opportunities to train others. Ask for a volunteer (who is not an auditor) to walk through the audit process with you as an assistant. This will provide others with a better understanding of what audits are and why they are necessary.

Involving people creates a feeling that everyone is a vital contributor to the goal of the company - compliance.