The 9000 Resource

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.

Download Four-Month-Plan.doc

Download Seven-Month-Plan.doc

Download Ten-Month-Plan.doc

Ready to use Gap Analysis Checklist

The Gap Analysis is one of the most important steps in your project.

It helps you determine your path:

• You know where you are.
• The Standard tells you where you need to be
• Anytime they differ you need to change your processes to bridge the gap

The 9000 Store has developed the Gap Analysis Checklist to help you map your path.

The Gap Analysis Tool Kit will:        

• Provide the tools and checklist you need to conduct your Gap Analysis         
• Provide a detailed checklist to use to compare your current systems to the requirements of ISO 9001.
• Help you identify the requirements that your organization is already meeting, and those that need to be addressed
• Give you the information you need to determine resources and a timeline for your project.

It includes:

• A detailed, 43 page checklist (MS Word) with guidance on what to look for to evaluate your current processes and their compliance to the ISO 9001:2000 Requirements.          
• Space for notes and observations                
• Project Plan               
• Project Plan Template
• All for $49 (that's like getting a GPS for the price of a map!)
               

When traveling to unknown areas, a map is a necessity. Likewise, a Gap Analysis will provide you with valuable information to help you plan your Implementation Project. Our Checklist will give you the information you need to bridge the Gap.

You can buy and download today. USD$49

Buy now (English)

Buy Now (Spanish)

Buy Now (Italian)
      

 

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

Where to buy ISO 9001 Standards

 

ISO 9001 Standards are available from Techstreet.com in either electronic or printed format

       

ISO 9001:2000 Standard
Document Number: ISO 9001
International Organization for Standardization
Replaces and incorporates ISO 9001, ISO 9002, & ISO 9003.

       

This single certifiable Standard now applies to all organizations regardless of size, industry, product or service. It's more flexible than its predecessors, and has an emphasis on customer satisfaction, continual improvement and efficiency. Organizations currently certified to ISO 9002 or 9003 will work to this new Standard.

       

16949 Standard (automotive)                               

The ISO/TS 16949 Checklist is used to determine conformance to the ISO/TS 16949. Proper use of this manual will promote consistency between activities and personnel determining ISO/TS 16949 conformance.

       

ISO 13485 Standard (medical device)
Specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related products.

 

Step 8 Registration Audit

First you will need to select a Registrar. When you choose a Registrar you are starting a relationship that will last at least 3 years, most likely longer. You will want to make a careful decision to lay the groundwork for a smooth and lasting relationship. Read our blog post about how to select a Registrar.

When the day of your Registration Audit has arrived, it is time to showcase your Quality Management System. The Auditor or Auditors are coming in to see how you have addressed the requirements of ISO 9001, and how you have designed your QMS.

Preparing for the Audit

Prepare the employees

• Before the Audit you will want to make sure that all employees know that the audit will be taking place, and the purpose of the audit. This will help them understand how to respond to the auditors' questions. You want employees to respond openly and honestly to the auditor.  The auditor is looking for evidence that you are complying with the requirements of ISO 9001, your employees are the ones that will be providing that evidence. Preparing them to answer the auditors questions will make the audit go more smoothly.
• This is not a test. If the auditor asks a question, they are looking for information on how something works, not if the employee has all the answers but how the employee goes about finding answers and information. Do procedures provide information? If the information is not in a procedure, where does the employee go next, do they ask a supervisor? Use our Employee Flyers to update employees on this issue and other implementation steps throughout your project.

Prepare the facility

• Make sure all areas of the facility are clean and neat; there are potential nonconformances hiding in any given mess.
• Make sure documents are available where every they need to be used.
• Check bulletin boards, counters, cupboards, drawers for uncontrolled documents, un calibrated measuring and monitoring instruments and unidentified parts or supplies.

Prepare for the Auditor

• Have a copy of the Quality Manual and Quality System Procedures available for the auditor.
• Designate a place for them to work when they are not out in the facility. They will need to work on their documentation and reporting.
• Assign someone to go with the Auditor to show them where different areas and departments are. Coach this person to let employees answer the auditors questions, not answer the questions themselves unless the question was directed to them.

Step 7 Internal Audits

It is necessary to demonstrate that your ISO 9001 Quality System is effective. During an internal audit you will compare your quality system against the requirements of the standard. You will select a group of internal auditors from within your company to perform the audits.

You will begin once your system has been implemented and will need to perform internal audits before your Registration Audit. The Registration Audit is the audit which is performed by the Registrar who will issue your ISO 9001 Certificate upon successful completion of that audit.

Before your Registration Audit you will need to use and improve your system for 2-3 months. Read our blog post about using and improving your system for more details.

Choose your audit team

You will want to have a number of trained internal auditors for your audit program. You will be auditing each area of your facility once or twice a year, with an audit team of 1 to 4 auditors depending on the size of the area. You will want to have enough auditors trained so that the auditors will not audit their own area, and so that you are not pulling one person away from their work too often. A general guidance number is 10% of the total number of employees; a company with 50 employees would train 5 auditors, and company of 100 would train 10. As the number of employees goes up, the percentage would go down.

Look for employees that have a strength in investigating issues and that are good communicators. The better people skills the auditors have, the smoother your audits will be performed.

Step 8: The Registration Audit

Step 6 Training

Setting up an effective ISO 9001:2000 system will require training.

1. Train the ISO 9001 Project Manager
   Having your project manager trained on ISO 9001 and implementation will result in a more effective and efficient system and implementation process.
2. Train Employees
   The ISO 9001 standard requires that employees are trained in on ISO 9001.
3. Train Internal Auditors
   Your team of Internal Auditors will need an understanding of ISO 9001 and on ISO 9001 Internal Auditing.

Training Resources available from The 9000 Store:

1. Implementation Training for Project Managers: computer-based, in-depth training about ISO and the implementation process.
2. Employee Training: Computer-based individual training  or Introductory Training PowerPoint Presentation
3. Internal Auditor Training Materials: allows you to conduct your own training class in-house for your audit team.

Step 7: Internal Audits

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