The 9000 Resource

Step-by-step ISO 9001 Workbook

Step-by-step ISO 9001 Workbook

If you are wondering where to begin to build your ISO 9001 system, you can find out exactly how to do it by working through a set of step-by-step checklists that make up the ISO 9001 Workbook.

The first step in your ISO 9001 project is to define and build a Quality Management System (QMS) according to the requirements of the ISO 9001 standard.      

• Checklists and Exercises
  The ISO 9001 Workbook is a series of detailed checklists, exercises and instructions that take you through 28 systematic tasks for your organization to consider and complete.
• View list of workbook contents
• Training Presentations
  The Workbook includes a set of 3 ISO 9001 PowerPoint training presentations designed to be a companion to the Workbook. Use these to train everyone in the company on the ISO 9001 implementation and system.

Your business is unique in its specialty and in its approach to processes and to quality. You will be able to tailor your QMS to work for your particular business while ensuring that you meet the requirements of ISO 9001.

The Workbook is part of our do-it-yourself-workshop approach along with the ISO 9001 Documentation Package.

These products are all integrated to work together to help you achieve certification. This is an effective method that is well suited to small and medium size enterprises.

The identified workbook tasks and exercises are conducive to a very hands-on approach and the work can be systematically and successfully completed with a small multi-tasking staff.

This workbook has been used successfully around the world in a variety of industries.

US $275

If you are wondering where to begin to build your ISO 9001 system, you can find out exactly how to do it by working through a set of step-by-step checklists that make up the ISO 9001 Workbook.

The first step in your ISO 9001 project is to define and build a Quality Management System (QMS) according to the requirements of the ISO 9001 standard.      

• Checklists and Exercises
  The ISO 9001 Workbook is a series of detailed checklists, exercises and instructions that take you through 28 systematic tasks for your organization to consider and complete.
• View list of workbook contents
• Training Presentations
  The Workbook includes a set of 3 ISO 9001 PowerPoint training presentations designed to be a companion to the Workbook. Use these to train everyone in the company on the ISO 9001 implementation and system.

Your business is unique in its specialty and in its approach to processes and to quality. You will be able to tailor your QMS to work for your particular business while ensuring that you meet the requirements of ISO 9001.

The Workbook is part of our do-it-yourself-workshop approach along with the ISO 9001 Documentation Package.

These products are all integrated to work together to help you achieve certification. This is an effective method that is well suited to small and medium size enterprises.

The identified workbook tasks and exercises are conducive to a very hands-on approach and the work can be systematically and successfully completed with a small multi-tasking staff.

This workbook has been used successfully around the world in a variety of industries.

US $275

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.

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

Where to buy ISO 9001 Standards

Buy ISO Standards from Techstreet.com

ISO 9001:2008 (Formerly ISO 9001:2000)

The latest version of ISO 9000. This single certifiable Standard now applies to all organizations regardless of size, industry, product or service.

• English (US Only) <Buy Now>

• English (Outside the US) <Buy Now>

• Spanish (Global Availability) <Buy Now>

• French & German (Global Availability) <Buy Now>

ISO 9004:2000 Guidance Document

Quality management systems - Guidelines for performance improvements (ISO 9004); Trilingual version EN ISO 9004
DIN-adopted European-adopted ISO Standard

• English (US Only) <Buy Now>

• English (Outside the US) <Buy Now>

ISO 14001:2004 Standard

Environmental management systems - Requirements with guidance for use

• English (US Only) <Buy Now>

• English (Outside the US) <Buy Now>

TS 16949:2002 Standard (Automotive)

ISO/TS 16949 defines the quality management system requirements for the design and development, production and, when relevant, installation and service of automotive-related products. 30-Sep-2002

• English (US Only) <Buy Now>

• English (Outside the US) <Buy Now>

ISO 13485 Standard (Medical Devices)

• English (US Only) <Buy Now>

• English (Outside the US) <Buy Now>

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 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

Planning your ISO 9001 Planning Meetings

A. Planning your meeting

Determine who should attend. Include top management. Answer these questions:

1. Who will be able to decide which employees will be assigned tasks?
2. Will they know whether the employees' workload will be able to accommodate the assigned tasks?

Create an Agenda, items to include:

1. Review Task list.
2. Determine how to group tasks.
3. Group tasks by the area responsible for the requirement where possible. (If you can group requirements, you can assign a set of requirements to an individual or team from the relevant area.)
4. Assign the tasks to individuals or teams.
   
   • Review the responsibilities to make sure that they are well dispersed, not assigned heavily to one group or one individual.
5. Determine resources required for completion of the tasks.
6. Will teams or individuals need assistance with other responsibilities during the ISO 9001:2000 project?
7. What kind of technical guidance will be needed to allow these teams or individuals to complete the tasks efficiently and effectively?
   
   • An external consultant?
   • An internal consultant?
   • Assistance from the management representative?
   • Prepared materials?
   • Special Training?
8. Assign dates to tasks.
   
   • Stagger start dates according to resources available.
   • Determine which tasks you need to complete in the beginning to allow others to build on, for example: Management Responsibility. Complete the Quality Policy and Quality Goals as well as identifying key processes and their interrelation early on in the project.
   • Estimate the amount of time needed to complete each task based on the amount of resources available to the task.

B. Holding the meeting

1. Follow your agenda, fill in responsibility and dates on your task list as you proceed.
2. Keep minutes of the meeting, including attendees. This will show top mana

ISO 9001 Resource Management

The Scope of Resource Management includes

• Human Resources
• Facilities and equipment
• The manufacturing or service environment

Your organization needs to be asking whether these resources are sufficient to create quality products or service and customer satisfaction? Auditors will be looking to see if the lack of these resources is at the root cause of nonconformances. You should consider these resources or insufficient resources as a potential cause of nonconformances. As internal audits or your corrective action system identify problems with resources as a root cause, improvements to the resources are necessary. Providing adequate resources is a core element of your QMS.

Human Resources

In addition to employees being trained for a job, the effectiveness of that training must be measured, the criteria for competence determined. The employee must be aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objectives. Can you tell an auditor what the competency requirements are for a specific position? Are you then able to show the auditor that employees in that position have met those requirements and been effectively trained as required?

Facilities and Equipment

Auditors will evaluate the buildings, workspace, equipment, and supporting services to determine if they contribute to nonconformances. Issues would be identified in this area if it is evident that the inadequate provision of resources is at the root cause of QMS nonconformances.

Work Environment

Environmental factors have a direct impact on product or service quality. Factors such as cleanliness, temperature, ergonomics, or lighting can all affect quality or cause nonconformances. Auditors will consider environmental issues, and may determine that inadequate control of the working environment is the root cause of a QMS nonconformance.

ISO 9001:2000 Implementation Resources and Assistance

The 9000 Store is here to help you create a QMS to meet the requirements of ISO 9001:2000. Project managers don't need to do it alone; our documents outline tried and proven Quality Processes to address the requirements of the standard. Our experts answer your questions by email as you tailor these processes to your organization, creating your own unique Quality Management System. We provide the tools you need to train your employees efficiently and effectively. Visit our store today to see how we can help you make your project a simple success!

Implementing ISO 9001 without a Consultant

In these times of tight budgets and cost saving measures, an ISO 9000 Consultant is a luxury that many companies have decided to do without. But how can a Project Manager be responsible for implementing ISO 9000, if they have not done it before?

As an ISO 9000 Consultant myself, I understand the burden that is placed on quality managers and others that are asked to lead this project. It can be a daunting task, reading the standard and trying to apply it in your organization. Your organization is different from all others, how does the standard apply to it?

Take advantage of the resources and tools that are available to you. There is no reason that you need to start your system from scratch. There are a number of professionals that have developed documented ISO 9001:2000 procedures and quality manuals. Organizations have realized that there is a real benefit in having professionals design quality systems procedures that state how the organization is meeting the requirements of the standard. In the past the best way to get these procedures was to hire a consultant, and they would come in, bringing their basic procedures with them, and customize them to suit the organization.

Now consultants have made these procedures available to you, and you do the customizing. The 9000 Store offers procedures, forms and a quality manual that have been developed based on a decade of experience in wide ranging industries. Used as an alternative to an ISO 9000 consultant, these are a very cost effective way of getting the expertise you need to develop an effective ISO 9001:2000 QMS.

But remember, your organization is different from all others. What about the questions you have on how the standard applies in your situations? If you are not using a consultant, it can be difficult to find someone to answer your questions. To support their products The 9000 Store also answers questions by email as you work on the customization. They also sponsor our ISO 9000 2000 Information Site, to provide you with articles, tutorials and information to help you complete your project without a consultant.

Make use of the resources and training available online today:

1. Take an online implementation course
2. Purchase an ISO 9001:2000 Documentation Package
3. Customize the documentation
4. Train your employees

A number of different packages are available online, we recommend the The 9000 Store. Here is a quote from a recent customer:

"We had our pre-audit on Wednesday and did very well on it. I want to thank you for all the help in getting us to the point where we are now. We went it alone like you had said we could and we are very happy with the results. When we started this I was worried it would be too much to handle because of all the documentation involved. Your ISO 9001-2000 doc's were a godsend. By doing it without a consultant, I believe you get a lot better understanding of the quality system."

ISO 9001 Gap Analysis Report

Summarize the audit findings in the form of a task list.

You will usually identify several categories of tasks.

1. Processes that comply with the standard and are documented.
2. Processes that comply with the standard and must be documented.
3. Processes that do not comply with the standard and must be redesigned.
4. Processes required by the standard that are not currently in place.

For each requirement (or set of requirements) of the standard you will want to identify the status of the current system. The ISO 9001:2000 Steering Team will use this information as they assign responsibility and timelines to Teams. Task Teams will be assigned responsibility for development of a procedure.

Conducting a Gap Analysis

1. Follow the schedule that you have prepared. Go into each area of the facility to evaluate the current quality system.
2. Focus on what is in place, and what is not in place. Remind auditors that you are not focusing on compliance or non compliance to the current system, but on the design of the current system, and how it matches the ISO 9001:2000 requirements.
3. Take notes on what is in place, and what will need to be developed and changed. Take complete notes, reference documents and examples.

Next: Gap Analysis Report