ISO 9001 Documented Quality Management System FAQ's

  1. Which QMS is right for my organization?
  2. What is the ISO 9000 2008 Documented Quality Management System?
  3. How can the ISO 9000 2008 Documented Quality Management System help me?
  4. Will it work for my type of organization?
  5. What does it include?
  6. How does it work?
  7. Is it easy to use?
  8. What if we have a question?
  9. How do we customize?
  10. Will employees be able to follow these procedures?
  11. Can I download it and begin using it today?
  12. Does buying this package guarantee registration?
  13. Can I use it for more than one facility?

Which QMS is right for me?

The 9000 Store provides a variety of QMS products so you can choose the right one for your organization. Consider these when selecting a QMS:

  • Complete QMS -
    • This is a COMPLETE QMS, with a procedure for each of the (20) requirements in the standard, which is what the auditors will find the most useful. It also includes more tools (Flowcharts, software, training, etc.) and is the best value.
    • Includes 2 hour Project Manager Training to implement a QMS
    • Includes Flowcharts and flowcharting software.
  • Basic QMS
    • It covers the (6) minor requirements of ISO 9001, plus (7) additional ones common to most companies (purchasing, etc.). The other requirements are addressed in the Quality Manual and it defers to the forms for the other details.
    • Includes 2 hour Project Manager Training to implement a QMS
    • Additional procedures can be purchased separately
    • Flowcharts and flowcharting software can be purchased separately.
  • Lean QMS
    • If you just want to "meet the minimum" then this is for you. It only includes the 6 minimum procedures required by the standard. The other 14 requirements are addressed in the manual to meet the minimum.
    • Additional procedures can be purchased separately
    • Flowcharts and flowcharting software can be purchased separately.
  • All Packages include (4) PowerPoint Presentations & Guides
    • Executive Overview
    • Benefits of ISO 9001
    • Implementing ISO 9001
    • Understanding Document Control
  • ISO 9001 Project Manager's Guide
  • Implementation Tips and Techniques Article

What is the Documented Quality System?

This is a fully developed set of Quality System Documents (Manual, Procedures, Forms and Flowcharts) for you to use to design and document an ISO 9001 Quality Management system.

How can it help me?

It will help you by:

Providing well designed and integrated quality system processes that address the requirements of ISO 9001.

Providing documented procedures. Simply edit the procedures to make this Quality System your own.

Showing you where and how to edit the procedures.
Providing examples of how requirements of the standard can be met. Each process has been completely developed and documented to address the requirements.

Will it work for my type of organization?

Yes. Our Quality Management System is flexible and adaptable. Each organization's Quality Management system will be as individual as the organization itself. Your Quality Management System will be made up of Procedures and Work Instructions that describe your specific work processes, and those that describe how you have designed your quality system.

This system provides you with a proven quality system design, documented as a Quality Manual and Quality System Procedures and Forms. All are fully integrated to work together.

Our system is being used in industries including: rubber, tobacco, banking, consulting, services, plastics, electronics, steel, geophysical instrumentation, thin film coatings, accounting systems, microbiology labs, network providers, medical diagnostics, universities, food production, construction and many others.

What does it include?

The Documented Quality System includes a Quality Manual, twenty Procedures and all the forms that are referenced in those procedures. All are documented in Microsoft Word, and provided to you in an electronic format for easy editing. A master list is provided in Excel.

Quality Manual:

Section 1: Scope
Section 2: Normative Reference
Section 3: Definitions
Section 4: Quality Management System
Section 5: Management Responsibility
Section 6: Resource Management
Section 7: Product Realization
Section 8: Measurement, Analysis and Improvement

Procedures:

  • Control of Quality Records
  • Management Responsibility
  • Design and Development
  • Customer Related Processes
  • Customer Property
  • Control of Nonconforming Product
  • Purchasing
  • Preservation of Product
  • Identification and Traceability
  • Planning of Product Realization Processes
  • Control of Production and Service Provision
  • Control of Monitoring and Measuring Devices
  • Monitoring, Measuring and Analysis of Product and Realization Processes
  • Monitoring, Measuring and Analysis of Customer Satisfaction
  • Infrastructure
  • Competence, Awareness and Training
  • Internal Audits
  • Corrective Action
  • Preventive Action

Each Procedure includes:

  • Purpose
  • Responsibilities
  • Definitions
  • Equipment/Software
  • Instructions
  • Forms & Records
  • Attachments
  • Related documents
  • References
  • Revisions

Forms:

  • Document Revision Checklist
  • Document Change Request Form
  • Key Process Master List
  • QMS Measuring, Monitoring and Analysis Table
  • Quality Records Table
  • Software Inventory
  • Approved Subcontractor List
  • Supplier Quality Report
  • Measurement Equipment Listing
  • Quality Planning Table
  • Design Plan
  • Training Action Plan
  • Product Realization Monitoring, Measuring and Analysis
  • Corrective/Preventive Action Request
  • Internal Audit Report
  • Applicable Procedure by Work Area
  • Internal Audit Plan

How does it work?

You will receive the documents in electronic format. You can choose to download them immediately from the Internet, or choose to order a CD with the electronic documents.

The documents are in Microsoft Word, ready for editing. The project manager or ISO Steering Team assigns responsibility to individuals or teams for reviewing the procedures and making edits to customize them. Any of the text may be edited; some text is blue, highlighting areas of procedures that are very specific and will most likely need customization.

Is it easy to use?

Yes. These documents are very easy to use. They are in the widely used Microsoft Word program so anyone familiar with word can work with them.

What if we have a question?

No problem! We provide email or phone technical assistance. You can e-mail our experts at any time with questions that you have on the product, how to use it, how it applies to your organization, guidance on customization, technical questions on the standard or other questions you have. We are here to support you and your project.

How do we customize?

By editing the blue text. We provide suggestions and examples. An effective way of customizing the procedures is to assign responsibility to a small team of employees that have responsibility for area or process that the procedure describes. Provide the team with a copy of the Documented Procedure.

The team compares the Documented Procedure to the existing process and any existing documentation. Some changes will be made to the existing process, using the Documented Procedure as a guide, so the processes meet the requirements of the standard. Some changes will be made to the Documented Procedure so it works for your organization.

Some of the Documented Procedures will be new to your organization. For example, many organizations do not have a procedure for Planning of Product Realization Processes. In this case you will have responsible people review the Documented Procedure to make any changes for your organization.

For detailed help on your implementation project we provide a free Project Manager's Implementation Guide

Will employees be able to follow these procedures?

Yes, they are designed to be easily read, understood and followed. The style and format are both reader friendly. The processes themselves are as simple and straightforward as they can be while addressing the requirements of ISO 9001.

The procedures will provide you with a Quality Management System that will lead your organization to continual improvement in an efficient, effective manner and meet ISO 9001 requirements. You will find that the procedures are not complicated, the processes they outline do not require sophisticated tools, training or software.

Can I download it and begin using it today?

Yes, if you order the downloadable version you will receive an email immediately after you place your order. The e-mail will have the download link.

You may also order on CD if you prefer and we will ship it to you.

Can I use it for more than one facility?

The system includes a copyright license for one facility or site. You will need to purchase a system for each site. Quantity discounts are available. Please contact us for details.

Does buying this package guarantee registration?

The package has been tested and audited rigorously to ensure that it meets the requirements of the standard. However, you will need to implement the Quality Management System. That will include:

Identifying the processes in your organization that affect quality
Determining how to control, measure & improve them.
Identifying quality goals for your organization and your processes.

The Documented Quality Management System is a great way to get your project started, saving you time, money and avoiding frustration. Implementing ISO 9001 will require a team effort from your organization-getting the procedures fully implemented, training employees, setting goals, controlling your work processes and measuring, monitoring and improving those processes.