If you are just starting an ISO 9001 implementation or you are preparing for another external audit, ISO9000Resources is here to help. This site will take you step-by-step through a basic implementation in record time. Use the links to the right to jump to specific areas of interest.
Here is our 15-step detailed plan for creating and maintaining an ISO 9000 compliant or certified quality system:

Evaluate Your Quality System and Start The Implementation Project
Assess your current quality system using a gap analysis check sheet and then make sure that management will commit the correct level of resources to complete the project. Use the implementation cost information to get the big picture of the cost. Save the gap analysis for later use as an internal audit (once you have an internal audit system).

Develop The Quality Goals and Implementation Plan
Start at the top. Develop the quality objectives and quality statement. Use the samples on this web site as a basis for developing quantifiable objective and a quality statement that is memorable and fulfills the ISO requirements for a customer focus. Post the objectives and statement around the facility. Make an implementation plan with a timeline and assign resources.

Create The Documentation Control Procedures
You need this document first so that you have an established system for maintaining revision control. All the documents that you create as part of your new quality system should have unique tracking numbers and revisions. The documentation control is used in conjunction with the engineering change order system to maintain revision control.

Create The Corrective and Preventive Actions
Also known as the Engineering Request and Order (ECR/ECO) system. Use this system to approve and release all documentation in conjunction with the documentation control procedure.

Generate A Quality Manual
Purchase an ISO 9001 quality manual or copy the sample quality manual from this site. Adapt the manual to include your quality statement and any special needs.
Generate the product flow chart and organization chart for the company as part of the quality manual. The org chart should show quality responsibilities for key personnel like the Quality System Management Representative (QSMR).

Start Training Employees and Maintaining Training Records
Write the training procedure and start maintaining a training records notebook. Perform ISO awareness training and log the training in everyone’s training records. Once you have created all your procedures and work instruction you will record the training of these process in this notebook.

Inventory and Customer Fulfillment Documentation Generation
Create your purchasing control, inventory control, service and all customer-fulfillment procedures. You will need to build some history of processing inventory for any internal audit to be worthwhile.

Purchasing Control Documentation
Create your purchasing control procedures. Complete some transactions including ordering, receiving, building and shipping product to demonstrate the complete inventory management . Some of the inventory should be nonconforming so the auditor can follow both good and bad materials through the process.

Design Control
Create your design control procedure and then generate notebooks for all current design projects. Start using revision control on the project specifications. Hopefully you will have some short-term projects that can be completed prior to the next internal audit. The company should have a completed design notebook for the certification audit.

Maintaining Nonconforming Materials
Create your nonconforming materials procedure and begin tracking defects in a central database, file or notebook. Make sure that everyone properly labels nonconforming materials. Build some history of nonconforming materials (including corrective actions) before the next internal audit.

Calibration And Maintenance Of Equipment
Write your calibration and maintenance procedure and enter all production equipment into a database or spreadsheet. Set up a calibration schedule and have all appropriate equipment calibrated. Record the status on the device and in the database.

Generate Detail Instructions
The company now has most of your key operational systems in place. Now you can create your detailed work instructions that are used for process control. These may be very simple and may be created dynamically or the processes may be performed by qualified personnel without work instructions.

Perform A Management Review Meeting
Present the quality data that has been collected and discuss goals and ISO status. Log this meeting in your management review notebook.

Perform An Internal Audit And Close All Findings
Create the internal audit program including an annual schedule. Choose an internal audit team and perform an internal audit. This audit should be logged in the audit records and should generate corrective actions in the engineering change order system. Close all these corrective actions. If possible, perform another management review to present the status of the new quality system.

Schedule The Certification Audit
At this point the company will have records to show that there is a quality systems in place and working. The company should schedule their certification audit.

Quality System Database
Our Microsoft Access database can manage many of your repetitive record keeping functions. It is available as part of our documentation pachage.

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