Welcome to ISO 9000 Resources, the source for cost-effective, battle-tested quality system information. Our experienced staff of consultants has taken the guesswork out of ISO 9001 development by creating a full range of ready-to-use ISO 9001 products. Some of this information is derived from our work with the ReGenPod whole-body photobiomodulation system and the FDA / ISO requirements. Every product is based on years of practical real-world experience — more than just compliant, they are effective and efficient. Our products save your company money and time while focusing your resources on shipping quality on time and on budget. All products are 100% guaranteed.

ISO 9001 Starter Kit

The perfect entry point for companies just starting implementation. This kit jump-starts a successful ISO project.

$45

ISO 9001 Documentation Kit

A proven quality manual plus the most critical procedures, forms, and documents — the backbone of a world-class quality system.

$195

ISO 9001 Total Quality System

Every manual, flow chart, plan, form, schedule, procedure, and guide in our library. The ultimate resource for an effective and efficient quality system.

$495 $295
100% satisfaction guaranteed — if our products don’t accelerate your ISO project, we’ll refund your purchase.

New to ISO? Try our 17-step implementation plan

A pragmatic project plan that takes a company from zero to a registrar-ready quality system. Each step links to the deeper article on this site.

Get the big picture

Understand the basic elements of ISO 9001:2015 including the cost of certification and how it changes the way you do business. Our starter kit is one of the best tools for getting started. If you’re a long way from compliant, a turnkey Quality Management System dramatically accelerates the project. ISO 9001 consulting is available at any point. Perform a QMS evaluation to estimate resources, then create and approve a project justification.

Evaluate your quality system and start the project

Assess your current system using a gap analysis check sheet, then secure the management commitment to finish. Save the gap analysis — once an internal audit system is in place, it makes a perfect baseline audit.

Develop the implementation plan and quality goals

Develop the quality objectives, quality statement, and project scope. Use the samples on this site as the basis for measurable quality objectives and a customer-focused quality statement. Create an implementation plan with timeline, cost, and resources, and submit it to management for approval.

Create the documentation control procedures

Establish your document control system first — that gives you a frame for creating every other document with proper revision control. Documents need unique tracking numbers and revisions; the control process pairs with the engineering change order (ECO) system to maintain that.

Create the corrective and preventive actions system

The corrective and preventive actions system is usually built into the Engineering Change Request and Order (ECR/ECO) workflow, used to approve and release all documentation alongside the documentation control procedure. The ECR/ECO system is one of the best areas to automate.

Generate a quality manual

Purchase an ISO 9001 quality manual or copy our sample quality manual. Adapt the manual to your own quality statement and any special needs, and include a product flow chart and an organizational chart that shows quality responsibilities for key personnel like the Quality System Management Representative (QSMR).

Start training employees and maintaining records

Write the ISO 9001 training procedure and start a training records notebook. Run ISO awareness training and log it in everyone’s record. As you create procedures and work instructions, you’ll record training on each one in this notebook.

Inventory and customer fulfillment documentation

Create your inventory control, service, and customer-fulfillment procedures. Process some real inventory before the first internal audit so the auditor has history to look at.

Purchasing control documentation

Create your purchasing control procedures. Run end-to-end transactions — ordering, receiving, building, and shipping — to demonstrate the system. Include some nonconforming inventory so an auditor can follow both good and bad material through the process.

Maintain nonconforming materials

Create your nonconforming materials procedure and start tracking defects in a central database, file, or notebook. Make sure everyone properly labels nonconforming materials, and build some history (including corrective actions) before the next internal audit.

Design control

Create your design control procedure and generate notebooks for current design projects. Use revision control on the project specs. Aim to have at least one completed design notebook ready for the certification audit.

Calibration and maintenance of equipment

Implement your calibration and maintenance procedures. Enter all production equipment into a database or spreadsheet, set up a calibration schedule, and have all relevant equipment calibrated. Track each device’s status in the database.

Detailed work instructions

With key operational systems in place, create the detailed work instructions used for process control. These can be very simple, created dynamically, or even skipped where work is performed by “qualified” personnel without written instructions.

Management review

Hold a management review meeting. Present the quality data collected so far and discuss goals and ISO status. Log the meeting in your management review notebook.

Internal audit and closure

Use a turnkey internal audit package or the internal audit samples on this site. Build the internal audit program with an annual schedule, choose an audit team, and run an internal audit. Log it in the audit records, generate corrective actions through the ECO system, and close them all. If possible, run another management review to present the new system’s status.

The certification audit

By now you have records showing the quality system is real and working. Choose a Registrar and schedule the certification audit.

Continuous improvement

At successful companies, the improvements never end. Whether ISO-certified or not, focus on continuous improvement of products, processes, and the quality system itself.

What customers say

“This looks like it’s exactly what we needed. Short and sweet and not cumbersome.”
— Henry, MAETS