Case Study 3: ISO 9001 Quality Management System (QMS)

Challenge: A small manufacturer of custom enclosures for the oil and gas industry was mandated to obtain ISO 9001 certification by a major customer in order to obtain future business.

Outcome: A quality management system based on the ISO 9001, International Standard, Quality management system was implemented in twelve months. Thirty five procedures were created to document the system and provide the necessary controls to meet the standard and obtain 3rd party certification.

The Process
Gap Analysis: The ISO 9001 standard was used to create a gap analysis to the current state.

Prioritization: The procedures were prioritized based on criticality to the customer. The manufacturing processes were selected as the starting point as they are critical to product quality. The processes were observed, mapped and documented as work instructions- including pictures and appropriate detail to match the skills and competency of the current workforce.

Schedule: Approximately four procedures were documented and approved each month. The limiting factor is the amount of time that the company can spend on creating the system in addition to their day to day activities. Some critical requirements required new procedures to be created. Processes like traceability, documentation, metrics and non-conformance tracking were implemented. Since this was a job shop, general procedures had to be created to allow for the customization of the product to meet the individual customer requirements. After all the procedures, forms and records were created, internal audits were conducted to ensure all requirements were met.

The Results: Underwriters Laboratories was contracted to perform the pre-audit and the certification audit to the ISO 9001:2008 standard. The audit was conducted over two days with minimal findings and recommendation for approval. The prime customer was satisfied with the results and will continue to do business with the panel manufacturer.


QMS Deployment

Challenge: Create a Quality Management System based on the ISO 9001 Requirements from scratch.

Outcome: A system that meets the ISO 9001 requirements and third party certification.

Results: Customer acceptance of the Quality Management System, continued sales with a prime customer and the ability to obtain new customers.