Creating and operating a quality management system (QMS) that meets the requirements of the ISO 9001 Standard can be a real challenge. One way to simplify this difficult task is to use a software package specifically designed for an ISO 9001 QMS as well as geared toward gaining ISO certification. It can help with multiple facets of managing an ISO 9001 Quality Management System by automating both mundane and complex of aspects of the QMS to help gain and maintain ISO Certification.
Document and Record Control
Document and record control is the most common finding in compliance audits. Quality management software can simplify this element of the quality management system to eliminate document and record control findings. ISO software makes it easier to track paper documents if they are needed, and where possible it can move an organization toward a paperless system. Paperless systems can be more easily controlled as well as reduce document printing, storing, and management costs.
Corrective and Preventive Action
Logging and tracking Corrective and Preventive Action (CAPA) activity is another common problem area for organizations in maintaining an ISO 9001 compliant quality management system. Properly managing and clearing corrective actions in a timely way is critical for a functional QMS. ISO software not only simplifies tracking and logging of CAPA items, it will flag extended open items and bring them to the attention of quality managers so they can be cleared before exceeding defined open item limits.
Customer Satisfaction Feedback
Collecting customer feedback is an ISO 9001 requirement, yet many organizations only make a token effort to truly hear and use the voice of the customer. A well-designed ISO software program will interface with sales and customer service to collect customer feedback for the QMS. With an integrated software approach, a business doesn’t have to feign its commitment to collecting customer feedback. It can collect, process, and analyze real customer comments and feedback as an integral part of the QMS.
Process Measurement
The ISO 9001 QMS requires a continually improving process approach. This means constantly collecting process data, analyzing it, and then applying what is learned to improve process effectiveness and efficiency. This takes a commitment to measurement and improvement that most organizations find difficult to fulfill. A comprehensive ISO software program will make it easy to capture critical measurements for key processes, and then provide real time dashboards, visual displays, and regular reports. Measuring and improving processes sets organizations that realize true improvement and value from ISO 9001 apart from the organizations that constantly spend money on quality management without realizing its benefits.
Calibration Management
Meeting the ISO 9001 calibration requirements is another challenge for many organizations, and another frequent area for audit findings. The right QMS software can also simplify this component of the quality management system, and eliminate the negative ramifications of getting caught with out-of-calibration test and measurement equipment.
Find the Right ISO Software
There are dozens and dozens of ISO 9001 quality management software packages available. To begin the software selection process, it is important to list the needs and priorities of your QMS and other requirements like hosting platforms, interfacing with other enterprise applications, scalability, and ease of use. By automating certain components of the QMS, quality managers can spend their time on more important things and increase the value of their ISO 9001 efforts.