Companies and businesses seeking ISO certification in order to expand their reach to potential customers must first have in place a quality management system that defines, documents, controls, and seeks to continuously improve its final product based on customer feedback through the involvement of every employee within the company. While there are many components that go into an effective quality management system, they are not rigorously defined, and interpretation is primarily left to each business as to how it controls and implements the continuous-improvement process within its organization.
ISO 9001, on the other hand, has very specific requirements and components that must be in place before a business is eligible for ISO certification. These requirements are divided into eight categories with twenty-one key elements that must be considered for each step in the process. Written procedures, training, standard operating procedures, document control, records management, design reviews, supplier evaluation and performance monitoring, and non-conforming product disposition are just some of the documents and records that must be maintained and available for audit, internal or external.
Depending on the complexity of a company’s product or service, the documentation and record-keeping requirements for ISO compliance can be daunting, and for some smaller businesses with limited resources and budgets, overwhelming. In every instance, a business will have to assign additional duties to individuals within the organization to maintain compliance, or establish new positions or departments wholly responsible for ISO management. This can result in a significant commitment of valuable resources, increase the workload of already overloaded staff, or create a financial burden for cash-limited businesses. In some cases, companies have completely abandoned the notion of ISO certification based on financial, personnel, and time-commitment burdens.
Fortunately, ISO compliance lends itself perfectly to computerized record-keeping and control, and as a result many developers have built and offer complete quality management software suites to help businesses establish and maintain compliance with ISO recordkeeping, procedure control, and documentation. Software packages specifically established to provide all of the templates for ISO 9001 are available on the open market. While the establishment of a complete working system still requires time and effort, the task can be minimized by taking advantage of available software packages. In most cases, quality management software can completely eliminate the need for paper-based recordkeeping, reducing the workload and constant attention required of physically-maintained systems.
Template-based software can help a business develop ISO-required quality manuals, quality mission statements, roles and responsibilities charts, standard operating procedures, supplier evaluation documents, non-conforming product procedures and controls, training records, customer complaint forms, material certification and tracking sheets, and internal audit forms. Also, because all of these documents must be access controlled, current, and valid, the software can limit access to the documents to only those personnel who must have them to perform specific tasks. Documents that get printed out can be given a time limitation before they are considered invalid, another important aspect of ISO document control, which prevents confusion as to which version of a document is the most current. This Document Management System (DMS) is an all-inclusive repository for access to forms as well as file-retention of completed documents.
Quality management software can also be integrated into a business’s email or other internal calendar system to provide time-based reminders to any member within the organization when deadlines are approaching, an individual requires retraining, documents are about to expire and require revalidation, equipment is due for calibration, or an internal audit is due. This feature is especially useful for corrective-action assignment, follow-up, and completion notification, and can send notifications when a final review of a Corrective Action Preventive Action (CAPA) analysis and its completed corrective actions is required.
Another valuable, although not necessarily essential, component of a computer-based quality management system is the addition of an on-line Learning Management System (LMS). The LMS allows individuals to retrain or certify on specific topics and procedures, once or on a recurring frequency. An integrated system can record the employee has attempted the training, completed it satisfactorily along with the final score, and prevent individuals from accessing specific information in the DMS if they have not successfully completed training on a specific topic or procedure prior to a deadline. Again, reminders can be sent to individuals, managers, or department clerks, reminding them when training is due, who must complete the training, and by when it must be completed.
A computer-based quality management system does not take all of the initiative and burden out of the hands of the business. It is still up to the organization to develop key processes to manage and set the requirements to successfully implement those processes within the guidelines of ISO certification. There will still be time and effort involved to establish the program, develop roles and responsibilities, and get systems in place to monitor compliance, including required internal audits. While the front-end of the process is still heavily loaded for a business from a time and commitment standpoint, once established, an all-inclusive computerized quality management system can dramatically ease the long-term maintenance component of a viable ISO compliance system.
Back to Quality Management Software