Managing quality levels within a regulated industry can always be a challenge. Without proper quality management, your business will run inefficiently and risk incurring penalties from failing to comply with regulations. This process can become even more difficult and complex when operating within an international regulatory environment where you must deal with multi-country regulations. Implementing and utilizing quality management software (QMS) can provide the necessary tools and solutions to help you navigate the international regulatory environment successfully.
As mentioned before, if your company conducts business across multiple countries you will have to deal with international regulations. Many of these international regulations and requirements can be met through compliance with ISO 9000.
ISO 9000 is a group of quality standards developed by the International Organization for Standardization that aims to help organizations meet the needs of consumers as well as meet regulatory requirements. Although compliance with ISO standards is voluntary, most customers prefer to do business with companies that are ISO certified.
Among the family of ISO 9000 standards, ISO 9001 2008 is typically the most used as it can be applied to all types of businesses. The standards associated with ISO 9001 2008 mainly relate to quality management; QMS can provide the processes and solutions necessary to comply with these standards.
Quality management software can make it easy to conform to ISO standards and get your company ISO certified.
In regards to document control, QMS can help meet ISO requirements by tracking changes to documents and creating reports that confirm they comply with ISO standards. Along with ensuring compliance, QMS can also increase efficiency by automating document approval processes.
Another area where QMS can help your business manage quality levels in the international arena is with Corrective and Preventative Actions (CAPA). ISO standards require that your business perform management reviews of all corrective and preventative actions taken, as well as present documentation that demonstrates control of nonconformity. Quality management software can provide a system and a process that can guide your quality team through every step of the CAPA process and allow for CAPA forms to be generated from existing forms through integration with other quality processes. Also, errors and issues arising from the manual transfer of information can be virtually eliminated through automated data entry.
QMS can also help your business better adhere to ISO requirements in terms of customer complaints. ISO standards mandate that examinations of customer feedback be conducted by management. Quality management software can streamline this process to improve efficiency and ensure that nothing slips through the cracks. Through a simplified process, QMS can shorten the lifecycle of a complaint and quickly move it from submission to resolution.
Meeting ISO standards and complying with international regulations can add an extra element of difficulty when it comes to managing quality levels. Without the appropriate quality management systems in place, your business can quickly run into trouble. However, taking advantage of QMS can help your company overcome the challenges presented by a multi-country, multi-regulatory environment.
Declan Peltier is on Google+.