Quality Management at ECT- Transitioning from ISO 9001:2008 to ISO 9001:2015

ECT has transitioned it’s Quality Management System from ISO 9001:2008 to ISO 9001:2015. ECT’s Quality Management System (QMS) has been rooted in ISO 9001 requirements since 1995. This means all of ECT’s internal processes are geared toward fully satisfying customer requirements while giving additional assurance that ECT’s internal systems are being constantly evaluated to reduce risk and waste while increasing product quality and consistency.

The international ISO 9001 standard provides a set of requirements that allow various kinds of organizations from manufacturers to hospitals to develop a robust internal framework that drives improvement in overall performance with a focus on producing goods and delivering a service experience that truly meet customer expectations and requirements. This foundation has allowed the organization to develop controlled, results-oriented processes not only in design and manufacturing, but in customer service, quality control, purchasing, planning, and product delivery as well. The latest revision of this standard, ISO 9001:2015, includes many of the elements of ISO 9001:2008 such as Management Review, Resource Management, Internal Audits, and Control of Production, but adds new enhanced requirements that encourage evidence-based decision making and the application of pre-determined controls during changes in internal processes. ISO 9001:2015 also introduced an entirely new requirement, actions to address risks and opportunities. While the concept of risk prevention was an underlying theme in earlier versions of ISO 9001, ISO 9001:2015 requires that organizations actively plan to address risk and opportunities and integrate these activities into their QMS.

ECT first began planning for transition of its QMS to ISO 9001:2015 in 2016 and completed its transition and recertification audit to the new standard in January 2018. When ECT’s ISO 9001:2008 certification expires in March of this year, the organization’s QMS registrar, NQA, will issue a new ISO certificate to the 2015 standard.

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