Puritan Products has had ISO 9001 Certification since 2003. This firmly entrenched culture of quality management has allowed us to excel with a 100% successful audit rate since becoming ISO certified. For a copy of our current ISO certificate click here.
ISO 9001:2008 is an international standard for quality management systems (QMS) that many companies adhere to. ISO 9001 was first issued in 1987, with subsequent updates in 1994, 2000 and the current 2008. This standard was designed for organizations that need to demonstrate their ability to consistently provide product that meets customer and applicable statutory and regulatory requirements. ISO 9001 is based on a set of eight quality management principals. These principles, as stated in ISO’s free brochure download, “Quality management principles,” are:
- Customer Focus – Organizations depend on their customers and therefore should understand current and future customer needs, should meet customer requirements and strive to exceed customer expectations.
- Leadership – Leaders establish unity of purpose and direction in the organization. They should create and maintain the internal environment in which people can become fully involved in achieving the organization’s objectives.
- Involvement of People – People at all levels are the essence of an organization and their full involvement enables their abilities to be used for the organization’s benefit.
- Process Approach – A desired result is achieved more efficiently when activities and related resources are managed as a process.
- System Approach to Management – Identifying, understanding and managing interrelated processes as a system contributes to the organization’s effectiveness and efficiency in achieving its objectives.
- Continual Improvement – Continual improvement of the organization’s overall performance should be a permanent objective of the organization.
- Factual Approach to Decision Making – Effective decisions are based on the analysis of data and information.
- Mutually Beneficial Supplier Relationships – An organization and its suppliers are interdependent and a mutually beneficial relationship enhances the ability of both to create value.
A revision to ISO 9001 is expected to be adopted by the end of 2015. Companies will have up to three years to become compliant once the revision is approved and published. To learn more about the differences between ISO 9001 certification to the 2008 standard versus to the 2015 standard click here.
We encourage you to review our comprehensive Quality Overview, designed as a self-audit, prepared by our Director of Quality using questions routinely received from customer and regulatory agent audits. This audit will provide you with a glimpse into our Quality Management System and answer many of your questions—from both an ISO and GMP perspective.