We recently renewed our ISO 9001 certification to update it from ISO 9001:2008 to ISO 9001:2015. ISO certifications are important not only to us, but also our customers, but what does it mean to be ISO certified? Put simply, ISO 9001 standards are designed to help organizations ensure that they meet the needs of customers while meeting statutory and regulatory requirements related to the products they produce and sell. The standards are published by the International Organization for Standardization (ISO). Each country has a recognized national standards body that makes the ISO 9001:2015 requirements available to companies who seek certification. ISO itself doesn’t certify companies; there are certification bodies that handle the auditing of organizations and issue the compliance certificates.
During the ISO audit, an auditor examines extensive samples of the functions, products, services, and processes of the company. The company is required to maintain documented procedures in the control of documents and records, internal audits, control of nonconforming products/services, corrective action, and preventive action. The company also has to supply documentation on any other procedures required to effectively operate, as well as a quality policy and a Quality Manual. As you can imagine, it takes a significant commitment by the company seeking certification to develop all of this material and to implement these procedures.
What does this really mean for our customers, and how does this certification impact the quality of product we produce at Apex? The certification shows that quality management drives our operations here at Apex. The certification is understood and followed by all employees. We regularly audit our quality system for conformance and effectiveness based on all the data we record. When we develop new products for clients, we test at each stage and document if the product is meeting design requirements, regulatory requirements, and customer needs. All of these efforts are designed to ensure delivering the highest quality products to our customers.
The combination of external audits and internal audits by our staff is how we ensure maintaining our ISO 9001:2015 certification. We continually test to ensure our quality system is working for the benefit of our customers, and we continually explore what improvements can be made.
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