For example, pharmaceuticals that are distributed in the United States are required to be in compliance with 21 CFR Part 211. Conformance to the Code of Federal Regulations is mandatory and is enforceable by the United States Food and Drug Administration (USFDA), and if not adhered to, can have serious implications. This need for compliance, quality and safety provides a good rationale for pharmaceutical managers to consider ISO 9001:2015 certifications. Pharma companies strive to provide their customers with consistent, high quality goods and services and to ensure that their customers are satisfied. The International Standards Organization (ISO) as a whole aims to ensure that products and services are safe as well as reliable by producing standards that can be incorporated into any organization large or small, complex or simple in the nature of the products/services offered. Certification to ISO 9001:2015 demonstrates that a specific set of criteria for the quality management system

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