Here are a few challenges that a company might face when implementing the ISO 9001 standard: Knowledge deficit. The lack of knowledge and understanding of how the standard works and what benefits it can bring to the organization. Individual needs and requirements. Every company takes diverse approaches when implementing the standard. It happens due to the differences in interpretation of the requirements and clauses of ISO 9001, which are caused by the differences in organizations’ structure, needs, and current state of their business. Multi-site coordination. Large organizations with multiple locations can meet some hurdles, as they must guarantee consistent roll-out of business processes across all their locations. Process approach. ISO 9001:2015 requires a process approach to ensure the smooth and correct functioning of a quality management system. It identifies business and operational processes inside the company and assigns identification for effectiveness which could be quite challenging to many companies.