ISO 9001 is a customer service-oriented, quality management standard first adopted in 2000 by the international organization for standardization (ISO). According to the standard, organizations must demonstrate the ability to meet or exceed customer satisfaction in terms of product function, quality and performance. Likewise, compliant organizations must also maintain strict adherence to regulatory requirements, industry standards, and best practices regarding production processes and outcomes. In short, ISO 9001 standards ensure that organizations offer quality products while simultaneously encouraging and acting on feedback from customers, end-users, and regulatory agencies.
International consensus was used to help determine standards universally applicable to all organizations regarding products and services that meet both customer and regulatory requirements. Conformity to regulatory requirements and customer expectations, however, are not enough to meet ISO 9001 standards. Organizations must also establish systems for and actively participate in continuous improvement initiatives. Self audits, voluntary client audits, and independent third party certification bodies are encouraged to help organizations with efforts for continuous improvement.
The ISO 9001 standard and its requirements are intended to apply to all organizations, regardless of size or industry. As such, the ISO does not dictate how an organization must meet requirements, only that guideline requirements are met. Generic standards provided under such conditions allow each organization to determine its own unique processes and controls to maintain compliance. Certain clauses within the text of the standard outline criteria by which an organization may qualify for exclusion in the rare event of an inapplicable requirement. Excluded standards cannot affect the organization's responsibility to ensure quality production, lest claims of conformity be subject to refusal for ISO 9001 certification.
Among the ISO 9000 family of standards, ISO 9001, as revised in 2008 and supplemented in 2009, is the only standard for which organizations can seek certification. Certification is not a requirement of compliance, but certification serves to reassure customers that the organization is indeed in compliance. When applied to business to business environments, an ISO 9001 certification helps instill confidence, especially in situations involving new business relationships or joint ventures.
For example, a manufacturing plant in the United States may struggle to perform due diligence on an overseas supplier due to geography. Knowing the organization is compliant with ISO 9001 standards can help allay concerns. Documentation that the supplier not only states compliance but has passed the rigors of certification further instill confidence in the new business to business relationship. All things being equal, ISO certification could, in fact, sway a contract or business relationship decision, especially for organizations with limited resources to conduct due diligence.