ISO 9001 is a quality management standard that requires organizations to meet or exceed customer satisfaction and regulatory requirements while continuously improving their processes. Certification is not required but can instill confidence in business-to-business relationships. The standard applies to all organizations and allows for unique processes and controls.
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 functionality, quality and performance. Likewise, compliant organizations must also maintain strict adherence to regulatory requirements, industry standards, and best practices related to manufacturing processes and outcomes. In short, ISO 9001 standards ensure that organizations deliver quality products while simultaneously encouraging and acting on feedback from customers, end users and regulatory agencies.
International consensus has been used to determine standards universally applicable to all organizations regarding products and services that meet both customer and regulatory requirements. Compliance with regulatory requirements and customer expectations, however, is not enough to meet ISO 9001 standards. Organizations must also establish systems and actively participate in continuous improvement initiatives. Self-audits, voluntary customer audits, and independent third-party certification bodies are encouraged to help organizations commit to continuous improvement.
The ISO 9001 standard and its requirements are intended to apply to all organisations, regardless of size or sector. As such, the ISO does not dictate how an organization shall meet the requirements, only that the requirements of the guidelines are met. The generic standards provided in these terms allow each organization to determine its own unique processes and controls for maintaining compliance. Certain clauses within the text of the standard criteria outline under which an organization can qualify for exclusion in the rare event of an unenforceable requirement. Excluded standards cannot affect the organization’s responsibility to ensure quality production, lest declarations of conformity are subject to refusal of ISO 9001 certification.
Among the ISO 9000 family of standards, ISO 9001, revised in 2008 and supplemented in 2009, is the only standard for which organizations can apply for certification. Certification is not a compliance requirement, but certification serves to reassure customers that the organization is indeed compliant. 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 facility in the United States may have difficulty performing due diligence on an overseas supplier due to geography. Knowing that your organization complies with ISO 9001 standards can help allay your worries. Documentation proving that the supplier not only declares compliance, but has passed the rigors of certification, instills further confidence in the new business-to-business relationship. All things being equal, ISO certification could, in fact, influence a contractual or business relationship decision, especially for organizations with limited resources to conduct due diligence.
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