Requirements and Principles ISO 9001
ISO 9001 is the internationally recognized and most widely used standard for quality management (QM) in companies. It defines the minimum requirements for the introduction of a quality management system (QMS). The standard is aimed at companies of all types, sizes, and industries. In this white paper, the requirements, principles, and prerequisites of the quality standard are described in more detail.
Requirements of ISO 9001 for the QMS One of the most important requirements for a company‘s quality management system is to map its processes and activities. This central requirement has existed since the transition from ISO 9001:1994 to ISO 9001:2000 and has remained an important part of the standard ever since. In the new ISO 9001:2015, this process-oriented approach was extended. Aspects that were dealt with in an informative way in older versions, such as expectations related to interested parties, are now requirements. Section 4 of the ISO 9001 quality standard, „Context of the organization“, provides more details for understanding the business context:
Section 4.1: External and internal issues relevant to the strategic direction of the organization. The factors that have an impact on the quality management system must be determined. A distinction is made between:
• External topics aspects that arise, for example, from legal, technical, competitive, market, cultural and economic contexts.
• Internal topics aspects arising from values, corporate culture, or performance of the organization Seite 1/ 5 White Paper Requirements and Principles ISO 9001
Section 4.2: Understanding the needs and expectations of interested parties. An interested party is a person or stakeholder with (potential) influence on the company. It is therefore one of the requirements of ISO 9001: 2015 to determine who the interested parties are and what their influence on the QMS is.
Section 4.3: Definition of the scope of the management system. To determine the scope of application, the following aspects must be taken into account:
• internal and external topics,
• the requirements of interested parties,
• the products and services produced by the company
Section 4.4: Implementation of the quality management system and its processes. The areas of the application must be documented and accessible.
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