What are the ISO 9001 specifications?
The ISO 9001 standard is organized into ten sections. The first three are introductory, while the last seven contain the Quality Management System requirements against which a company can be certified. The following are the seven main clauses: Context of the organization This section discusses the requirements for understanding your organization before implementing a QMS. It includes the requirements for identifying internal and external issues, identifying interested parties and their expectations, defining the QMS's scope, and identifying your processes and how they interact. Interested parties' expectations include regulatory requirements as well. Leadership The leadership requirements address the need for top management to be involved in the QMS implementation. Top management must demonstrate commitment to the QMS by focusing on the customer, defining and communicating the quality policy, and assigning roles and responsibilities throughout the organization. Operation The ...