<P> Essentially the layout of the standard is similar to the previous ISO 9001: 2008 standard in that it follows the Plan, Do, Check, Act cycle in a process - based approach, but is now further encouraging this to have risk - based thinking . (section 0.3. 3 of the introduction) The purpose of the quality objectives is to determine the conformity of the requirements (customers and organizations), facilitate effective deployment and improve the quality management system . </P> <P> Before the certification body can issue or renew a certificate, the auditor must be satisfied that the company being assessed has implemented the requirements of sections 4 to 10 . Sections 1 to 3 are not directly audited against, but because they provide context and definitions for the rest of the standard, not that of the organization, their contents must be taken into account . </P> <P> The standard no longer specifies that the organization shall issue and maintain documented procedures, however, ISO 9001: 2015 requires the organization to document any other procedures required for its effective operation . The standard also requires the organization to issue and communicate a documented quality policy, a quality management system scope, and quality objectives . The standard no longer requires compliant organizations to issue a formal Quality Manual . The standard does require retention of numerous records, as specified throughout the standard . New for the 2015 release is a requirement for an organization to assess risks and opportunities (section 6.1) and to determine internal and external issues relevant to its purpose and strategic direction (section 4.1). The organization must demonstrate how the standard's requirements are being met, while the external auditor's role is to determine the quality management system's effectiveness . More detailed interpretation and implementation examples are often sought by organizations seeking more information in what can be a very technical area . </P> <P> International Organization for Standardization (ISO) does not certify organizations itself . Numerous certification bodies exist, which audit organizations and, upon success, issue ISO 9001 compliance certificates . Although commonly referred to as "ISO 9000" certification, the actual standard to which an organization's quality management system can be certified is ISO 9001: 2015 (ISO 9001: 2008 will expire by around September 2018). Many countries have formed accreditation bodies to authorize ("accredit") the certification bodies . Both the accreditation bodies and the certification bodies charge fees for their services . The various accreditation bodies have mutual agreements with each other to ensure that certificates issued by one of the accredited certification bodies (CB) are accepted worldwide . Certification bodies themselves operate under another quality standard, ISO / IEC 17021, while accreditation bodies operate under ISO / IEC 17011 . </P>

What are the primary requirements of iso 9001
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