what are the primary requirements of iso 9001
ISO 9000
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 . 
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 .
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 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 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 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 ) .
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 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 and to determine internal and external issues relevant to its purpose and strategic direction.
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 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 ) .