Establishes format and content requirements for a schedule that lays out on-site quality audit visits and related activities in support of certification to third-party quality standards.
The Quality Audit Site Visit Schedule lays out a timeline for on-site audits and related/similar activities based on requirements in quality standard(s) with the end objective of certification to those quality standard(s).
a. Use this DID for schedules to support on-site quality audits carried out by contractors or governmental entities external to the audited organizational unit. The term audit shall be used herein to encompass any inspection, review, evaluation, assessment, analysis, or similar activity involving an examination relative to a fixed standard. Any reference to an auditor shall be understood include an inspector, reviewer, evaluator, assessor, analyst, or examiner. All references to standards shall be understood to mean specific, identified, codified, published quality standards. Associated measures of value or worth are also included within the scope of quality, such as, but not limited to, reliability, effectiveness, utility, surety, feasibility, practicability, maintainability, producibility, or sustainability.
b. Do not use this DID for quality audits that are conducted by the organizational unit (self-audits or internal audits) or by a unit within the audited unit's chain of command.
c. Do not use this DID for audits or similar events conducted exclusively off-site. A site visit is mandatory for use of this DID. This DID can be used when a portion of the audit process is conducted off-site so long as there is a site visit associated with the audit event.
d. This DID applies to schedules for on-site audits that support one or more quality standards with requirements related to monitoring, surveillance, accreditation, or certification. Scheduled audits directly support certification of meeting or exceeding one or more relevant quality standard(s). The term certification shall be understood to include accrediation, validation, as well as any equivalent or similar terms used by relevant standard(s).
e. A key focus of the schedule shall be on audit hour requirements so as to ensure (1) availability of Government personnel and facilities, and (2) adequate length, scope, and depth of audit to meet the requirements of relevant standard(s) in support of certification.
f. This DID is applicable when a Government organizational unit enters into a contract, interagency agreement, or other formal relationship where the unit is audited to one or more standard(s). All references to a contract herein shall be understood to refer to any agreement made in writing between the audited unit and the auditing entity.
g. This DID can be achieved only when the auditing firm or agency has the certification, accreditation, or other credentials requisite for the audit.
h. Some examples of entities producing third-party standards to which this DID could apply are as follows: International Organization for Standardization (ISO), American Society for Quality (ASQ), American National Standards Institute (ANSI), International Electrotechnical Commission (IEC), and the Society of Automotive Engineers (SAE). This DID can also apply when the standard is created, maintained, or owned by an external Government agency (e.g., the Food and Drug Administration, Environmental Protection Agency, or Occupational Safety and Health Administration). Audits in support of a third-party standard typically will not be carried out by the third-party organization creating or promulgating the relevant quality standard.
i. Some examples of third-party quality standards to which this DID could apply are as follows: ISO9001 (Quality Management Systems - Requirements), ISO/IEC17025 (General Requirements for the Competence of Testing and Calibration Laboratories), ANSI/ISO/ASQ Q9001 (Quality Management Systems - Requirements), and SAE AS9100 (Quality Management Systems: Aerospace Requirements). This DID can also apply when the standard is a governmental standard (e.g., EPA or FDA Good Laboratory Practices or OSHA Voluntary Protection Program) that is created, maintained, or owned by an external agency. Such external governmental standards shall be regarded as third-party standards for the sake of this DID.
j. This DID may be used alone or in conjunction with other DIDs.
k. This DID may be used when the Government requires a schedule for external (independent) quality audit site visits for a non-governmental entity.
l. This DID is a first issuance and does not supersede any other DID.