Mandatory Documents & Records:The standard specifies that the organisation shall issue and maintain the following six documented Procedures:

Control of Documents (4.2.3)Control of Records (4.2.4)Internal Audits (8.2.2)Control of Nonconforming Product / Service (8.3)Corrective Action (8.5.2)Preventive Action (8.5.3)

In addition to these procedures, ISO 9001:2008 requires the organization to document any other procedures required for its effective operation. The standard also requires the organisation to issue and communicate a documented quality policy, a Quality Manual (which may or may not include the documented procedures) and numerous records, as specified throughout the standard.

Mandatory Documents & Records:The standard specifies that the organisation shall maintain the following RECORDS:

Records determined by the organization to be necessary to ensure effective planning, operation and control of processes (4.2.1)Records of management review (5.6.1)Records of education, training, skills, and experience (6.2.2 e)Records of evidence that realization processes and product meet requirements (7.1 d)Records of review of customer requirements and follow-up actions (7.2.2)Records of design and development input (7.3.2)Records of design and development review (7.3.4)Records of design verification actions (7.3.5 )Records of design validation actions (7.3.6 )Records of design changes and results (7.3.7 )

Mandatory Documents & Records:Records of the evaluation of suppliers (7.4.1)Records of special process validations (7.5.2 d)Records of the unique identification of product (traceability)(7.5.3)Records of lost, damaged or unsuitable customer property (7.5.4)Records of the basis of calibration used when no traceable standards exist (7.6 a)Records of the results of calibration (7.6)Records of assessment of product when calibration is out of tolerance (7.6)Records of internal audits (8.2.2)Records of person(s) authorizing release of product to the customer (8.2.4)Records of the nature of nonconformities and subsequent actions (8.3)Records of the results of corrective action taken (8.5.2 e)Records of the results of preventive action taken (8.5.3 d)