- As much as needed to meet the requirements of the standard. To become ISO certified, your company or organisation must submit documents that report its internal processes, procedures, and standards. These documents (or Quality Management System) determine that your company can consistently provide quality products and services.
- An exhaustive list of the mandatory documents and records can be seen below:
Scope of the Quality Management System (clause 4.3)
Quality policy (clause 5.2.2)
Quality objectives and how these will be achieved (clause 6.2)
Monitoring and measuring resources (7.1.5.1)
Monitoring and measuring equipment calibration records* (clause 7.1.5.2)
Records of competency in staff (clause 7.2)
Product/service requirements review records (clause 8.2.3.2)
Design and development inputs record (clause 8.3.3)
Records of design and development controls (clause 8.3.4)
Records of design and development outputs (clause 8.3.5)
Record of design and development changes (clause 8.3.6)
Criteria for evaluation and selection of suppliers (clause 8.4.1)
Characteristics of product or service to be provided (clause 8.5.1)
Identification and Traceability records (8.5.2)
Records about customer property including any changes (clause 8.5.3)
Production/service provision change control records (clause 8.5.6)
Release of products and services (clause 8.6)
Control of nonconforming outputs (clause 8.7.2)
Monitoring and measurement results (clause 9.1.1)
Internal Audit results (9.2.2)
Results of the management review (clause 9.3.3)
Results of corrective actions, including opportunities for improvement (clause 10.2.2)
To ensure that these files are available and easily accessible to auditors is also a requirement.