User
What are mandatory documents for ISO 9001?
Experta
ISO 9001 specifies the following documents as required:
- Scope of the QMS—Clause 4.3 (usually documented as QMS Scope document
- Quality policy—Clause 5.2 (usually documented as Quality Policy)
- Quality Objectives and Plans for Achieving Them-Clause 6.2 (usually documented as List of Quality Objectives)
- Criteria for evaluation and selection of suppliers-Clause 8.4.1 (usually documented as Criteria for evaluation and selection of suppliers document)
- Compliance Obligations Document-Clause 7.5.3.2 (usually documented as List of External Documents, only if they apply to the product or service)
Note: ISO 9001 also specifies the following records as mandatory:
- Monitoring and measuring equipment calibration records- Clause 7.1.5.1 (usually documented as Maintenance and Calibration Record)
- Records of training, skills, experience, and qualifications-Clause 7.2 (usually documented as Training certificates and CVs)
- Product/service requirements review records-Clause 8.2.3.2 (usually documented as Customer Requirement Review Checklist)
- Record about design and development outputs review-Clause 8.3.2 (usually documented as Project Plan and Review)
- Records about design and development inputs-Clause 8.3.3 (usually documented as Project Plan and Review)
- Records of design and development controls-Clause 8.3.4 (usually documented as Design Review Minutes)
- Records of design and development outputs-Clause 8.3.5 (usually documented as Design Review Minutes)
- Design and development change records-Clause 8.3.6 (usually documented as Change Review Record)
- Characteristics of product to be produced and service to be provided-Clause 8.5.1 (usually documented as Product Specification)
- Records about customer property-Clause 8.5.3 (usually documented as Notification to a Customer about Changes on his Property)
- Production/service provision change control records-Clause 8.5.6 (usually documented as Production/Service Change Review Record)
- Record of conformity of product/service with acceptance criteria-Clause 8.6 (usually documented as Record of Traceability)
- Record of nonconforming outputs-Clause 8.7 (usually documented as Non-conformity Record)
- Monitoring and measurement results-Clause 9.1.1 and 9.1.3 (usually documented as Matrix of Key Performance Indicators and Data Analysis Report )
- Internal audit program-Clause 9.2 (usually documented as Internal Audit Program)
- Results of internal audits-Clause 9.2 (usually documented as Internal Audit Report)
- Results of the management review-Clause 9.3 (usually documented as Management Review Minutes)
- Results of corrective actions-Clause 10.2 (usually documented as Corrective Action Form)
Note: You will know if a document is mandatory by reading ISO 9001. It states pretty clearly what needs to be documented using a phrase like “The organization shall maintain documented information” or recorded using a phrase like “The organization shall retain documented information of …” for example, the evidence of the internal audit results.”
Note: ISO 9001:2015 has no requirement for mandatory documented procedures. Each organization has the authority to determine which documented procedures are relevant for their QMS.