The mandatory documents required by ISO9001 are at least
1. First-level document-manual
Quality manual (a document describing the quality system structure, including program documents) Reference, including quality policy and quality objectives)
2. Secondary documents - procedures
Document and data control procedures
Record management procedures
< p>Nonconforming product control proceduresInternal audit management procedures
Corrective action procedures
Preventive action procedures
3. Level 3 documents -Instructions and forms
Production instructions
Inspection instructions
Other instructions (prepared according to the actual needs of the enterprise)
< p>Various forms (prepared according to the actual needs of the enterprise)The degree of quality system documentation varies according to the circumstances of the enterprise. Therefore, in addition to the above mandatory documents
Enterprises must also develop relevant procedures, instructions and forms according to the needs of their own system operations.
The above three-level documents are guiding documents that employees need to abide by.
The following documents are objective record documents, which are evidence that the company implements the ISO9001 quality management system.
It is also the basis for the company to analyze and improve.
4. Level 4 documents - quality records
The mandatory records are:
Records of management review
Employee education and training , skills and experience
Production-related records
Records of contract reviews
Records of design and development input
Relevant Records of design and development review
Records of design and development verification
Records of design and development validation
Records of design and development changes
Records of review of design and development changes and necessary actions taken
Records of the results of supplier evaluations and any necessary actions resulting from the evaluation
Where traceability is available Traceability records where required
Records related to customer property management
Measuring tool calibration records
Internal audit records
< p>Quality inspection recordsDisposal records of non-conforming products
Concession release records
Corrective action records
Preventive action records
And other records that prove that the company has implemented the quality management system and produced during the implementation process.
ISO9001 certification requires at least 6 months of evidence of quality management system operation.