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TS 16949 MANDATORY RECORD REQUIREMENTS:

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Section
4.2.1 General
4.2.3 Control of
documents
4.2.3.1 Engineering
specifications
4.2.4 Control of
records
4.2.4.1 Records
retention
5.6.1 Management
Review General
5.6.1 .1 Quality
Management
system
Performance
6.2.2 Competence,
Awareness, and
Training
7.1 Planning a
product realization
7.2.2 Review of
requirements
related to the
product
7.3.2 Design and
development inputs
7.3.4 Design and
development
review
7.3.5 Design and
development
verification
7.3.6 Design and
development of
validation
7.3.7 Control of
design and
development
changes
7.4.1 Purchasing
process
7.5.2 Validation of
processes for
production and
service provision
7.5.3 Identification
and traceability
7.5.4 Customer
property
7.6 Control of
monitoring and
measuring devices
8.2.2 Internal audit
(QMS,
Manufacturing
process audit ,
product audit)
8.2.3.1 Monitoring
and measurement
of manufacturing

Description
Reference to records required by the standard
For records are controlled according to 4.2.4
Records of date on which engineering specifications are
implemented in production (includes updation dates of documents)
Records are established and maintained to provide evidence of
conformity
The control of records shall satisfy regulatory and customer
requirements
Management Review records
Monitoring of quality objectives and reporting and evaluation of cost
of poor quality. Records to show at a minimum , evidence of
achievement of quality objectives and customer satisfaction
Education, training, skills, and experience
Evidence is recorded that the realization processes and resulting
product meet requirements
Results of the review and actions are rising from the review

Inputs relating to product requirements


Results of the reviews and any necessary actions
Results of the verification and any necessary actions
Records of the results of validation and any necessary actions
Results of the review of changes in any necessary actions

Results of supplier evaluations and any necessary actions are rising


from the valuation
Requirements for records as applicable

Where traceability is a requirement, the unique identification of the


product
Records of customer property that has lost, damaged, or unsuitable
for use
Where no standards exist, bases used for calibration is recorded
Records of the results of calibration and verification are maintained
Records of validity of previous measuring results when equipment is
found not to conform to requirements
Records of audit results
Implied records for reporting verification follow up activities and
results
Records of effective dates of process changes

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processes
8.2.4 Monitoring
and measurement
of product
8.3 Control of nonconforming product
8.5.2 Corrective
action
8.5.2.4 Rejected
product test /
analysis
8.5.3 Preventive
action

Records indicates the person(s) authorizing the release of the


product
The nature of nonconformities and any subsequent actions taken,
including concessions obtained
Records for corrective action results taken
Records of rejected product analysis
Records for preventive action results taken

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