Documented information.

4.3 The scope of the organization's quality management system must be available and
maintained as documented information.
4.3.1 Support functions, whether located on-site or off-site (such as design, company
corporate offices, and distribution), These exclusions must be justified and maintained as
documented information.
4.4.2 To the extent necessary, the organization must:
a) maintain documented information to support the operation of its processes;
b) preserve documented information to have confidence that the processes are carried out
as planned.
5.2.2 The quality policy must be available and maintained as documented information.
5.3.1 Senior management should designate individuals with the responsibility and authority
to ensure that customer requirements are met. This designation must be documented.
This includes, but is not limited to, the selection of special features, the establishment of
quality objectives and related training, corrective and preventive actions, product design
and development, capability analysis, information logistics, customer performance reports
and customer websites.
6.1.2.1 Risk analysis. The organization must retain documented information as evidence of
the results of the risk analysis.
6.1.2.2 Preventive action. The organization must retain documented information on the
actions taken.
6.1.2.3 Document contingency plans and retain documented information describing any
updates, including the person(s) who authorized any changes.
6.2.1 Quality objectives and planning to achieve them The organization shall maintain
documented information on quality objectives.
7.1.5.1 The organization shall retain appropriate documented information as evidence that
monitoring and measurement resources are fit for purpose.
7.1.5.2 The basis used for calibration or verification must be retained as documented
information;
7.1.5.2.1 Calibration/verification records, when inspection measurement and testing
equipment is found to be out of calibration or defective during its verification or planned
calibration or during its use, documented information about the validity of the previous
measurement results obtained with this inspection measurement and testing equipment,
including the date of the last calibration with the associated measurement standard and
the next expiration date indicated in the calibration report.
7.1.5.3.1 Internal laboratory, This scope of the laboratory must be included within the
documentation of the quality management system. The laboratory must specify and
implement, at a minimum, requirements for:
a) the adequacy of laboratory procedures;
b) the competence of the people in the laboratory;
c) product testing.
7.2 retain appropriate documented information as evidence of competence.
7.2.3 Competency of the internal auditor, when training is provided to achieve competency,
documented information must be maintained that demonstrates the instructor's
competency with the requirements necessary for training the internal auditor.
7.3.1 The organization shall maintain documented information that demonstrates that all
employees are aware of their impact on product quality and the importance of their
activities in achieving, maintaining and improving quality, including customer requirements
and the risks involved. towards the customer for non-conforming products.
7.5.1.1 The organization's quality management system must be documented and include a
quality manual
7.5.3.2.1 The organization must define, document and implement a records retention policy.
8.1 Planning and operational control, conservation of documented information to the extent
necessary to:
1) have confidence that the processes have been carried out as planned;
2) demonstrate the conformity of products and services with your requirements.
8.2.3.1.1 Review of requirements for products and services The organization shall retain
documented evidence of a customer-authorized exemption from the requirements for formal
review set out in section 8.2.3.1 of ISO 9001.
8.2.3.2 Manufacturing feasibility. The organization must retain documented information,
where applicable:
a) on the results of the review;
b) about any new requirements for the products and services.
8.2.4 Changes in requirements for products and services. The organization shall ensure
that, when requirements for products and services are changed, the relevant documented
information is changed, and that relevant persons are aware of the changed requirements.
8.3.2.3 Development of products with integrated software, the organization must retain
documented information from a self-assessment of its software development capability.
8.3.3 Inputs for design and development. The organization must retain documented
information on design and development inputs.
8.3.3.1 Inputs for product design. The organization shall identify, document, and review
input requirements for product design as a result of the contract review.
8.3.3.2 Inputs for manufacturing process design. The organization shall identify, document
and review input requirements for the design of the manufacturing process.
8.3.3.3 documentation of all special features in plans (where required), risk analysis (such
as FMEA), control plans and operator or standardized work instructions; special features
are identified with specific symbols or marks and are displayed in all these documents;
8.3.4 Design and development controls, documented information on these activities is
preserved.
8.3.4.4 Product approval process The organization must obtain documented product
approval prior to shipment, if required by the customer. Records of this part approval must
be maintained.
8.3.5.2 Manufacturing process design outputs, the organization shall document
manufacturing process design outputs in a manner that allows verification against
manufacturing process design inputs.
8.3.6 Design and development changes. The organization must retain documented
information on:
a) design and development changes; b) the results of the reviews;
c) the authorization of the changes; d) actions taken to prevent adverse impacts.
8.3.6.1 For products with embedded software, the organization shall document the software
and hardware version as part of the change record.
8.4 Control of processes, products and services supplied externally. The organization must
retain documented information of these activities and any necessary actions arising from
the evaluations.
8.4.2.3.1 Software for automotive products or automotive products with integrated
software, the organization shall require the third-party supplier to retain documented
information from a self-assessment of its software development capabilities.
8.4.2.4.1 Second-party audit, document the criteria to determine the need, type, frequency
and scope of second-party audits.
8.5.1.3 Verification of the commissioning work, maintain documented information for the
people who carry out the commissioning.
8.5.1.5 Total productive maintenance The organization must develop, implement and
maintain a documented total productive maintenance system.
Documented maintenance objectives, for example: OEE (in Spanish, Overall Equipment
Effectiveness), MTBF (in Spanish, Mean Time Between Failures), MTTR (in Spanish, Mean
Time to Repair) and preventive maintenance compliance metrics.
Regular review of the maintenance plan and objectives and a documented action plan to
implement corrective actions when objectives are not achieved.
8.5.1.6 Management of production tooling and manufacturing, testing and inspection
equipment and tooling, documentation of tooling design modification, including the level of
product engineering change.

8.5.2.1 The organization shall conduct an analysis of internal, customer, and regulatory
traceability requirements for all automotive products, including the development and
documentation of traceability plans, based on risk or failure severity levels for the products.
employees, clients and consumers.
Ensure that documented information is preserved in the medium (electronic, paper) that
allows the organization to meet response time requirements.
8.5.3 Property belonging to clients or external suppliers, When the property of a client or an
external supplier is lost, damaged or otherwise considered unsuitable for use, the
organization must inform the client or external supplier of this. and preserve documented
information about what happened.
8.5.6 Change control The organization shall maintain documented information that
describes the results of the review of the changes, the persons authorizing the change, and
any necessary actions arising from the review.
8.5.6.1 Change control – supplement, document evidence of the corresponding risk analysis.
Obtain documented approval prior to implementation of the change.
8.5.6.1.1 Process controls for temporary changes. The organization shall identify,
document, and maintain a list of process controls, including inspection, measurement, trial,
and error-proofing equipment, including the primary process control and approved
alternative or backup methods.
8.6 Release of products and services. The organization must retain documented information
on the release of products and services. Documented information must include:
a) evidence of conformity with the acceptance criteria;
b) traceability to the people who authorize the release.
8.6.1 Release of products and services – supplement
The organization shall ensure that the planned arrangements to verify that the requirements
of the product or service have been met are contemplated in the control plan and are
documented as specified in the control plan.
8.7.1.4 Control of reprocessed product, the organization shall retain documented
information about the disposition of reprocessed product, including quantity, disposition,
date of disposition, and applicable traceability information.
8.7.1.5 Control of repaired product The organization shall retain documented information
about the disposition of repaired product, including quantity, disposition, date of
disposition, and applicable traceability information.
8.7.2 Non-compliant product. The organization must retain documented information that:
a) describe the nonconformity;
b) describe the actions taken;
c) describe all concessions obtained;
d) identify the authority that decides the action regarding the nonconformity.
9.1 Monitoring, measurement, analysis and evaluation, the organization must retain
appropriate documented information as evidence of the results.
9.1.1.1 Monitoring and measurement of manufacturing processes, significant events in the
process, such as tooling change or machine repair, must be recorded and retained as
documented information.
9.2.2 Internal audit, retain documented information as evidence of the implementation of
the audit program and the results of the audits.
9.3.3 Management review outputs The organization shall retain documented information as
evidence of the results of management reviews.
9.3.3.1 Management review outputs – supplement. The organization must retain
documented information as evidence of the results of management reviews.
10.2.2 Non-conformity and corrective action. The organization must retain documented
information as evidence of:
a) the nature of the nonconformities and any subsequent action taken;
b) the results of any corrective action.
10.2.4 Error proof. Details of the method used should be documented in the process risk
analysis (such as the PFMEA) and the frequency of testing should be documented in the
control plan.