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ISO 90012015 Mandatory Documented Information – Documents and Records

Did you know that recently release ISO 9001:2015 requires you to maintain 5 documented information (procedures) and retain 22 documented information (records)? Have a look at these.

Mandatory Documents

Scope of the Quality Management System (4.3)

Scope of the QMS including the products and services covered and the justification of the requirements that can not be applied.

Operation of Processes (4.4.2 a)

Information to support the operations of processes

Quality Policy (5.2.2)

Quality policy to be available as documented information

Quality Objectives (6.2.1)

Maintain documented information on the quality objectives

Control of production and service provision (8.5.1)

Information that defines characteristics of products and services, activities to be performed, and the results to be achieved.

 

Mandatory Records

Operation of Processes (4.4.2 b)

Information necessary to have confidence that processes are being carried out as planned.
Monitoring and Measurement Resources (7.1.5.1)

Information as evidence of fitness for purpose of monitoring and measurement resources.
Measurement Traceability (7.1.5.2)

When such standards exist, the basis used for calibration or verification shall be retained as documented information
Competence (7.2)

Information as evidence of competence.
Operational Planning and Control (8.1)

Information necessary to have confidence that the processes have been carried out as planned and conform to requirements.
Requirements Review (8.2.3)

Information describing the results of the review of requirements related to products and services.
Design and Development Planning (8.3.2)

Information needed to demonstrate that design and development requirements have been met.
Design and Development Inputs (8.3.3)

The organization shall retain documented information on design and development inputs.
Design and Development Controls (8.3.4)

Documented information of these activities is retained.
Design and Development (8.3.5)

Information resulting from the design and development process.
Design and Development Changes (8.3.6)

Information on design and development changes, results of reviews, authorization of changes and the actions taken to prevent adverse impacts
Externally Provided Products and Services (8.4.1)

Information of the results of the evaluation, selection, monitoring of performance, and re-evaluation of external providers
Control of production and service provision (8.5.1)

Information that defines the characteristics of the products to be produced, the services to be provided, or the activities to be performed; and the results to be achieved.
Traceability (8.5.2)

Information necessary to enable traceability
Property belonging to customers or external providers (8.5.3)

When the property of a customer or external provider is lost, damaged or otherwise found to be unsuitable for use, the organization shall report this to the customer or external provider and retain documented information on what has occurred.
Control of Changes (8.5.6)

Information describing the results of the review of changes, the persons authorizing the change, and any necessary actions arising from the review.
Release of Products and Services (8.6)

Information on the release of products and services including evidence of conformity with the acceptance criteria; and traceability to the person(s) authorizing the release.
Control of nonconforming outputs (8.7.2)

Information on the nonconformity; actions taken; concessions obtained; the authority deciding the action in respect of the nonconformity.
Monitoring, measurement, analysis and evaluation – General (9.1.1)

Results of monitoring and measurement activities.
Internal Audit (9.2.2)

Information as evidence of the implementation of the audit programme and the audit results
Management Review (9.3.3)

Information as evidence of the results of management reviews.
Nonconformity and Corrective Action (10.2.2)

Information as evidence of the nature of the nonconformities, actions taken, and the results of any corrective action.

January 21, 2018

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