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Required Procedures and Records For 2015

ISO mandates that organizations maintain records related to the quality management system scope, quality policy, objectives, supplier evaluation, calibrations, training, product reviews, design reviews and changes, production requirements, customer property, production changes, conformity, nonconformities, monitoring results, audits, management reviews, and corrective actions. Additionally, common non-mandatory documents include procedures for context analysis, risk management, competence, equipment, documents, sales, design, production, warehousing, nonconformities, customer satisfaction monitoring, audits, and management reviews.

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62 views

Required Procedures and Records For 2015

ISO mandates that organizations maintain records related to the quality management system scope, quality policy, objectives, supplier evaluation, calibrations, training, product reviews, design reviews and changes, production requirements, customer property, production changes, conformity, nonconformities, monitoring results, audits, management reviews, and corrective actions. Additionally, common non-mandatory documents include procedures for context analysis, risk management, competence, equipment, documents, sales, design, production, warehousing, nonconformities, customer satisfaction monitoring, audits, and management reviews.

Uploaded by

Jeff Drew
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as XLSX, PDF, TXT or read online on Scribd
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ISO Mandatory Documents and Records:

Scope of the QMS (4.3)


Quality Policy (5.2)
Quality Objectives (6.2)
Criteria for evaluation and selection of suppliers (8.4.1)

Calibration records (7.1.5.1)


Training records (7.2)
Product/service requirement review records (8.2.3.2)
Design and development outputs review (8.3.2)*
Design and development inputs (8.3.3)*
Design and development controls (8.3.4)*
Design and development outputs (8.3.5)*
Design and development change records (8.3.6)*
Characteristics of product to be produced and service to be provided (8.5.1)
Customer property records (8.5.3)*
Production/service provision change control records (8.5.6)
Record of conformity of product/service with acceptance criteria (8.6)
Record of nonconforming outputs (8.7.2)
Monitoring and measurement results (9.1.1)
Internal Audit results (9.2)
Management Review (9.3)
Results of Corrective Actions (10.1)

Non-mandatory, but most commonly used documents:

Procedure for determining context of the organization and interested parties (4.1 & 4.2)
Procedure for addressing risks and opportunities (6.1)
Procedure for competence, training and awareness (7.1.2, 7.2, 7.3)
Procedure for equipment maintenance and measuring equipment (7.1.5)
Procedure for Document and Record Control (7.5)
Sales Procedure (8.2)
Procedure for Design and Development (8.3)
Procedure for production and service provision (8.5)
Warehousing procedure (8.5.4)
Procedure for management of nonconformities and corrective actions (8.7 and 10.2)
Procedure for monitoring customer satisfaction (9.1.2)
Procedure for internal audits (9.2)
Procedure for management review (9.3)

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