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ISO9001-2015 Standard Audit Documents Checklist PDF

This document provides a checklist of requirements and evidence needed for an ISO 9001:2015 audit. It lists the clauses of the standard and types of documentation or records that should be reviewed to ensure requirements are met. This includes documents covering the quality management system, operational procedures, monitoring and measurement, management reviews, and handling of nonconformities. The checklist is intended to guide auditors in evaluating whether the organization is properly implementing and maintaining its quality system.

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2K views4 pages

ISO9001-2015 Standard Audit Documents Checklist PDF

This document provides a checklist of requirements and evidence needed for an ISO 9001:2015 audit. It lists the clauses of the standard and types of documentation or records that should be reviewed to ensure requirements are met. This includes documents covering the quality management system, operational procedures, monitoring and measurement, management reviews, and handling of nonconformities. The checklist is intended to guide auditors in evaluating whether the organization is properly implementing and maintaining its quality system.

Uploaded by

merrwon
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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QMS ISO9001:2015 standard Audit Documents Checklist

ISO Requirements of the Quality System Evidence


9001:2015
Clause No.

4.1 Understanding the organization and its context


Register of organization and its context
4.2 Understanding the needs and expectations of interested
parties. Register of interested parties

4.3 Determining the scope of the quality management system


Scope of Certification
4.4 Quality management system and its processes Documented information to the extent necessary to have confidence that the
processes are being carried out as planned

5.1 Leadership and commitment


JOINT MANAGEMENT CONSENT IN QMS
5.2 Policy Quality Policy

5.3 Organizational roles, responsibilities and authorities. Org. Chart, Job Description,

6.1 Actions to address risks and opportunities Risk & Opportunities Plan

6.2 Quality objectives and planning to achieve them Quality Objectives

6.3 Planning of changes Change Management Form

Bright Business Consultants Company Limited www.brightconsultant.com.hk Tel.: 26861327 Provision of ISO9001:2015 Training and documentation Service
7.1 Resources
Evidence of fitness for purpose of monitoring and measuring resources 7.1.5.1

Evidence of the basis used for calibration of the monitoring and measurement
resources (when no international or national standards exist) 7.1.5.2

7.2 Competence Evidence of competence of person(s) doing work under the control of the
organization that affects the performance and effectiveness of the QMS (clause
7.2)

7.3 Awareness Training Records / Memo / Poster

7.4 Communication Email

7.5 Documented information Master List of Manual, Procedures, Forms, Standards, drawing, spec, BOM, etc

8.1 Operational planning and control Project Schedule / Procedures

8.2 Requirements for products and services Results of the review and new requirements for the products and services
(clause 8.2.3).

8.3 Design and development of products and services Records needed to demonstrate that design and development requirements
have been met (clause 8.3.2)
Records on design and development inputs (clause 8.3.3)
Records of design and development outputs (clause 8.3.5)
Design and development changes, including the results of the review and the
authorization of the changes and necessary actions (clause 8.3.6)

8.4 Control of externally provided processes, products and


services Records of the evaluation, selection, monitoring of performance and re-
evaluation of external providers and any and actions arising from these
activities (clause 8.4.1)

Bright Business Consultants Company Limited www.brightconsultant.com.hk Tel.: 26861327 Provision of ISO9001:2015 Training and documentation Service
8.5 Production and service provision
Evidence of the unique identification of the outputs when traceability is a
requirement (clause 8.5.2)

Records of property of the customer or external provider that is lost, damaged
or otherwise found to be unsuitable for use and of its communication to the
owner (clause 8.5.3)

Records of Post-delivery activities evidence - include actions under warranty
provisions, contractual obligations such as maintenance services, and
supplementary services such as recycling or final disposal (clause 8.5.5)

Results of the review of changes for production or service provision, the


persons authorizing the change, and necessary actions taken (clause 8.5.6)

8.6 Release of products and services


Records of the authorized release of products and services for delivery to the
customer including acceptance criteria and traceability to the authorizing
person(s) (clause 8.6)
8.7 Control of nonconforming outputs
Records of nonconformities, the actions taken, concessions obtained and the
identification of the authority deciding the action in respect of the
nonconformity (clause 8.7)

9.1 Monitoring, measurement, analysis and evaluation


Results of the evaluation of the performance and the effectiveness of the QMS
(clause 9.1.1)
9.2 Internal audit
Evidence of the implementation of the audit programme and the audit results
(clause 9.2.2)
9.3 Management review Evidence of the results of management reviews (clause 9.3.3

Bright Business Consultants Company Limited www.brightconsultant.com.hk Tel.: 26861327 Provision of ISO9001:2015 Training and documentation Service
10.1 + 10.2 General + Nonconformity and corrective action Evidence of the nature of the nonconformities and any subsequent actions
taken (clause 10.2.2)

Results of any corrective action (clause 10.2.2)

10.1 + 10.3 General + Continual improvement Management Review Meeting Minutes

Bright Business Consultants Company Limited www.brightconsultant.com.hk Tel.: 26861327 Provision of ISO9001:2015 Training and documentation Service

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