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ISO 9001 Documentation and Record-Keeping Audit Checklist

This checklist is focused on evaluating the documentation and record-keeping practices within quality management systems in manufacturing, ensuring compliance with ISO 9001 standards.

ISO 9001 Documentation and Record-Keeping Audit Checklist

by: audit-now
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About This Checklist

In the manufacturing industry, proper documentation and record-keeping are essential for maintaining quality management systems and ensuring compliance with ISO 9001 standards. The ISO 9001 Documentation and Record-Keeping Audit Checklist serves as a crucial tool for quality managers and auditors to assess the effectiveness of documentation practices. By utilizing this checklist, organizations can streamline their documentation processes, facilitate effective training for new employees, and enhance the traceability of quality-related actions. This proactive approach addresses common challenges such as inadequate documentation and lack of accountability, ultimately leading to improved compliance during audits and assessments. Ensuring robust documentation practices not only supports continuous improvement but also fosters a culture of quality within the organization.

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Industry

Manufacturing

Standard

ISO 9001 - Quality Management Systems

Workspaces

Training Areas
Manufacturing Facilities
Quality Assurance Areas

Occupations

Quality Documentation Specialist
Quality Assurance Manager
Internal Auditor
Training Coordinator
1
Is there a documented procedure for document control?
2
Is there a defined record retention policy?
3
What is the frequency of document reviews (in months)?
Min: 1
Target: 12
Max: 24
4
What suggestions do you have for improving documentation practices?
5
What is the status of the recent audit findings related to documentation?
6
Is the document compliant with ISO 9001 standards?
7
How many stakeholders were involved in the document creation?
Min: 1
Target: 1
Max: 50
8
When is the next scheduled review for this document?
9
Has training been provided on this document's content?
10
What feedback have users provided regarding this document?
11
Is the document aligned with the organization's quality policy?
12
What percentage of employees have completed training on this document?
Min: 0
Target: 90
Max: 100
13
Is version control applied to the document?
14
What challenges have been faced in implementing this document?
15
When is the next scheduled review date for this document?

FAQs

The checklist focuses on evaluating the documentation and record-keeping practices within quality management systems in compliance with ISO 9001 standards.

Quality documentation specialists, quality assurance managers, internal auditors, and training coordinators should utilize this checklist.

This checklist can be effectively applied in manufacturing facilities, quality assurance departments, and training programs.

It provides a framework for documenting training processes and ensures that new employees are effectively onboarded with quality management practices.

Organizations can expect improved documentation practices, enhanced traceability, and better compliance during audits and assessments.

Benefits of ISO 9001 Documentation and Record-Keeping Audit Checklist

Streamlines the documentation process for quality management.

Facilitates effective training and onboarding of new employees.

Enhances traceability of quality-related actions and decisions.

Supports compliance audits and external assessments.

Promotes a culture of accountability and continuous improvement.