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ISO 9001:2015 Documentation Checklist

This document provides a checklist for ISO 9001:2015 certification, outlining mandatory documents and records required for compliance, such as quality policies, objectives, and procedures for audits and corrective actions. It also includes recommended non-mandatory documents that can enhance the quality management system, like process flowcharts and work instructions. The checklist serves as a practical guide for organizations working on their ISO 9001 certification project.

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28 views5 pages

ISO 9001:2015 Documentation Checklist

This document provides a checklist for ISO 9001:2015 certification, outlining mandatory documents and records required for compliance, such as quality policies, objectives, and procedures for audits and corrective actions. It also includes recommended non-mandatory documents that can enhance the quality management system, like process flowcharts and work instructions. The checklist serves as a practical guide for organizations working on their ISO 9001 certification project.

Uploaded by

muyiwa07
Copyright
© All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd

ISO 9001:2015

Documentation
Checklist

Open or print this checklist


when you are working on
your ISO 9001 certification
project.

[Link]
Mandatory Documents

1. Scope of the Quality Management System (QMS)


Define the scope and boundaries of the QMS.

2. Quality Policy
Create a statement of the organization’s commitment to quality.

3. Quality Objectives
Set specific, measurable goals related to quality.

4. Procedure for Control of Documents


Establish a process for creating, approving, distributing, and
updating documents.

5. Procedure for Control of Records


Develop a process for identifying, storing, protecting, retrieving, and
retaining records.

6. Procedure for Internal Audits


Plan and document steps for internal audits.

7. Procedure for Control of Nonconforming Products


Define a process for identifying, segregating, and disposing of
nonconforming products.

8. Procedure for Corrective Action


Create a process for investigating nonconformities and taking
corrective actions.

9. Procedure for Preventive Action


Develop a process for identifying potential nonconformities and
preventing their occurrence.

1
Mandatory Records

1. Records of Calibration and Maintenance of Monitoring and Measuring


Equipment
Maintain evidence of equipment calibration and maintenance.

2. Records of Training, Skills, Experience, and Qualifications


Document employee training and qualifications.

3. Product Identification and Traceability Records


Keep records to ensure product traceability.

4. Records of Design and Development Outputs, Reviews, Changes, and


Verification
Document the design and development process.

5. Records of Supplier Evaluations and Assessments


Provide evidence of supplier evaluations.

6. Internal Audit Reports


Record internal audits and findings.

7. Management Review Minutes


Maintain records of management review meetings and decisions.

8. Records of Nonconformities and Corrective Actions


Document nonconformities and corrective actions taken.

2
Non-Mandatory Documents
(Recommended)

1. Process Flowcharts
Create visual representations of processes.

2. Work Instructions
Develop detailed instructions for performing specific tasks.

3. Forms and Templates


Standardize forms for data collection and reporting.

4. Quality Manual
Provide an overview of the QMS, including the quality policy and
objectives.

5. Procedure for Risk Management


Outline steps for identifying and managing risks.

6. Procedure for Customer Feedback and Complaints Handling


Establish a process for collecting and addressing customer
feedback and complaints.

7. Procedure for Supplier Communication and Coordination


Develop steps for managing communication with suppliers.

8. Preventive Maintenance Schedules


Create a timetable for regular maintenance activities.

3
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