ISO 9001 Checklist

Use this ISO 9001 Compliance Checklist for self-assessments to evaluate your QMS, ensure adherence to standards and identify areas for improvement.

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ISO 9001 Checklist

ISO 9001 Checklist

Quality Management System And Documentation

Management Responsibility

Resource Management

Product Realization

Measuring, Analysis And Improvement

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Checklist by GoAudits.com – Please note that this checklist is intended as an example. We do not guarantee compliance with the laws applicable to your territory or industry. You should seek professional advice to determine how this checklist should be adapted to your workplace or jurisdiction.

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ISO 9001 Checklist

Use this ISO 9001 Compliance Checklist for self-assessments to evaluate your QMS, ensure adherence to standards and identify areas for improvement.

1. Have you identified your core business processes and defined how they are operated and controlled?

2. Do the core processes have measurements applied to them and are they regularly reviewed?

3. Where you outsource work that could affect product/service quality, have you defined how this will be controlled?

4. Do you have a documented quality policy and defined how it is reviewed?

5. Are the quality objectives defined in a way that can be measured?

6. Do you have a quality manual that covers the requirements defined in the standard?

7. Do you have procedures for the control of documents and records?

1. Do you have evidence of management commitment to the system and are they actively involved in the management reviews?

2. At a strategic level, have management defined the activities that are critical to meeting customer requirements?

3. Have a management representative and deputy been appointed?

4. Have you defined the frequency and method of carrying out management reviews of the system?

1. Have all staff who can affect quality been trained in their role and do they understand how their roles fit within the quality management system?

2. Are there appropriate records for training, skills and education?

3. Is the work infrastructure and work environment suitable for meeting customer and regulatory requirements?

4. Does the work environment meet all regulations and is it fit for purpose?

1. Is there a defined plan/process for the provision of products and services?

2. Is there a defined method by which customer requirements are agreed?

3. Are all appropriate regulatory and legal requirements identified as part of the review of customer requirements?

4. If changes to specification or orders are accepted do you have a method to ensure that these are communicated and controlled?

5. Is the process of managing customer complaints and feedback defined?

6. If you carry out product design, are the inputs to the design process defined and documented?

7. Have you defined how you verify that the final design meets the design specification?

8. Are the design stages defined and reviews carried out with appropriate personnel at all stages?

9. Do you have a method to validate that the final product will operate as intended?

10. Are all changes to the design specification verified and validated and results recorded?

11. Have you defined how suppliers are selected and their performance reviewed?

12. Is the process for receiving and approving supplied goods defined?

13. Do you have a defined method of identification and traceability for products as they go through the realization process?

14. Do you have records of calibration or verification of measuring equipment?

1. Do you have a way of monitoring customer satisfaction and perception?

2. Do you have a defined procedure for performing and analysing internal audits?

3. Do you have a procedure for identifying potential non-conformities in the system? This may be a ‘risk assessment’ for instance

4. Do you have a procedure for identifying non-conformities, their cause, and implementing actions to prevent reoccurrence?

5. Do you have a documented procedure for dealing with non-conforming products which prevent them from being delivered?