By selecting this article, you’ve decided to complete the questionnaire for a clearer understanding of the current state of your Quality Management System (QMS).
Below is a list of 25 questions that you will need to answer relating to your company. You will answer by scoring the question from 0 to 4 points:
0 = No action or progress is evident in your organisation
4 = Your company holds documentation, records and practices the activities stated to the full extent of the ISO 9001 standard
Once you have finished scoring the questions, you will need to add up your scores for a total sum. The results of the evaluation will be based on that final sum. This will help you understand the value of this series to you and where your gaps are.
Important – Please score all the questions with the intention of giving a fair representation of your quality management system status.
Complete the Questionnaire
If you’re uncertain of any terminology relating to the standard whilst completing the questionnaire, we have provided articles in our ISO 9001 category to provide you with more context on the subject.
Lets get started…
2. Have you determined the processes needed for the QMS to function properly and the applicability of those processes?
3. Is top management demonstrating leadership and commitment to the QMS, customer focus, the establishment of the QMS and regularly conducting reviews of the quality policy?
4. Has top management ensured the resources required from the QMS have been assigned, they are communicated with and understand their related responsibilities and authorities?
5. Have you identified the risks and opportunities that need to be addressed relating to the QMS, including plans to address them?
6. Has the organisation established quality objectives, including realistic plans to achieve them?
7. Where the need for change to the QMS has been determined, is the change carried out in a planned manner?
8. Have you identified and provided all the resources needed for the QMS to be effective, including: people, infrastructure, environment for the operation of QMS processes, and any monitoring and measuring resources?
9. Have you determined and made available the knowledge necessary, for the operation of its processes/conformity, and an assessment for the necessary competence of person(s) doing the work under its control that affects its quality performance?
10. Have you determined what internal and external communications are relevant to the QMS, including ensuring persons doing work under the organisations control being made aware of QMS requirements?
11. Have you established the documented information requirements of the standard, and the necessary controls over them?
12. Have you planned, implemented and controlled the processes needed to meet the QMS requirements, and implemented the actions determined in 6?
13. Have you established processes for communicating with customers, determined requirements for the products and services, and reviewed those requirements?
14. Have you established a design and development process (where needed) including planning, inputs, controls, outputs and changes?
15. Have you ensured that externally provided processes, products, and services conform to the QMS requirements, including: identifying the type and extent of controls, and provide necessary QMS information for external providers?
16. Have you implemented controlled conditions for production and service provision, including delivery and post-delivery activities?
17. Have you used suitable means to identify outputs, and the status of outputs with respect to monitoring and measuring with unique identification (where required)?
18. Do you exercise care with customer or external providers property, and is this reported back to the property owner if damaged, lost, or unsuitable for use?
19. Have you ensured preservation of outputs, and meet requirements for post-delivery activities?
20. Do you review and control changes, including not releasing products and services until the planned arrangements have been completed?
21. Do you identify and control outputs, that do not conform to requirements so as to prevent their unintended use or delivery?
22. Have you determined and implemented the QMS requirements for monitoring and measuring, including customer perceptions of the degree to which requirements have been met?
23. Have you analysed and evaluated data from monitoring and measuring and conducted internal audits according to the audit programme?
24. Has top management undertaken management reviews (at planned intervals), to discuss the QMS, ensuring its continuing suitability, adequacy, effectiveness and alignment with their strategic direction?
25. Have you determined, selected and implemented opportunities for improvement (including the QMS), and taken action when nonconformity occurs (involving effective corrective action)?
Now, add up the scores you assigned to the questions, the results are….
Score between 0 – 10
- Summary: The organisation has not assigned an individual to be responsible for establishing and maintaining QMS processes and standards. Customer focus is below average, if any. There is likely exposure to high customer complaints and nonconformities.
- QMS Level: Fire fighing, no QMS identified.
- Risk: Very high
Score between 11 – 30
- Summary: The organisation has likely appointed a supervisor to manage the QMS with a limited customer focus. The organisation may have already identified and implemented a few QMS processes and initaives that are designed to help them manage the quality of their products and service, however, the company has not adopted the processes and initiatives in full. QMS may not be the organisations main focus but currently have processes in placed to meet legal compliance.
- QMS Level: Superficial, generally issues have been identified once the product or service has been produced and delivered.
- Risk: High
Score between 31 – 60
- Summary: The organisation has appointed a Quality representative (or equivilient) at middle management level. They have considered the organisation needs and those of their interested parties. The resources to to implement it have been identified and partly capable of implementing it. The organisation may have established a number of good controls to manage and keep the customer compliants at bay.
- QMS Level: Reactive with little opportunity for major ‘breakthroughs’ within the organisation.
- Risk: Medium
Score between 61 – 80
- Summary: Organisation-wide customer focus. The Quality Manager has recently established a QMS and is focused on Continual Improvement or the QMS processes have been updated. The effectiveness of the QMS is being monitored closely. The organisation may be looking for ways to improve the competency of staff and the awareness of QMS responsibilities internally.
- QMS Level: Continual improvement. The organisation may be aiming for certification with a third party.
- Risk: Low
Score between 81 – 100
- Summary: The organisation has a Quality Director with resources to implement improvement strategies in the business. The QMS is firmly estbalished with high customer focus across the whole organisation. The Quality team is competent in their ability to manage change and requirements of interested parties.
- QMS Level: Follow the QMS ISO 9001 model or similar, demonstrating ‘breakthrough’ strategies.
- Risk: Very low
The results above are the average representation of a business with those scores, however they are not a reflection on your business intentions, after all, that’s why you are taking this evaluation!
What to do now
Take a look at our post Considerations when Planning ISO 9001 for more guidance what to do next…