GPIN Internal Audit Questionnaire

Questionnaire for ISO 9001:2015 Internal Audit

ISO 9001:2015 Internal Audit

Clause #4
4.1. How has the organisation determined external and internal issues relevant to its purpose and strategic
direction?
4.2. How have you determined what interested parties are relevant to the QMS? How have you determined
what requirements those parties have that are relevant to the QMS?
4.3. How have the boundaries and applicability of the QMS been used to establish the scope of the organisation?
4.4. How has the QMS been established? Show me how this is implemented. How is it maintained and
continually improved?

Clause #5
5.1. How top management demonstrates leadership and commitment w.r.t. the QMS by taking
accountability of the effectiveness of the QMS.
5.2. How top management demonstrates leadership and commitment w.r.t. customer focus ensuring
5.3. Quality Pilicy and its communication
5.4. How does top management assign the responsibility and authority

Clause #6
6.1. How are the internal and external issues and interested parties considered when planning for the QMS
6.2. How are risks and opportunities determined and addressed
6.3. How are actions planned to address risks and opportunities?
6.4. How are actions integrated and implemented into the QMS processes? How do you evaluate the
effectiveness of the actions?
6.5. Where are the quality objectives and are these at all relevant functions, levels and processes?
6.6. How are changes to the QMS planned systematically?

Clause #7
7.1. Demonstrate how resources are determined for the establishment, implementation, maintenance and
continual improvement of the QMS.
7.2. How do you provide persons necessary to consistently meet customer, applicable statutory and regulatory
requirements for the QMS including the necessary processes?
7.3. How do you determine, provide and maintain the infrastructure for the operation of processes to achieve
products and service conformity?
7.4. How do you determine, provide and maintain the environment for the operation of processes to achieve
products and service conformity
7.5. How are the resources determined for ensuring valid and reliable monitoring and measuring results, where
used?
7.6. How do you determine necessary knowledge for the operation of processes? How do you determine
necessary knowledge to achieve conformity of products and services?
7.7. How do you maintain this knowledge and how do you make it available to the extent necessary?
7.8. How You determine the necessary competence of people doing work under your control that affects quality
performance.
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7.9. How are people aware of: The quality policy? Relevant quality objectives? Their contribution to the
effectiveness of the QMS? The benefits of improved performance? The implications of not conforming with
the QMS requirements?
7.10. How do you determine internal and external communications relevant to the QMS?
7.11. What documented information do you have as required by this standard?
7.12. What documented information do you have as being necessary for the effectiveness of your QMS?
7.12.1. Creating and updating, Control of documented information

Clause #8
8.1. How are processes needed to meet requirements for provision of products and services planned,
implemented and controlled?
8.2. What are your processes for communicating with customers? How do you communicate information?
8.3. How do you review: Customer requirements for delivery and post-delivery?
8.4. How do you confirm customer requirements where the customer does not provide a documented
statement?
8.5. How do you ensure externally provided processes, products and services conform to specified
requirements?
8.6. What documented information do you have of the results of evaluations, monitoring of performance and
reevaluations of external providers?
8.7. Show me how you communicate to external providers, applicable requirements
8.8. What controlled conditions do you have for production and service provision, including delivery and post-
delivery activities? (Order Processing)
8.9. Show me how planned arrangement have been implemented at appropriate stages to verify product and
service requirements have been met. Show me what evidence you retain (warehouse procedure for product
delivery)

Clause #9
9.1. how you determine: What needs to be monitored and measured?
9.2. Methods for monitoring, measurement, analysis and evaluation to ensure valid results?
9.3. How do you monitor customer perception of the degree to which requirements have been met?
9.4. How do you obtain information relating to customer views and opinions of your products and services?
9.5. What methods for obtaining and using this information do you have?
9.6. Show me where the results of analysis and evaluation are used to provide inputs to management review.
9.7. Are internal audits being conducted at planned intervals? Do they determine whether the QMS conforms
to the requirements of ISO 9001 and to the other requirements established by Organisation?
9.8. Can you show me audit program(s) that takes into consideration the quality objectives, importance of the
processes, customer feedback, changes impacting the organisation and the results of previous audits?
9.9. What is the frequency that top management reviews the organisation's QMS? How is the QMS deemed
suitable, adequate and effective?
9.10. What kinds of information are reviewed in management reviews? These must include: actions
status of previous reviews; changes to internal/external issues relevant to the QMS;
9.11. Show me that management reviews include decisions and actions relating to: Continual
improvement opportunities; The need for changes to the QMS including resource needs.
9.12. Show me what documented information you have as evidence of management reviews.
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Clause #10
10.1. How do you determine and select opportunities for improvement? What necessary actions have
you implemented so that you have met customer requirements and enhanced customer satisfaction?
10.2. Show me how you have: Improved processes to prevent nonconformities;
10.3. Improved products and services to meet known and predicted requirements; Improved QMS
results.
10.4. When nonconformities occur, show me how; You react;
10.5. Show me how correction actions were appropriate to the effects of the nonconformities
encountered.
10.6. What documented information can you show me as evidence of: The nature of the
nonconformities and subsequent actions taken; The results of any corrective action.
10.7. Demonstrate that outputs of analysis and evaluation and the outputs from management review
are considered to confirm if there are areas of underperformance or opportunities that shall be addressed
as part of continual improvement.