Realize audits externally now

We carry out audits for your company in accordance with the relevant standards, both internally and externally.

The internal audit is an essential prerequisite for any certification. If your company does not have internal auditors or you would like an objective view, we will be happy to carry out the audit. We strictly adhere to the guidelines of the DIN EN ISO 19011 standard, the guideline for auditing management systems.

We draw up a detailed audit plan, develop specific audit questions and check the relevant documents in advance. On site, we evaluate whether the requirements of the underlying standard are being met and properly implemented. The preliminary findings are discussed directly on site. We then draw up a comprehensive audit report containing all the deviations, observations and recommendations found in relation to the relevant standard requirement. In addition, potential areas for improvement are identified and explained.

We carry out audits on the basis of the DIN EN ISO 19011 guidelines for auditing management systems.

We are the reliable partner for internal and external audits for several companies and pay attention to cost-efficient solutions. You will receive the audit report within 7 days at the latest. Where possible, we bundle the appointments geographically in order to reduce travel costs.

What are classic audit questions?

Here is an example from DIN EN ISO 9001:

4 Context of the organization

4.1 Understanding the organization and its context

  • Are external and internal topics defined?
  • Are the topics relevant to their purpose and strategic direction?
  • Can the topics achieve the intended results of the quality management system?
  • Is the information on these external and internal issues monitored and verified?
  • Have positive and negative factors or conditions been considered?
  • Were the topics considered in the results such as legal, technical, competitive, market-related, cultural, social or economic as well as international, national, regional or local?

☐ Note:

☐ Deviation / finding / recommendation recognized?

4.2 Understanding the needs and expectations of interested parties

Once the requirements have been defined:

  • Customers?
  • applicable legal and regulatory requirements?
  • Are they relevant for the interested parties?
  • Is information available on these interested parties and their requirements?
  • How are these monitored?

☐ Note:

☐ Deviation / finding / recommendation recognized?

4.3 Defining the scope of the quality management system

  • Have the limits and applicability of the quality management system been determined?
  • Is the scope of application defined?

The following is taken into account when defining this scope:

  1. The external and internal topics?
  2. The requirements of the relevant interested parties?
  3. the products and services of the organization / company?
  4. Are all requirements of DIN EN ISO 9001:2015 applicable?
  5. Is the scope of application defined in writing?
  6. Exclusions defined for the scope of application?
  7. Does the scope indicate the types of products and services?

☐ Note:

☐ Deviation / finding / recommendation recognized?

4.4 Quality management system and its processes

4.4.1

  1. Is the quality management system established, implemented, maintained and continuously improved?
  2. Are necessary processes and their interactions described?

Have the processes:

  1. the required inputs and expected results?
  2. determines the sequence and interaction of the processes?
  3. the criteria and procedures ensured, determined and applied?
  4. the monitoring, measurement and related performance indicators?
  5. required resources and their availability?
  6. the responsibilities and powers?
  7. compliance with the specific risks and opportunities?
  8. the process evaluation?
  9. Changes to ensure the intended results?
  10. the process improvement?

4.4.2

  • Is there documented information on the implementation and maintenance of the processes?
  • Is the documented information kept to the necessary extent?

☐ Note:

☐ Deviation / finding / recommendation recognized?

5 Guidance

5.1 Leadership and commitment

5.1.1 General information

  • Does top management show leadership and commitment to the QMS?

Has the top management:

  1. assumed accountability (effectiveness of QM)?
  2. the quality policy and quality objectives?
  3. Are the goals and policies of the organization’s strategic direction aligned?
  4. ensure that requirements are integrated into the processes?
  5. risk-based thinking encouraged?
  6. resources provided?
  7. convey the importance of meeting the requirements?
  8. ensure that intended results are achieved?
  9. Are there people in place to ensure the effectiveness of the quality management system?
  10. Improvement promoted?
  11. relevant managers to clarify leadership roles?

☐ Note:

☐ Deviation / finding / recommendation recognized?

5.1.2 Customer orientation

  • Are customer and regulatory requirements identified, understood and consistently met?
  • Are compliance risks and opportunities identified and addressed?
  • Is the focus on improving customer satisfaction maintained?

☐ Note:

☐ Deviation / finding / recommendation recognized?

The DIN EN ISO 19011 standard is available from DIN MEDIA.

You can also carry out internal audits using our „Audits“ template.

Download process flow as PDF
Audit 19011
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