Auditing ISO 9001:2015 Clause 7.0 - Support

by Walt Prystaj

Auditing Clause 7 of ISO 9001:2015, "Support," requires evaluating how the organization manages resources, competence, awareness, communication, and documented information necessary to operate an effective Quality Management System (QMS). Here’s a guide for auditing Clause 7 with objectives, sample questions, and evidence to look for.

Objectives for Auditing Clause 7

1. Assess the Management of Resources: Verify that the organization identifies and provides adequate resources for the QMS, including people, infrastructure, and work environment.

2. Evaluate Competence, Awareness, and Training: Ensure that personnel are competent, aware of the QMS requirements, and understand their roles in achieving quality objectives.

3. Review Communication Effectiveness: Confirm that internal and external communication processes are established to support the QMS.

4. Verify Control of Documented Information: Ensure that documented information is controlled, accessible, and maintained to support QMS processes.

Audit Plan for Clause 7

7.1 Resources

• Objective: Ensure that the organization identifies and provides necessary resources (human, infrastructure, work environment) for the QMS.

• Sample Questions:

  • How does the organization determine resource needs for the QMS?

  • What infrastructure and equipment are essential to product/service quality, and how are they maintained?

  • How is the work environment managed to ensure it supports quality objectives?

• Evidence to Look For:

  • Records of resource planning and allocation (e.g., budget reports, infrastructure maintenance records).

  • Calibration and maintenance records for key equipment and tools.

  • Environmental controls or policies (e.g., cleanliness standards, safety measures) that support the work environment.

7.1.5 Monitoring and Measuring Resources

• Objective: Verify that the organization has determined the resources needed to monitor and measure the quality of its products and services.

• Sample Questions:

  • How are measurement resources (e.g., calibrated equipment) identified and managed?

  • What process is followed for equipment calibration, and how is calibration status monitored?

• Evidence to Look For:

  • Calibration records, including certificates, calibration intervals, and status logs.

  • Equipment lists or logs detailing measurement resources and maintenance schedules.

  • Corrective actions for out-of-calibration equipment.

7.2 Competence

• Objective: Ensure that personnel are competent for their roles based on education, training, and experience.

• Sample Questions:

  • How are competence requirements determined for each role affecting quality?

  • What training or qualification records exist to demonstrate employee competence?

  • How are training needs identified and addressed?

• Evidence to Look For:

  • Competence matrices or job descriptions detailing required skills and qualifications.

  • Training records, certifications, or on-the-job training logs.

  • Competency assessments and follow-up actions where additional training or skills development was needed.

7.3 Awareness

• Objective: Confirm that employees are aware of the quality policy, relevant QMS objectives, and their role in supporting the QMS.

• Sample Questions:

  • How does the organization ensure that employees are aware of the quality policy and objectives?

  • Can employees explain how their roles contribute to achieving QMS objectives?

• Evidence to Look For:

  • Records of communication or training sessions on the quality policy and objectives.

  • Interviews or surveys with employees to assess their understanding of quality objectives and their responsibilities.

  • Documentation or signage displaying the quality policy in accessible areas.

7.4 Communication

• Objective: Verify that communication processes support the QMS internally and externally.

• Sample Questions:

  • How does the organization determine the communication needs for QMS processes?

  • What methods are used to communicate QMS requirements to relevant stakeholders?

• Evidence to Look For:

  • Communication plans or records detailing internal and external communications (e.g., emails, meetings, bulletins).

  • Evidence of stakeholder engagement, such as customer or supplier meetings, reports, or feedback loops.

  • Examples of communication of QMS performance metrics to employees.

7.5 Documented Information

• Objective: Ensure that documented information needed for the QMS is controlled, accessible, and maintained.

• Sample Questions:

  • How is documented information controlled to ensure it is current, available, and accurate?

  • What procedures are in place for document creation, updating, and approval?

  • How does the organization prevent unauthorized access to documented information?

• Evidence to Look For:

  • Document control procedures detailing creation, approval, revision, and distribution of documents.

  • Logs or registers of controlled documents, including version control and status.

  • Access control records, showing who can access sensitive or restricted QMS documents.

Practical Tips for Auditing Clause 7

1. Examine Documentation Before the Audit: Review documented procedures, job descriptions, and competence matrices ahead of time to gain a clear picture of the organization’s approach to support functions.

2. Observe the Work Environment: Look for physical evidence of resource management, such as clean, organized workspaces, calibrated equipment, and maintained infrastructure.

3. Conduct Interviews Across Departments: Speak with employees at various levels to verify competence, awareness, and understanding of the quality policy and objectives.

4. Check for Consistency in Document Control: Ensure that document control practices are consistent across departments, especially in maintaining current versions and accessibility.

Example Evidence to Collect

• Resource and Infrastructure Records: Documents showing resource planning and maintenance of infrastructure and equipment.

• Competence and Training Records: Employee training and qualification records showing alignment with role requirements.

• Communication Records: Documentation of internal and external communications related to QMS performance or objectives.

• Document Control Logs: Logs or registers showing the status, versions, and distribution of QMS documents, including restricted access where necessary.

• Employee Awareness Records: Evidence that employees understand the quality policy and their role in achieving QMS objectives, such as training completion records or interview notes.

Example Questions Summary

1. Resources:

   • How does the organization determine its resource requirements?

   • What records exist for maintenance of critical infrastructure?

2. Competence and Awareness:

   • How are competencies determined and verified?

   • How does the organization ensure employees are aware of QMS objectives?

3. Communication:

   • What methods are used for internal and external communication regarding QMS?

4. Document Control:

   • What processes are in place for document control, including updates and access?