ISO 9001:2015 Requirement Auditing. (Clause 7)

Clause 7 in ISO 9001:2015 is titled "Support" and focuses on the resources, competence, infrastructure, and documented information needed to support the Quality Management System (QMS). Auditing Clause 7 involves assessing how well the organization has identified and provided the necessary support to ensure the effective implementation and maintenance of the QMS. Here's a guide on auditing Clause 7 and the evidence that can demonstrate implementation:

1. Review Resource Management:

- Examine the organization's documented procedures, records, or plans related to resource management, such as human resources, infrastructure, and work environment.

- Verify that the organization has identified and provided the necessary resources to support the implementation and maintenance of the QMS.

2. Evaluate Competence and Training:

- Review documented information, such as training plans, competency matrices, or performance records, to assess how the organization determines the necessary competence for individuals working within the QMS.

- Verify that the organization has provided appropriate training, education, or other actions to ensure that personnel are competent to perform their assigned tasks.

3. Verify Awareness and Communication:

- Review documented information, such as training records, meeting minutes, or communication logs, to assess how the organization ensures that personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of quality objectives.

- Verify that the organization has established effective communication channels to disseminate information about the QMS and its performance.

4. Examine Infrastructure and Work Environment:

- Review documented information, such as maintenance logs, inspection records, or facility management plans, to assess how the organization ensures that the necessary infrastructure and work environment are available to support the operation and control of its processes.

- Verify that the organization has identified and addressed any infrastructure-related risks or maintenance requirements.

5. Assess Documented Information:

- Review the organization's documented information, including procedures, work instructions, records, and other relevant documents, to verify that it meets the requirements of the QMS.

- Verify that the documented information is controlled, accessible, and regularly reviewed for adequacy and effectiveness.

Here are some examples of evidence you can look for during an audit(Clause 7):

1. Resources:

- Resource allocation records: Documentation showing the allocation of resources, such as personnel, infrastructure, equipment, or technology, to support the operation and maintenance of the quality management system (QMS).

- Training records: Records of employee training activities, including training plans, training materials, attendance registers, and training evaluation results.

- Competence assessments: Documentation of assessments conducted to verify the competence of individuals performing activities that impact product or service quality.

2. Competence:

- Job descriptions and competency frameworks: Documented job descriptions that outline the required competencies for specific roles within the organization, along with competency frameworks or matrices used to assess and develop employee skills.

- Performance evaluations: Records of performance evaluations, appraisals, or assessments conducted to measure employee performance against defined competencies and objectives.

- Training and development plans: Individual or organizational training and development plans that identify the competency gaps and outline the actions required to bridge those gaps.

3. Awareness:

- Training completion records: Evidence of employees' completion of awareness training programs related to the QMS, quality policies, objectives, and relevant procedures.

- Communication records: Documentation of internal communication mechanisms used to raise awareness of the QMS, including emails, newsletters, posters, or intranet postings.

- Employee surveys or feedback: Records of surveys or feedback mechanisms used to assess employee awareness and understanding of the QMS and its importance.

4. Documented Information:

- Document control records: Evidence of controlled documents, including document registers, revision logs, distribution records, and change control records.

- Documented procedures and work instructions: Records of documented procedures, work instructions, guidelines, or manuals that provide guidance on how specific tasks or activities are performed within the organization.

- Document review and approval records: Records of document reviews and approvals, including evidence of multiple stakeholder involvement, verification of accuracy, and compliance with applicable requirements.

5. Communication:

- Communication plans: Documentation of communication plans or strategies that outline how internal and external communication related to the QMS is managed and executed.

- Meeting minutes: Records of meetings where QMS-related information is communicated, such as management review meetings, team meetings, or project meetings.

- Customer communication records: Evidence of effective communication with customers, including correspondence, meeting minutes, or documented agreements.

6. Control of Monitoring and Measuring Equipment:

- Calibration records: Documentation of calibration activities performed on monitoring and measuring equipment, including calibration certificates, calibration schedules, and traceability records.

- Maintenance records: Evidence of maintenance activities conducted to ensure the proper functioning and accuracy of monitoring and measuring equipment.

- Equipment identification and labeling: Records of equipment identification and labeling systems used to ensure appropriate identification and traceability of monitoring and measuring equipment.

Remember, the specific evidence required may vary depending on the organization's context, size, and industry. It's important to consider the organization's unique circumstances and tailor the evidence collection process accordingly during the audit.