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
Assess the Management of Resources: Verify that the organization identifies and provides adequate resources for the QMS, including people, infrastructure, and work environment.
Evaluate Competence, Awareness, and Training: Ensure that personnel are competent, aware of the QMS requirements, and understand their roles in achieving quality objectives.
Review Communication Effectiveness: Confirm that internal and external communication processes are established to support the QMS.
Verify Control of Documented Information: Ensure that documented information is controlled, accessible, and maintained to support QMS processes.
Detailed 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
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.
Observe the Work Environment: Look for physical evidence of resource management, such as clean, organized workspaces, calibrated equipment, and maintained infrastructure.
Conduct Interviews Across Departments: Speak with employees at various levels to verify competence, awareness, and understanding of the quality policy and objectives.
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
Resources:
How does the organization determine its resource requirements?
What records exist for maintenance of critical infrastructure?
Competence and Awareness:
How are competencies determined and verified?
How does the organization ensure employees are aware of QMS objectives?
Communication:
What methods are used for internal and external communication regarding QMS?
Document Control:
What processes are in place for document control, including updates and access?