ISO 9001:2015 Requirement Auditing. (Clause 8)

Clause 8 in ISO 9001:2015 is titled "Operation" and focuses on the planning and control of the organization's operational processes. Auditing Clause 8 involves assessing how well the organization plans, executes, and controls its operational activities to meet customer requirements and achieve the intended outcomes. Here's a guide on auditing Clause 8 and the evidence that can demonstrate implementation:

1. Review Operational Planning:

- Examine the organization's documented procedures, plans, or work instructions related to operational planning.

- Verify that the organization has defined criteria for product and service requirements, identified process inputs and outputs, and planned the necessary resources and controls for effective process execution.

2. Verify Process Execution:

- Select specific processes within the QMS and review documented information, such as work orders, production records, or service reports, to assess how the organization executes its processes.

- Verify that the processes are carried out in accordance with the planned arrangements, including the use of appropriate methods, tools, and techniques.

3. Assess Monitoring and Measurement:

- Review documented information related to monitoring and measurement activities, such as inspection records, test reports, or process performance metrics.

- Verify that the organization has established processes to monitor and measure the characteristics of the products, services, and operational activities to ensure conformity to requirements.

4. Verify Product and Service Control:

- Review documented information, such as control plans, inspection criteria, or service delivery records, to assess how the organization controls the realization processes for its products and services.

- Verify that the organization has implemented appropriate controls to ensure that products and services meet specified requirements before delivery to customers.

5. Assess Nonconformity Control:

- Review documented information, such as nonconformity reports, corrective action records, or customer complaints, to assess how the organization identifies, evaluates, and controls nonconformities.

- Verify that the organization has processes in place to take appropriate actions to address nonconformities, including root cause analysis, corrective actions, and preventive actions.

Here are some examples of evidence you can look for during an audit

(Clause 8):

1. Operational Planning and Control:

- Work instructions and procedures: Documentation of work instructions, procedures, or standard operating procedures (SOPs) that provide detailed guidance on how specific activities or processes are performed.

- Production or service records: Records that capture information related to the production or service delivery process, such as production logs, service reports, job cards, or process checklists.

- Capacity planning records: Evidence of capacity planning activities, including production schedules, resource allocation plans, or demand forecasts.

2. Requirements for Products and Services:

- Customer requirements documentation: Records of customer requirements, specifications, contracts, purchase orders, or service level agreements (SLAs) that define the expectations and quality criteria for the products or services.

- Product or service design records: Documentation of product or service design activities, including design plans, drawings, specifications, prototypes, or design review records.

- Change management records: Documentation of change requests, change control logs, or change impact assessments related to product or service requirements.

3. Design and Development (if applicable):

- Design and development plans: Records of design and development plans that outline the activities, responsibilities, and milestones associated with the design and development process.

- Design verification and validation records: Evidence of design verification activities, such as test reports, inspection records, or simulation results, to ensure that the design meets the specified requirements.

- Design review meeting minutes: Records of design review meetings, including attendance records, agendas, minutes, and action items.

4. Production and Service Provision:

- Production or service records: Documentation of production or service provision activities, including work orders, production logs, inspection records, test reports, or service delivery records.

- Nonconformity records: Records of nonconformities identified during production or service provision, along with corresponding corrective or preventive actions taken to address the nonconformities.

- Records of product release or service acceptance: Evidence of product release or service acceptance criteria, including inspection records, conformity certificates, or customer sign-offs.

5. Identification and Traceability:

- Product or component identification records: Records of unique identification numbers, labels, or tags assigned to products or components to ensure traceability throughout the production or service process.

- Traceability logs: Documentation that captures the traceability of products or components, including records of materials used, suppliers, production dates, or batch/lot numbers.

- Recall or withdrawal records: Evidence of procedures or records in place to manage product recalls or withdrawals, including communication plans, customer notifications, or recall logs.

6. Preservation of Product:

- Product handling and storage records: Evidence of proper handling, storage, and preservation of products or components to prevent damage, deterioration, or contamination.

- Packaging and labeling records: Documentation of packaging and labeling processes, including packaging specifications, labeling instructions, or records of labeling inspections.

- Physical condition checklists: Records or checklists used to verify the physical condition and integrity of products or components before, during, or after production or service provision.

7. Control of Monitoring and Measuring Equipment:

- Calibration certificates: Records of calibration certificates for monitoring and measuring equipment, demonstrating that equipment is calibrated and traceable to recognized standards.

- Maintenance records: Documentation of maintenance activities performed on monitoring and measuring equipment, including schedules, maintenance logs, and repair records.

- Equipment performance records: Evidence of equipment performance verification, such as accuracy checks, stability tests, or repeatability studies.

8. Measurement, Analysis, and Improvement:

- Data collection and analysis records: Documentation of data collection methods, analysis techniques, and statistical tools used to monitor and analyze process performance, product quality, or customer satisfaction.

- Internal audit records: Records of internal audits conducted to assess the effectiveness of the quality management system, including audit plans, checklists, findings, and corrective actions.

- Management review records: Documentation of management review meetings, including agendas, minutes, actions, and decisions taken to evaluate the performance of the quality management system and identify areas for improvement.

- Nonconformity and corrective action records: Records of nonconformities identified, corrective actions taken, and their effectiveness in preventing recurrence.

9. Continual Improvement:

- Improvement projects and initiatives: Documentation of improvement projects, initiatives, or Kaizen events undertaken to enhance processes, increase efficiency, reduce waste, or improve customer satisfaction.

- Lessons learned records: Records of lessons learned from previous projects or experiences that have been captured, shared, and used to prevent the recurrence of issues or improve performance.

- Employee suggestions or feedback: Documentation of suggestions, ideas, or feedback provided by employees for process improvement, innovation, or cost reduction.

10. Customer Satisfaction:

- Customer feedback records: Records of customer feedback, surveys, or complaint logs that capture customer satisfaction, concerns, or suggestions for improvement.

- Customer satisfaction metrics: Measurement of customer satisfaction using metrics such as Net Promoter Score (NPS), customer satisfaction index (CSI), or customer complaint resolution time.

- Customer testimonials or reviews: Evidence of positive customer testimonials, reviews, or references that demonstrate customer satisfaction and the organization's ability to meet customer expectations.

Remember, the examples provided are not exhaustive, and the evidence required for implementation in Clause 8 may vary depending on the organization's specific context and industry. During an audit, it's essential to assess the organization's processes, activities, and documentation to determine if the requirements of Clause 8 are effectively implemented and supported by evidence.