Monitoring the ongoing effectiveness of your ISO 9001 Quality Management System (QMS) is crucial for compliance and continual improvement.
It involves regularly evaluating QMS performance against the standard and your internal business requirements to identify non-conformities and improvement opportunities. Corrective action is then taken to address issues and enhance processes, ensuring compliance and driving sustained success.
What are the monitoring requirements for ISO 9001?
The key requirements for monitoring quality systems include:
- Completing internal audits: These audits assess the effectiveness of the QMS in meeting both ISO 9001 requirements and internal business standards.
- Collecting and analysing data: Data is used to measure performance and identify trends, providing insights into areas of strength and improvement within the QMS.
- Collecting and reviewing feedback: Feedback from customers and employees is collected and reviewed to gain insights into satisfaction levels and areas for enhancement.
- Taking corrective action: Findings from monitoring activities are used to address issues promptly and implement corrective measures, fostering continuous improvement.
- Assessing effectiveness and making adjustments: Implemented solutions are evaluated for their effectiveness, and adjustments are made as necessary to optimise the QMS.
Monitoring quality systems is essential because it ensures ongoing compliance with customer, regulatory, and ISO 9001 requirements. This results in improved business performance, enhanced customer satisfaction, and sustained quality compliance, ultimately contributing to the organisation’s long-term success.
How to monitor systems according to ISO 9001
1. Establish a monitoring plan
To establish an effective monitoring plan, start by defining how systems will be tracked and monitored, creating a step-by-step guide to inform the process.
Identify critical processes and sites, decide on the data to be collected, and establish reliable collection methods. Determine monitoring frequency, assign responsibilities, and set clear parameters for acceptable performance levels.
Finally, specify a procedure for corrective action if performance falls below acceptable levels, outlining responsibilities and protocols for resolution.
2. Conduct an ISO 9001 internal audit
An ISO 9001 internal audit involves systematically evaluating your organisation’s processes, systems, and procedures to assess their effectiveness and compliance to the standard’s requirements.
Before your audit, prepare by defining the scope of the audit to set the boundaries for evaluation, and then create an auditing checklist outlining the key criteria to be assessed.
The actual audit process begins with your auditor establishing an audit schedule to determine the frequency of audits for different business areas based on their level of risk and importance.
This is followed by a document review stage where auditors examine documented evidence of compliance, such as quality manuals, procedures, and records, to ensure they meet the ISO 9001 requirements.
The main stage of your audit is process review. This is where an auditor assesses your compliance to ISO 9001 requirements through on-site audits, close-out meetings, and reporting. The auditor identifies discrepancies and areas for improvement, developing a plan to address non-conformances. After corrective action is implemented and evidenced, the certification body issues certification.
After completing an audit, keep records of your results to ensure everything is documented and can be referred to in future if required.
3. Analyse performance using data
Analysing performance using data is essential for organisations aiming to optimise operations, enhance effectiveness and monitor systems over time.
Through data analysis, you can identify patterns and trends, evaluate your QMS’s effectiveness, determine areas for improvement, and make informed decisions. These insights make it possible to drive continuous improvement, proactively manage risks, and capitalise on growth opportunities, ultimately contributing to long-term success and competitiveness.
Cloud-based systems are a great option for seamless, streamlined data collection where insights are presented in a user-friendly way. Leveraging cloud-based systems offers advantages like accessibility, real-time data, customisation, automated workflows, and robust security to keep your sensitive data secure.
4. Review and update your monitoring plan
Regularly reviewing and updating your monitoring plan is crucial to ensure it aligns with evolving business needs and changes within the organisation.
As quality systems are monitored over time or company changes occur, adjustments may be necessary to maintain your plan’s effectiveness. Therefore, reviewing the plan periodically, considering feedback from internal audits and data analysis, and making changes as needed is essential.
By incorporating insights from ongoing monitoring activities, you can refine your approach to quality management, address emerging issues, and drive continual improvement, enhancing overall performance and compliance to ISO 9001.
Contact us for assistance monitoring your ISO 9001 systems
Available Australia-wide, our consultants are experts in compliance. We can help you maintain your certified status, achieve continual improvement and reach your compliance goals.
For assistance maintaining your quality management system, get in touch with our team.