Five Typical Roles and Responsibilities
While the specific naming and place on the organizational chart may vary – all quality management programs have at least five “role types”. These role types are a minimum requirement for any quality program.
1. ISO 9001 Quality Management Systems Associate
Each employee (ISO 9001 Quality Management Systems
Associate) needs to know who is responsible for the various elements of the QMS to ensure a successful implementation. You should develop and make available to all employees a list of key personnel and their job descriptions, responsibilities, along with an organizational chart of key employees as they relate to the QMS.
This should effectively define, document, and communicate the organizational structure of the QMS.
Please note that this method is a suggestion, and other ways of meeting the requirement for organizational structure may be used.
ISO standards dictate you should seek evidence that your organization’s personnel have not only been advised of their QMS responsibilities and authorities, but also that they understand these in the context of the overall purpose of the QMS. This is why everyone in a company needs to complete his or her ISO 9001 Certified Quality Management Systems Associate
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training and certification.
It is a requirement of ISO that the top management must assign relevant roles, responsibilities and authority for:
• Preserving the integrity of the organization’s QMS during changes;
• Determining opportunities for improvement.
2. ISO 9001 Quality Management Systems Internal Auditor
Your dedicated ISO internal auditor is typically a senior member of staff with previous experience in managing or close association with your operational processes and systems. Their role is to audit your QMS relevant documentation per the requirements of ISO 9001 (or
other pertinent standard to which the management system must comply). In addition, the internal audit will confirm that the BAU operations follow the scope, guidelines and objectives laid out in that documentation.
“Internal auditing is an independent, objective assurance and consulting activity designed to add value and improve an organisation’s operations”
Behaviours and Responsibilities
There are strict behavioural guidelines to which an ISO internal auditor must adhere when performing their duties. Here is a short list of just some of the responsibilities to be undertaken by an ISO internal auditor and the behaviours to which they must remain true.
• Independent, unbiased auditing
• Objective assessment of factual evidences
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• Fair and impartial treatment of relevant personnel
• Attentive, careful and thoughtful analysis
• Thorough performance of and full engagement with the audit process
• To reach clear and unambiguous conclusions (which can be supported) based on audit observations & to remain true to those conclusions
3. ISO 9001 Quality Management Systems Lead Auditor
A lead auditor is the one who is responsible for leading the audit team in an organization. He or she prepares the audit plan, delivers meetings and submits audit report at the end of quarter or year. Conducting audits is the main responsibility of a lead auditor and that needs to be done on a daily basis.
Typical duties include:
• Lead audit must be qualified (e.g., an ISO 9001 Lead Auditor, or similar) to perform a quality assessment
• Independent from the QMS (e.g., No conflict of interest such as operating controls or governing the QMS).
• Creating an annual audit plan
• Executing against the audit plan (e.g., Performing audits of the QMS and ISO 9001 requirement checks)
• Reporting results to management
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4. ISO 9001 Quality Management Systems Lead Implementor
Typical duties of ISO 9001 Lead Implementors include:
• Implementing the concepts and requirements defined in ISO 9001:2015.
• Implementing the underlying principles concerning Organizational Context, Leadership, Process Approach, and risk-based thinking.
• Assist leaders to recognize what is meant by leadership and top management in terms of management systems.
• Ensure that the specific top management requirements defined in management system standards that are based on Annex SL, e.g. ISO 9001 for Quality management systems and how these requirements may be addressed.
• I m p l e m e n t t h e p ro p e r f u n c t i o n i n g o f t h e
responsibilities, authorities and accountabilities related to leadership and management roles within organizations and the wider role of leaders within the business.
• Recoginize and implement the common risk-based requirements for a management system as defined in the management system standards that are based on Annex SL, e.g. ISO 9001:2015 - Quality management system requirements and how they may be addressed.
• Establish the high-level risk management structure and associated requirements as defined in ISO 31000:2009 Risk management principles and guidelines, and how these may be used to demonstrate conformity with a quality management system standard.
• Implement the requirements concerning “Context of the organization” as defined in the management system standards that are based on Annex SL- ISO 9001:2015.
• Understanding and address the requirements for
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context of the organization may be addressed and how they may be demonstrated.
• I m p l e m e n t t h e i n te r re l a t i o n s h i p s b e t we e n organization context and risk and opportunity i d e n t i fi c a t i o n , a n d e x p l a i n w h y e f f e c t i v e communication is essential in ensuring the management system is aligned with the business environment.
• Establish the procedures of how to define a process and standardise it with respect to an understanding of what aspects are key to the specific requirements of interested parties.
• Understand where in a process key measures are located and their role in enabling performance evaluation and fulfilment of intended management system outcomes.
• Implement the documentation requirements based on ISO 9001:2015.
5. ISO 9001 Quality Management Systems Quality Manager
Typical duties of ISO 9001 Quality Managers include:
• Ensure that the organization’s Quality Management System conforms to customer, internal, ISO 9001, and regulatory/legal requirements.
• Ensure evaluation of, and reporting on, vendor quality systems.
• Oversee inspection (examination) of incoming materials, ensuring that they meet requirements.
• Manage the monitoring, measurement, and review of internal processes, especially those that affect the quality of the organization’s products.
• Lead a team of Quality engineers, inspectors, auditors, analysts, and technicians
• Work with customers, employees, contractors, and outsourcing firms to develop product requirements.
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• Report to top management on the performance of the QMS (e.g., results of quality audits, corrective actions), including the need for improvement.
• Conduct periodic management review meetings.
• Oversee product recalls.
• Responsible for accuracy and timely inspection/
calibration of monitoring and measuring devices.
• Keep up on standards, regulations/laws, issues, and news with respect to product (service) quality.