ISO 9001 Clause 7.1.2, “People,” is a crucial element of the Quality Management System (QMS) standards. This clause emphasizes the importance of having the right people with the necessary skills and competence to implement the QMS effectively, operate processes, and maintain control over them.
Breakdown of Clause 7.1.2 People
- Determining Personnel Needs: The organization must identify and assess the personnel required to implement its QMS. This includes considering the roles and responsibilities needed to achieve quality objectives, manage processes, and maintain the QMS effectively. Typical roles needed for a QMS include a Quality Manager, Quality Inspector(s) (QA, QC), Quality auditor(s), plus maybe a Quality Engineer(s) for a technical environment.
- Providing the Necessary Personnel: Once the personnel needs are identified, the organization must ensure that it has the right people in place. This involves hiring, training, and assigning individuals to roles that match their skills and competencies (see clause 7.2).
- Effective Implementation: The effective implementation of the QMS requires the right people with the necessary competence. They are responsible for carrying out processes, monitoring performance, and taking corrective actions when necessary to maintain quality.
In practical terms, this clause means that the organization should ensure that the individuals responsible for various aspects of the QMS are well-equipped with the knowledge and skills required to meet quality objectives. For example, in a healthcare setting, medical staff, nurses, and administrative personnel must be competent to ensure patient safety and the delivery of high-quality care.
Example Conformance with ISO 9001 Clause 7.1.2 People
TechnoWidget Inc. manufactures precision components used in the aerospace industry. The company employs around 200 staff members, ranging from production operatives to engineers and administrative personnel. Clause 7.1.2 People requires the organization to determine and provide the persons necessary to implement its quality management system effectively and to operate and control its processes.
Implementation at TechnoWidget Inc.:
1. Determining Personnel Needs
TechnoWidget Inc. conducted a comprehensive analysis of its quality management system to identify critical processes and the competencies needed for each role involved in these processes. This included production, quality control, quality management, procurement, and design roles.
2. Recruitment and Selection:
Based on the competency requirements, the HR department updated job descriptions to clearly outline the necessary skills and qualifications. During recruitment, emphasis was placed on selecting candidates who met these specific competency requirements.
3. Training and Development:
Onboarding programs were established to train new employees on the company’s quality management processes, emphasizing the importance of quality standards and their role in meeting customer requirements. Regular training sessions were scheduled to update existing employees on new equipment, technologies, and changes in quality standards, ensuring ongoing competency.
4. Performance Evaluations:
Performance evaluation processes were aligned with quality objectives. Employees were assessed not only on their productivity but also on their adherence to quality standards and their involvement in continual improvement initiatives.
5. Documentation and Records:
The HR department maintained detailed records of all training programs, personnel qualifications, and performance reviews. This documentation helped demonstrate compliance during ISO audits and provided a basis for continuous improvement in human resource practices.
6. Employee Engagement in Quality Improvement:
TechnoWidget Inc. encouraged a culture where employees at all levels were invited to suggest process improvements. This involvement was facilitated through regular team meetings and an open-door policy by the management.
By ensuring that the right people with the right skills were involved in each critical process, TechnoWidget Inc. maintained high-quality standards and compliance with ISO 9001:2015. The proactive approach to managing human resources under Clause 7.1.2 people not only improved the effectiveness of their QMS but also enhanced employee satisfaction and retention rates.
This example illustrates how aligning HR strategies with quality management system requirements can lead to sustained organizational success and compliance with ISO 9001 standards.
ISO 9001 Clause 7.1.2 People
Compliance with ISO 9001 clause 7.1.2 people requires that organizations have documented processes and the right people to execute those processes effectively. This is vital for achieving and maintaining quality standards and customer satisfaction.
