ISO 9001 Clause 7.1.2, titled "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 effectively implement the QMS, operate processes, and maintain control over them.
Breakdown of Clause 7.1.2
Determining Personnel Needs: The organization must identify and assess the personnel required for the implementation of its QMS. This includes considering the roles and responsibilities needed to achieve quality objectives, manage processes, and maintain the QMS effectively.
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: Having the right people with the necessary competence is essential for the effective implementation of the QMS. 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, it's crucial that medical staff, nurses, and administrative personnel are competent in their roles to ensure patient safety and the delivery of high-quality care.
ISO 9001 Clause 7.1.2 People
Compliance with ISO 9001 standards requires that organizations not only have documented processes but also the right people in place to execute those processes effectively, which is vital for achieving and maintaining quality standards and customer satisfaction.