An ISO-compliant quality system, such as one based on ISO 9001, requires an organization to determine the necessary competence for personnel whose work affects quality performance (Clause 7.2). The most effective and systematic method to achieve this is by conducting a formal needs analysis for each job category. This process involves defining the required knowledge, skills, and abilities for a role and then assessing the current competency levels of employees. The identified gap between the required and actual competence directly informs targeted and efficient training plans, ensuring alignment with the quality management system's objectives and regulatory requirements.

A. Allowing employees to identify their own training needs: This approach is subjective and incomplete; employees may not be fully aware of all organizational needs or required job competencies.

C. Requiring all employees to complete the same training courses: This "one-size-fits-all" method is inefficient and ineffective, as it fails to address the specific, role-based competency requirements.

D. Requiring supervisors to identify training for their employees: While a valuable input, relying solely on supervisors can lead to inconsistency and subjectivity, lacking the rigor of a systematic analysis.

1. International Organization for Standardization (ISO). (2015). ISO 9001:2015 Quality management systems — Requirements. Clause 7.2

"Competence

" states the organization must "determine the necessary competence of person(s) doing work under its control that affects the performance and effectiveness of the quality management system." This necessitates a structured analysis

not ad-hoc methods.

2. Goetsch

D. L.

& Davis

S. B. (2014). Quality Management for Organizational Excellence: Introduction to Total Quality (7th ed.). Pearson. In Chapter 10

"Education and Training

" the text emphasizes that a "job/task analysis" is a critical step to identify specific training needs for various positions to ensure competence.

3. Pyzdek

T.

& Keller

P. A. (Eds.). (2017). The ASQ Certified Quality Engineer Handbook (4th ed.). ASQ Quality Press. Chapter 6

"The Quality System

" explains that fulfilling the competence requirements of ISO 9001 involves a systematic process to identify gaps between required and existing skills

which is the definition of a needs analysis.