Toughest ISO 9001:2000 Requirements (6.2.2)

Clause 6.2.2, Competence, Awareness, and Training, states:

The organization shall:
a) determine the necessary competence for personnel performing work affecting product quality,

Competence is defined in ISO 9000:2000 as the “demonstrated ability to apply knowledge and skills”.

Competence involves the education, training, skills, and experience necessary for people to carry out their assigned tasks. It also includes people not directly involved in making the product, or delivering the service, because their work may affect quality (e.g., planning, purchasing, and customer service).

However, every person may not need all four of the competency attributes. The requirement is that people have the appropriate combination of competencies for their jobs. Also, don’t overlook the competence required for management, as well as, for any temporary or part-time employees.

When planning work allocations, training is one of the primary actions that can be taken to achieve the necessary competence. The training process begins with an analysis of the competence needs for current and planned activities. The next step is to determine the competence levels of the personnel assigned to, or already performing, these activities. You then identify any gaps that exist between the required competence and available resources. This information is used to define possible training solutions.

Training needs may be also be identified as the result of management reviews (5.6), internal audits (8.2.2), corrective actions (8.5.2), and preventive actions (8.5.3). Also, evolving customer requirements, and continual improvement plans, may result in the need for new competencies.

See ISO 10015:2001, Guidelines for Training, to:

  • Identify and analyze training needs
  • Design and plan the training
  • Provide for the training
  • Evaluate training outcomes
  • Monitor and improve the training process

The April 2002 newsletter provides more information about this training guidance document.

b) provide training or take other actions to satisfy these needs,

Although training may end up being the best solution, don’t overlook other actions, such as, changing processes, improving procedures, rotating jobs, outsourcing, or recruiting fully training people. If your organization wants to acquire the training from an outside source, read “Ten Tips for Choosing a Training Provider” in the November 2002 newsletter.

Training must be carried out by people with the appropriate skills, qualifications, and experience. Therefore, records should be maintained as evidence of the special competence of employees used as trainers.

c) evaluate the effectiveness of the actions taken,

It is not enough to just take actions (including training) and keep records, you must also evaluate the effectiveness of those actions. In the case of training, your organization may want to consider these 6-R’s:


Reaction: What was the reaction of the participants? This measure is an assessment of the student satisfaction as expressed on an evaluation form at the end of the training session.



Retention: What learning has taken place? This measure can be determined through a pre-test and post-test to indicate how much information has been retained by the students. It can show what skills, knowledge, or attitudes have changed, and by how much.



Relevance: Have the participants applied what they learned? Students assess the relevance of the training through a follow-up evaluation a few months after they return to their jobs.


Rating: Has their job performance improved? This rating summary of the participants is extracted from their performance appraisals while maintaining strict confidentiality of personal information.

Results: Did the application of the learning produce the desired results? This measure focuses on the business results achieved after the training has completed. Business results can be judged by comparing performance data to measurable targets, as well as, witnessing process results during internal audits. 

Return: Did the monetary value of the results exceed the cost of the training? This measure of return on investment compares the monetary benefit of the training to its costs.

If “on-the-job” training is required, then its effectiveness must also be evaluated. 

d) ensure that its personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objectives, and,


Employees should be told their jobs are important and given timely feedback on their performance against departmental objectives.  The place to start is during orientation sessions for new employees. This awareness training could cover the:


  • nature of the business
  • health, safety, and environmental regulations
  • quality policy and objectives
  • role of new employees
  • relevant procedures and instructions

Management must keep employees informed of their contributions. Therefore, good communications is essential (see clause 5.5.3). Methods may include bulletin board postings, department meetings, electronic reports, and email notes.

A good way to explain the relevance and importance of a job is to relate it to the quality policy, meeting requirements, and satisfying the customer. Ensure the transmitted information is clear and understandable, as well as, adapted for the intended audience.

e) maintain appropriate records of education, training, skills, and experience (see 4.2.4).

Records must be kept of the competencies for all employees whose work may affect product quality. If a job requires a specific education level, there must be proof the people performing that job have the necessary degree, e.g., an official school transcript. If job training is required, records must be available as evidence that employees have successfully completed the training, e.g., class rosters, course certificates, and test results. If special skills are needed, records must show that the employees have demonstrated those skills, e.g., equipment sign-off forms.

The records should clearly indicate that employees are deemed competent to perform their assigned tasks.