ISO 9001 Training
 Understanding ISO 9001:2008

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ISO 9001 Training

Understanding ISO 9001:2008
Requirements for Quality Management Systems

6.2 Human Resources  

6 Resource Management

6.2 Human Resources  

6.2.1 General 

Personnel performing work affecting conformity to product requirements shall be competent on the basis of appropriate education, training, skills and experience. 

NOTE Conformity to product requirements can be affected directly or indirectly by personnel performing any task within the quality management system. 

6.2.2 Competence, Training and Awareness 

The organization shall: 

a) determine the necessary competence for personnel performing work affecting conformity to product requirements, 

b) where applicable, provide training or take other actions to achieve the necessary competence, 

c) evaluate the effectiveness of the actions taken, 

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 

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

 




 



 

 

 

 

 

 

 

 

 

ISO 9001 Training - Key Explanation Points and Tips:

You will recall under clause 5.1e top management is responsible for ensuring the availability of resources which includes HR. Clause 5.5.1 requires top management to define the organization and its responsibilities and authorities. Clause 6.1 required that adequate resources (e.g. HR) be determined and provided. And here in clause 6.2 the specific requirements for controlling HR are defined.

Planning for HR process controls must include determining - competency criteria; skills evaluation; identification of training needs; types of training; provision of training; how training effectiveness is evaluated; methods to communicate awareness of the importance of quality requirements and meeting quality objectives, to all employees.

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.

Criteria for competency must be developed based on appropriate education, skills, training and experience for activities, tasks, functions and processes. The level and detail of such qualifications, skills, training and experience will depend upon the complexity of product, process, technology and customer and regulatory requirements.

It is up to your organization to determine the necessary criteria for the various functions and activities affecting product and QMS based on these factors. A “Skills Matrix” is a useful tool used by organizations to determine and manage the competency levels required by different activities and functions. 

Organizations undergo significant changes through growth or decline, acquisitions, new technology and new products and processes, Also, many organizations are now outsourcing their production labor to save on payroll costs and benefits. Labor related nonconformities can easily arise in such cases. Planning for your HR process must ensure that contract and agency personnel performing work affecting product quality have adequate competency and training. Appropriate records must be kept of such training.

Quality awareness must be focused on meeting customer and regulatory requirements. The process to promote quality awareness may include the use of methods such as - cross-functional teams; involvement in quality planning; quality circles; improvement suggestions; product workshops; zero defect programs, product review checklist; etc.

QMS personnel must be motivated to achieve the organizations quality objectives. The process to motivate employees may include the use of methods such as - employee recognition awards; ongoing training programs; performance reviews, employee surveys; poster campaigns; etc,. 

You must determine and keep appropriate records of education; training; skills and experience. These records must demonstrate the effective operation of HR process controls (see first sentence of clause 4.2.4 quality records).

Performance indicators to measure the effectiveness of the HR process in determining competency and training needs of the workforce, could include - employee turnover; employee complaints; number of instances unqualified personnel were found performing QMS activity; number of instances competency criteria were not met; and number of instances no training or competency records maintained; etc.

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