Effective Corrective and Preventive Action (CAPA) Programs
ISO 9001, as well as its’ industry specific supersets like ISO 13485, AS9100C, and ISO/TS 16949, require that your Organization engage in Corrective and Preventive Action Programs. These are two of the most important sub-clauses in the standard and contain no less than 2 of the 6 mandated procedures.
But what is specifically required of the Organization and its’ Quality Management System, and what are the formal responsibilities?
Quality Resource Center offers webinar based training to satisfy those broad topics. Our fast paced, technically rich course will help you understand what is meant by ISO 9001:2008 when it says –
“8.5.2 Corrective Action
The organization shall take action to eliminate the causes of nonconformities in order to prevent recurrence. Corrective actions shall be appropriate to the effects of the nonconformities encountered.
A documented procedure shall be established to define requirements for
a) Reviewing nonconformities (including customer complaints),
b) Determining the causes of nonconformities,
c) Evaluating the need for action to ensure that nonconformities do not recur,
d) Determining and implementing action needed,
e) Records of the results of action taken (see 4.2.4), and
f) Reviewing the effectiveness of the corrective action taken.”
AND
“8.5.3 Preventive Action
The organization shall determine action to eliminate the causes of potential nonconformities in order to prevent their occurrence. Preventive actions shall be appropriate to the effects of the potential problems.
A documented procedure shall be established to define requirements for
a) Determining potential nonconformities and their causes,
b) Evaluating the need for action to prevent occurrence of nonconformities, c) determining and implementing action needed,
d) Records of results of action taken (see 4.2.4), and
e) Reviewing the effectiveness of the preventive action taken.”
Our seasoned professional instructors offer world class experience and expertise.
Quality Resource Center webinars are designed to answer these questions and more. We will instruct you on methods of not only complying with the requirements of ISO 9001, but also how to deliver maximum value from the process that will assist in making your efforts all the more effective. Key to this will be how you plan and identify non-conformance and opportunities for improvement.
Sign up today for one of our webinars. We can also tailor a customized training program designed to fit the unique requirements of your organization. Contact us at (800) 244-5409 or Email Us today.