Why It Is Critical for Employees to Stay in Compliance with Iso Standards

MGMT415

When an organization claims they are ISO 9000 certified, what they are really saying is that they comply with international standard that provide requirements for an organization's quality management system (QMS). They are indicting they comply with standards published by the International Organization for Standardization which is referred to as ISO 9000, and indicating they have a QMS that meets the standards of ISO 9001 which is the only standard in the ISO 9000 family which is used for the intention of conformance assessment. Executive management teams should have ISO training to gain understanding of ISO principles and understand why a commitment to the principles is so important. All employees should have a basic understanding of ISO quality system and the documentation procedures required (Measures, n.d.)

It is important for employees to stay compliant because tracking and documentation is a requirement for the purpose of ensuring product quality. The FDA mandates documentation and proof of required and completed training especially with regulated companies. Two requirements (21 CFR 211.25 and 820.25) ensure employees understand how to accomplish their job within company and industry guidelines (Curran, n.d.).

The manager has the responsibility for the quality of product that the organization is putting out, therefore; ultimately he would be responsible for the problem. With the ISO standards they generally work within a chain of quality for production. Not following the principles of ISO could result in part of the process being out of specifications and resulting in inefficiencies in the product run and possibly causing the firm money if and when the customers are not happy. A manager's responsibility is being a good role model. By not enforcing the ISO standards he sets a poor example for his subordinates. Counseling on the importance of ISO standards, along with him/her being held accountable for any discrepancies that may arise due to his non-compliance.

References

Curran, B., Automating Training Control Processes to Comply with FDA and ISO Requirements,

n.d., Retrieved from http://www.mastercontrol.com/newsletter/automating_training_control_processes_0710.html

Measures, A., Demand Media, ISO Certification Training, n.d., Retrieved from http://smallbusiness.chron.com/iso-certification-training-4830.html