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Management responsibility.

M E Donawa1

  • 1Donawa and Associates Ltd., Rome, Italy.

Medical Device Technology
|May 8, 1995
PubMed
Summary

Management commitment is crucial for successful quality systems (EN ISO 9001, EN ISO 9002). This article examines management responsibility in the 1994 standards and their updates.

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Area of Science:

  • Quality Management Systems
  • International Standards Organization (ISO)

Background:

  • The 1994 versions of EN ISO 9001 and EN ISO 9002 emphasize management's role in quality systems.
  • Effective quality management hinges on top management's recognition and execution of their responsibilities.

Purpose of the Study:

  • To analyze the management responsibility clauses within the 1994 EN ISO 9001 and EN ISO 9002 standards.
  • To highlight the changes introduced in the 1994 standards compared to earlier versions regarding management's role.

Main Methods:

  • Review of EN ISO 9001 and EN ISO 9002 standards (1994 version).
  • Comparative analysis of management responsibility provisions between the 1994 standards and their predecessors.

Main Results:

  • Management responsibility is a foundational element for quality system implementation and maintenance.
  • The 1994 standards introduced specific modifications to management responsibility requirements.

Conclusions:

  • Top management's active involvement and acknowledgment of quality duties are indispensable for a functioning quality system.
  • Understanding the evolution of management responsibility clauses is key for organizations adhering to ISO quality standards.

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