Regional Basic Professional Training Course in Korea

❙ 437 ❙
7. Quality Assurance
(1) Enterpriser shall establish measures to assure that conditions adverse to quality, such
as failures, malfunctions, deficiencies, deviations, defective material and equipment,
and nonconformances are promptly identified and corrected.
(2) In the case of significant conditions adverse to quality as provided in the foregoing
Paragraph (1), the measures shall assure that the cause of the condition is determined
and corrective action taken to preclude repetition, and the identification of the
significant condition adverse to quality, the cause of the condition, and the corrective
action taken shall be documented and reported to appropriate levels of management.
❱ Article 84 (Quality Assurance Records)
(1) Sufficient records shall be maintained to furnish evidence of activities affecting
quality, which includes:
1. Operating logs;
2. Results of reviews;
3. Results of inspections and tests;
4. Results of audits;
5. Results of monitoring of work performance;
6. Results of materials analyses; and
7. Documents evidencing the qualifications of personnel, procedures, and equipment.
(2) Inspection and test records provided in item 3 of the foregoing Paragraph (1) shall, as
a minimum, identify:
1. Inspector or data recorder;
2. Type of inspection or testing;
3. Results of inspection or testing;
4. Acceptability; and
5. Action taken in connection with any deficiencies noted.