ISO 13485 LA Practice Questions - PECB ISO 13485 Lead Auditor Exam

Exclusions are not permitted under any circumstances in ISO 13485 Any clause may be excluded provided justification is documented in the quality manual Exclusions are permitted only for clauses in Section 7 where requirements do not apply due to the nature of the organization's activities, and such exclusions must be stated in the quality manual Exclusions require prior written approval from the certification body before audit