ISO 13485 Internal Audit Plan Guide
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ScribdTranslationsISO 13485 Internal Audit Plan Guide
Translated by
ScribdTranslationsPQB E 42 v 2016 A 02 ISO 13485 process audit plan
Example of internal audit plan process in a company certified ISO 13485
(Non-exhaustive list - will be adapted to each specific application)
Audited company:
Codification of
document :
Date de l’audit :
Scope of the audit:
Auditor:
People at
contact:
Rules of
confidentiality :
Plan
sampling :
Normes : ISO 13485, ISO 19011
Audit Objectives: Identify opportunities for process improvement
Check the compliance of practices
Determine the effectiveness of the process
…
Documents to see: (report of last audit, follow-up of actions, minutes of last
process review, procedures, questionnaire
Give and Sector / theme Process / Points to audit
time
10 minutes 1. Opening meeting
Objectives of the audit
Field of audit
Procedure
Security constraints
People
Schedules
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ISO 13485 process audit plan PQB E 42 v 2016 A 02
30 m 2. Data from the previous audit Follow-up of actions
20 m 3. Identity of the process
Function of the audit
Responsibility
Type process
Cartography
Triggers
Resources (human and material)
Constraints
20 m 4. Pilot and actors
Role
Mission
Responsibilities
Customer requirements
Staff awareness
Versatility
15 m 5. Purpose and clients
Purpose of the process
Clients of the process
15 m 6. Domain and interactions
Scope of the process
Activities (sub-processes)
Interactions with other processes
Outgoing product
Product cleanliness
Sterilization
Mastery of contamination
20 m 7. Objectives and indicators
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PQB E 42 v 2016 A 02 Plan d’audit processus ISO 13485
Company quality policy and objectives
Objectives and indicators of the process
Means to achieve the objectives
Communication
Results of the last process review
20 m 8. Input elements
Documentation
Supplier evaluation
Applicable regulatory requirements
Product identification and traceability
20 m 9. Output elements
Applicable regulatory requirements
Communication results
Analyze results
30 m 10. Implementation
Planning
Documentation
Means of implementation
Maintenance
Error prevention methods
Identification and traceability
Product modification
Storage
Feedback
15 m 11. Surveillance and Measurement
Records
Calibration
Maintenance
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ISO 13485 process audit plan PQB E 42 v 2016 A 02
15 m 12. Safety and environment
Specific training
Risks
Preventive measures
Emergency situations
25 m Improvement
PDCA Loop
Audits
Complaints
Measurement of the effectiveness of the process
Corrective and preventive actions
15 m 14. Preparation of the meeting of
fence
25 m 15. Closing meeting
Audit report
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