ISO 13485 audit checklist about improvement
ISO 13485 audit checklist about improvement
Clause 8.5
8.5.1 (Continual improvement) General
• Can you demonstrate that Organization’s QMS effectiveness continually improves?
• Can you demonstrate that Organization identifies and implements changes to ensure continued QMS effectiveness?
• What tools do you use? (See 5.6, 8.2.2, 8.4, 8.5.2, 8.5.3)
• Documented procedures?
• Records
• documented procedures
8.5.2 Corrective action
• Do corrective actions records identify and address root cause(s)?
• (Do root causes match actions?)
• Are actions taken appropriate to the severity of the problem?
• Can you show me a documented procedure defining requirements for each of the following?
a) reviewing nonconformities (including customer complaints)
b) determining the causes of nonconformities
c) evaluating the need for action to ensure that nonconformities do not recur
d) determining and implementing action needed
e) records of the results of any investigation and of action taken
f) reviewing the corrective action taken and its effectiveness
• Can you show me records of investigation and corrective actions taken?
8.5.3 Preventive action
• How do you determine potential nonconformities to take action one?
• Do preventive action records identify and address root cause(s)?
• Are actions taken appropriate to the severity of the problem?
• Can you show me a documented procedure defining requirements for each of the following?
a) determining potential nonconformities and their causes,
b) evaluating the need for action to prevent occurrence of nonconformities,
c) determining and implementing action needed,
a) (records) recording of the results of any investigation and of action taken (see 4.2.4), and
d) reviewing preventive action taken and its effectiveness.
• Can you show me records of preventive actions taken?
Related documents:
Advertisement
Sponsor sites:
1. Phrases For Performance Appraisals.
2. Interview questions and answers.
This entry was posted
on Sunday, November 22nd, 2009 at 5:21 am and is filed under ISO 13485 checklist.
You can leave a response, or trackback from your own site.
