**Procedure for evaluation, audits and resolution of complaints**
===Header===
^Name^Unique ID^ Edition/Date of Edition ^
|Procedure for evaluation, audits and resolution of complaints|nchsls:c:general:document:04||(1) 03-01-2014|


^Preparing authority^Approving authority^Review period^
|All teaching staff|Quality Manager|1 year| 



|**Printed copy of this document is considered uncontrolled.** It should be compared with controlled electronic copy before use|

======Processes requiring this procedure====== 
Quality control process
======Purpose======
Procedure for evaluation, audits and resolution of complaints is to collect, anlayse and use information from customers and laboratory personnel and third parties to improve quality of laboratory services.
======Scope====== 
The information is collected from patients, doctors, laboratory personnel and external agencies e.g accreditation bodies. 
======Users of the procedure======
Laboratory director, quality manager and HODs of departments uses this proccedure.
======Procedure======
Following information is collected and analysed. Communicate analysis done and any action taken to information provider.Supply analysis done and any action taken/required as input to management review.
^Information^Some collection methods^Record Name^Maintained at^Storage period^
|Assessment of user feedback|Verbal and written opinion from patients,clinicians and their representatives. Meetings, written and oral complaints, newspaper and other communication media coverage and any other mode of information as to whether the service has met the needs and requirements of users. **Caution:** ensure confidentiality of feedback provider, where relevent|Assessment of user feedback.|Laboratory director and  department/section level|2 years|
|Staff suggestions|Verbal and written opinion from personnel and their representatives.Meetings, written and oral complaints and other mode of information as to any aspect of laboratory. **Caution:** ensure confidentiality of feedback provider, where relevent|Staff suggestions|Laboratory director and  department/section level|2 years|
|Reviews by external organizations|Invite NABL assessment as required for maintaining accreditation. Take appropriate actions for closing nonconformities raised by NABL assessment team.|Reviews by external organizations|Laboratory director and  department/section level|2 years|
|Internal Audits|See below|Internal Audits|Laboratory director and  department/section level|2 years|
=====Internal Audits=====
  -Quality manager is **responsible** for planning and conduct of internal audit{{:nchsls:c:general:document:letter_for_internal_audit.doc|letter_for_internal_audit}}. Laboratory director is **responsible** for maintaining records and presenting its report as input to management review.
  -**Training:** Train personnel for performing internal audit.
  -**Maintaining objectivity and impartiality of the audit process:** Audit of a department/section is done by another department/section as far as possible.
  -**Method:** A given group of auditor audits all clauses for a section/department.
  -**Scope:** Audit for all clauses of ISO:15189:2012 and NABL-112 at **frequency** of least once a year. Depth of audit for various clauses may differ depending on need.
  -**Criteria for audit:** 
     -Review procedure documentation
     -Observe process implemetation
     -Review records generated by processes
     -Pay special attention to nonconformities found in last audit as well as last NABL assessment.
     -When nonconformities are identified, personnel responsible for the area being audited take necessary action and ask laboratory director for necessary help.