ISO 9001:2015 QMS Doc. No.
EEP/QMS/CORP/SOP/O5
Location: QMSM Issue No. 1
Revision No. 0
Nonconformity and corrective action Title Page
NONCONFORMITY AND CORRECTIVE ACTION PROCEDURE
Issued by: Approved by:
Signed: Signed:
Date: Date:
ISO 9001:2015 QMS Doc. No. EEP/QMS/CORP/SOP/O5
Location: QMSM Issue No. 1
Revision 0
No.
Nonconformity and corrective action Page 1 of 8 pages
CONTENTS:
0.0 Table of contents
0.1 Distribution list
0.2 Amendment sheet record
1. Purpose
2. Scope
3. References
4. Terms and definitions
5. Process requirements
a. inputs and outputs
b. Sequence and interactions
c. Monitoring, measurement and evaluation
d. Resources
e. Responsibilities
f. Risks and opportunities
g. Improvement
6. Method
7. Documented information retained
Appendices
ISO 9001:2015 QMS Doc. No. EEP/QMS//CORP/SOP/O5
Issue No. 1
Location: QMSM
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0.1 Distribution List
This document is issued on controlled basis to the following staff members
Copy No. Copy Holder
1 Chief Executive Officer
2 Executive Officers
3 Directors
4 Managers
5 QMS Manager
ISO 9001:2015 QMS Doc. No. EEP/QMS/CORP/SOP/O5
Location: QMSM Issue No. 1
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0.2 Amendment Sheet Record
NO DATE Details of change Authorization
YYYY-MM-DD Page Clause/sub-clause and comment
ISO 9001:2015 QMS Doc. No. EEP/QMS/CORP/SOP/O5
Location: QMSM Issue No. 1
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1.0 Purpose
This procedure has been established to define the system used by the EEP, for the control
of nonconformity and corrective action, in accordance with the requirements of ISO
9001:2015.
2.0 Scope
This procedure covers the actions taken by EEP when a nonconformity occurs,
including any arising from the complaints up to the time corrective actions have been
implemented and their effectiveness determined
3.0 TERMS AND DEFINITIONS
i. QMS: Quality Management System
ii. CEO: Chief Executive Officer
iii. EO: Executive Officer
iv. HOD: Head of Department
v. HOS: Head of a section
vi. CORP: Corporate
vii. SOP: Standard operating procedures
viii. NC: Nonconformity
ix. CA: Corrective action
x. QMSM: QMS Manager
xi. PM: Process map
xii. DRIM: Documents and Records Identification Manual
4.0 References
3.1 ISO 9000:2015 QMS Fundamentals and vocabulary
3.2 ISO 9001:2015 QMS requirements
ISO 9001:2015 QMS Doc. No. EEP/QMS/CORP/SOP/O5
Location: QMSM Issue No. 1
Revision No. 0
Nonconformity and corrective action Page 5 of 8 pages
5.0 Process requirements
5.1 Inputs and outputs
a. Inputs
I. Nonconformities
II. Reports (Audits, inspections, tests, monitoring and measurement)
III. Complaints
b. Outputs
i. Corrective actions
ii. Risks and opportunities updates
iii. Changes to QMS
5.2 Sequence and interactions
The processes sequence and interactions are captured in the EEP quality
manual, EEP/QMS/CORP/QM, Appendix 1
5.3 Monitoring, measurement and evaluation
a) Number of nonconformities/ Defects/ Returns
b) Number of complaints
See also quality manual EEP/QMS/CORP/QM, Appendix 2
5.4 Resources
a) Personnel
b) Monitoring and measurement resources
5.5 Responsibilities
The HODs and QMS Manager are responsible for the implementation of the
process
5.6 Risks and opportunities
The risks and opportunities associated with the processes are documented in
the enterprise risk and opportunities’ register, EEP/QMS/CORP/QMSR/21/1
5.7 Improvement
a. Enhanced Inspection, monitoring and measurements
b. Establishment of effective customer feedback mechanisms
c. Effective Corrective actions
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6 METHOD
7.1 Identification and Reporting of Non-conformity
7.1.1 Non-conformity shall be identified through any of the following activities:
a) Virtual observations, Inspection, monitoring, measurements and testing
b) Internal audits
c) External audits.
d) Customer complaints.
e) Processes’ performance trends.
6.1.2 Identified Non-conformity shall be captured in the nonconformity and corrective
action form and reported to the relevant HOD.
6.2 Determination of the NC causes and corrective action
6.2.1 The HOD / Designate shall review and analyze the conformity, and initiate
determination of the causes of the nonconformity and if similar nonconformities
exist, or could potentially occur.
6.2.2 The HOD / Designate will perform root cause analyses to establish the root course
of the nonconformity in order to take the appropriate corrective action. Details of
the root cause and the proposed corrective action will be entered in the non-
conformity and corrective action form.
6.3 Review of the effectiveness of the corrective action
The HOD / designate shall review the effectiveness of the corrective actions after
three months and record the finding in the non-conformity and corrective action
form. If the corrective action is not effective then root cause analysis shall be
done again to determine an appropriate corrective action.
6.4 Risk and Opportunities update
The HOD in liaison with the QMSM will update the risk and opportunities register
as appropriate.
6.5 Changes to the QMS
THE HOD, if necessary, will make the appropriate changes to the QMS.
ISO 9001:2015 QMS Doc. No. EEP/QMS/CORP/SOP/O5
Location: QMSM Issue No. 1
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Appendix 7.1 Process Map, EEP/QMS/CORP/SOP/O5/PM
Staff HOD/Designate
Start
1
Detection of Review and analyse NC and
nonconformity others which may exist or have
potential to occur
Fill in the NC part of
NC/CA form
Perform root course analysis
1
Determine the root course and
implement corrective action
1
Review of corrective actions
Is corrective No
action effective
yes
Update risks and
opportunities
Implement changes to
QMS, if necessary
End
ISO 9001:2015 QMS Doc. No. EEP/QMS/CORP/SOP/O5
Location: QMSM Issue No. 1
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Appendix 7.2 Nonconformity /Corrective Action Form EEP/QMS/CORP/SOP/O5/F1
Location: DATE: Ref No:
Department HOD:
Section: Assigned Person:
Details of Non-Conformity
Date completed………………………..Signature…………………………
Nonconformity review and analysis
Date completed………………………..Signature…………………………
Root cause analysis
Corrective Actions
Review of Corrective Actions for effectiveness
Date completed………………………..Signature…………………………
Risks and opportunities identified
Date completed………………………..Signature…………………………
Changes to QMS
