QP.00/00
PROCEDURE MANUAL (As per ISO 9001:2008)
Doc. No.
: NIOS/PM/00
Issued to
: MR
Issue No.
: 01
Rev. No.
: 00
Date of Issue
: 16.07.2014
NATIONAL INSTITUTE OF OPEN SCHOOLING A-24-25, Institutional Area, Sector-62 NOIDA -201309 (U. P.) Website: www.nios.ac.in l E-mail :
[email protected] Phone : 0120-2402889 l Fax : 0120-2403172 Toll free Number 1800 180 9393
QP.01/00
Procedure Manual
CONTENTS S.No. Document Title No.
ISO 9001:2008 Clause
Rev No.
Revision Date
1 2 3 4 5 6 7
QP.00 QP.01 QP.02 QP.03 QP.04 QP.05 QP.06
4.2.3 4.2.3 4.2.3 4.2.3 4.2.4 8.2.2
00 00 00 00 00 00
dd.mm.yy dd.mm.yy dd.mm.yy dd.mm.yy dd.mm.yy dd.mm.yy
All All All All All MR
8 9 10 11 12
QP.07 QP.08 QP.09 QP.10 QP.11
8.3 8.5.2, 8.5.3 5.6 8.4 7.2.3, 8.2.1
00 00 00 00 00
dd.mm.yy dd.mm.yy dd.mm.yy dd.mm.yy dd.mm.yy
All All Mgt, MR All All
13 14
QF.01 QF.02
1.1, 5.1 4.2.3
00 00
dd.mm.yy dd.mm.yy
All MR
5.6.2
00
dd.mm.yy
MR
15
QF.03
5.6.1
00
dd.mm.yy
MR
16
QF.04
8.2.2 8.2.2
00 00
dd.mm.yy dd.mm.yy
MR MR
8.2.2
00
dd.mm.yy
MR
8.5.2, 8.5.3. 4.2.4 8.4 7.2.3, 8.2.1 8.2.1 6.2.2 4.2.3 8.2.2
00 00 00 00 00 00 00 00
dd.mm.yy dd.mm.yy dd.mm.yy dd.mm.yy dd.mm.yy dd.mm.yy dd.mm.yy dd.mm.yy
All All All All All All All All
17 18
QF.05 QF.06
19
QF.07
20 21 22 23 24 25 26
QF.08 QF.09 QF.10 QF.11 QF.12 QF.13 QF.14
Note: ❖ ❖
Title Page (Procedure Manual) Contents Amendment Record Sheet Control of Documents Control of Records Internal Quality Audits Control of Non-conforming Products/Services Corrective and Preventive Actions Management Review Analysis of Data Client/User Feedback Statutory and Regulatory Requirements Distribution of Record Agenda for Management Review Meeting Minutes of Management Review Meeting Annual Internal Quality Audit Programme Internal Quality Audit Schedule Internal Quality Audit Non-Conformity Report Corrective and Preventive Action (CAPA) List of Records Analysis of Data Client/User Feedback Client/User Complaint Register Training Feedback Form List of Documents of External Origin Internal Audit Observation Sheet
Page No.
Applicable to
This Contents sheet is revised whenever changes (Addition, Revision or Deletion) are made in the Procedure Manual. Whenever a revision/ addition is made to any part of this Procedure Manual, the revision number is incremented and page no. is amended in the contents accordingly.
Note: This Procedure Manual is the property of National Institute of Open Schooling (NIOS), Govt. of India and is not to be reproduced in part or full without the permission of the SECRETARY/MR. Approved by: ………………………… SECRETARY
Issued by: ………….....................……………………………. Management Representative (MR)
QP.02/00
Procedure Manual
AMENDMEND RECORD SHEET Sl.No.
Doc. No.
Para No.
Changes Incorporated
Reasons for Change
New Date Revision No.
Remarks
1
2
3
4
5
6
N.B.: This Amendment Record Sheet is filled up whenever changes are made in the Procedure Manual.
Note: This Procedure Manual is the property of National Institute of Open Schooling (NIOS), Govt. of India and is not to be reproduced in part or full without the permission of the SECRETARY/MR. Approved by:
Issued by:
………………………… SECRETARY
………….....................……………………………. Management Representative (MR) 1
16.07.2014
QP.03/00
Procedure Manual
CONTROL OF DOCUMENTS 1.
Purpose To control all the documents required for the Quality Management System in NIOS, with regards to approval before issue, review, revision and re-approval, issue of updated documents, identification and retrieval, to prevent unintended use of obsolete documents and to identify and control the distribution of documents of external origin.
2.
Scope This procedure is applicable to all the internal documents and externally originated documents available with NIOS.
3.
Responsibility
3.1
The Head of the NIOS is responsible for approval of the Quality Manual, Procedure Manual, Process Documents and all other QMS documents (including amendments) prior to its issue.
3.2
The Management Representative is responsible for review of all the documents (including amendments) prior to its issue.
3.3
The Management Representative is responsible for issuing/re-issuing the Quality Manual, Procedure Manual, Process Documents and all other QMS documents (including amendments) after approval/re-approval.
3.4
The Management Representative shall maintain updated Master List of ISO documents and shall withdraw the Obsolete Documents from the controlled copyholder.
4. Activities: 4.1
Documentation Structure 4.1.1 The Quality Management System Documentation is in two tiers consisting of Quality Manual and Procedure Manual. 4.1.2 The Quality Manual gives the description of the QMS of NIOS, the basic policy with respect to the various clauses of ISO 9001:2008, the scope of the Quality Management System, justification of all exclusions, references of each documented procedure, references of the Process Documents of all the Department/Division which are under
Note: This Procedure Manual is the property of National Institute of Open Schooling (NIOS), Govt. of India and is not to be reproduced in part or full without the permission of the SECRETARY/MR. Approved by:
Issued by:
………………………… SECRETARY 16.07.2014
………….....................……………………………. Management Representative (MR) 2
Procedure Manual the Scope and description of the sequence and interaction of the processes included in QMS. 4.1.3 The Procedure Manual contains the Procedures and Forms on the six mandatory Procedures and other topics required to ensure the effective planning, operation and control of Processes in NIOS. 4.1.4 The list of the procedures is given in the Quality Manual. 4.2
Identification of Documents 4.2.1 The Management Representative shall identify the requirements for preparation of documents. 4.2.2 The MR shall ensure that all the documents (Quality System Manual, Procedure Manual, Processes, Formats etc.) are readily identifiable by providing unique identification number and name and issue number. 4.2.3
All the QMS documents shall be controlled and identified as “Controlled Copy” by means of rubber stamp on the cover pages of the documents.
4.2.4
Uncontrolled copy (if any) shall be identified as “Uncontrolled Copy” by means of rubber stamp on the cover page of the document.
4.2.5 Copy of the individual holder shall be identified by its copy number, whereas master copy is identified by “Master Copy” stamp on the cover page. 4.2.6 The cover page of the Procedure Manual and the Quality Manual shall have a document number, document title, issue number, issue date, revision number, page number, column showing reviewing authority and approving authority for the document. All other pages of the documents shall have the relevant document number, revision number, creation/revision date and page number. 4.2.7 The File Numbering System at NIOS is: “Serial Number of the Std. Head/ Serial Number of the File opened during the Year/ Year of Opening the File; in four digits / Abbreviated symbol identifying the Section”.
Note: This Procedure Manual is the property of National Institute of Open Schooling (NIOS), Govt. of India and is not to be reproduced in part or full without the permission of the SECRETARY/MR. Approved by:
Issued by:
………………………… SECRETARY
………….....................……………………………. Management Representative (MR) 3
16.07.2014
Procedure Manual For Opening files, File Numbers as indicated below have been allotted to the various Department/Divisions: 1.
Evaluation Department/Division
:
F-1 to 20 e.g. 1) F-1-1/2011/NIOS/Eval./M&M. 2) F-2-1/2011/NIOS/Eval./Conf.
2.
Student Support Service (SSS) Department/Division
: F-21 to 40 e.g. 1) F-21-1/2011/NIOS/SSSS/Admission 2) F-22-1/2011/NIOS/SSSS/Accreditation.
3.
Administration Department/Division
:
F-41 to 60 e.g. 1) F-41-1/2011/NIOS/Admn/Pers 2) F-42-1/2011/NIOS/Admn/Maintenance
4.
Academic Department/Division
:
F-71 to 90 e.g. 1) F-71-1/2011/NIOS/Acad./OBE 2) F-72-1/2011/NIOS/Acad./LIB
5.
Vocational Department/Division
:
F-91 to 110 e.g. 1) F-91-1/2011/NIOS/Voc./I lunar 2) F-92-1/2011/NIOS/Voc./Tech
6.
Computer Division
:
F-121 to 130 e.g. 1) F-121-1/2011/NIOS/CD/ 2) F-121-2/2011/NIOS/CD/
7.
Regional Office, Delhi
:
F-....... to........... e.g. 1) F-.....-1/yyyy/NIOS/RO/
4.2.8
All rubber stamps pertaining to the Quality Management System are available and controlled by the Management Representative. 4.2.8.1
The Management Representative shall maintain a list, showing the identification status of externally originated documents available within the
Note: This Procedure Manual is the property of National Institute of Open Schooling (NIOS), Govt. of India and is not to be reproduced in part or full without the permission of the SECRETARY/MR. Approved by:
Issued by:
………………………… SECRETARY 16.07.2014
………….....................……………………………. Management Representative (MR) 4
Procedure Manual Institute. All the externally originated documents like- standards, manuals, specifications etc. shall be identified by unique identification numbers and shall be enlisted. 4.3
Review, Approvals and Issue of Documents: The Quality Management System documents are approved as below:
4.4
4.5
4.3.1
The Management Representative shall review the documented statement of the Quality Policy and the Quality Objectives, Quality System Manual and Procedure Manual for their suitability, adequacy and clarity. The Head of the Institute shall approve such documents reviewed by the Management Representative.
4.3.2
The MR shall review the Quality Manual and the Procedure Manual once in a year, to ensure their suitability.
4.3.4
The MR shall distribute the controlled copies to all the authorized copyholders.
4.3.5
The MR shall maintain the Document Distribution List indicating that duly reviewed and approved documents are issued to the authorized copyholders and acknowledgement is received from the controlled copyholder.
4.3.6
Uncontrolled copy of the Quality System Manual can be issued only for reference purpose. No uncontrolled copy of the Procedure Manual shall be issued to any one, without the written permission of the Head of the Institute.
Legibility of Document and Current Revision Status 4.4.1
The Management Representative shall ensure that all the QMS documents are printed with legible ink.
4.4.2
No handwritten document / correction shall be allowed in a controlled copy.
4.4.3
The Management Representative shall maintain a list of the updated documents showing the current revision status of the documents that are available at the point of use.
Revision/ Amendments of Documents 4.5.1
Any person can send a request in writing, for a new document or for a change to the existing document, to MR.
4.5.2
The MR studies the request w.r.t. the need for change, consequential changes, provisions of latest ISO 9001 standard, quality objectives and decides along with the HOD, about the changes to be made.
4.5.3
If changes are to be made, the following are done by the MR: t
Prepare the modified or new document.
t
Incorporate appropriate revision number & note.
t
Get Master Copy, approved by the approving authority.
Note: This Procedure Manual is the property of National Institute of Open Schooling (NIOS), Govt. of India and is not to be reproduced in part or full without the permission of the SECRETARY/MR. Approved by:
Issued by:
………………………… SECRETARY
………….....................……………………………. Management Representative (MR) 5
16.07.2014
Procedure Manual
4.6
t
Update contents page.
t
Record the changes in the amendment record sheet (QM.04 for the Quality Manual) and QP.02 for the Procedure Manual.
t
Stamp the Title Page and the Last Page as “Controlled Copy” in red.
t
Issue the revisions as controlled copy to each controlled copyholder and keep record in QF.01.
4.5.4
Document change request shall be reviewed and approved by competent authority and shall be discussed in the Management Review meeting.
4.5.5
Revision details of all the Quality system Procedures/Documents shall be available in the “Amendment Record Sheet” (QP-02).
4.5.6
In the event, when the person who has originally approved the documents is not available, the background information of the changes shall be made available to the approving authority.
4.5.7
When any document is revised more than ten times, new issue number shall be assigned to that document and it shall be duly reviewed and approved by the competent authority.
Disposal of Obsolete Copy and Issue of Revised Document 4.6.1 The page of document that is revised shall be issued to all the controlled copyholders. 4.6.2 Revised document/ Page shall be issued by the Management Representative through document distribution list to the controlled copyholders. 4.6.3 Uncontrolled copies are out of the scope of reviewing amendments made to the Quality System Manual and Procedure Manual. 4.6.4 All the old pages of the documents for which new revision has been issued, shall be identified as “Obsolete Copy”. 4.6.4 All obsolete copies shall be disposed off properly, with the permission of the MR. One copy of such obsolete document shall be retained by the MR, for future reference or for knowledge purpose and shall be filed separately.
4.7
Control of Other Documents 4.7.1 The documents are mostly prepared in the soft copies. The concerned Department/ Division controls all the documents other than QMS including documents of external origin like Acts, Guidelines, Government Plocies, Specifications etc. Record of all such documents is maintained. In case, copies are made and distributed, records of distribution are kept in soft or hard copy. 4.7.2 Each Department/Division Head maintains a list of Files in the Department/Division, with unique identification number, on each file. The file list is as per QF.08.
Note: This Procedure Manual is the property of National Institute of Open Schooling (NIOS), Govt. of India and is not to be reproduced in part or full without the permission of the SECRETARY/MR. Approved by:
Issued by:
………………………… SECRETARY 16.07.2014
………….....................……………………………. Management Representative (MR) 6
Procedure Manual 5.
Records
Sl. No.
Record
5.1
Location
Maintained By
Review/ Time
Disposition
List of QF-08 Documents including Files
MR’s Office/ Department/ Division
MR/SO
Until revised
Weeding out
5.2
Document Distribution Record
QF-01
MR’s Office
MR/SO
Until revised
Weeding out
5.3
List of Externally Originated Documents
QF-13
MR’s Office/ Department/ Division
MR/SO
Until revised
Weeding out
6.
Identification
References
6.1
ISO 9001: 2008- Element No. 4.2.3
6.2
QM-01- Quality System Manual
Note: This Procedure Manual is the property of National Institute of Open Schooling (NIOS), Govt. of India and is not to be reproduced in part or full without the permission of the SECRETARY/MR. Approved by:
Issued by:
………………………… SECRETARY
………….....................……………………………. Management Representative (MR) 7
16.07.2014
QP.04/00
Procedure Manual
CONTROL OF RECORDS 1.
Purpose To establish and implement a uniform method for identifying, collecting, indexing, filing, handling, retaining and disposing of quality records in the Institute.
2.
Scope This procedure is applicable to records generated and maintained by NIOS and also the records related to and important for NIOS, as evidence of achievement of process quality and effective functioning of the Quality Management System of NIOS.
3.
Responsibility:
3.1
The responsibility for maintenance of the quality records shall be of the respective custodians as described in various procedures of the Quality Management System.
4.
Activities:
4.1
Identification and Approval 4.1.1
All records required for the Quality Management System are maintained to provide evidence of conformance to requirements and effective operation of the Quality Management System. Every record shall possess a unique Identification Number and the Lists of Quality Records shall include all the identified records. For records of NIOS also, the same File Numbering System, as mentioned in 4.2.7 of QP.03 is used.
4.2
Storage, Retention, Protection and Disposition of Records 4.2.1
Retention period shall be decided for every record, including Department/Division Level Records. The quality records are retained, at least for the period required to fulfil contractual obligations/for the retention period mentioned in the concerned Process / Procedure doc.
4.2.2
All the records are kept in appropriate Files and stored in safe places (e.g. racks, cabinets, if hardcopy and inside a folder with defined access rights, if softcopy). The storage is done in such a way that easy identification and quick retrieval to records, is possible.
4.2.6
Once in a year, the MR organises an inspection of the safe storage, protection and disposition of the records at NIOS.
4.2.7
The quality records shall be stored in a suitable place (environment) so that they are: t
Easily retrievable when needed.
t
Protected against any unauthorized changes.
t
Protected against extreme environmental conditions.
Note: This Procedure Manual is the property of National Institute of Open Schooling (NIOS), Govt. of India and is not to be reproduced in part or full without the permission of the SECRETARY/MR. Approved by:
Issued by:
………………………… SECRETARY 16.07.2014
………….....................……………………………. Management Representative (MR) 8
Procedure Manual t
Protected against damage or deterioration.
t
Protected against pest attacks.
t
With proper backups.
4.2.8 Retention periods for all the quality records shall be defined in the Master List of QMS Records, maintained by the MR and in the Department/Division specific Lists of Records maintained by the concerned Department/Division Head. The designated custodians of the records shall retain the Quality Records, at least for the period specified. 4.2.9 On completion of the retention period, the holder (-s) and MR, additionally determine the Usefulness of records after reviewing them. The records not found useful shall be disposed off as waste paper/removed from the Server, after proper authorization by the Head of the Department. 4.3.
Legibility and Retrieval 4.3.1 The quality records, generated at NIOS, shall be in the specified formats and filed in the appropriate Files. 4.3.2 All the quality records shall be legibly written without using any erasable means like pencil. 4.3.3 Any changes to the quality records shall be stricken out and signed by the responsible person, for entries in the record. 4.3.4 Records may be in English/Hindi in Hard or in Soft.
5.
Records
Sl. No.
Record
1.
2.
6.
Identification
Location
Maintained By
Review/ Time
Disposition
List of QMS QF-08 Records including Files
MR’s Drawer/ Safe Folder
MR
Until revised
Weeding out/ Removal from the specified location
List of QF-08 Department/ Division Level Records, including Files
Drawer/ Safe Folder of the Department/ Division Head
HOD/ Concerned Department/ Division Head
As specified or Until revised
Weeding out/ Removal from the specified location
References 6.1
ISO 9001: 2008 – Clause 4.2.4
6.2
QM-01 – Quality system manual
Note: This Procedure Manual is the property of National Institute of Open Schooling (NIOS), Govt. of India and is not to be reproduced in part or full without the permission of the SECRETARY/MR. Approved by:
Issued by:
………………………… SECRETARY
………….....................……………………………. Management Representative (MR) 9
16.07.2014
QP.05/00
Procedure Manual
INTERNAL QUALITY AUDIT 1.
Purpose To establish, define, plan, organise, conduct and implement methods to carry out Internal Quality Audits in all Department/Divisions as well as of the MR and the Top Mgt. of NIOS, so as to verify compliance of the Quality Management System to ISO 9001:2008 Standard’s requirements, to determine effectiveness of the implementation and maintenance of the System and also to take action to resolve the non-conformity (-ies), if any.
2.
Scope This procedure is applicable to all the internal auditing activities related to the Quality management system within NIOS.
3.
Responsibility
3.1
The Management Representative is responsible for organising Internal Audits, getting the audit reports compiled and presenting the same in the Management Review Meeting.
3.2
Certified Internal auditors are responsible for carrying out audits, preparing audit reports and submitting the same to the MR.
3.3
The Auditees are responsible for giving necessary information to the Auditors, for acknowledging Corrective Action Report (CARs) and also for carrying out corrective actions as specified in the corrective action requests.
4.
Procedure:
4.1
Planning 4.1.1 Audit Plan for conducting audit shall be prepared in the beginning of the Calendar Year that will include Internal as well as External audit plans. Audit plan shall be prepared after considering the importance of the processes and areas to be audited. 4.1.2 Internal Audit shall be conducted at least once in every six months at NIOS. 4.1.3 The Internal Quality Audit Programme for the year is prepared as per format (QF.04). Depending upon the importance of the activities of a particular Department/Division, findings of previous audit and the status of implementation of the Quality Management System in that Department/Division, the frequency of internal quality audit can be increased as decided by the Management Representative.
4.2
Notification for the Audit 4.2.1
The Management Representative prepares the schedule for each audit in Format No. QF.05 and circulates it in advance, based on the audit plan.
Note: This Procedure Manual is the property of National Institute of Open Schooling (NIOS), Govt. of India and is not to be reproduced in part or full without the permission of the SECRETARY/MR. Approved by:
Issued by:
………………………… SECRETARY 16.07.2014
………….....................……………………………. Management Representative (MR) 10
Procedure Manual
4.3
4.2.2
Audit notification shall include the date of audit, scope of the audit, criteria of the audit, area to be audited, list of auditors and auditees.
4.2.3
The MR shall ensure that the auditors are selected from the team of Certified Internal Auditors. MR will assign the internal quality audit work to the auditors for conducting audits or to external contracted auditors. MR maintains the list of certified internal auditors.
4.2.4
The auditors are assigned to carry out audits in a Department/Division, other than the Department/Division in which they are working. All the employees are subject to audit, including the SECRETARY/MR.
Audit Execution 4.3.1
Based on the schedule, each internal quality auditor carries out the audit.
4.3.2
In order to assist in the conduct of the audit, there is a “Check List” for every Department/ Division that facilitates a smooth and in-depth audit.
4.3.3 The mode of audit may be one or combination of: t
Examination of documents.
t
Examination of work in progress.
t
Examination of past records.
t
Discussions with the process owners and the concerned officers.
4.3.4 During the audit, the internal auditor: t Covers the entire scope of the audit through random sampling. t Notes down observations made during the audit, in the audit observation sheet. t Classifies any deviation (-s) from the requirement of the manual or standards observed in the internal audit, as non-conformitiy (-s) and documents all nonconformities during the conduct of audit in Corrective Action Report (CAR). t Verifies the corrective actions taken by auditee on the non-conformities raised during earlier audit and records it on the non-conformity report. t Gets the audit non-conformity report signed by the concerned auditee, along with acknowledgement with proposed corrective action and target date of completion and hands over the original of the report to the auditee and sends the copy to the MR. Note: This Procedure Manual is the property of National Institute of Open Schooling (NIOS), Govt. of India and is not to be reproduced in part or full without the permission of the SECRETARY/MR. Approved by:
Issued by:
………………………… SECRETARY
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16.07.2014
Procedure Manual 4.3
Reporting and Closing the Audit 4.3.1
The auditor shall prepare audit report giving details of non-conformities issued; follow up audit, if required; date for next internal audit to be conducted and recommends for improvement.
4.3.2
Auditor grades the non-conformities as: Major: A significant non-compliance or complete omission of a QMS requirement. Minor: An incidence of a failure to comply with a procedure or a QMS requirement. Observation: A finding, which is not a non-conformity at present, but can lead to nonconformity, if not attended.
4.3.3
Auditor submits the report to the MR for record and timely corrective actions. MR shall ensure that the auditee, responsible for the area audited, take corrective action without undue delay to eliminate detected non-conformities and their causes.
4.3.4
Follow up activities shall be scheduled to verify the effective implementation of corrective action. The auditor verifies the results of follow up activities and shall record it on both the copies of form QF 06 with MR and auditee. MR verifies audit non-conformity report with respect to the effectiveness of corrective actions taken and closes the audit report by signing on it, as evidence of an effective follow-up.
4.3.5
One copy of the audit report shall be issued to the auditee for record and necessary action.
4.4.6
The auditee takes corrective action and records it on the audit report and sends to MR.
4.4.7 On receipt of information about corrective action completion report from auditee, the MR assigns the verification work of the corrective actions to the same auditor or some other auditor(-s). 4.4.8
The auditor verifies the corrective actions taken by the auditee and records it on both the copies of Form QF.06 with MR and Auditee. MR verifies audit non-conformity report with respect to effectiveness of corrective actions taken and closes the audit report by signing on it as the evidence of an effective follow-up.
4.4.9
Internal Audit and Corrective Action taken shall be discussed during the Management Review Meeting.
4.4.10 Once in a year, MR assesses the competence of the internal auditors and makes arrangements for up gradation of auditing skills as appropriate. 4.5
Competence of Auditor
4.5.1
Auditor conducting internal audit shall be a qualified internal auditor.
4.5.2
If required, a consultant can be hired by NIOS for the purpose of conducting internal audit.
Note: This Procedure Manual is the property of National Institute of Open Schooling (NIOS), Govt. of India and is not to be reproduced in part or full without the permission of the SECRETARY/MR. Approved by:
Issued by:
………………………… SECRETARY 16.07.2014
………….....................……………………………. Management Representative (MR) 12
Procedure Manual 5. Records Sl. No.
Record
Identification
Location
Maintained By
Retention Period in year
Disposition
5.1
Audit Plan
QF-05
MR’s Office
MR
3 Years
Weeding out
5.2
Annual Internal Audit Programme
QF-04
MR’s Office
MR
3 Years
Weeding out
Non -conformity Report
QF-06
MR’s Office
MR
3 Years
Weeding out
Audit Observation Sheet QF-14
MR’s Office
MR
3 Years
Weeding out
5.3 5.4
6. References 6.1
ISO 9001: 2008 – Element No. 8.2.2
6.2
QM-01 – Quality System Manual
Note: This Procedure Manual is the property of National Institute of Open Schooling (NIOS), Govt. of India and is not to be reproduced in part or full without the permission of the SECRETARY/MR. Approved by:
Issued by:
………………………… SECRETARY
………….....................……………………………. Management Representative (MR) 13
16.07.2014
QP.06/00
Procedure Manual
CONTROL OF NON-CONFORMING PRODUCT/SERVICES 1.
Purpose To ensure that the work or service that does not conform to the Client/User and project requirements, statutory & regulatory or other requirements are identified and controlled to prevent its unintended use and further processing.
2.
Scope All non-conforming products/services of NIOS.
3.
Responsibility
3.1
Head of a Department/Division is responsible for identifying the non-conformities during monitoring stages.
3.2
HOD is authorized for deciding corrective action of the identified NC’s including disposal of non-conforming product/service.
4.
Activities:
4.1
Identification, Segregation and Recording of Non-Conforming Products and Services 4.1.1
4.1.2
4.2
The non-conforming products/ services are detected or identified, through inspection, during any stage of the process, based on: v
Verification and checking carried out on the process at various stages especially for completion of activities.
v
Monitoring of process by NIOS.
v
Internal & External Audits.
v
Feedback from employees, including complaints.
v
Analysis of data and including achievement of objectives.
The non-conforming products or services are identified and segregated to the extent possible (by marking wherever possible), so that the same do not get mixed up with the conforming items, especially in case of un-approved proposals or specifications.
Review and Disposition of Non-Conformity 4.2.1
The designated personnel shall determine the possible disposition decision and shall review the non-conformity.
4.2.2
If the non-conformity is such that it can be set right or corrected immediately, reprocessing work is carried out immediately.
Note: This Procedure Manual is the property of National Institute of Open Schooling (NIOS), Govt. of India and is not to be reproduced in part or full without the permission of the SECRETARY/MR. Approved by:
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………………………… SECRETARY 16.07.2014
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Procedure Manual
4.3
4.2.2
Depending on the nature and severity of the non-conformity, the competent authority deals with the non-conformity.
4.2.3
If the non-conformity is detected after the starting of the next stage of activities, the background of the same is traced and the activity is correctly identified. Then, the nonconformity is evaluated and the defects are analysed.
4.2.5
If the non-conformity can be rectified, the item/ service shall be reprocessed and reworked. After rectification, re-inspected, before accepting it. In case, it is still nonconforming, the rectification process is repeated, till it is approved.
4.2.6
Records of all significant non-conformities are maintained, in Form No. QF.07.
Non-conformity after Delivery 4.3.1 Non-conformity detected after delivery shall be verified by the competent authority. 4.3.3
Nonconformity log register shall be maintained to evaluate the occurrence of non conformities and nonconformities of repetitive nature are taken up for necessary corrective/preventive action.
4.3.4 Nonconformity log shall be reviewed in the Management Review Meeting. 5.
Records
Sl. No.
Record
Identification
Location
Maintained By
Retention Period in year
Disposition
5.1
CAPA (Corrective and Preventive Actions)
QF-07
HOD’s Chamber
HOD
3
Weeding out
6. References 6.1
QM 01 – Quality System Manual
6.2
ISO 9001: 2008- Element No. 8.3
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Procedure Manual
CORRECTIVE AND PREVENTIVE ACTIONS 1.
Purpose To ensure that potential and actual non-conformities are identified and actions taken to eliminate their cause(s), so that the potential non-conformity does not occur due to preventive action and that corrective action is taken for the non-conformity which has already occurred.
2.
Scope This procedure is applicable to all actual and potential non-conformities requiring corrective and preventive actions which deal with detected nonconformities in product and processes of Quality Management System at NIOS.
3.
Responsibility 3.1
Head of the Institute is responsible for monitoring the effectiveness of corrective and preventive actions, taken in the Institute.
3.2
The Management Representative is responsible for follow up of corrective and preventive actions taken and monitoring the effectiveness of the actions taken.
3.3
The HOD is responsible for: u
Taking corrective and preventive actions, as per the responsibilities allotted.
u
Ensure that actions are taken immediately for any sort of complaint.
u
Responsible for keeping the Institute’s compliance to the quality system
4.
Activities:
4.1
Correction to be done 4.1.1
The non-conformities are properly identified.
4.1.2
Non-conformities are recorded in Form No. QF.06, in case of internal audits and in Form No. QF.07, in case of others.
4.1.3
Actual detected non-conformity is studied and actions identified to eliminate the detected non-conformity viz. corrections.
4.1.5
Immediate (without undue delay) corrections are made to set right, the actual NC in the situation observed and reported.
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Procedure Manual 4.1.6
4.2
It is checked and verified by the responsible one (-s) that the NC has been eliminated.
Corrective Actions 4.2.1 Each detected “Significant” non-conformity is analysed to determine the cause of the problem. Separate analysis is made for each NC. The “Significant” is judged by the HOD. The actual non- conformities are generally derived from: n
Internal & External Audit reports;
n
Client/User Complaints;
n
Client/User Feedback;
n
Relevant Quality Records;
n
Results of process reviews;
n
Output of data analysis;
n
Output from Management Review Meetings.
4.2.2 Based on the cause analysed for each problem / NC, the specific actions to be taken, shall be determined, to: n
Eliminate the cause of the problem;
n
Ensure that it does not occur again
4.2.3 Root cause of the identified non-conformity is analysed by the assigned Authority and approved by the MR and necessary corrective action is initiated along with the target date of implementation. Depending on the degree and nature of the detected NC, root cause analysis shall be carried out using various sources of information, such as previous records, audit reports, service reports, feedback reports, etc. Any relevant root cause analysis shall be documented and referred in Corrective Action Report. 4.2.4 The corrective action plan shall be recorded in Form No. QF.07, with person responsible and target date. Assigned person takes the action and records it on the same Form. 4.2.5 After the action, the HOD shall review and evaluate the effectiveness of the action taken. 4.2.6 Corrective Action Report (CAR) is recorded for the identified NC’s by the affected Department/Division and forwarded to the Management Representative for review of corrective action requested. Corrective action shall be reviewed and discussed by all concerned, in the Management Review Meeting. Note: This Procedure Manual is the property of National Institute of Open Schooling (NIOS), Govt. of India and is not to be reproduced in part or full without the permission of the SECRETARY/MR. Approved by:
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Procedure Manual 4.2.7 Necessary corrective action shall be initiated to eliminate the non-conformities raised, during internal audit and effective implementation shall be monitored during the follow up activities. 4.3
Preventive Actions 4.3.1
The Potential non-conformities shall be identified, based on: v The Trends of the concerned processes; v Trends of the parameters, related to the works; v Internal and External Audits; v Observations of the Top Management; v Frequent deviation; v Suggestions for improvement.
4.3.2
Each potential non-conformity is analysed, to determine the cause of the problem. Separate analysis is made for each NC.
4.3.3
Based on the cause analysed for each problem / NC, the specific actions to be taken are determined, to: v Eliminate the cause of the potential problem; v Ensure that it does not re-occur.
4.4
4.3.4
It is checked that the actions identified are appropriate to the impact of the problem, likely to be encountered viz. magnitude of the potential problem and likely risks.
4.3.5
The preventive action plan along with the person responsible and target date is recorded in Form No. QF.07.
4.3.6
The assigned person takes the preventive action, on time, to eliminate occurrence of the NC in all conditions and records it in Form No. QF.07.
4.3.7
After the action has been taken, the HOD reviews and evaluates the effectiveness of the preventive action taken by verifying as to whether the potential NC has actually occurred or not.
Follow up for Effectiveness 4.4.1
Each Department/Division keeps separate records of the Corrective and Preventive actions, taken.
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Procedure Manual 4.4.2
4.5
5.
The HOD presents the status of the corrective and preventive actions for the concerned Department/Division, in the Half Yearly Management Review Meeting for review and improvement.
Procedural Steps for Handling Client/User Complaints 4.5.1
The suggestions and feedbacks regarding NIOS’s services are collected from the Client/Users through complaints/ feedbacks either verbally or in writing or through mail. Client/Users’ complaint is recorded in the Complaint Register. These complaints are analyzed and sent to concerned function for further action.
4.5.2
MR shall investigate the potential causes of the Client/User complaints and ensure corrective and preventive action to prevent recurrence of such complaints.
4.5.3
Client/User Complaints Register is updated suitably, after resolving the complaint. A quarterly summary report is prepared and submitted for discussion in Management Review Meeting. Action taken about the complaint is prepared and submitted for discussion, in MRM.
4.5.4
Client/User feedback is also collected once in a year to analyse the satisfaction level, for the services provided.
Records
Sl. No.
Record
Identification
Location
Maintained By
Retention Period in year
Disposition
5.1
Corrective Action and Preventive Action Report
QF-07
HOD’s shelf
HOD
3 years
Weeding out
Non Conformance Report
QF-06
HOD’s shelf
HOD
3 years
Weeding out
5.3
Minutes of MRM
QF-03
HOD’s shelf
HOD
3 years
Weeding out
5.4
Client/User Complaint Register QF-11
HOD’s shelf
HOD
3 years
Weeding out
5.2
6.
References 6.1
ISO 9001: 2008 – Clause No. 8.5.2.
6.2
QM-01 – Quality System Management.
Note: This Procedure Manual is the property of National Institute of Open Schooling (NIOS), Govt. of India and is not to be reproduced in part or full without the permission of the SECRETARY/MR. Approved by:
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QP.08/00
Procedure Manual
MANAGEMENT REVIEW 1.
Purpose To carry out Management Review of the Quality Management System of NIOS at planned & defined intervals to ensure the continuing suitability, adequacy and effectiveness of the Quality Management System. It also aims at establishing, implementing and providing guidelines for conducting Management Review Meeting (MRM).
2.
Scope This procedure is applicable to all MRMs conducted at NIOS.
3.
Responsibility The Management Representative is responsible to ensure that MRMs are conducted on time, as per the planned interval, as decided by the management of NIOS.
4.
Procedure:
4.1
Planning - Management Review Meeting 4.1.1
MR conducts a formal review of the Quality Management System by the Top Mgt. of NIOS, at least twice a year, to ensure continuing suitability of the QMS, its adequacy and its effectiveness. If felt necessary, the review is carried out more frequently.
4.1.2 MR can also call for MRM, on need basis, prior to the scheduled period. 4.2
Notification of Agenda 4.2.1
Prior to each meeting, the Management Representative circulates the agenda for the meeting as per QF.02.
4.2.2 Notification of MRM shall be prepared and circulated to all the participating members, at least one week in advance, before the meeting. 4.2.3 Notification for the Management Review Meeting shall indicate date, time, venue and agenda for the meeting. 4.2.4 4.3
MR or in absence of MR, the Officer authorized by the Top Mgt. shall prepare the agenda for the meeting.
Conducting the Meeting 4.3.1
Management Review Meeting shall be conducted as per the scheduled date and time, mentioned in the notification.
4.3.2
Minimum quorum for conducting the meeting shall be 1/3 of the total members who have been nominated to attend the MRM. If the required quorum is not met, meeting
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Procedure Manual shall be adjourned and postponed for............. If the required quorum cannot be maintained even after the adjournment of the meeting, then the Top Mgt. and the MR shall conduct the meeting.
4.4
4.3.3
The Head of the Institute shall chairs the Management Review Meeting. Attendance sheet of all members invited and those who attended shall be maintained as a record while conducting the meeting.
4.3.4
All points stated in the agenda shall be discussed in the meeting.
Input (Agenda) to the Meeting 4.4.1
The following points shall be considered for issuing/setting up of agenda:
t
Review of minutes of meeting and action taken report from previous meeting, if any;
t
Results of Audit;
t
Evaluation of compliance with the legal requirements;
t
Client/User’s/ Interested party’s’ feedback including Client/User suggestions;
t
Status of preventive and corrective action;
t
Review of policy and objectives;
t
Resources required;
t
Review of “ Process Performance Monitoring”;
t
Recommendations for Improvement;
t
Changes that could affect the Management System.
Agenda of the meeting shall not be restricted to the above points only and can have other points, as deemed necessary. 4.5
Output of the Meeting 4.4.1
All the points discussed in the meeting shall be recorded and the Management Representative shall prepare the ‘Minutes of Meeting’.
4.4.2
The MR circulates the minutes of the meeting in Format No. QF.03, to all members attending the meeting.
4.4.3
The MR shall follow up on the implementation of action points, as decided during the meeting.
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Procedure Manual 5.
Records
Sl. No.
Record
Identification
Location
Maintained
Retention
Disposition
5.1
Notification/ Agenda for MRM
QF-02
MR’s Office
MR
3 Years
Weeding out
5.2
Minutes for MRM
QF-03
MR’s Office
MR
3 Years
Weeding out
6. References 6.1
Procedure on Internal Quality Audits No. QP.06
6.2
Procedure on Corrective & Preventive Actions No. QP.08
6.3
ISO 9001:2008 – Clause No. 5.8
6.4
QM-01 – Quality System Manual
Note: This Procedure Manual is the property of National Institute of Open Schooling (NIOS), Govt. of India and is not to be reproduced in part or full without the permission of the SECRETARY/MR. Approved by:
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QP.09/00
Procedure Manual
ANALYSIS OF DATA 1.
Purpose To determine, collect and analyse data related to the Quality Objectives and all other parameters of the various Processes, to demonstrate the effectiveness of the Quality Management System and to evaluate where continual improvement of the effectiveness of the Quality Management System can be made.
2.
Scope All data collected by each Department/Division.
3.
Responsibility Head of the Institute and Management Representative.
4.
Activities:
4.1
Collection of data
4.2
5. Sl. No.
4.1.1
Head of the Institute determines the data to be collected in order to monitor achievement of each objective on 6 monthly basis.
4.1.2
Data pertaining to progress of each service/work, shall be collected.
Analysis of data 4.2.1
Actual data shall be collected and analysed against the target.
4.2.2
The data shall be recorded.
4.2.3
Analysis is done to see if the data is as per the requirements and norms. The variance is calculated.
4.2.4
Based on the analysis, improvement actions are identified and recorded as corrective or preventive actions in Form No. QF.07.
Records Record
Identification
Location
Maintained By
Retention Period in year
Disposition
Department/ Division Head
5 Years
Weeding out
5 Years
Weeding out
5.1
Records in each By title Department/ Division
Department/ Division
5.2
Institute Record
HOD’s Chamber HOD
By title
6. References 6.1
Procedure on Corrective and Preventive Actions No. QP.08
6.2
Procedure on Management Review No. QP.05.
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Procedure Manual
CLIENT/USER FEEDBACK 1.
Purpose To monitor Client/User satisfaction levels through feedbacks, so as to enhance the satisfaction levels.
2.
Scope Feedbacks from all the clients/ Client/Users and interested parties.
3.
Responsibility: Head of the Institute.
4.
Activities:
4.1
Monitoring feedback
4.2
5.
4.1.1
Every year, the concerned Director sends Form No. QF.10, to each Client/User/user with the request that the feed back may be given for improvement.
4.1.2
In case of a meeting with Client/User/user, feedback is obtained in Form No. QF.10, from the Client/Users, if appropriate. In case, the representatives of Client/Users visit NIOS, feedback may be asked, wherever applicable.
4.1.3
On receipt of the feedback by anyone in the Institute, the same is forwarded to the concerned Director.
Analysis 4.2.1
The Director analyses the feedback and records it in Form No. QF.09 (Analysis of Data).
4.2.2
The trend of Client/User/user satisfaction is monitored.
4.2.3
In case of any adverse remarks or suggestions, the same is recorded in Form No. QF.07 and corrective and preventive actions are taken.
Records
Sl. No.
Record
Identification
Location
Maintained By
Review/ Time
Disposition
5.1
Client/User Feedback form
QF.11
HOD’s office
HOD
Until Revised
Weeding out
Corrective and Preventive Action.
QF.07
HOD’s office
HOD
Until Revised
Weeding out
5.2
6.
References
6.1
Procedure on Analysis of Data No. QP.09
6.2
Procedure on Corrective and Preventive Actions No. QP.08
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Procedure Manual
STATUTORY AND REGULATORY REQUIREMENTS 1.
Purpose To ensure that all statutory and regulatory requirements are determined, implemented, monitored and all required reports submitted to the concerned regulatory bodies on time, so that it does not result in hassles for NIOS.
2.
Scope All statutory and regulatory requirements applicable to the works, processes, facilities and resources.
3.
Responsibility SECRETARY and MR.
4. 4.1
Activities: Statutory and Regulatory Requirements. 4.1.1 The Head of NIOS identifies the statutory & regulatory requirements of the Institute. 4.1.2 All these requirements are recorded.
5.
4.1.3
The compliance is monitored and ensured that all dues and reports are submitted on Time.
4.1.1
The database is updated, as per changes in regulations.
Records
Sl. No.
Record
Identification
Location
Maintained
Review/ Time
Disposition
5.1
Statutory and Regulatory Requirements in respective File(s)
Name & No.
Department/ Division Head’s Office
Concerned Department/ Division Head
Until Revised
Weeding out
6.
References
6.1
Procedure on Management Review No. QP.05.
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Procedure Manual NATIONAL INSTITUTE OF OPEN SCHOOLING (NIOS)
DISTRIBUTION RECORD FOR QUALITY MANUAL AND PROCEDURE MANUAL Maintained by: MR Doc. No.: Sl. No.
Rev. No.: Name of Document(-s)
Review Date: Rev. No. Copy No. of contents page
Copy Date Holder of Issue - Designation
Signature
Note: u Records of distribution are maintained for the original issue of the manuals as per QM.05. u Records of issue of all revisions to the manuals are recorded in this format. u The signature in the last column should be of the recipient.
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Procedure Manual NATIONAL INSTITUTE OF OPEN SCHOOLING (NIOS)
AGENDA FOR MANAGEMENT REVIEW MEETING Ref. No.:
Date:
Sub: Next Management Review Meeting The next Management Review Meeting will be held on date _________________at _____________ Hrs (time) at ____________________________(location and venue). The following points will be discussed in the meeting: t Review of action points (follow-up actions) of last Management Review Meeting/SMG Meeting – to be presented by respective persons, who were assigned the task. t Continuing suitability of the Quality Policy and the Quality Objectives– to be discussed. t Fulfilment of statutory & regulatory requirements in NIOS – to be discussed. t Results of External and Internal audits – to be presented by the MR. t Effectiveness of corrective and preventive actions - to be presented by the HOD. t Client/User/User feedback (including Complaints & Grievances) – to be presented by the HOD. t Process Performance, deviations and progress with respect to Client/Users/Users requirements – to be presented by the HOD. t Resource allocation requirements, if any – to be presented by the HOD. t Training needs, if any – to be presented by the HOD. t Deviations from the System and changes that could affect the QMS – to be discussed. t Suggestions & recommendations for improvement of QMS and its processes – To be discussed. t Any other relevant point. The HOD is requested to attend the meeting and brief the management on the implementation of quality management system pertaining to their sphere of responsibility.
Signature MR
Date:
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Distribution: Chairman, Secretary, Directors
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MINUTES OF MANAGEMENT REVIEW MEETING Date of Management Review Meeting: Persons Present: Ref. No.: Sl. No. Subject 1
Review of action points of last Meeting
2
Continuing suitability of Quality Policy
3
Fulfilment of statutory & regulatory requirements
4
Achievement of Quality Objectives
5
Results of external and internal audits
6
Effectiveness of corrective and preventive actions
7
Client feedback (including complaints)
8
Process Performance, deviations and progress with respect to Clients/ Users requirements
9
Resource allocation
10
Training needs
11
Deviations and changes that could affect the QMS
12
Suggestions & recommendations for improvement of QMS and its processes
Decision taken
Action by (Resp.)
Target Date
Remarks
Signature Management Representative
Date: Distribution: Chairman, Secretary, Directors.
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Procedure Manual NATIONAL INSTITUTE OF OPEN SCHOOLING (NIOS)
ANNUAL INTERNAL QUALITY AUDIT PROGRAMME Ref. No.
:
Financial Year : Function
Month Jan
Feb
Mar
Apr
May
Jun
July
Aug
Sep
Oct
Nov
Dec
Top Mgt. Evaluation Department Student Support Services (SSS) Department Administration Department Academic Department Vocational Department Computer Division Regional Office MR
Signature Management Representative
Date:
Distribution: Chairman, Secretary, Directors of the Departments/Divisions.
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Procedure Manual NATIONAL INSTITUTE OF OPEN SCHOOLING (NIOS)
INTERNAL QUALITY AUDIT SCHEDULE
Date of Audit: Ref. No.: Sl. No. Department/Division
Auditee
Auditor
Time
Scope
Remarks, if any
1 2 3 4 5 6 7 8 9 10 Note: v The auditors shall conduct the audit as per the above schedule. Auditor can do minor adjustments in date and time in consultation with the Auditee. v The Auditor shall hand over the Audit Non-Conformity report duly signed by Auditee to the MR.
Signature Management Representative
Date:
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Procedure Manual NATIONAL INSTITUTE OF OPEN SCHOOLING (NIOS)
INTERNAL QUALITY AUDIT NON-CONFORMITY REPORT Ref. No. Date of Audit Department/Division Auditee(s) Auditor(s) Scope Document Reference
: : : : : :
Para No.
ISO9001 Clause Reference
Finding along with objective evidence
Signature of Auditee
Date:
Signature of Auditor
Cause Analysis and Corrective Action Plan:Date: Corrective Actions taken: YES Details: Date:
Major, Minor or Observation
Signature of Auditee
NO Signature of Auditee
Verification of Corrective Actions for Effectiveness: Date:
Signature of Auditor
Non Conformity report reviewed for effectiveness and decision: Report Closed:
YES
NO
Remarks, if any: Date:
Signature of MR
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Procedure Manual NATIONAL INSTITUTE OF OPEN SCHOOLING (NIOS)
CORRECTIVE AND PREVENTIVE ACTIONS Ref. No. : Department/Division: Date
Action (Corrective or Preventive) Plan Action taken Details of detected non-conformity or potential non-conformity
Source Root Cause references Analysed & details
Correction to Whether Action to By By be made Corrective be taken whom when Action or Preventive Action
Signature Action & Date taken (Signature & Date)
Review by HOD for effectiveness. (Signature & Date)
Note: This format is to be made in landscape format for ease of use.
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Procedure Manual NATIONAL INSTITUTE OF OPEN SCHOOLING (NIOS)
LIST OF RECORDS INCLDING FILES Department/Division: Ref. No.:
Sl. No.
Record
Identification
Location
Maintained
Retention
Disposition
1 2 3 4 5 6 7 8 9 10
Note: This list is made by each Department/Division for the records kept in that Department/Division. This is to be updated when new records are added.
Prepared By
Approved by
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Procedure Manual NATIONAL INSTITUTE OF OPEN SCHOOLING (NIOS)
ANALYSIS OF DATA Ref. No.: Department/Division: Location: Month: Sl. No.
Note
Objective / Parameter
:
Target
Actual achieved
Variance
Improvement Recorded Actions in QF.07 – identified Yes or No Yes or No
Signature
This sheet is to be used to monitor objectives, targets for the month, statutory and regulatory requirements for the month etc.
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Procedure Manual
NATIONAL INSTITUTE OF OPEN SCHOOLING (NIOS)
CLIENT/USER FEEDBACK Ref. No.:
To, (Indicate name of Client/User here) Sir, As a most valuable Client/User of our Work/Service, we at NIOS, request you to kindly give us your free and fair feedback in the format below. This is required as a part of our ISO 9001:2008 based system for our improvement so that we can provide you better services in future. We request you to please spare a few moments for us for this. Thanking you Yours faithfully, (For and on behalf of HOD) ——————————————————————————————————————————————
CLIENT FEEDBACK Sl. No.
Criteria
Excellent 5
1
Overall Quality of our services
2
Adherence to schedule by NIOS
3
Response and coordination from NIOS
Very good 4
Good
Satisfactory
3
2
Poor 1
Overall observations about the services from NIOS: Suggestions for improvement of the working of NIOS, if any:
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COMPLAINT REGISTER For the Internal as well as the Learners
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4
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TRAINING FEEDBACK Ref. No.: Name of the participant: Designation: Training details: Period of training: Give rating: 5 Excellent, 4 Good, 3 Satisfactory, 2 Fair, 1 Poor Sl. No.
Criteria
1
Relevance of Course content to your needs
2
Course presentation
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7
Duration of training
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LIST OF DOCUMENTS OF EXTERNAL ORIGIN Ref. No.: Sl. No.
Review Date: Doc. Title
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INTERNAL QUALITY AUDIT OBSERVATION SHEET Ref. No. Date of Audit: Department/Division Auditee(s) Auditor(s) Scope Sl. No.
: : : : : Observation
ISO 9001:2008 Clause Ref.
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