Iso 17021 Manual
Iso 17021 Manual
Iso 17021 Manual
TITLE: GENERAL
0. GENERAL
1. Director General 1
2. Addl. Director General 2
3. DDG- Incharge of MSC Activity 3
4. Deputy Director General (Central) 4
5. Deputy Director General (Eastern) 5
6. Deputy Director General (Northern) 6
7. Deputy Director General (Southern) 7
8. Deputy Director General (Western) 8
9. Head (Management Systems Certification Department) 9
10. Internal Audit Officer 10
11. Personnel and Training Officer 11
12. Management System Certification Officer (Central) 12
13. Management System Certification Officer (Eastern) 13
14. Management System Certification Officer (Northern) 14
15. Management System Certification Officer (Southern) 15
16. Management System Certification Officer (Western) 16
17. Accreditation Body 17
18. Document Control Officer (Master Copy) 18
BUREAU OF INDIAN STANDARDS MANAGEMENT
MANAGEMENT SYSTEMS CERTIFICATION SYSTEM MANUAL
TITLE: GENERAL
To ensure that each copy of the Manual contains a complete record of Amendments, this
Amendment Sheet should be updated for each revised/new pages of the Manual. While issuing any
amendment, an acknowledgment slip will be included for signatures and return by all Controlled Copy
holders.
TITLE: GENERAL
0.3 CONTENTS
Section Ti t l e
0 General:
1. Introduction
1.1 Purpose
1.2 Scope
1.3 Administration of the Manual
4. Organization
4.1 General
4.2 Organization Chart
4.3 Functional Roles and Responsibilities
5. Document Control
5.1 Issue
5.2 Amendment
BUREAU OF INDIAN STANDARDS MANAGEMENT
MANAGEMENT SYSTEMS CERTIFICATION SYSTEM MANUAL
TITLE: GENERAL
DOC: MSC-M1-5 ISSUE: 01 DATE: JAN 2013 PAGE: 4 OF 4
6.1 Application
6.2 Stage 1 Audit
6.3 Planning and Selection of Audit Team
6.4 State 2 Audit
6.5 Follow-up
6.6 Licensing
6.7 Surveillance and Renewal
6.8 Appeals
6.9 Complaints
6.10 Use of Standard Marks and Licence
6.11 Control of Process of Certification
6.12 Financing
6.13 Licensing to Foreign Organizations
7. Personnel
7.1 Selection
7.2 Training and Registration
7.3 External auditors/external technical experts
7.4 Monitoring of Performance
7.5 Maintenance and Improvement of competence
9. Records
10. Confidentiality
11. Publications
TITLE: INTRODUCTION
DOC: MSC-M1-5 ISSUE: 01 DATE: JAN 2013 PAGE: 1 OF 2
APPROVED BY: DG
PREPARED BY: HEAD (MSCD)
1. INTRODUCTION
Bureau of Indian Standards has been established since April 1987 through the Bureau of Indian Standards Act,
1986 for the harmonious development of the activities of standardisation, marking and quality certification of
goods and for matters connected therewith or incidental thereto. It carries out the functions of standards
formulation, certification and other related activities. The Management Systems Certification (MSC) activities of
the Bureau of Indian Standards (BIS) consists of a series of activities aimed at assessing the ability of an
organization’s Management System(s) and thereby providing third party Certification to the organizations.
The list of various management systems certification schemes under operation is given in Annex I. Certificate
of conformity of an organization to one or more management system(s) standards demonstrates that the
organization has implemented and is maintaining an effective management system in the area(s) specified on
the licence/certificate as per the relevant Indian Standards. The certification services are open to all
organizations, irrespective of size and affiliation within the country and to other countries depending upon the
relations, agreements and feasibility of operations.
The MSC activities of BIS are carried out through systematic, documented policies and procedures. This system
has been documented in following levels:
a) Manual (titled as Management System Manual) describes the policies, structure, procedures,
methodologies and responsibilities for the General Management System Requirements in line with option 2
of clause 10.3 of ISO/IEC 17021:2011;
b) Procedures which describe the sub-system elements and control of operations of BIS Management Systems
Certification activities;
c) Guidelines for carrying out various activities; and
d) Forms which support the overall system and control.
The policies and procedures as laid down in the Manual and related documents describe the management system
established for BIS Management Systems Certification (MSC) activities. These are non-discriminatory in
nature. These policies and procedures as laid down and followed distinguish clearly between MSC activity and
other activities of BIS like, standards formulation, product certification, training, etc.
1.1 Purpose
This Management System Manual describes the policies, structure, procedures and methodologies for operating
and maintaining effective Management Systems Certification Activities which are in line with ISO/IEC 17021.
1.2 Scope
This Manual covers all aspects of MSC activities which are being operated under the provisions of Bureau of
Indian
Standards Act 1986, and the Rules and Regulations made there under. It also meets the requirements of
ISO/IEC
17021 which has been brought out through a matrix relating to the requirements of ISO/IEC 17021 vis-à-vis
the provisions made under controlled documents. The manual covers various Management System
Certification Schemes under operation as per Annex-I and combination of two or more management systems
(integrated Management System Certification Schemes).
BUREAU OF INDIAN STANDARDS MANAGEMENT
MANAGEMENT SYSTEMS CERTIFICATION SYSTEM MANUAL
TITLE: INTRODUCTION
DOC: MSC-M1-5 ISSUE: 01 DATE: JAN 2013 PAGE: 2 OF 2
This Manual is the property of Bureau of Indian Standards and shall not be copied or reproduced without
the express written permission of the Bureau of Indian Standards. It is issued under the authority of the
Director General.
This Manual and its distribution is controlled when identified as a CONTROLLED copy. Such a copy will
possess a unique number allocated to each recipient.
The Document Control Officer (DCO) of the MSC activity is responsible for the maintenance and operation of
the
Document Control System.
The DCO will maintain a distribution list which gives the designation of the holder of the controlled copy and
copy number of the Manual distributed. Any uncontrolled copy (not under amendment control) if in circulation
shall be marked "Uncontrolled Copy" on cover page.
Each recipient of the copy of the Manual is responsible for ensuring that the latest issue is in
use.
E-Copies of this Manual would be made available to users on demand and would be termed as uncontrolled
copies.
Related Documents
ISO/IEC 17021: 2011 Conformity Assessment - Requirements for Bodies Providing Audit and
Certification
Management Systems
MSC-F5-12 Document Matrix Relating Requirement of ISO/IEC 17021 to MSC
Documents
BUREAU OF INDIAN STANDARDS MANAGEMENT
MANAGEMENT SYSTEMS CERTIFICATION SYSTEM MANUAL
APPROVED BY: DG
PREPARED BY: HEAD (MSCD)
Due to globalization of Indian economy and opening up of trade across nations many industries
from around the globe have shown interest in BIS management system certification. BIS extends the
services of Management Systems Certification to other countries based on the request received from
such countries depending upon the relations, agreements and feasibility of operations. BIS would ensure
that the auditors understand the language, culture and business environment of these countries. It is
ensured that either the audit team possesses the knowledge of language, culture and business
environment or alternatively other arrangements like interpreter and/or awareness programmes would be
arranged for auditors.
BUREAU OF INDIAN STANDARDS MANAGEMENT
MANAGEMENT SYSTEMS CERTIFICATION SYSTEM MANUAL
The main activities of BIS, other than management systems certification, include standards formulation,
product certification, standards promotion, international cooperation, laboratory management and
testing, and training services. All these activities, including Management Systems Certification activity,
have an independent set up which consists of Head of departments responsible for these activities and
officers and staff working under them. There is, therefore, no conflict of interest with other functions of
BIS, which may affect the confidentiality, objectivity or impartiality of the management systems
certification activity. No function of BIS involves consultancy for the development of management
systems, services to design, implement or maintain management systems and/or those services that
BIS certifies/registers. DDG - Incharge of MSC activity and Dy. Director General in the regions are
also involved in other activities like planning & coordination, public relations, legal, product
certification, promotional activities, laboratory testing, enforcement, etc. However, no conflict of
interest exists as all these functions are undertaken independently and do not affect the operations of
Management Systems Certification.
The National Institute of Training for Standardization (NITS) was established to promote Quality and
the concept of Standardization among the Indian Industry as this is one of the function of BIS as laid
down in BIS Act. To ensure independence confidentiality, objectivity and impartiality of the MSC
activity, the Training Institute has been established under a separate stream of operation which is headed
by Deputy Director General (Training Institute) who is independent of operation of BIS Management
Systems Certification Scheme. The NITS provides services to industry by organizing general
awareness training programme and lead auditor training programmes on quality, environmental,
occupational health & safety, food safety and other management systems and related topics. These
programmes including in-house training programmes are devised in such a way that they are not
company specific and are generic in nature. These programmes are confined to the provision of
generic information and advice which is freely available in the public domain. The intention of
organizing these programmes is to only to create awareness on quality, environment, safety & health
of employees, food safety, information security etc. It is the responsibility of the Director General of
BIS to ensure that in no circumstances, the training programmes organized by NITS will contravene the
requirement of the international standard to avoid any potential conflict of interest in relation with
management systems certification activities.
Standards Formulation Departments of BIS or any other department including MSC may make available
and publish on request information on the basis for interpretation of the requirements of the
assessment and other related standards. This shall not be considered as consultancy or necessarily
creating a conflict of interest.
Operation of Product Certification Scheme of BIS does not have any existing or potential conflict of
interest with the operation of Management Systems Certification services provided by BIS. There is
no undue pressure on product certification certificate holders (licensees) to adopt Management Systems
Certification Schemes.
BUREAU OF INDIAN STANDARDS MANAGEMENT
MANAGEMENT SYSTEMS CERTIFICATION SYSTEM MANUAL
APPROVED BY: DG
PREPARED BY: HEAD (MSCD)
BIS does not provide any kind of consultancy services for advising, preparing, development,
implementation, on any matter relating to Management Systems for any organization. Therefore,
neither the situation exists for marketing this activity of consultancy services nor BIS suggests or
markets any specified consultancy or training services undertaken by other organization. BIS
management system certification activities are not marketed or offered as linked with the activities of
management system consultancy organization. The training services provided by BIS are also not
marketed or suggested by Management Systems Certification for any simpler, easier or less expensive
certification process.
BIS does not certify any other certification body offering management system certification. It also
does not offer internal audit services to its licensees.
Management of impartiality and independence of MSC activity is assured at three levels as given
below:
i) Strategy & policy – Bureau, Executive Committee, Management Systems Certification Scheme
Committee, Management Review Committee, DG, ADG & DDG - Incharge
ii) Decisions on certification – DG/ADG/DDG -
Incharge/DDGRs iii) Auditing – Panel of auditors
BIS Management Systems Certification Scheme (MSCS) Committee represents a balance of interests of
various stakeholders such that no single interest predominates. It monitors the impartiality
and functioning of the MSC activity.
BIS personnel including its senior executive and staff are free from any commercial, financial and other
pressures for undertaking Management Systems Certification activity and other activities undertaken by
it which might influence the results of the certification process.
In case the nodal Central Govt. Department/Ministry which has the responsibility of administrative
control of BIS or any other organization under the control of this nodal Govt. Department/Ministry
applies for Management Systems Certification, BIS would ensure that certification process involving
audits and decision is undertaken in such a manner that it ensures impartiality through the use of a team
leader who is from outside BIS (i.e., external auditors/external technical experts) for the audits and
decision on certification is taken by MSCS Committee ensuring that representatives from the Ministry
do not have significant influence on decision on certification. This is ensured by the distribution of
voting rights and majority opinion prevails.
2.7 Outsourcing
APPROVED BY: DG
PREPARED BY: HEAD (MSCD)
2.8 Liability and Financing of BIS MSC
BIS is a statutory body and all its Income and Liability rests with the Central Government. Income and
Expenditure for various activities of BIS are made through a common pool called the BIS Fund
which finances MSCS activity along with other activities.
BIS has adequate arrangements (for example insurance or reserves) to cover liabilities arising from
its operations in each of its activities.
BIS operates MSC Activity as per the requirements specified in ISO/IEC 17021. BIS may
seek accreditation of one or more Management System Certification Schemes which it operates.
Related Documents
Bureau of Indian Standards is committed to offer Management System Certification Services to all
organizations in an impartial manner and fulfilling the requirements of ISO/IEC 17021 as a
minimum. These services are geared to all sectors of industry and the Government to maintain and
continually improve the quality of products and services; protect environment, occupational health and
safety of employees and ensure food safety.
It is the responsibility of all those concerned in the operation of Management Systems Certification
Services, including certified organizations and external auditors/external technical experts that
each activity in the operation leads to excellence thereby enhancing the credibility and image of
Bureau of Indian Standards.
BIS provides Management Systems Certification Services to all organizations against national
standard(s) on various Management Systems like Quality Management Systems as per IS/ISO 9001,
Environmental Management Systems as per IS/ISO 14001, Occupational Health & Safety Management
Systems as per IS
18001, Hazard Analysis & Critical Control Point as per IS 15000, Food Safety Management Systems
as per IS/ISO 22000, and Service Quality Management Systems as per IS 15700.
BIS provides these services to all organizations irrespective of their size and affiliations. The conflict
of interest which may arise in the provision of these services have been identified, analyzed and
documented including steps taken to eliminate/minimize such conflicts.
policy;
b) understand the spirit and intent of this policy; and
c) recognize their responsibility towards its successful implementation.
(Director General)
Bureau of Indian Standards
BUREAU OF INDIAN STANDARDS MANAGEMENT
MANAGEMENT SYSTEMS CERTIFICATION SYSTEM MANUAL
APPROVED BY: DG
PREPARED BY: HEAD (MSCD)
3.2 Objectives
Related Documents
ISO/IEC 17021: 2011 Conformity Assessment - Requirements for Bodies Providing Audit and
Certification Management Systems
MSC-G 6.4-01 Guidelines for time schedule for grant of licence.
MSC-F3.2-01 Form for obtaining feedback from customer
4. ORGANIZATION
4.1 General
The BIS MSC is operated and maintained in such a way that effective guidance is provided to each
region of BIS in the execution of the MSC, and that clear lines of responsibility and authority are
assigned and communicated to personnel in decision-making roles.
4.2 Organization Chart for MSC Activity
4.2.1 The Organization Chart for MSC activity is as given
below:
Organization Chart
BUREAU
Executive Committee
MSCS Committee
Director General
DDG-Incharge DDGR
MSCO(R)
Head (MSCD)
NOTE: DDGR - Deputy Director General for each region i.e. R = C,E,N,S, or
W
MSCO(R) - Regional Management Systems Certification Officer (R = C for Central, E for Eastern,
N
for Northern, S for Southern, W for Western and F for Foreign Regions)
Deputy Director General in each region (DDGR) i.e. in Central Region at New Delhi; Western Region
at Mumbai; Eastern Region at Kolkata; Southern Region at Chennai; and Northern Region at
Chandigarh and the respective Regional Management Systems Certification Officer MSCO(R) along
with auditors and supporting staff are responsible for undertaking MSC activities in the various
regions. Management Systems Certification activities related to foreign clients are dealt by MSCD and
such clients are covered under Foreign Region which would be designated as ‘F’).
BUREAU OF INDIAN STANDARDS MANAGEMENT
MANAGEMENT SYSTEMS CERTIFICATION SYSTEM MANUAL
TITLE: ORGANIZATION
DOC: MSC-M1-5 ISSUE: 01 DATE: JAN 2013 PAGE: 2 OF 5
Head (MSCD)
TITLE: ORGANIZATION
DOC: MSC-M1-5 ISSUE: 01 DATE: JAN 2013 PAGE: 4 OF 5
The Deputy Director General Region (DDGR) is responsible for operation of management systems
certification activities within his/her region through Management Systems Certification Officer (Region)
(MSCO(R)). S/he is responsible for decisions on assessment i.e. processing of
applications/grant/surveillance/renewal/cancellation, change of scope, complaint
handling/investigations, facilitate accreditation of management systems, achievement of targets for
management systems activities, etc. DDGR has the authority to send quotation, fill-up tenders, respond
to queries and deal with related matters as per the existing guidelines.
Head, Management Systems Certification Department (MSCD) is the Management Representative for
Management Systems Certification activities and has responsibility for maintaining uniformity
of operation of the BIS MSC in various regions, and management systems implementation within BIS.
S/he acts as central coordinator for all the Management Systems Certification schemes/activities carried
out by the regions and is also the member secretary of Management Review committee. S/he has the
responsibility and authority for ensuring the establishment, implementation and maintenance of
management systems as per ISO/IEC 17021. S/he reports the performance of the management
systems and any need for improvement in schemes to the management.
MSCO(R) reports directly to the DDGR for the day to day activities and provides necessary
information to Head (MSCD) through DDGR for monitoring and control of MSC activities. In case
more than one officer is nominated for the responsibilities of MSCO(R) in a region, they may be
designated as MSCO(R), Dy MSCO(R) etc. However, they will undertake all the functional roles and
responsibilities as mentioned under the designation MSCO(R) in MSCS documentation or other related
documents, in their respective assigned area of Management Systems Certification and assist DDGR in
the activities/responsibilities/areas/regions mentioned and authorized for DDGR.
The Document Control Officer (DCO) is responsible for the operation of the Document Control System
which applies to all documentation relating to BIS MSC. This includes policies, procedures,
guidelines, records and publications for external consumption.
BUREAU OF INDIAN STANDARDS MANAGEMENT
MANAGEMENT SYSTEMS CERTIFICATION SYSTEM MANUAL
TITLE: ORGANIZATION
DOC: MSC-M1-5 ISSUE: 01 DATE: JAN 2013 PAGE: 5 OF 5
The Internal Audit Officer (IAO) has the responsibility of coordinating all of BIS MSC activities in the
area of internal audit in order to maintain the effectiveness of the management systems operated within
the scheme as well as to ensure the policies contained in this Management System Manual are
implemented.
5. DOCUMENT CONTROL
5.1 Issue
It is the policy of BIS MSCS to maintain and operate procedures to control all documents and
information relating to the system of certification. These documents are reviewed and approved for
adequacy by authorized personnel prior to issue. It is ensured that the Manual and the relevant
associated documents are accessible to all relevant personnel.
This control ensures that pertinent issues of appropriate documents are available at all locations
where operations essential to the effective functioning of the management system are performed
and that obsolete documents are promptly removed from all points of use. It ensures that documents
remain legible and readily identifiable. Documents of external origin are suitably identified and their
distribution is controlled.
Matrix relating requirements of ISO/IEC 17021:2011 to MSC documents is maintained and updated
as and when changes are made in the existing document, as required, or new documents are introduced.
The electronic copies of applicable and current version of documents/formats & forms are available
on BIS intranet (under the folder “Auditors’ Kit”).
5.2 Amendment
Changes and amendments to documents within the management system are reviewed and approved by
the same functions, where possible, that performed the original review and approval unless specifically
designated otherwise. The designated functions shall have access to pertinent background
information upon which to base their review and approval where practicable. The nature of the change
is identified in the appropriate attachments. A master list is maintained to identify the current revisions
of documents in order to preclude the use of obsolete documents. Documents may be reissued after a
practical number of changes have been made.
Responsibility
It is the responsibility of the Document Control Officer to ensure that this policy and procedures
for control are followed. It is the responsibility of all personnel to inform the Document Control Officer
whenever a new document is needed or a change in existing document becomes apparent.
DCO is responsible for issue and distribution control of all documents pertaining to the management
system and the recall and disposal of obsolete documents at Headquarters and for their distribution to
the regions.
BUREAU OF INDIAN STANDARDS MANAGEMENT
MANAGEMENT SYSTEMS CERTIFICATION SYSTEM MANUAL
MSCO(R) is responsible for issue and distribution control of all documents in the respective region
including the recall of obsolete documents, and issue of updated or new information and publications to
applicants and licensees.
Related Documents
Policy
BIS operates and maintains a systematic approach for the operation of Management Systems
Certification Scheme which satisfies the requirements of national and international standards and their
equivalents. In doing so, BIS MSC maintains a comprehensive, documented system which provides for
effective and systematic methods of operation. The certification process confines itself to matters
specifically related to the scope of certification and locations of the applicants/licensees. In the event
of any changes to the certification standards and/or requirements for certification, due notice would be
given to the applicants/licensees and it would be ensured that each applicant/licensee complies with the
new requirements. The applicant/licensee would inform the Bureau promptly about any changes related
to Legal, Commercial, Organizational Status or Ownership, Organization and Management, Contact
Address and Sites, Scope of Operations, major changes to the Management Systems and processes. For
initial certification for management systems, the audits are undertaken in two stages, namely, the Stage 1
audit (comprising of Adequacy Audit and Preliminary visit/Planning and selection of audit team) and
the Stage
2 audit (called as Initial Audit or Certification Audit and may includes follow-up audit, if
required).
Recertification may be considered based on Stage 2 audit only (for which it is called as Renewal
Audit. An audit programme and audit plan for the entire certification cycle consisting of initial audit,
two surveillance audits and a renewal audit is worked out. The audit plan covering the objectives, scope and
criteria shall be developed for all the audits in the programme as per 9.1.2 of ISO/IEC 17021: 2011.
Integrated Management Systems Certification is also undertaken as per the relevant guidelines for same.
Transfer of accredited Management System Certification from another Certification Body to BIS is
also
undertaken as per the guidelines for the same.
Flow Chart
Responsibility
Head (MSCD) as Management Representative has the responsibility for ensuring the maintenance of the
management systems, both documented and practiced, in continual compliance with this policy.
BUREAU OF INDIAN STANDARDS MANAGEMENT
MANAGEMENT SYSTEMS CERTIFICATION SYSTEM MANUAL
Related Documents
6.1 Application
Policy
BIS operates its Management System Certification activity involving processing of application, granting
licence from its five regional offices located across the country viz. Delhi, Mumbai, Kolkata, Chennai &
Chandigarh. For applications received from overseas organizations, MSCD processes the same.
Application procedures for Management Systems Certification have been clearly documented and
communicated to the applicant. Documentation in this respect includes the following:
• the forms for submitting application along with the questionnaire-cum-declaration form;
• the steps to be followed for grant of licence;
• the terms and conditions to be agreed for the provision of the services; and
• that all organizations without discrimination are able to apply to the BIS Management Systems
Certification Schemes.
The terms and conditions that apply to the services of BIS Management Systems Certification activity
as laid down in the Application Form and reference made therein to Certification Regulations and
Guidelines for Applicants, describe the rights and responsibilities of applicants/licensees. The sectors
for which BIS MSC Scheme is accredited would be made known to the applicant. BIS also reviews the
requirements of certification in other sector before accepting the application and the same is informed to
the applicant In case of any new sector to be certified, BIS makes all efforts to identify the competent
auditors, experts and other personnel either within BIS or from outside. Accordingly, the applicant is
informed whether BIS has the ability in understanding the sector and the administrative ability to
manage audits in the new sector. The applicant agrees with the terms and conditions by signing the
application form
The application (request) of the applicant is reviewed and if required, necessary actions are taken as
per the laid down procedures and guidelines
BUREAU OF INDIAN STANDARDS MANAGEMENT
MANAGEMENT SYSTEMS CERTIFICATION SYSTEM MANUAL
Responsibility
All MSCO(R) have the responsibility for maintaining information, certification regulations,
Application Forms, Guidelines for Applicants and other related publicity material and supply to
prospective applicants. The application form and related information is also available on BIS website
www.bis.org.in
The Document Control Officer is responsible for ensuring that the MSCO(R) are issued with the
latest release of documentation to enable them to fulfill their roles in this respect.
Related Documents
Bureau of Indian Standards Act, 1986.
Bureau of Indian Standards Rules, 1987.
Bureau of Indian Standards (Certification) Regulations
1988.
MSC-P6.1-01 Procedure for processing review of
applications. MSC-P6.1-02 Procedure for closure of applications.
MSC-P6.9-01 Procedure for dealing with complaints
MSC-P11-02 Procedure for handling enquiries.
MSC-G6.1-01 Guidelines for closure of
applications.
MSC-G11- 01 Guidelines for applicants (for various management
systems)
MSC-F6.1-01 Form for Application/Licence
Register
6.2 Stage 1 Audit
Adequacy Audit and Preliminary Visit
Policy
Each application shall have to be accompanied by a controlled copy of applicant’s Manual and other
relevant documents, as required (also accepted in an electronic version). The document(s) are
examined for verifying conformance to the relevant standard. Adequacy audit and preliminary visit as
planned are executed.
Procedures for adequacy Audit together with criteria for determination of suitability are maintained
for guidance to the auditors carrying out this task.
Procedures are maintained for carrying out the preliminary visit for the guidance of the auditors carrying
out the task. During the preliminary visit, identification of expertise required for specific scope sectors
for the initial/certification audit is undertaken.
Finding of the stage 1 is documented and communicated to the applicant, including identification of any
areas of concern that could be classified as nonconformity during the stage 2 audit. A brief report
about the results of stage 1 audit is submitted to the Applicant.
BUREAU OF INDIAN STANDARDS MANAGEMENT
MANAGEMENT SYSTEMS CERTIFICATION SYSTEM MANUAL
APPROVED BY: DG
PREPARED BY: HEAD (MSCD)
Responsibility
The Document Control Officer has the responsibility for ensuring procedures and guidelines are
clearly documented and maintained for carrying out this task.
The MSCO(R) will appoint the auditor(s) for carrying out the adequacy audit, preliminary
visit.
The auditor(s) carrying out the adequacy audit and preliminary visit is(are) responsible for adhering to
the prescribed methods and criteria whilst doing so and/or clear recording of the findings.
Related Documents
ISO/IEC 17021 : 2011 Conformity Assessment - Requirements for Bodies Providing Audit
and
Certification Management Systems
IS/ISO/TS 22003:2007 Food safety management systems -- Requirements for bodies providing audit
and certification of food safety management systems
MSC-P6.2-01 Procedure for adequacy audit.
MSC-P6.2-02 Procedure for preliminary visit.
MSC-G6.2-01 Guidelines for audit time scale
estimation
MSC-G6.3-01 Guidelines for selection of
auditing
MSC-G7.1-01 Guidelines on criteria for personnel for
auditing
MSC-G7.3-01 Guidelines on criteria for external auditor for
auditing
MSC-G7.5-01 Guidelines on criteria for competence for various management
systems
Policy
An Audit Programme for initial Audit (Certification) is planned and team of auditors chosen for
execution of Initial Audit is predetermined based on an estimate of the technical and resource
requirements for the task. The personnel are chosen from the list of approved auditing personnel and are
suitably qualified to successfully execute their responsibilities
The names and, when requested, the available background information for each member of audit
team and audit plan are informed to the applicant with sufficient notice to appeal and if there are any
objections, the same are evaluated and accordingly actions are taken.
The audit time is determined with justification to accomplish a complete and effective audit as per
existing guidelines. Where multi-site sampling is utilized, a multi-stage sampling plan is developed.
BUREAU OF INDIAN STANDARDS MANAGEMENT
MANAGEMENT SYSTEMS CERTIFICATION SYSTEM MANUAL
The appropriate working documents which comprise of audit checklist/report format, etc are provided to
the audit team. The process of conducting the on-site audit has been described in a procedure. An audit
report is submitted for each audit.
Responsibility
The Personnel and Training Officer has the responsibility of ensuring that competent personnel are
available and are proposed for executing the audit. The list of auditing personnel is regularly updated
and put up on BIS Intranet.
MSCO(R) has the responsibility to recommend the audit team in accordance with Guidelines for
selection of audit team, estimation of audit time and is also responsible for ensuring compliance to the
procedures for preparation for auditing, for audit planning, communicating with applicant and audit team
members, providing working documents to audit team and coordination and execution of the audit plan.
Deputy Director General (Region) has the responsibility to approve the nomination of the audit team in
accordance with the Guidelines for Audit Team Selection.
Director General has the responsibility for approval of nomination of officer of level of Additional
Director General. ADG has the responsibility for approval of nomination of officer of the level of Sc.
‘G’ and DDG.
Related Documents
ISO/IEC 17021 : 2011 Conformity Assessment - Requirements for Bodies Providing Audit
and
Certification Management Systems
MSC-P6.4-01 Procedure for conduct of audits
MSC-P6.7-01 Procedure for surveillance and renewal MSC-
G6.2-01 Guideline for Audit time scales estimation
MSC-G6.2-02 Guidelines for integrated management
systems MSC-G6.2-03 Guidelines for audit of multi-site units
MSC-G6.3-01 Guidelines for selection of audit
team
MSC-G7.1-01 Guidelines on criteria for personnel for
auditing
BUREAU OF INDIAN STANDARDS MANAGEMENT
MANAGEMENT SYSTEMS CERTIFICATION SYSTEM MANUAL
The integrity and impartiality of the audit team whilst executing the audit are ensured at all times
both through the documented procedure and guidelines as well as any supervision placed on the team.
Each audit commences with an opening meeting and concludes with a closing meeting and includes a
full report by the audit team on the findings of the audit based on analysis of all information and
audit evidence gathered during the audits. These are clearly and objectively documented in the form of a
report.
A brief report is submitted to the applicant during the closing meeting. A detailed report is submitted
by the team leader to MSCO(R) and any differences from the report submitted to the applicant are
explained/ brought out clearly for the benefit of the applicant. Applicants are requested to give feedback
on the conduct of audit with the purpose of identifying areas of improvements particularly that related to
certification process.
Any non-conformity found is recorded, and the applicant is required to undertake root cause analysis and
describe the specific corrections and corrective actions, taken or planned to be taken, to eliminate the
detected nonconformities as well as the causes for these non-conformities, within a defined time frame.
Audit team may identify opportunities for improvements but does not recommend specific
solutions.
Responsibility
DDGR is responsible for ensuring the systems are in place and followed for the successful execution
of the audit in their respective region. MSCO(R) is responsible for the successful execution of systems
and audits for his region. He is also responsible for the upkeep of the applicant records.
Team leader is responsible for carrying out the audit in line with prescribed guidelines and procedures
for factual reporting and recording.
Related Documents
6.5 Follow-Up
Policy
The corrections and corrective actions submitted by the applicant for the nonconformities pending
from the stage 2 audit are reviewed for acceptance. Based on such review, the applicant is informed if
an additional full audit, an additional limited audit, or documented evidence (to be confirmed during
subsequent surveillance audits) will be needed to verify effectiveness of the actions taken.
Responsibility
The applicant is responsible for the timely resolution of deficiencies as outlined in the audit
report.
Team leader is responsible for review of corrections and corrective actions submitted by the
applicant. For situations such as non-availability of the team leader, such review can be got done
through other auditor of the audit team or even done by MSCO(R).
Related Documents
MSC-P6.4-01 Procedure for conduct of audits
6.6 Licensing
Policy
The decision to grant or not to grant a licence is based on the recommendation by the audit team and is
taken by the person who has not participated in the audit. The assessment, the requirements of
certification and the decision thereof are limited to the scope of certification. The Bureau grants
certification in the form of a licence to applicants who have demonstrated successfully their
compliance with the requirements of the applicable standard and BIS MSC requirements. The
licence is qualified by a Schedule, which defines the scope of the management system covered by the
licence.
This Licence is valid for duration of not more than 3 years from the date of approval and is subject to
the agreed Terms & Conditions and in accordance with BIS (Certification) Regulations, 1988 as
amended from time to time. Licence is renewed subject to continued compliance with the terms &
conditions of the regulations and documentation under BIS MSC.
The authority for granting, renewing, changing the scope, suspending or cancelling certification is not
delegated to any person or body outside BIS.
Any amendment to the certification is processed as per the laid down procedures/guidelines.
Similarly, decisions on change, suspension, cancellation etc., are undertaken based on the documented
procedures and guidelines.
BUREAU OF INDIAN STANDARDS MANAGEMENT SYSTEM
MANAGEMENT SYSTEMS CERTIFICATION MANUAL
Responsibility
DDGRs are responsible for granting the Licence within the Region under their respective jurisdiction. In
case, the audit team comprises of DDG(R), Sc. G/DDG - Incharge of MSC activity is responsible
for granting the licence. In case ADG/Sc’G’ or DDG other than DDG(R) is part of the audit team,
DDG(R) is responsible for granting the licence. Similarly, approval for amendment in scope,
reduction, suspension, withdrawal, cancellation, etc., is accorded by DDG(R) and other officers under the
circumstances mentioned above.
MSCO(R) is responsible for verifying, based on the documentation and through other means, that all
necessary pre-qualifications have been fulfilled prior to recommending that a licence be awarded and
also for amendment in scope, reduction, suspension, cancellation, etc.
Related Documents
Policy
The Licensee at all times during the life of the Licence is subjected to regular surveillance activities as
per the Audit Programme, which includes on-site audits, assessing the Licensee’s management system's
fulfillment of specified requirements with respect to the standard to which the certification is
granted. Other surveillance activities may include
The Licensee is also subjected to renewal audits for compliance to the requirements of the Licence.
Surveillance and renewal audits are undertaken as per the laid down procedure and guidelines. The
surveillance is carried out at least once a year in the certification cycle. The date of the first
surveillance audit following initial certification should not be more than 12 months from the last day
of the stage 2 audit.
Renewal (or recertification) audits are planned in the third year and conducted to evaluate and confirm
the continued conformity and effectiveness of the management system as a whole, and its continued
relevance and applicability for the scope of certification. The procedures and guidelines are consistent
with those for initial audit.
Licence is renewed for a period of three years. However, this period may be slightly reduced in order to
align with the validity dates of other licences provided the licensee agrees to pay the licence fee for the
entire three year period.
Special audits for extension of scope or short notice audits (like for complaint investigation, changes in
the structure of the client organization) may also be conducted in response to a request by the licensee.
Any change in scope, suspension, cancellation, etc., of the licence may result from surveillance
activities and renewal audits as given in the section for licensing.
Responsibility
The MSCO(R) at each regional office has the responsibility of scheduling, coordinating surveillance and
renewal activities in the region and that prescribed records are maintained for review of performance of
each license. The MSCO(R) is responsible for ensuring that a schedule of surveillance and renewal
is established for each Licensee and that it is followed.
The DDGR is responsible for ensuring adequate resources are available for carrying out this task and also
for timely taking actions based on the inputs of surveillance audit/renewal audit throughout the region.
Related Documents
6.8 Appeals
Policy
BIS Management System Certification Scheme provides for an independent and impartial appeals
process. All decisions relating to grant, renewal, suspension or cancellation of Management System
Certification licence by BIS under the Management System Certification Scheme can be subject to
appeal. Appeals shall be made formally, in writing, not later than 90 days from the date of intimation
of the decision of BIS, marked for the attention of the Secretary, Department of Consumer Affairs,
Ministry of Consumer Affairs, Food and Public Distribution, Government of India, in accordance with
Section 16 of the Bureau of Indian Standards Act, 1986.
The appellant would be provided an opportunity to formally present his case. Appeal findings
including the reasons for the decision taken shall be informed to the appellant in writing. The decision of
the Appellate Authority is final.
Related Documents
6.9 Complaints
Policy
Complaints received by BIS related to Management System Certification activity is treated with
utmost importance. A documented procedure for handling complaints is operated and maintained which
ensures adequate recording, investigation and resolution. All complaints received be recorded and
acknowledged prior to investigation. Complainant is notified as to the results of the findings of
investigation of the complaint. Complaints are regularly reviewed to identify possible trends or
weaknesses or areas of improvement which can be made within the MSC activity.
Complaints received by licensee for their product and/or services are verified by the auditors during each
audit (initial, surveillance, renewal, special) for their redress.
Responsibility
The Deputy Director General-Incharge and Deputy Director General (Region) as given in the
documented procedure, are responsible for determining the correct redress process for a complaint,
either against BIS or an applicant or a licensee, and for resolving it within the stipulated time.
The Management Systems Certification Officer (MSCO) of the region and Head (Management Systems
Certification Department) as given in the documented procedure, are responsible for the efficient
coordination of investigations and timely resolutions of complaints which could originate from any
member of the public, body corporate, or applicant.
Related Documents
Policy
The Standard Mark for each Indian Standard on management system is notified in the official
Gazette.
The use of the licence(s) and its related Standard Mark(s) is carefully controlled. Licensee is clearly
instructed and monitored regarding use and display of the Licence(s) and the Standard Mark(s) as well as
the penalties to be imposed for misuse. The Standard Mark(s) is not used on a product or
product
BUREAU OF INDIAN STANDARDS MANAGEMENT
MANAGEMENT SYSTEMS CERTIFICATION SYSTEM MANUAL
Head (Management Systems Certification Department) is responsible for ensuring that clear
instructions are documented.
The MSCO(R) is responsible for communicating to licensees on the appropriate usage of the
licence(s)
and the Standard Mark(s).
Auditors are responsible for checking on the usage of the licence(s) and the Standard Mark(s) during
surveillance and renewal audit.
Related Documents
Policy
It is the policy of BIS MSC to ensure that certification of organizations to requirements of relevant
management system standard, shall be administered in a controlled, impartial, non-discriminatory
manner and without any undue financial or other conditions to any applicant.
BUREAU OF INDIAN STANDARDS MANAGEMENT
MANAGEMENT SYSTEMS CERTIFICATION SYSTEM MANUAL
DDG - Incharge, DDGR, MSCO(R) and Head (Management Systems Certification Department) are
responsible for the analysis of the accounts figures and reporting the same to the ADG, DG, and to
the MSCS Committee.
Related Documents
MSC-P6.12-01 Procedure for control of finances and collection of
fees.
Policy
BIS extends the services of Management Systems Certification to other countries based on the
request received from such countries depending upon the relations, agreements and feasibility of
operations. The licensing policy is the same as defined in 6.6
Responsibility
DG, BIS approves the nominations of all auditors and experts for the audit of foreign organizations.
Sc.
‘G’/DDG-Incharge is responsible for grant/renewal/suspension/cancellation/ expiry of licence to
foreign
organizations. Head (MSCD) is responsible for ensuring fulfillment of certification criteria, collection
of fees, review of audit report and processing for various stages of certification to foreign organizations.
MSCO (F) is responsible for verifying, based on the documentation and through other means, that all
necessary pre-qualifications have been fulfilled prior to recommending that a licence be granted and also
for amendment in scope, suspension, cancellation, etc.
Related Documents
TITLE: PERSONNEL
DOC: MSC-M1-5 ISSUE: 01 DATE: JAN 2013 PAGE: 1 OF 3
7. PERSONNEL
7.1 Selection
Policy
All personnel involved in the BIS MSCS are assigned activities for which they are adequately trained
and have relevant experience and are competent to fulfill their roles. DDG(R)s and MSCO(R) are to be
competent to assess applications, conduct review of applications, select auditors and verify their
competence and also brief auditors, arrange training, and implement assessment, surveillance and re-
assessment procedures. The authorized personnel are competent to decide on granting, renewing,
changing the scope, suspending or cancelling certification. They are also able to deal with complaints and
appeals.
Training of personnel is carried out in a planned and controlled manner to ensure maximum
effectiveness. Sufficient number of personnel and if required external auditors/external technical experts
are empanelled for undertaking audits. Personnel have the knowledge and skills and experience as
per the kind of activity assigned to them especially in the technical areas/scope sectors for which they
undertake audits. No personnel including external auditors/external technical experts are involved in any
consultancy services, employment or any kind of relation with the organization for which they are
deputed for the auditing. Team Leaders, Auditors and expert(s) meet the requirements as given
under guidelines for criteria for auditing personnel and competence criteria for specific management
systems in line with the corresponding national/international standard and accreditation requirements, as
applicable.
Responsibility
The Personnel and Training Officer has the responsibility for ensuring personnel requirements, audit
records and maintenance of training records. Training plans and updated skill records are established
and maintained for the effective use of human resources within the BIS MSCS.
Sc. ‘G’/DDG - Incharge is responsible for ensuring that only qualified personnel are selected in the
execution of the certification process
DDG(R) is responsible for ensuring that only selected personnel are utilized/nominated in the execution
of the certification process.
Head (Management Systems Certification Department), and the MSCO(R)s are responsible for ensuring
that all supporting staff reporting to them are assigned tasks for which they are adequately trained. They
also maintain the related training records.
Selection
All personnel utilized for carrying out the Management Systems Certification audits are selected based
on pre-identified requirements including knowledge and skills. The other personnel engaged in
the
BUREAU OF INDIAN STANDARDS MANAGEMENT
MANAGEMENT SYSTEMS CERTIFICATION SYSTEM MANUAL
TITLE: PERSONNEL
DOC: MSC-M1-5 ISSUE: 01 DATE: JAN 2013 PAGE: 2 OF 3
Personnel and Training Officer maintains a record of all personnel who could be utilized in the
certification process and this contains, as a minimum, their name and contact details, audit records,
discipline (expertise), training, experience and qualifications.
All personnel utilized for certification are trained as and when there are any changes in auditing
practices and/or management system standards.
BIS engages the services of external auditors/external technical experts. The policies specified for
BIS personnel regarding knowledge; skills and registration are equally applicable for external
auditors/external technical experts as well.
Selection
The Personnel and Training Officer maintains comprehensive criteria for the selection of external
auditors/external technical experts. They are required to formally apply for status as an approved
external auditor and this becomes a data of approved individuals for carrying out audit work
within the certification scheme. External auditors/External technical experts are utilized only for
activities for which they can demonstrate technical capability, impartiality and experience.
Agreement
Individual external auditors/external technical experts have to give a written undertaking by which
they commit themselves to comply with the applicable procedures and policies of BIS. It also
includes elements of impartiality, confidentiality, fee structure, independence from commercial and
other interests and other requirements as applicable. In case an individual external auditor/technical
expert is a part of an organization, s/he submits No Objection Certificate from the employer.
The Personnel and Training Officer is responsible for controlling all external auditors/external technical
experts in order to provide a central point of reference and communication.
BUREAU OF INDIAN STANDARDS MANAGEMENT
MANAGEMENT SYSTEMS CERTIFICATION SYSTEM MANUAL
TITLE: PERSONNEL
DOC: MSC-M1-5 ISSUE: 01 DATE: JAN 2013 PAGE: 3 OF 3
The Management Review Committee comprises of DG (as Chairman), ADG, Sc. G/DDG-Incharge,
DDG(R)s, Head (MSCD), DCO, PTO, IAO and MSCO(R)s. Other officers may also be invited, as
necessary. Head (MSCD) acts as Secretary.
Records of Management Review Meeting are maintained. Any corrective/ preventive actions agreed and
allocated by the Management Review Committee, are initiated, action completed, recorded, closed out
and confirmed by the Internal Audit Officer.
Responsibility
The Sc. ‘G’/DDG-Incharge of MSC activity is responsible for ensuring that the Management
Review meeting is held.
BIS MSC has established a procedure for identification of nonconformities in its operation. Actions are
taken to eliminate the causes of nonconformities in order to prevent reoccurrence. Corrective actions
taken have to be appropriate to the impact of the problems encountered.
BIS MSC has established a procedure for taking preventive actions to eliminate the causes of
potential nonconformities. Preventive actions taken shall be appropriate to the probable impact of the
potential problems.
BUREAU OF INDIAN STANDARDS MANAGEMENT
MANAGEMENT SYSTEMS CERTIFICATION SYSTEM MANUAL
Head (MSCD) is responsible for scheduling the meeting of the Management Review by Management
Review Committee. He prepares the agenda and the minutes of the meeting. He ensures effective
implementation of corrective and/or preventive actions including follow-up actions, and ensures
recording the results for reporting to the MSCS Committee.
Related Documents
ISO/IEC 17021:2011 Conformity Assessment - Requirements for Bodies providing audit and
certification of management systems
MSC-P8-01 Procedure for internal audits and
reviews
MSC-P8.2-01 Procedure for corrective action and preventive
actions
MSC G8.1-01 Guidelines on role of audit planning
group
MSC G8.1-02 Guidelines on Internal Audit
Schedules
MSC-G8.2-01 Guidelines for management
review
BUREAU OF INDIAN STANDARDS MANAGEMENT
MANAGEMENT SYSTEMS CERTIFICATION SYSTEM MANUAL
TITLE: RECORDS
DOC: MSC-M1-5 ISSUE: 01 DATE: JAN 2013 PAGE: 1 OF 1
9. RECORDS
Policy
Procedures are established and maintained to define the controls needed for the identification, storage,
protection, retrieval, retention time and disposition of records of all key activities related to management
systems certification. The records are identified, managed and disposed off in such a way as to ensure
that the integrity of the process and confidentiality of the information are maintained. Records are
stored in such a way that retrieval methods are effective and their condition preserved. Retention
periods are a minimum of five years for all records. Records of applicants and licensees are retained for
the duration of the current cycle plus one full certification cycle, as applicable. The integrity of the
process and confidentiality of the information in the records is ensured by storing the records in a
room/designated area. After its retention period is over, the records are physically destroyed.
Responsibility
The Head (MSCD) has the responsibility of establishing and maintaining effective procedures for
the management of records for the BIS MSC activities, including storage, retrieval and retention.
The Head (MSCD) is responsible at MSCD Department, and the MSCO(R) in his/her region, for
ensuring that records procedures are adhered to.
Related Documents
TITLE: CONFIDENTIALITY
DOC: MSC-M1-5 ISSUE: 01 DATE: JAN 2013 PAGE: 1 OF 1
10. CONFIDENTIALITY
Policy
All MSC activities ensure full confidentiality of their applicants’/licensees’- confidential material or
information held by the BIS MSCS. Each applicant/licensee file are segregated from the others and
no comparison is made by MSCS personnel between findings of audits in one applicant/licensee to those
of another. All personnel who may gain access to confidential information are bound by a
confidentiality agreement not to disclose any information considered to be confidential by the
applicant/licensee without written agreement of the applicant/licensee and to take the utmost care in
filing and handling of confidential information.
All team leaders, auditors, technical experts and external auditors/external technical experts are bound
by a code of professional ethics which, together with contractual arrangements with each individual,
shall remain in force at all times.
All personnel including external auditors/external technical experts are required to keep all
information confidential, particularly from fellow employees and from their other employers.
Any information other than that available under public domain required about a applicant/licensee or
individual is to be provided to third party with his/her written consent. In case, any confidential
information is required by law to be released to a third party, the applicant/licensees or individual
concerned would, unless regulated by law, be intimated in advance about the information provided.
When any confidential information is shared with accreditation body or peer assessment body, it is
informed to the applicant/licensee.
Responsibility
The Deputy Director General- Incharge and Dy. Director General (R) are responsible for ensuring all
personnel are aware of the importance of confidentiality as well as adhere to good practices which
safeguard this area, and that procedures are operated in such a way as to maintain this confidentiality
MSCO(R), Head (Management Systems Certification Department) and team leader are responsible for
ensuring that all audit team members including external auditors/technical expert and staff complete
statements of confidentiality.
Related Documents
TITLE: PUBLICATIONS
DOC: MSC-M1-5 ISSUE: 01 DATE: JAN 2013 PAGE: 1 OF 1
11. PUBLICATIONS
Policy
It is the policy of BIS MSC to publish, update or make available on request information regarding
the management systems certification and how they are operated, the requirements for obtaining
certification and a list or register of licensees including status and the scope of their certification.
The information regarding certification schemes of various management systems is available on BIS
web-site www.bis.org.in
The requirements for certification includes a description of the rights and duties of certified
organizations including requirements for and restriction against the use of the Standard Mark and use of
words referring to the certificate granted. These publications are reviewed at least once in three years
and at any other time as and when change may be considered necessary.
Responsibilities
It is the responsibility of the MSCO(R) to ensure that all publications are available to the
applicants, licensees and anybody else.
Related Documents
APPLICANT
SUBMISSION OF APPLICATION
SCRUTINY REJECT
BY BIS
APPLICANT
ANNEX-I
ACTIONS TAKEN ACCEPTED
ADEQUACY
AUDIT
ACTIONS REQUIRED
APPLICANT
ACTIONS TAKEN
PRELIMINARY
ACTIONS REQUIRED VISIT/ PRE-
AUDIT
FOLLOW UP
(if, required)
Satisfactory AUDIT Unsatisfactory
APPLICANT REPORT
ACTIONS REQUIRED
Unsatisfactory CLOSE
Satisfactory APPLICATION
CLOSE
APPLICATION
LICENCE GRANTED
SURVEILLANCE
RENEW AL