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1
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Introduction
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1.1
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ICRS operates a Management System Certification scheme under
which certifications are granted to clients, namely manufacturers,
distributors, importers, assemblers, service organizations whose
documented Management System conforms to ISO 9001:2000 on a continuous
and consistent basis.
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1.2
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1.3
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This scheme is applicable to all
organizations regardless of size, type and product/service provided.
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1.4
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1.5
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The rules
that govern this scheme are given in clause 3 of this certification
document.
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2
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DEFINITIONS
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2.1
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Audit – Systematic
independent and documented process for obtaining audit evidence and
evaluating it objectively to determine the extent to which audit
criteria is fulfilled.
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2.2
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Certificate
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Document indicating that a client’s management system conforms to
management system standard and any supplementary documentation required
under the system.
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2.3
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Certified client – The party that is
responsible for the product, process or service and able to ensure that
management system is exercised.
This definition may apply to manufacturers, distributors,
importers, assemblers, service organizations etc. It could be a
company, corporation, firm, enterprise or institution, or part or
combination thereof, whether incorporated or not, public or private,
that has its own functions and administration.
Notes:
1.
For
organizations with more than one operating unit, a single operating
unit may be defined as an organization.
2.
The Organization is the entity
that is responsible for the management system and is able to ensure
that the management system is operating effectively.
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2.4
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Stage 1 Audit - An abridged audit that involves a review
of an Organization's operation to determine their initial preparedness
for the initial stage 2 audit.
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2.5
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Short notice audit – Audit of certified
clients at short notice to investigate complaints or in response to
changes or as follow up on suspension.
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2.6
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Quality
Management System (QMS) – Management System to direct and control an
organization with regard to quality.
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2.7
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Certification Body - Third-party,
which assesses and certifies the Management System of an organization
with respect to applicable Management System Standards and any
supplementary documentation required under the system.
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2.8
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Certification System – System, having it’s own rules of procedure and management for
carrying out the audit leading to the issuance of a certification
document and its subsequent maintenance.
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2.9
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Suspension of
Certification - A status of Certification, normally of a temporary nature, issued
by ICRS. While Certification is suspended, an organization may not
advertise or promote its status as a certified organization.
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2.10
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Scope of Certification - The activities of the
organizations that are included within the management system.
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2.11
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Technical Experts - Person who provides
specific knowledge or expertise to the audit team, but who may not
participate as an auditor. Specific knowledge or expertise is that
relates to the organization, process or activity or language or culture
to be assessed.
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2.12
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Withdrawal of
Certification - Requires return of the Certificate, cessation of use of
related accreditation/Certification body marks, logos or symbols in any
form, and any reference to certification status.
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3
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Requirements
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3.1
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Initial Audit for Certification
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3.1.1
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Upon acceptance of the RSA
and MA by ICRS and agreement by both parties, [please refer ICRS-01-01
(F)-R00, ICRS-01-06A (F)-R00, ICRS-02-01B (F)-R00 and ICRS-01-02
(F)-R00], ICRS will make the necessary arrangements with the applicant
for further action.
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3.1.2
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ICRS shall perform a
review of the client’s documented system for compliance to
applicable standards. For
document review the following documents are requested from the client.
QMS
Certification: Quality Manual and Procedures.
Integrated management
system documentation for QMS or EMS is
considered if all the elements of each relevant management system
standard are addressed.
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3.1.3
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The audit team during the
audit (s) shall carry out the following
a) to
examine and verify the structure, policies, processes, procedures,
records and related documents of the client organization relevant to
the management system,
b) to
determine that these meet all the requirements relevant to the intended
scope of certification,
c) to
determine that the processes and procedures are established,
implemented and maintained effectively, to provide a basis for
confidence in the client's management system, and
d) to
communicate to the client, for its action, any inconsistencies between
the client's policy, objectives and targets (consistent with the
expectations in the relevant management system standard or other
normative document) and the results.
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3.1.4
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ICRS will perform audits
in two stages at the client premises. Stage 1 on-site audit is for the
purpose of determining a preliminary status of the organization’s
compliance with relevant standards and readiness for the initial stage
2 audit. Objective of the stage 1 audit are as per clause 5.2.2 of
ICRS-QP-02. The observations made during the stage 1 audit shall be
resolved before the stage 2 audit in no case
it shall not exceed 90 days. When it exceeds 90 days, consideration
will be based on the complexity of the issue. Stage 2 on-site audit is
to evaluate the implementation including effectiveness of the
client’s management system.
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3.1.5
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ICRS shall nominate a
competent audit team to evaluate all information collected from the
applicant and to conduct the audit on its behalf. Experts in the areas
to be audited may be attached to the team as technical experts/advisers
and language translators. Arrangements will be coordinated with the
auditee for a mutually acceptable schedule for the audit.
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3.1.6
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The auditee
shall be informed of the names of the members of the audit team (and
technical experts, if applicable) to carry out the audit, with
sufficient notice to appeal in writing against the appointment of any
particular auditors or experts. ICRS may use empanelled auditors.
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3.1.7
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The audit
team shall audit the management system of the auditee covered by the
defined scope of certification against all applicable certification
requirements and in accordance with relevant system and provide a
formal written report of its findings as to the Auditee’s
conformity with all of the certification requirements. The audit team
shall also verify the effectiveness of internal quality audit and
management review and also the stage of implementation of decision(s)
taken at management review. The auditee is invited to comment on the
report and to inform the specific actions taken, or planned to be taken
within a defined time, to rectify any nonconformity with the
certification requirements identified during the audit. ICRS shall
inform the auditee of the need for full or partial follow up audit or
documentary evidence. All identified nonconformances shall be closed prior
to certification.
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3.1.8
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Sufficient
data on an Auditee’s compliance with relevant standard(s),
gathered during the certification review and surveillances, is relevant
and necessary to determine whether the Auditee’s system conforms
to the standard(s). In the event that certain specific data or other
information related to compliance are not made available to ICRS for
review because of an assertion of legal privilege or their proprietary
nature, certification shall not be granted, or shall not continue. ICRS
shall obtain demonstration by objective evidence that the full system
requirements relating to compliance, covering the applicable section of
the standard, have been effectively implemented by sufficiently
documented and verifiable means that includes documented procedure for
evaluating compliance, objective evidence of it’s
implementation, review by management and identified corrective and
preventive actions.
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3.2
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Certification
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3.2.1
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The decision whether or
not to certify an Auditee’s management system shall be taken by
ICRS on the basis of the information gathered as part of the
certification activities. Those who make the certification decision
shall not have participated in the audit. The auditee shall be notified
of the certification decision in writing.
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3.2.2
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ICRS
shall provide to each of its clients whose management system has been
certified, a certificate [form ICRS-03-01(F)-R00] signed by an
authority who has been assigned such responsibility. Certificate is
valid for three years from the date of issuance. Upon receipt of the
certificate by the client, the organization is authorized to use the
ICRS’s and the accreditation body’s marks, logos, and
symbols, in accordance with procedure for use of certification /
Accreditation Body’s Marks, Logo and Symbols, (ICRS-QP-14).
ICRS shall
process any application for amendment/extension to the scope of a
certification that has already been granted according to procedure
(ICRS-QP-03).
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3.2.3
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The amount
and manner of payment shall be informed to prospective applicant
through Registration Service Agreement [ICRS-01-06A (F)-R00). The
certification shall be processed according to “Master Agreement
for certification services”.
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3.2.4
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Any outstanding
fees associated with the certification activity must be paid in full
prior to certificate issuance.
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3.3
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Maintaining of
Certification
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3.3.1
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ICRS
shall maintain regular surveillance of the client’s management
system. Surveillance of a client’s management system shall be
performed at least once per year and shall ensure that over a period of
three years the entire management system is audited against every
applicable element of the relevant standard. The date of the first
surveillance audit following initial certification shall not be more
than 12 months from the last day of the stage 2 audit. The second
surveillance audit shall be carried out within one month ahead and
three month after the due date. A
re-certification of compliance to requirements is required to continue
for additional three-year period.
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3.3.2
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Surveillance and/or audit frequencies will be
modified as necessary if a certified client makes major modification to
its management system or other changes, which could affect the basis
for Certification. The client shall notify ICRS in writing of these
modifications/changes (i.e., change of ownership, changes in key
personnel or equipment, plant relocation, modification/elimination of
procedures/processes, modification to scope etc) for evaluation. Or if
analysis of a complaint or any other information indicates that the
certified client no longer complies with the requirements of ICRS.
Surveillance and re-certification procedures shall be consistent with
those concerning initial certification of the client’s management
system
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3.3.3
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ICRS will conduct short notice audit to
investigate complaints.
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3.3.4
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Renewal of Certification
will be based on the fresh contract.
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3.4
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Suspension and Withdrawal
of Certification
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3.4.1
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All suspensions will be decided
by the ICRS certification decision making group (Ref Sec 5.5.2 of
ICRS-QP-03). Notification to the client shall be in writing including
the conditions necessary under which the suspension will be removed.
Examples that may prompt suspension are:
1. Non-Payment in accordance
with the requirements of the agreement;
2. Significant areas of
non-conformance with applicable Management Standards;
3. Ineffective or delayed
correction of observed non-conformities;
4. Ineffective completion and
implementation of program revisions required to meet
revised Management Standards;
5. Misuse of the
Accreditation Body marks, logos and symbols.
6. Certified client has
voluntarily requested for suspension.
7. In the event of certified
organization is not able to consent ICRS to conduct first surveillance
audit not
more than 12 months from the last
day of stage2 audit, second surveillance three month after its due
date.
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3.4.2
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On
fulfillment of the indicated conditions and confirmation by the client,
such changes shall be reviewed by CDMG for removal of suspension.
Client shall be informed of the decision.
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3.4.3
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The
certification can be kept in suspended condition for only 6 months.
Certification shall be withdrawn or scope shall be reduced in case the
client fails to resolve the issues resulted
the suspension.
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3.4.4
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ICRS shall withdraw
Certification under the following conditions.
1. Under the relevant
provisions of Clause 3.4.1;
2. At the request of the
Organization;
3. If the Management System
Rules are changed and the Organization either will not or cannot ensure
conformance to the new requirements within the agreed time frames;
4. If the Organization fails
to meet financial obligations as agreed with ICRS;
5. Closure of a company or
facility;
6. Noncompliance or failure
to execute ICRS contractual requirements;
7. Falsification of any
nature;
8. Other conditions deemed
appropriate or formally agreed between ICRS and the organization.
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3.4.5
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Certifications
placed in suspension shall require an on-site audit of corrective
action prior to reinstatement at the discretion of ICRS. Certifications
that are withdrawn will require the certificate to be returned to ICRS
and a full recertification performed of the entire management system
prior to reinstatement.
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3.5
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Extension
of a Client Scope
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3.5.1
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If a client requires extension of scope, must be submit in
writing to ICRS for evaluation. ICRS will determine required action and
determine any audit activity necessary to decide on extension. This may
be conducted in conjunction with a surveillance audit. This audit
conducted as per laid down procedure (ICRS-QP-02).
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3.5.2
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Based on the recommendation by CDMG. A revised certificate will
be issued indicating the revised scope.
The new certificate shall include revised current certificate
issuance date. Original certification date and expiry date shall remain
the same.
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3.6
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Reduction of client scope
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3.6.1
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During the surveillance audit / short notice audit, if the audit
team /auditor noted any non-conformity or situation that may lead to reduction
of scope. Audit team leader / auditor shall report the situation with
his findings (ICRS-02-08B (F) – R00).
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3.6.2
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ICRS will reduce the scope of certification when the client has
persistently or failed to meet the certification requirements for those
parts of the scope of certification. All such reduction should be in
line with the requirements of the standard used for certification.
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3.7
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Changes in the Certification requirements, Revision
to management system standards
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3.7.1
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In the
event of changes to the management system Certification criteria or
revisions to applicable international standards ICRS will provide
notification to the client specifying an effective date for the
proposed change. The effective date shall be as provided by
accreditation bodies, relevant international bodies, or the
Certification body. ICRS will specify a plan and schedule for
monitoring the client’s actions to achieve conformity to the
revised criteria. Where permitted, the effective date will be mutually
agreed between ICRS and the client to allow sufficient time for
implementation and/or as decided by the competent authority.
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3.7.2
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Within three
months after receipt of the notification of change(s), the client shall
inform ICRS whether it accepts the change(s). If the client informs
ICRS that it accepts the change(s), and if the outcome of a
supplementary audit is favorable, the change(s) will be considered part
of this agreement from the effective date of the change. If the client
does not accept the change(s) or fails to respond, or the outcome of
any future audit is unfavorable this agreement will terminate no later
than effective date of the change and the conditions of Clause 3.4.1
shall come into force.
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3.8
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Complaints / Appeals
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3.8.1
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An Organization who is
aggrieved in any way as a result of this agreement or by other actions
of ICRS as they relate to the Certification process may file a written
complaint. This must be received by ICRS within 30 days of occurrence.
If the complaint is not satisfactorily resolved, the Organization may
appeal the decision to ICRS, within 30 days of the original
disposition. If the Organization is still not satisfied, the dispute
may be referred to courts located at Delhi
/ New Delhi.
All parties to the dispute must agree to abide by the decision of the
court (ICRS-QP-06).
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4
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Auditee’s/Clients Responsibilities
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Organizations are required
to fulfill the following additional responsibilities:
Organizations are required to fulfill the
following additional responsibilities:
a)
Conforms to the requirements of the certification body when
making reference to its certification status in communication media
such as the internet, brochures or advertising, or other documents,
b)
Does not make or permit any misleading statement regarding its
certification,
c) Does
not use or permit the use of a certification document or any part
thereof in a misleading manner,
d) Upon suspension or withdrawal of its
certification, discontinues its use of all advertising matter that
contains a reference to certification, as directed by the certification
body (see 3.4.1 and 3.4.4),
e)
Amends all advertising matter when the scope of certification
has been reduced,
f)
Does not allow reference to its management system certification
to be used in such a way as to imply that the certification body
certifies a product (including service) or process,
g)
Does not imply that the certification applies to activities that
are outside the scope of certification,
h) Does not use its certification in such a
manner that would bring the certification body and/or certification,
i)
The certified client has the responsibility for conformity with
the requirements for certification,
j)
Client shall provide suitable
date for surveillance date as and when due, and
k)
Client shall make the payments
as and when they are due.
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