17021-1-2015 - Checklist - Final
17021-1-2015 - Checklist - Final
17021-1-2015 - Checklist - Final
Legend: C – Complies, O – Observation, T – To Address at office Assessment , N – Nonconformity, N/A – Not Applicable, F – Further information required
Page 1 of 74
ISO 17021:2011 Checklist for all CBs
UNITED ACCREDITATION FOUNDATION
Is the certification body responsible for its Covered under section 5.1.3 of the manual, Yes, same has been
decisions relating to certification, including the addressed in the certification contract. Refer the same under article 10 of
granting, refusing, maintaining of certification, the certification audit contract
expanding or reducing the scope of
certification, renewing, suspending or
restoring following suspension,, or
withdrawing of certification ?
5.2 Management of impartiality
5.2.1 Conformity assessment activities shall be Covered under 5.2.1 of the Manual. Top Management commitment is stated
undertaken impartially. The CAB shall be to be available on web-site of the CB website: www.qcspl.com
responsible for the impartiality of its
Unbiased audit is emphasized upon
conformity assessment activities and shall not
allow commercial, financial or other pressures
to compromise impartiality
5.2.2 The CAB shall have top management The analysis is referred in 5.2.2 of Manual and requirements covered in
commitment to impartiality in management Annexure 17 and Annexure 3 and 17 has been amended accordingly. Form
system certification activities. The CAB shall for conflict of interest and confidentiality agreement is available and
have a policy that it understands the maintained
importance of impartiality in carrying out its
management system certification activities,
manages conflict of interest and ensures the
objectivity of its management system
certification activities.
NOTE: A relationship that threatens the impartiality of The same has been addressed in article 7 of the certification audit contract
the certification body can be based on and the conflict of interest form. same are followed during deputation of an
ownership, governance, management, auditor for a particular audit.
personnel, shared resources, finances,
contracts, marketing and payment of a sales
commission or other inducement for the
referral of new clients, etc.
The risk assessment process shall include Record Ref: Annex 17 - Risk analysis – QCS Also addressed in
identification of and consultation with section 5.2.3 of DOC NO:QCS/M/01, ISSUE – 02, REV - 04
appropriate interested parties to advise on
matters affecting impartiality including
openness and public perception. The
consultation with appropriate interested
parties shall be balanced with no single
interest predominating.
5.2.4 A CAB shall not certify another CAB for its Has been addressed in section 5.2.4 of the Quality manual.QCS no way
quality management system. caters to the needs of certifying another CAB
Does the certification body have adequate QCS has done the analysis of the risk associated with the
arrangements (e.g. insurance or reserves) to certification activities and adequate arrangements have been done
cover liabilities arising from its operations in to cover the liabilities.
each of its fields of activities and the Ref Doc no: Annex 18
geographic areas in which it operates?
5.3.2 Does the certification body evaluate its DOC NO:QCS/M/01, ISSUE – 02, REV - 04 section 5.3.2
finances and sources of income and addresses the same
demonstrate to the committee specified in 6.2
that initially, and on an ongoing basis,
commercial, financial or other pressures do
not compromise its impartiality?
6.2.1 The CAB shall have a process for the DEFINED IN MANUAL UNDER SECTION 6.2.1
effective control of certification activities
delivered by branch offices, partnerships,
agents, franchisees, etc., irrespective of their
legal status, relationship or geographical
location. The CAB shall consider the risk that
these activities pose to the competence,
consistency and impartiality of the CAB.
6.2.2 The CAB shall consider the appropriate level
and method of control of activities undertaken
including its processes, technical areas of
CABs’ operations, competence of personnel, DEFINED IN MANUAL UNDER SECTION 6.2.2
lines of management control, reporting and
remote access to operations including
records.
7 Resource requirements Refer Quality manual section 7
7.1 Competence of management and Refer Quality manual section 7
personnel
7.1.1 General considerations Refer Quality manual section 7
Does the certification body apply any In case required, the competence criteria is defined and necessary
additional specific competence criteria where documents amended.
they have been established for a specific
certification scheme, e.g. ISO/TS 22003
(Food safety management systems).
NOTE The term 'technical area' can be
applied differently depending on the
management system standard being
considered. For any management system, the
term is related to products and processes in
the context of the scope of the management
system standard. The technical areas can be
defined by a specific certification scheme (e.g.
ISO/TS 22003); or can be determined by the
certification body.
See standard for examples of the application
of the term 'technical area' for different types
of management systems.
7.1.3 Evaluation processes
7.2.3 Does the certification body make clear to each Covered under 7.2.3 of QM Responsibilities,authorites and duties
person concerned their duties, responsibilities of concerned persons are explained to them and
and authorities? A copy is also issued to them for ready reference
7.2.4 Does the certification body have defined Covered under 7.2.4 of Manual & refer Annexure-6 & Annexure-9
processes for selecting, training, formally Annexure 20 covers all these
authorizing auditors and for selecting
technical experts used in the certification
activity?
Does the initial competence evaluation of an Done through witness audits.
auditor include a demonstration of applicable
personal attributes and the ability to apply
required knowledge and skills during audits?
7.2.8 The group or individual that takes the decision Defined in manual under section - Personnel involved in the certification activities
on granting, refusing, maintaining, renewing, under clause – 7.2.8
suspending, restoring, or withdrawing
certification, or on expanding or reducing the
scope of certification, shall understand the
applicable standard and certification
requirements, and shall have demonstrated
competence to evaluate the outcomes of the
audit processes including related
recommendations of the audit team.
7.2.10 The CAB shall monitor each auditor Addressed in 7.2.10 of the manual
considering each type of management system
to which the auditor is deemed competent.
The documented monitoring process for Witnessing of auditors are done as well as technical review of the reports
auditors shall include a combination of on-site submitted to evaluate the adequacy.
evaluation, review of audit reports and
feedback from clients or from the market.
This monitoring shall be designed in such a
way as to minimize disturbance to the normal
processes of certification, especially from the
client’s viewpoint.
Are there documented procedures and criteria
for monitoring and measurement of the
performance of all persons involved, based on
the frequency of their usage and the level of
risk linked to their activities?
Does the certification body review the
competence of its personnel in the light of
their performance in order to identify training
needs?
7.2.11 The CAB shall periodically evaluate the Addressed in 7.2.11Performance of auditors is monitored by
performance of each auditor on-site. The using a combination of the:
frequency of on-site evaluations shall be Onsite reports from the team leaders
Feed back from QM/TC after the review of reports
Information available on website and also Kolkata office time to time inform
a) audit processes;
his customer about current information through email and website
processes for granting, refusing, maintaining, Information available on website and also Kolkata office time to time inform
renewing, suspending, restoring or his customer about current information through email and website and also
b)
withdrawing certification or expanding or in scheme regulation vide annexure 15.
reducing the scope of certification;
types of management systems and Information available on website and also Kolkata office time to time inform
c)
certification schemes in which it operates; his customer about current information through email and website
a) geographical areas in which it operates; Specified in the relevant section of the manual
Information available on website and also Kolkata office time to time inform
b) the status of a given certification;
his customer about current information through email and website
the name, related normative document, Addressed in section 8.1.2 of the manual and also on the certificates issued
c) scope and geographical location (city and and on the website.
country) for a specific certified client.
8.1.3 Information provided by the CAB to any client QCS updates the website and is publicly accessible information
or to the marketplace, including advertising, about certifications Issued, granted, suspended or withdrawn on
shall be accurate and not misleading. regular basis (once in a week).
8.2.2 The certification document(s) shall identify the Addressed in section 8.2.2 of the manual
following:
the effective date of granting, expanding or All are detailed clearly on the certificate issued and covered in the annexure
reducing the scope of certification, or 15 scheme regulation.
b) renewing certification which shall not be
before the date of the relevant certification
decision;
the expiry date or recertification due date All are detailed clearly on the certificate issued. Refer section 8.2.2 of the
c)
consistent with the recertification cycle; manual and covered in the annexure 15 scheme regulation.
All are detailed clearly on the certificate issued. Refer section 8.2.2 of the
d) a unique identification code;
manual
the management system standard and/or All are detailed clearly on the certificate issued. Refer section 8.2.2 of the
other normative document, including manual
e)
indication of issue status (e.g. revision date or
number) used for audit of the certified client;
the scope of certification with respect to the All are detailed clearly on the certificate issued. Refer section 8.2.2 of the
type of activities, products and services as manual It is also enssured that there is no misleading information or
f)
applicable at each site without being ambiguity.
misleading or ambiguous;
QCS has the terms and conditions for the usage of the certification
mark including QCS and the accreditation board. These logos and
terms clearly specify the standards and the certification body and
the name, address and certification mark of Accreditation board. Also it clarifies that the mark is not to be used
the CAB; other marks (e.g. accreditation so as to indicate that this is product /packaging certification in any
g)
symbol, client’s logo) may be used provided way and this is only a system certification
they are not misleading or ambiguous; Reference: Annex 12.
in the event of issuing any revised The number is amended accordingly to maintain the uniqueness of the
certification documents, a means to certificate issued.
i)
distinguish the revised documents from any
prior obsolete documents.
8.3 Reference to certification and use of marks Addressed in section 8.3
A CAB shall have rules governing any 8.3.1 QCS has the terms and conditions for the usage of the
management system certification mark that it certification mark including QCS and the accreditation board.
8.3.1
authorizes certified clients to use. These rules These logos and terms clearly specify the standards and the
shall ensure, among other things, traceability certification body and Accreditation board. Also it clarifies that the
back to the CAB. There shall be no ambiguity, mark is not to be used so as to indicate that this is product
in the mark or accompanying text, as to what /packaging certification in any way and this is only a system
has been certified and which CAB has certification
granted the certification. This mark shall not Reference: Annex 12
be used on a product nor product packaging
nor in any other way that may be interpreted
as denoting product conformity.
A CAB shall not permit its marks to be applied Addressed in section 8.3.2. QCS has clearly addressed in the Annex
by certified clients to laboratory test, 12 that the Certification marks cannot be used on laboratory test,
8.3.2 calibration or inspection reports.
calibration or inspection reports or
certificates.
The statement shall include reference to: All the responsibilities and obligations of the clients as expected by
QCS are addressed in details in the Contract agreement form –
— identification (e.g. brand or name) of the
Annex 13 (8.5 to 8.10 page 4 of 6)
certified client;
— the type of management system (e.g.
quality, environment) and the applicable
standard;
— the CAB issuing the certificate.
The CAB shall through legally enforceable Addressed in section 8.3.4 of the manual
8.3.4
arrangements require that the certified client:
QCS has legally enforceable arrangements by getting the contract
conforms to the requirements of the CAB documents signed by all the clients (Annex 13) which specifies
when making reference to its certification action to deal with incorrect references to certification status or
a) status in communication media such as the misleading use of certification documents, marks or audit reports
internet, brochures or advertising, or other and necessary corrective and preventive actions to Be taken taken
documents; to deal with such situations
a detailed description of the initial and Addressed in relevant section of the manual.
continuing certification activity, including the
application, initial audits, surveillance audits,
and the process for granting, refusing,
a)
maintaining of certification, expanding or
reducing the scope of certification, renewing,
suspending or restoring, or withdrawing of
certification;
b) the normative requirements for certification; Has been shown in the manual’s relevant section.
information about the fees for application, Has been addressed in the quotation sent to client after receipt of
c)
initial certification and continuing certification; application form
the CAB’s requirements for clients to: Refer to the quality manual section 8.5.1 and also the same is addressed in
1) comply with certification requirements; the audit plan issued to the clients. The audit team comprising of Team
2) make all necessary arrangements for Leader/auditor/TE/Observer etc. Are clearly addressed.
the conduct of the audits, including
provision for examining documentation
and the access to all processes and
d) areas, records and personnel for the
purposes of initial certification,
surveillance, recertification and
resolution of complaints;
3) make provisions, where applicable, to
accommodate the presence of observers
(e.g. accreditation assessors or trainee
auditor);
the legal, commercial, organizational status As shown above and has been described in the relevant section.
a)
or ownership;
organization and management (e.g. key As shown above
b) managerial, decision-making or technical staff
);
c) contact address and sites; As shown above
scope of operations under the certified As shown above
d)
management system;
The CAB shall require an authorized QM ensures that an authorized representative (MR) of the
representative of the applicant organization to applicant organization providing the necessary information to
provide the necessary information to enable it enable it to establish the following:
to establish the following:
Refer Application form QCS/AF/F/01, The scope is specified
a) the desired scope of the certification; there.
relevant details of the applicant organization Detailed in the application form QCS/AF/F/01
as required by the specific certification
scheme, including its name and the
b) address(es) of its site(s), its processes and
operations, human and technical resources,
functions, relationships and any relevant legal
obligations;
identification of outsourced processes used by Detailed in the application form QCS/AF/F/01
c) the organization that will affect conformity to
requirements;
the standards or other requirements for which Detailed in the application form QCS/AF/F/01
d) the applicant organization is seeking
certification;
Detailed in the application form, name and details of consulting
whether consultancy relating to the Organization.
e) management system to be certified has been
provided and, if so, by whom.
determination of the conformity of the client’s i) Determine the conformity of the client's management system, or
a) management system, or parts of it, with audit parts of it, with audit criteria
criteria;
9.3.1.2 Stage 1
Planning shall ensure that the objectives of QCS ensures that the objectives of stage 1 can be met and the
stage 1 can be met and the client shall be client are informed about on site audit during stage 2 only for
informed multi site/temporary site.
9.3.1.2.1 of any “on site” activities during stage 1.
Where the available audit evidence indicates Has been addressed in relevant section of the quality manual.
that the audit objectives are unattainable or
suggests the presence of an immediate and
significant risk (e.g. safety), the audit team
leader shall report this to the client and, if
possible, to the CAB to determine appropriate
9.4.3.2
action. Such action may include
reconfirmation or modification of the audit
plan, changes to the audit objectives or audit
scope, or termination of the audit. The audit
team leader shall report the outcome of the
action taken to the CAB.
The audit team leader shall review with the Section 9.4.3.3 addresses the same. The same has ben addressed in the
client any need for changes to the audit scope relevant section of the manual.
9.4.3.3
which becomes apparent as on-site auditing
activities progress and report this to the CAB.
9.4.4 Obtaining and verifying information Has been addressed in the Quality manual section 9.4.4
During the audit, information relevant to the QCS ensures that information relevant to the audit objectives, scope
audit objectives, scope and criteria (including and criteria (including information relating to interfaces between
information relating to interfaces between functions, activities and processes) shall be obtained by appropriate
9.4.4.1
functions, activities and processes) shall be sampling and verified to become
obtained by appropriate sampling and verified
to become audit evidence.
Methods to obtain information shall include, Has been addressed in section 9.4.4.2 of the Quality manual.
but are not limited to:
9.4.4.2 a) interviews;
b) observation of processes and activities;
c) review of documentation and records.
The audit team leader shall attempt to resolve QCS ensures that the audit team leader shall attempt to
any diverging opinions between the audit resolve any diverging opinions between the audit team and
team and the client concerning audit evidence the client concerning audit evidence or findings and
9.4.5.4 or findings, and unresolved points shall be
unresolved points shall be recorded in the audit report.
recorded.
9.6.2.1 General
The CAB shall develop its surveillance
activities so that representative areas and
functions covered by the scope of the
9.6.2.1.1 management system are monitored on a
regular basis, and take into account changes
to its certified client and its management
system.
9.6.3 Recertification
Whenever possible, the CAB shall Has been addressed in the section 9.8.8 of the quality manual
acknowledge receipt of the complaint, and
shall provide the complainant with progress
reports and the result of the complaint.
9.8.8 The decision to be communicated to the Submission, investigation and decision on complaints shall
9.8.9 complainant shall be made by, or reviewed not result in any discriminatory actions against the
9.8.10 and approved by, individual(s) not previously complainant
involved in the subject of the complaint.
Whenever possible, the CAB shall give
formal notice of the end of the complaints-
handling process to the complainant.
Internal audits shall be performed at least Being planned every 12 months at the minimum. And also the
once every 12 months. The frequency of
same has been addressed.
internal audits may be reduced if the CAB can
10.2.6.3 demonstrate that its management system
continues to be effectively implemented
according to this part of ISO/IEC 17021 and
has proven stability.
The CAB shall ensure that: It is ensured that competent auditors are available. All the
a) internal audits are conducted by competent
paraphernalia are well taken care of. Has been addressed in
personnel knowledgeable in certification,
auditing and the requirements of this part of section 10.2.6.4 of the Quality Manual
ISO/IEC 17021;
b) auditors do not audit their own work;
10.2.6.4
c) personnel responsible for the area audited
are informed of the outcome of the audit;
d) any actions resulting from internal audits
are taken in a timely and appropriate manner;
e) any opportunities for improvement are
identified.