IJCA - Volume 2 - Flipbook - Page 10
10
The International Journal of Conformity Assessment
article would be a comprehensive review of ISO/
IEC 17011:2017, ILAC, and IAF requirements and
identify the risk-based approaches for providing
accreditation services.
An effect is a deviation from the expected and it
can be positive, negative, or both. Likewise, it can
address, create, or result in both opportunities
and threats. The most common and general risks
associated with accreditation-providing entities are
the requirements for the management of risks. These
risks associated with accreditation bodies (ABs)
are highlighted under different clauses of ISO/IEC
17011:2017 as shown in Table 01.
TABLE 01: CLAUSES OF ISO/IEC 17011:2017 CONSIST OF REQUIREMENTS WITH THE WORD “RISK”
Clause number of
ISO/IEC 17011:2017
Requirement
Common approaches of ABs to comply with the requirements
4.4.6
AB shall have a process to identify, analyze,
evaluate, treat, monitor and document on
an ongoing risk factor posed towards the
key objective of impartiality. These factors
are those arising from related activities and
relationships associated with the internal
management processes, including those
associated with the client.
Note: Risks to impartiality can be from
ownership, governance, management,
personnel, shared resources, finances,
contracts, outsourcing, training, marketing,
payment of sales commissions, personal
friendships, or other inducements for referral,
etc.
Impartiality is one of the major pillars of the credible
accreditation process. Therefore, ABs pay due attention to
identifying threats to impartiality through a systematic and
ongoing process and management of identified threats in
an unbiased manner. ABs introduce policies, controls, and
procedures to avoid potential threats, and continuously review
and monitor. If there are any unacceptable risks to impartiality,
ABs do not provide accreditation.
4.4.7
Where any risks to impartiality are identified,
document how AB eliminates such risks.
4.4.8
Top management shall review residual risks.
4.4.9/4.4.13
When unacceptable risks are identified and
cannot be mitigated to an acceptable level,
accreditation shall not be provided.
4.5.2
Evaluate risks arising from its activities and
have arrangements to cover liabilities.
Through professional indemnity insurance coverage, reserves
allocated and shown in accounts. Also, through governmental
ABs, sometimes by the nature of their establishment or
regulations, liabilities arising from accreditation activities are
covered. In addition, the terms and conditions of ABs have
a requirement for conformity assessment bodies (CABs) to
obtain insurance coverage or keep dedicated reserves.
7.4.6
In selecting the activities to be assessed, AB
shall consider the risk associated with the
activities, locations, and personnel covered
by its scope of accreditation.
Incorporation of mandatory requirements from International
Accreditation Forum (IAF) and International Laboratory
Accreditation Cooperation (ILAC) into ABs’ assessmentrelated process and introduction of own policies and
procedures to minimize risk associated with ABs' activities.
Scope of accreditation shall be assessed
taking all factors of risk into consideration.
ABs defined their own policies on the assessment of the scope
of CABs and determine the CAB’s competence before granting
accreditation. Application of different assessment techniques,
use of EQA results, and application of mandatory documents
of IAF for witnessing.
Documented procedures for identifying
opportunities for improvement, identifying
risks, and taking appropriate and timely
actions to preempt jeopardizing of required
standards.
Continuous monitoring of the conformity assessment and
accreditation world to identify new developments, changes,
use of the experience gained through operating accreditation
schemes, feedback of interested parties, monitoring and
evaluating of the performance of personnel involved in the
accreditation activities and accredited conformity assessment
bodies, review of all steps of the accreditation process, and
conducting a preliminary review of risks.
7.9.3
9.6
