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NEW QUESTION # 88
You work for a certification body. In two months, you will have to lead an audit of a pharmaceutical organisation, ABC, that manufactures vaccines to combat a pandemic. When planning the audit team, you select one of the certification body auditors who is professionally qualified in Biochemistry and Pharmacy.
However, she is not fully aware of all legal applicable requirements. You recommend the certification body hire a compliance expert to assist the audit team. In which two clauses of ISO 14001:2015 would you consider that auditors may need the help of the expert?
Answer: B,D
Explanation:
According to ISO 14001:2015:
Clause 4.2:
The organization must understand the needs and expectations of interested parties, which includes regulatory bodies and applicable legal requirements. Legal expertise may be necessary to fully assess this.
Clause 9.1.2:
The organization must evaluate compliance obligations, which requires understanding applicable legal requirements.
Legal compliance evaluation often requires specialized legal or regulatory knowledge, especially in highly regulated sectors like pharmaceuticals.
Reference: ISO 14001:2015 Clauses 4.2 and 9.1.2.
NEW QUESTION # 89
You must prepare an audit plan for a second-party audit of ABC's ISO 14001 environmental management system, an organisation that offers firefighting equipment to the Indian market. ABC's head office is in New Delhi; the manufacture of firefighting equipment is outsourced to organisation FIREF, located in Bangladesh.
The outsourced activities include design, production, logistics, and procurement. There are six ABC employees in the New Delhi head office and none in FIREF's Bangladesh plant.
What documented information required by ISO 14001:2015 would you need to review during the audit of ABC's EMS with reference to outsourced processes? Select two.
Answer: D,E
Explanation:
The correct answers are C and E .
ISO 14001:2015 requires the organisation to ensure that outsourced processes are controlled or influenced
. In this case, ABC has outsourced major activities to FIREF, including design, production, logistics, and procurement. Even though FIREF performs the work, ABC remains responsible for ensuring that relevant EMS requirements are addressed.
C). Contractual agreement between ABC and FIREF - Correct
The contract is key documented evidence showing how ABC communicates environmental requirements to FIREF and defines the controls or influence over the outsourced processes. This may include environmental controls, legal compliance expectations, reporting requirements, emergency arrangements, waste handling, procurement requirements, and monitoring obligations.
E). Reports of ABC audits on FIREF - Correct
Reports of ABC's audits on FIREF provide evidence that ABC is checking whether the outsourced processes are being controlled as planned. These reports help confirm whether ABC has evaluated FIREF's environmental performance, operational controls, compliance with agreed environmental requirements, and corrective actions where needed.
The other options are not the best answers:
A). FIREF's environmental policy - Incorrect
FIREF's environmental policy may be useful background information, but it is not required documented information for ABC's ISO 14001 EMS.
B). ABC's environmental manual - Incorrect
ISO 14001:2015 does not require an environmental manual.
D). Reports of internal audits carried out by FIREF - Incorrect
FIREF's own internal audit reports may be useful if available, but they are FIREF's EMS records, not required documented information of ABC's EMS.
F). Reports of FIREF's top management reviews - Incorrect
FIREF's management review records belong to FIREF's management system and are not required records for ABC's EMS audit.
Therefore, the two documents most directly required to verify ABC's control or influence over outsourced processes are C. Contractual agreement between ABC and FIREF and E. Reports of ABC audits on FIREF .
NEW QUESTION # 90
A management system meeting ISO 14001:2015 requirements is based on the Plan-Do-Check-Act (PDCA) cycle.
Which two elements of the management system are part of the 'Check' stage of the PDCA cycle?
Answer: B,F
Explanation:
As per ISO 14001:2015 Clause 10 (Improvement) and Clause 9 (Performance Evaluation):
The 'Check' phase includes activities that evaluate performance, such as:
Clause 9.1:
"The organization shall monitor, measure, analyze and evaluate its environmental performance." Clause 10.2:
"When a nonconformity occurs, the organization shall react to the nonconformity, evaluate the need for corrective action." Management review is part of the 'Act' phase (Clause 9.3), and Environmental Policy (Clause 5.2) belongs to
'Plan'.
Reference: ISO 14001:2015 Clauses 9.1, 10.2, 9.3, 5.2.
NEW QUESTION # 91
During discussions with the individual(s) managing the audit programme of a certification body, the EMS Manager of the client organisation asks that only one auditor is used for the audit duration to save on travel expenses.
Which combination of the following responses should the individual(s) managing the audit programme make?
Select two.
Answer: B,C
Explanation:
The correct answers are A and E .
A). Advise that the audit team make-up is a decision for the Certification Body - Correct For a certification audit, the Certification Body is responsible for determining the audit team composition.
This includes deciding the number of auditors, required competence, audit duration, technical expertise, impartiality, and ability to cover the full audit scope. The client may express a preference or raise a concern, but the client cannot dictate the audit team structure simply to reduce costs.
E). Suggest asking the Certification Body management to consider the request - Correct The request may be passed to appropriate Certification Body management for review. The Certification Body can consider whether the request is possible without compromising audit duration, competence, impartiality, coverage of the audit scope, or certification requirements. However, any change must remain under the Certification Body's control.
The other options are not appropriate:
B). Advise the EMS Manager that his request can be considered for future audits - Incorrect This avoids the current request rather than addressing it properly. The Certification Body may consider the request now, but only through its own competent review process.
C). Suggest that the EMS Manager choose another Certification Body - Incorrect This is unprofessional and unnecessary. The correct approach is to explain the Certification Body's responsibility and review the request appropriately.
D). Advise that the contract has already been signed and cannot be revised - Incorrect A signed contract does not automatically prevent changes. Changes may be possible if reviewed and approved by the Certification Body, provided audit integrity is maintained.
F). Advise that a remote audit could be conducted instead of an on-site audit - Incorrect Remote auditing cannot simply be substituted to reduce travel expenses. The use of remote audit methods must be justified and must still allow the Certification Body to achieve the audit objectives. For many certification audit activities, especially where operational controls and site conditions must be verified, on-site evaluation may be necessary.
Therefore, the best two responses are A and E .
NEW QUESTION # 92
Which one of the following is not part of the required knowledge of a technical expert appointed to an audit team?
Technical experts should know:
Answer: B
Explanation:
Comprehensive and Detailed Explanation From Exact Extract ISO 14001 Compliance Auditor:
The correct answer is D. How to raise a nonconformity report .
A technical expert provides specialist knowledge to support the audit team, but does not act as an auditor.
ISO 19011 defines a technical expert as a person who provides specific knowledge or expertise to the audit team and states that a technical expert does not act as an auditor. ( cdn.standards.iteh.ai ) Because the technical expert is not acting as an auditor, raising a formal nonconformity report is not their responsibility. Nonconformities are audit findings made from evaluating audit evidence against audit criteria; this is the responsibility of auditors in the audit team. ISO 19011 defines audit findings as the result of evaluating collected audit evidence against audit criteria. ( cdn.standards.iteh.ai ) Options A, B, and C are relevant because a technical expert should understand the certification and audit context well enough to support the audit properly and know when to provide advice . However, they should not independently raise nonconformities.
Therefore, the option that is not part of the required knowledge of a technical expert is D .
NEW QUESTION # 93
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