PECB ISO-9001-Lead-Auditor Exam With Confidence Using Practice Dumps

Comprehensive and Detailed In-Depth Explanation:

Toning down (or de-escalation) is a conflict resolution technique where:

Common agreements are emphasized to reduce tension.

Disagreements are addressed with a rational and constructive approach.

Option A describes compromise, and Option B describes authoritative resolution, which are different conflict resolution techniques.

According to clause 8.3 of ISO 9001:2015, the organization should establish, implement, and maintain a design and development process that is appropriate to ensure the subsequent provision of products and services. The design and development process should include the following activities:

•Determining the requirements for the products and services to be designed and developed, considering the intended use, the statutory and regulatory requirements, the customer and other relevant interested parties’ needs and expectations, and the potential risks and opportunities.

•Defining the design and development objectives, stages, responsibilities, and authorities, and ensuring the availability of adequate resources and competence.

•Implementing design and development controls, such as reviews, verification, and validation, to ensure that the design and development outputs meet the design and development inputs, and to identify and resolve any problems or errors.

•Maintaining documented information on the design and development inputs, outputs, reviews, verification, validation, and changes, and ensuring the traceability and conformity of the products and services to the requirements.

•Managing the design and development changes, by identifying, reviewing, and controlling them, and evaluating their effects on the products and services and the QMS.

In this case, the evidence statements that provide a meaningful audit trail for the design and development process are B, E, and F, because they relate to the design and development controls, the documented information, and the verification activities that are required by the standard. These options can help the auditor to assess the effectiveness and conformity of the design and development process, and to identify any nonconformities or opportunities for improvement. The other options are not directly related to clause 8.3, although they may be relevant for other aspects of the QMS, such as clause 7.2 on competence, clause 7.3 on awareness, clause 7.4 on communication, clause 8.2 on requirements for products and services, clause 8.4 on externally provided processes, products, and services, and clause 8.7 on control of nonconforming outputs. References: ISO 9001:2015, ISO 9001 Auditing Practices Group Guidance on Design and Development, ISO 9001 Clause 8.3 Design and development of products and services

According to ISO 19011:2018, clause 3.2, audit criteria are a set of policies, procedures or requirements used as a reference against which objective evidence is compared. Audit criteria are usually selected by the audit client or by agreement between the audit client and the auditee, and they should be appropriate for the audit scope and objectives1. Audit criteria may include, but are not limited to, the following sources2:

•ISO management system standards, such as ISO 9001, ISO 14001, ISO 45001, etc.

•Verbal statements by the general manager or other top management, as long as they are consistent with the documented policies and objectives of the organisation

•Verbal agreements with interested parties, such as customers, suppliers, regulators, etc., as long as they are documented and approved by the relevant authorities

•Health and safety notices, such as posters, signs, labels, etc., that communicate the organisation’s legal obligations, policies, or procedures

•Written agreements with interested parties, such as contracts, orders, specifications, etc., that define the requirements and expectations of the parties involved

•Organisation’s documented information, such as policies, procedures, manuals, records, etc., that describe the organisation’s management system and its processes

•Commitment to follow principles issued by an NGO, such as the United Nations Global Compact, the International Labour Organization, etc., as long as they are relevant to the organisation’s context and objectives

•Environmental aspects register, such as a list of the environmental impacts and risks associated with the organisation’s activities, products, and services

Therefore, the two options that are not potential audit criteria are F and H, as they are not reliable or verifiable sources of information, and they may not reflect the actual performance or conformity of the organisation’s management system. Commercial advertisements and claims made on the organisation’s website are forms of marketing communication that may be exaggerated, misleading, or inaccurate, and they are not subject to the same level of scrutiny or approval as the other sources of audit criteria.