At the end of a second-party audit, the audit team enters the meeting room to hold the closing meeting; only
two people are present and waiting for them: the Health and Safety supervisor and the Administrative Officer.
Neither has participated in the audit. However, the team had previously agreed with the auditee Quality
Manager on two nonconformities identified during the audit (NC1 and NC2).
They said:
Health and Safety Supervisor: "Good evening. We are sorry to inform you that the general manager was
involved in a serious car accident, and the other two managers have had to leave urgently to attend to the
emergency."
The Administration Officer: "Concerning 'nonconformity 2', the General Manager left a message asking us
to tell you that he does not accept it and requests you not to include it in the audit report. Here is a note in
which he explains why."
Which one of the following would be your preferred answer (as team leader) to the General
Manager's request?
You work for an organisation, 'ABC', which provides packaged food to the public. You are asked to lead a team (you as the leader and two other
auditors) to audit an external provider, 'XYZ', which provides packaging materials to your organisation. It is 4 pm, and the audit is dlose to an end;
you are having an internal meeting with the team to decide what will be presented to the auditee during the Closing meeting. The Closing meeting
was scheduled for 5 pm.
'XYZ' has two manufacturing lines: M1 is a clean room for primary packaging materials (i.e. will be in direct contact with the food), and M2 is for
secondary materials (i.e. will not be in direct contact with food).
Auditor 1 audited the two manufacturing lines.
You: "What findings would you report?"
Auditor 1: "I have one issue. Earlier today in the morning I saw some secondary material stocked in the clean room. I would propose raising a
nonconformity."
You: "How would you write the nonconformity?"
Auditor 1: "In the clean room, there was a pallet with secondary materials."
What additional information would you add to this text to complete the nonconformity report? Select six.
Audit criteria are a set of requirements used as a reference against which objective evidence is compared.
Which two of the following are not potential audit criteria?
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.
Which two of the following statements related to Stage 1 of an initial certification audit against ISO 9001:2015 are true?
The Stage 1 audit is a readiness review that verifies the organization's ability to conduct the Stage 2 audit. It involves reviewing the documented information, evaluating the site-specific conditions, and having discussions with personnel. The auditor does not verify the degrees of customer satisfaction, the compliance with legal requirements, or the results of the last management review during the Stage 1 audit. These are done during the Stage 2 audit or later in the certification process.Reference:
ISO 9001 Lead Auditor Reference Materials
ISO 9001 Lead Auditor Candidate Handbook
ISO 9001 Lead Auditor Course Material
ISO 9001 Lead Auditor Training Course IRCA Certified
Select the term that best describes the purpose of retaining documented information in a quality management system to ISO 9001.
Documented information is a means by which an organization demonstrates compliance. It communicates what we do and how we do things, it communicates what happened and what results were achieved. It is, essentially, a tool for communication. ISO 9001:2015 allows an organization flexibility in the way it chooses to document its quality management system (QMS). This enables each individual organization to determine the correct amount of documented information needed in order to demonstrate the effective planning, operation and control of its processes and the implementation and continual improvement of the effectiveness of its QMS. The standard states that the organization shall maintain documented information to the extent necessary to support the operation of processes and retain documented information to the extent necessary to have confidence that the processes are being carried out as planned. Therefore, the purpose of retaining documented information is to support the operation of the processes of the QMS, not to facilitate auditing, provide confidence or safeguard integrity, which are secondary benefits of documented information. Reference: Guidance on the requirements for Documented Information of ISO 9001:2015, ISO 9001:2015 documented information | CQI | IRCA, Documented Information Required by ISO 9001:2015 - 9000 Store
