ABC is a worldwide fast-food organisation. One of the branches, in downtown Cape Town, decided to
implement an ISO 9001 quality management system and you are the audit team leader (with two other
auditors) that will carry out the certification audits, Stage 2.
ABC receive the orders by phone or internet; some of the employees deliver the ordered food to indicated
addresses. The normal menu includes 15 different types of hamburgers; however, in the last two weeks,
due to a shortage of a special type of meat, they can only prepare six of the 15 varieties.
During the internal meeting of the audit team, you ask one of the auditors to describe what she has
observed. She audited the reception of orders from customers (via phone or internet) and the
communication of the orders to the kitchen. She noticed that the menu offering food on the website is still
the normal one, with 15 different hamburgers, and during a 30-minute period, she observed many
customers reluctantly accepting something other than the hamburger they preferred.
You, as audit team leader, inform the Quality Manager of your concern about the major nonconformity,
since you consider this a serious breach of the basic principles of quality that lasted two weeks without
action being taken.
Right at the beginning of the Closing meeting, you discuss the nonconformity with the General Manager.
She got quite upset and said she was going to make a complaint to the certification body and left the
room; the Quality Manager was the only member of ABC left with the audit team. The Quality Manager said the General Manager would not come back to the meeting.
What would you do? Choose the best from the following options:
Select six of the activities that are specifically required by ISO 17021-1 as part third-party (Certification Body) surveillance audit processes.
The activities that are specifically required by ISO 17021-1 as part of third-party (Certification Body) surveillance audit processes are:
* Option A: Audit use of certification marks on marketing materials. This option is correct because ISO 17021-1:2015 clause 9.6.2.2 requires the certification body to audit the client's use of marks and/or any other reference to certification, as applicable, to ensure conformity with the certification requirements.
* Option B: Review changes to the QMS since last visit. This option is correct because ISO 17021-1:2015 clause 9.6.2.2 requires the certification body to review any changes affecting the client's quality management system and its ability to continue to fulfil the requirements of the standard used for certification.
* Option C: Confirm effectiveness of internal audit and management review. This option is correct because ISO 17021-1:2015 clause 9.6.2.2 requires the certification body to confirm the continuing effectiveness of the client's quality management system, including the effectiveness of the internal audit and management review processes.
* Option F: Review the status of previously raised findings and audit effectiveness of any outstanding findings. This option is correct because ISO 17021-1:2015 clause 9.6.2.2 requires the certification body to review the status of findings and any corrective actions taken by the client in response to previous audits, and to verify the effectiveness of the implemented corrective actions.
* Option H: Verify legal compliance. This option is correct because ISO 17021-1:2015 clause 9.6.2.2 requires the certification body to verify the client's compliance with applicable statutory and regulatory requirements related to the scope of certification.
* Option I: Handling of customer complaints since last visit. This option is correct because ISO 17021-1:2015 clause 9.6.2.2 requires the certification body to review the client's handling of customer complaints related to the certified activities since the last audit.
The following options are not correct:
* Option D: Complete a full document review of the quality management system. This option is not correct because ISO 17021-1:2015 clause 9.6.2.2 does not require the certification body to complete a full document review of the quality management system during surveillance audits. A full document review is only required during the initial certification audit or when there are significant changes to the quality management system or the certification requirements.
* Option E: Failing to meet financial responsibilities. This option is not correct because ISO 17021-1:2015 clause 9.6.2.2 does not require the certification body to audit the client's financial responsibilities during surveillance audits. The certification body may have contractual arrangements with the client regarding the payment of fees, but this is not part of the surveillance audit process.
* Option G: Review the calibration status of the instrumentation. This option is not correct because ISO 17021-1:2015 clause 9.6.2.2 does not require the certification body to review the calibration status of the instrumentation during surveillance audits. The certification body may audit the client's monitoring and measuring resources as part of the quality management system requirements, but this is not a specific activity required by ISO 17021-1.
* Option J: Conduct a minimum number of annual surveillance audits during the certification period. This option is not correct because ISO 17021-1:2015 clause 9.6.2.2 does not require the certification body to conduct a minimum number of annual surveillance audits during the certification period. The certification body may determine the frequency and duration of surveillance audits based on the risk and performance of the client, but this is not a specific activity required by ISO 17021-1.
* ISO 17021-1:2015 Conformity assessment - Requirements for bodies providing audit and certification of management systems - Part 1: Requirements
* ISO 9001 Lead Auditor Course Material, Module 7: Audit Follow-up and Surveillance, Slide 8: Surveillance Audit
* ISO 9001 Lead Auditor Training Course - IRCA Certified, Section 7.2: Audit Follow-up and Surveillance
* Lead Auditor Exam Preparation Guide (EPG) Template - PECB, Section 3.2: Exam Content Outline, Subsection 3.2.1: Section 1 - Audit Fundamentals, Subsection 3.2.2: Section 2 - Audit Principles, Subsection 3.2.3: Section 3 - Audit Process, Subsection 3.2.4: Section 4 - Audit Competencies
You are carrying out an annual audit at an organisation that has been certificated to ISO 9001 for two years. The organisation offers home security
services. The scope of the quality management system covers alarm installation, alarm servicing, alarm monitoring and response. The business
operates from a single office and employs subcontract installers and service technicians across the country.
You have just completed the opening meeting. You are interviewing the Managing Director (MD).
You: "I would like to gain an understanding of how the quality management system has been supporting your business and its strategic direction."
MD: "We are continuing to face difficult times. The market is extremely competitive, and customers typically look for the least expensive option when
choosing home security services. We have not yet seen any business benefit from our quality management system."
You: "Tell me how you determine external and internal issues."
MD: "We use SWOT analysis (Strengths Weaknesses, Opportunities, Threats)."
You: "How have the outputs from your SWOT been used?"
Select two of the following audit trails would you take to explore the extent to which the SWOT analysis and the outputs from this
have been used to enable the business to achieve the intended results(s) of its quality management system according to ISO 9001.
Question no: 22 Verified Answer: = B. Establish how the organisation reviews
1: ISO 9001:2015 - Quality management systems --- Requirements
Knowledge and skills are requirements of the auditor's competence. Select two from the following topics of knowledge that apply to every member of an audit team auditing an ISO 9001 quality management system.
According to ISO 9001:2015, clause 7.2, an auditor shall have the competence to:
Understand the requirements of ISO 9001 and how they relate to the audit
Understand the organization's quality management system and its processes
Understand the applicable legal, regulatory, contractual and other requirements that affect the audit
Understand the needs and expectations of interested parties other than customers
Plan and conduct audits in accordance with ISO 19011
Evaluate audit evidence and draw appropriate conclusions
Communicate audit findings effectively1
Therefore, knowledge of ISO 9001 requirements and ISO 19011 audit principles are essential for every member of an audit team auditing an ISO 9001 quality management system.
Read the following role descriptions. Select two roles that are not directly involved in the audit process.
Rutha
3 days agoLizbeth
8 days agoArdella
16 days agoJenise
22 days agoIvan
24 days agoLavonna
1 months agoWhitley
1 months agoBrandon
2 months agoBernardine
2 months agoLai
2 months agoNoelia
2 months agoSusy
2 months agoVi
3 months agoFlorencia
3 months agoAlecia
3 months agoRory
3 months agoJina
3 months agoMalcolm
4 months agoAudry
4 months agoNada
5 months agoRutha
5 months agoFrancoise
6 months agoCharlene
6 months agoShawnee
6 months agoFernanda
6 months agoLeatha
6 months agoRene
7 months agoAmos
8 months agoLili
9 months ago