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| Section | Objectives |
|---|---|
| Topic 1: Quality Management System (QMS) Fundamentals | - ISO 9001:2015 Structure and Clauses
|
| Topic 2: Audit Planning and Preparation | - Audit Preparation
|
| Topic 3: Audit Reporting and Follow-up | - Corrective Actions
|
| Topic 4: Conducting Audit Activities | - On-site Audit Execution
|
| Topic 5: Audit Principles and Fundamentals | - Audit Concepts
|
>> ISO-9001-Lead-Auditor Exam Overview <<
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NEW QUESTION # 146
State the correct sequence of events in the certification process for an organisation to obtain third-party accredited certification to ISO 9001.
Answer:
Explanation:
Reference: ISO 9001:2015 Clause 9.2 emphasizes the planning of audits and their scheduling to achieve desired results.
Step 2: Conduct Certification Audit StagesThe certification process includes a two-stage audit.
Stage 1 Audit: Review of documentation to verify readiness and understanding of the Quality Management System (QMS).
Stage 2 Audit: A detailed evaluation of the implementation and effectiveness of the QMS against ISO 9001 requirements.Reference: Clause 8.1 of ISO 9001:2015 discusses operational planning and control, which includes the preparation for audit activities.
Step 3: Award ISO 9001 CertificateAfter successfully completing the certification audits and resolving any identified non-conformities, the certification body awards the ISO 9001 certificate. This certificate demonstrates that the organization's QMS meets the ISO 9001 standard.Reference: Clause 10 of ISO 9001:
2015 focuses on continual improvement and conformity, which leads to the certification issuance.
Step 4: Accredit Certification BodyCertification bodies must be accredited to ensure they meet international standards for certification. Accreditation is conducted by bodies like UKAS (United Kingdom Accreditation Service) or ANAB (ANSI National Accreditation Board), ensuring the credibility and global acceptance of the certification process.Reference: Clause 7.1.5 of ISO 9001 covers resource monitoring, which supports the integrity of the certification process.
By following these steps, organizations can ensure an effective and compliant certification process, achieving ISO 9001 certification.
NEW QUESTION # 147
ABC is a service organisation that cleans and irons bed and table linen for four large hospitals in the city centre. It claims to meet ISO 9001:2015 requirements. During an internal audit, an auditor observes that machine No. 4 is being operated with the three variables outside the limits established in the applicable documented procedure SP-701. The auditor has decided to raise a nonconformity.
Which six elements should be included in the nonconformity report?
Answer: C,D,G,H,I,J
Explanation:
B: Applicable procedure: SP-701
D: Identification number of the washing machine
H: The concentration of the cleaning liquid used vs the concentration fixed in SP-701 I: The planned duration of the process vs the minimum time required in SP-701 J: Weight of linen being washed vs the maximum weight required in SP-701 C: Competence record of the machine operator
NEW QUESTION # 148
You are conducting an audit at a single-site organisation seeking certification to ISO 9001 for the first time.
The organisation manufactures cosmetics for major retailers and the name of the retailer supplied appears on the product packaging. Sales turnover has increased significantly over the past five years.
You are interviewing the new Product Development Manager. You note that a software application called SWIFT is used to help control the product development process.
You have gathered audit evidence as outlined in the table. Match the ISO 9001 clause 8.3 extracts to the audit evidence.
Answer:
Explanation:
Explanation:
Audit Evidence and Applicable ISO 9001:2015 Clause 8.3 Extracts
* Half of all new products launched in the past 12 months were late. The Product Development Manager explains he has not got enough people on his team to cope with the demand for new products.# ISO 9001 Clause 8.3.2 e) - "...internal resource needs for the design and development of products and services..."
* The Product Development Manager explains many changes are made to cosmetic formulations during product development owing to retailer feedback. Only when confirmed by the retailer is the agreed formulation documented on SWIFT.# ISO 9001 Clause 8.3.5 - "...retain documented information on design and development changes..."
* The Product Development Manager explains that the customer confirms their approval to proceed with a new formulation by email. These emails are kept on SWIFT.# ISO 9001 Clause
8.3.6 - "...retain documented information on design and development outputs..."
* The Product Development Manager shows you evidence of consumer trials that are carried out for some new products before a full-scale launch.# ISO 9001 Clause 8.3.4 d) - "...conducted to ensure that the resulting products and services meet the requirements..."
* The Product Development Manager explains that an approved external laboratory is used to perform shelf-life stability trials on some formulations during product development.# ISO 9001 Clause 8.3.2 e) - "...external resource needs for the design and development of products and services..." ISO 9001:2015 Clause 8.3 (Design and development of products and services) requires organisations to plan, control, review, verify, validate, and document design and development activities to ensure products meet requirements.
Explanation of clause alignment:
* Clause 8.3.2 e) requires the organisation to determine both internal and external resource needs.
Lack of personnel causing late launches directly evidences internal resource shortfalls, while the use of an external laboratory demonstrates control of external resources.
* Clause 8.3.5 requires organisations to control design and development changes and retain documented information describing those changes, which is demonstrated by controlled updates in SWIFT following retailer confirmation.
* Clause 8.3.6 requires retention of documented information on design and development outputs, including customer approvals, which are evidenced by stored emails in SWIFT.
* Clause 8.3.4 d) requires design and development activities such as verification and validation, ensuring outputs meet requirements. Consumer trials prior to launch clearly meet this requirement.
ISO-aligned conclusion:
The evidence provided demonstrates structured control of product design and development, including planning, resourcing, change management, validation, and retention of documented information, all mapped directly to ISO 9001:2015 Clause 8.3 requirements.
NEW QUESTION # 149
During a third-party audit of a pharmaceutical organisation (CD9000) site of seven COVID-19 testing laboratories in various terminals at a major international airport, you interview the CD 9000's General Manager (GM), who was accompanied by Jack, the legal compliance expert. Jack is acting as the guide in the absence of the Technical Manager due to him contracting COVID-19.
You: "What external and internal issues have been identified that could affect CD9000 and its quality management system?" GM: "Jack guided us on this. We identified issues like probable competition of another laboratory organisation in the airport, legal requirements on COVID-19 continuously changing, the shortage of competent laboratory analysists, the epidemic declining soon, shortage of chemicals for the analysis. It was quite a good experience." You: "Did you document these issues?" GM: "No. Jack said that ISO 9001 does not require us to document these issues." You: "How did you determine the risks associated with the issues and did you plan actions to address them?" GM: "I am not sure. The Technical Manager is responsible for this process. Jack may be able to answer this question in his absence." Select two options for how you would respond to the General Manager's suggestion:
Answer: A,C
Explanation:
* D. I would look for evidence that the actions resulting from the risk assessment had been taken.
* According to ISO 9001:2015, Clause 6.1.2 requires the organization to plan actions to address risks and opportunities. The organization must integrate and implement these actions into its quality management system and evaluate their effectiveness. The auditor should seek evidence that the organization has assessed the risks and taken appropriate actions.
* B. I would ask to audit the Technical Manager by phone.
* As the Technical Manager is responsible for this process and is absent due to illness, it is reasonable to attempt to contact him to obtain accurate information. This ensures that the audit process is not unduly delayed and that the information is obtained from the appropriate person.
* A. I would not accept the legal compliance expert answering the question.
* While the legal compliance expert might not be the best source for technical details, outright rejecting their input is not appropriate. It is better to first verify if the expert can provide relevant information.
* C. I would delay the audit until the return of the Technical Manager.
* This would be an inefficient approach. Contacting the Technical Manager by phone is a more practical and reasonable option.
* E. I would ask for a different guide instead of the legal compliance expert.
* The guide's role is not necessarily to answer technical questions but to facilitate the audit. Since Jack is already familiar with the situation, replacing him may not add value.
* F. I would ask the consultant to leave the meeting since he is not an employee of the organization.
* This is inappropriate and could disrupt the audit process. There is no rule in ISO 9001 preventing a consultant from assisting in the audit if authorized by the organization.
Why Not the Other Options:
NEW QUESTION # 150
Match the process descriptions below to the process names:
Answer:
Explanation:
Explanation:
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NEW QUESTION # 151
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