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Exam ISO-9001-Lead-Auditor Topic 4 Question 60 Discussion
Actual exam question for PECB's ISO-9001-Lead-Auditor exam
Question #: 60
Topic #: 4
Question #: 60
Topic #: 4
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.
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.
Suggested Answer:
A screenshot of a computer AI-generated content may be incorrect.
Comprehensive and Detailed In-Depth Explanation:
* Clause 8.3.2 e) - Internal Resource Needs:Delays due to staff shortages highlight a lack of internal resources, directly relating to this clause that requires internal resource planning for design and development.
* Clause 8.3.6 - Design and Development Changes:Ongoing formulation changes due to feedback need to be documented and reviewed. This clause requires retention of documented information on changes.
* Clause 8.3.5 - Design and Development Outputs:Customer approvals for formulations are outputs of the design process and must be retained as documented information, as per this clause.
* Clause 8.3.4 d) - Design and Development Controls:Consumer trials are a validation activity. This clause ensures such trials are conducted to confirm that resulting products meet defined requirements.
* Clause 8.3.2 e) - External Resource Needs:Shelf-life tests done by an external lab are part of the external resources needed for development and are referenced here.
Comprehensive and Detailed In-Depth Explanation:
* Clause 8.3.2 e) - Internal Resource Needs:Delays due to staff shortages highlight a lack of internal resources, directly relating to this clause that requires internal resource planning for design and development.
* Clause 8.3.6 - Design and Development Changes:Ongoing formulation changes due to feedback need to be documented and reviewed. This clause requires retention of documented information on changes.
* Clause 8.3.5 - Design and Development Outputs:Customer approvals for formulations are outputs of the design process and must be retained as documented information, as per this clause.
* Clause 8.3.4 d) - Design and Development Controls:Consumer trials are a validation activity. This clause ensures such trials are conducted to confirm that resulting products meet defined requirements.
* Clause 8.3.2 e) - External Resource Needs:Shelf-life tests done by an external lab are part of the external resources needed for development and are referenced here.
by Bob at Jan 16, 2026, 07:17 PM
Here are all the actual test exam dumps for IT exams. Most people prepare for the actual exams with our test dumps to pass their exams. So it's critical to choose and actual test pdf to succeed.
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