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NEW QUESTION # 179
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:
The table below shows the possible matching of the ISO 9001 Clause 8.3 extract to the audit evidence.
Table
Audit evidence
ISO 9001 Clause 8.3 extract
Half of all new products launched in the past 12 months were late. The NPD Manager explains he has not got enough people on his team to cope with the demand for new products.
"8.3.2 e) ... internal ... resource needs for the design and development of products ..." The NPD 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.
"8.3.5 ... retain documented information ..."
The NPD Manager explains that the customer confirms their approval to proceed with a new formulation by email. These emails are kept on SWIFT.
"8.3.6 ... retain documented information ..."
The NPD Manager shows you evidence of consumer trials that are carried out for some new products prior to full-scale launch.
"8.3.4 d) ... conducted to ensure that the resulting products and services meet the requirements ..." The NPD Manager explains that an approved external laboratory is used to perform shelf-life stability trials on some formulations during product development.
"8.3.2 e) ... external ... resource needs for the design and development of products ..."
NEW QUESTION # 180
Which two of the following are the key expected results of a quality management system that conforms to the requirements of ISO 9001:2015?
Answer: A,B
Explanation:
According to the ISO 9001:2015 document, the key expected results of a quality management system that conforms to the requirements of ISO 9001:2015 are:
*the ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements;
*the enhancement of customer satisfaction.
These results are derived from the quality management principles of customer focus and process approach, which are the basis of the ISO 9000 family of standards1. Customer focus means understanding and meeting customer needs and expectations, as well as exceeding them when possible1. Process approach means managing activities as interrelated processes that function as a coherent system, which leads to consistent and predictable results1.
Therefore, the correct answer is C and F.
References: 2: ISO 9001:2015 - Quality management systems - Requirements 1: ISO - Quality management principles
NEW QUESTION # 181
You are carrying out an audit to ISO 9001 at an organisation which offers regulatory consultancy services to manufacturers of cosmetics.
You are interviewing the Technical Director (TD), who manages a team of regulatory experts responsible for providing regulatory services to customers.
You: "How do you ensure your regulatory team's competence concerning regulatory requirements is maintained?" TD: "The two Regulatory Experts we employ full-time have years of experience of working in the cosmetics industry." You: "How is their regulatory competence maintained?" TD: "They are dedicated individuals with lots of contacts in the sector." You: "How does the business enable them to maintain their understanding of current regulatory requirements?" TD: "We leave that up to them."
Answer:
Explanation:
Explanation:
A screenshot of a computer Description automatically generated
NEW QUESTION # 182
You are leading a team that is auditing a fruit juice manufacturer (ORANGE+), which markets its products in bottles of 0.5 and 1 litre. It is 4 pm, and the audit is close 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.
ORANGE+ has two manufacturing lines: M1 is a clean room for manufacturing and bottling the juices, and M2 is for packing and labelling the filled bottles in packets of 50 bottles each to be sent to retailers.
Auditor 1 audited the two manufacturing lines.
You: "What findings would you report?"
Auditor 1: "I have one issue. Earlier today, in the morning in M1, I observed a batch of 'sugarless orange juice' being filled into bottles with the label 'standard orange juice' on them." You: "How would you write the non-conformity?" Auditor 1: "Some bottles from a batch of 'sugarless orange juice' were labelled as 'standard orange juice'." What information would you add to this text to complete the non-conformity report? Select six.
Answer: B,D,E,F,G,I
Explanation:
A properly written nonconformity statement should contain:
* A clear description of the objective evidence.
* Reference to the audit criteria not fulfilled.
* Identification of where and when the evidence was found.
* Sufficient traceability to allow investigation and corrective action.
* Classification/grade where required by the certification body ' s process.
Why B is Correct
If any of the ORANGE+ procedures for bottling and labelling products were not being met.
The nonconformity should reference the specific internal procedure or audit criterion that was not followed.
Why C is Correct
The grade of nonconformity (major or minor).
In certification audits, nonconformities are typically classified according to certification body rules.
Why D is Correct
The date on which the evidence was identified.
The audit record should identify when the evidence was observed.
Why F is Correct
Batch number audited.
The batch number provides traceability and allows the organisation to investigate the affected product.
Why H is Correct
The description of the ISO 9001:2015 requirement not being complied with and the clause number.
A nonconformity must reference the audit criterion that was not fulfilled.
Why I is Correct
The place where the bottles with the wrong label were found.
The location where the evidence was observed should be recorded as part of the objective evidence.
Why the Other Options Are Incorrect
A). The regulatory requirements that apply to the juice being bottled.
May be relevant background information, but it is not essential information required to complete the nonconformity statement.
E). Composition of both sugar and sugarless juices.
Not required to establish the nonconformity.
G). Name of the supervisor and of the workers who were responsible for the bottling process.
Auditors report system failures, not assign blame to individuals.
J). The signature of the M1's supervisor accepting the non-conformity.
ISO 9001 and ISO 19011 do not require the auditee ' s signature to validate a nonconformity.
ISO-Aligned Conclusion
The six items that should be added to complete the nonconformity report are:
B). If any of the ORANGE+ procedures for bottling and labelling products were not being met.
C). The grade of nonconformity (major or minor).
D). The date on which the evidence was identified.
F). Batch number audited.
H). The description of the ISO 9001:2015 requirement not being complied with and the clause number.
I). The place where the bottles with the wrong label were found.
NEW QUESTION # 183
What does the application of the process approach in a QMS enable?
Answer: D
NEW QUESTION # 184
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