PECB ISO-9001-Lead-Auditor Exam Dumps - Actual Questions Answers

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 …”

According to ISO 19011:2018, clause 6.3.2, an audit plan should include the following information:

• The audit objectives, scope, and criteria
• The audit team members and their roles and responsibilities
• The audit schedule, including the sequence and timings of audit activities, such as opening meeting, document review, interviews, observations, closing meeting, etc.
• The expected time and duration of each audit activity and location
• The name and contact details of the auditee’s representative and other relevant parties
• The allocation of appropriate resources to support the audit activities
• The audit methods and techniques to be used, such as interviews, observations, sampling, etc.
• The audit documents and records to be prepared and retained
• The audit language and communication methods
• The audit risks and opportunities and how to address them
• The audit follow-up arrangements, if applicable

Therefore, the correct answer is D and F, as they are essential elements of an audit plan. The other options are either irrelevant or optional for an audit plan. References:

• ISO 19011:2018(en), Guidelines for auditing management systems, clause 6.3.2
• ISO 19011: Guidelines for Auditing Management Systems | ASQ, section “Making audit arrangements”
• ISO 19011 Management Systems Audit Checklist | Process Street, task 6.3.2

Nonconformity report

ISO 9001 Clause Number: 8.5.4 Nature of problem: Cleaning and sanitising records are not available for every batch. ISO 9001 requirement that has not been fulfilled: ISO 9001 - “The organization shall implement planned arrangements, at appropriate stages, to verify that the product requirements have been met.” Evidence: 40 cleaning records are available for 63 batches.