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ISO 9001 & QMS Deployment Flashcards

7 cards from real CPM practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.

Read the first 7 ISO 9001 & QMS Deployment flashcards as text

  1. When deploying ISO 9001 in a multi-site manufacturing company, which approach is generally preferred for maintaining a single certification?

    Answer: A single QMS with site-specific procedures under one corporate scope

    A single integrated QMS with consistent core processes and site-specific work instructions allows multi-site organizations to hold one certification covering all locations.

  2. Which ISO 9001:2015 clause covers 'Control of Externally Provided Processes, Products, and Services'?

    Answer: Clause 8.4

    Clause 8.4 governs the control of outsourced processes and purchased products and services, including supplier evaluation criteria.

  3. A plant manager wants to set quality objectives. According to ISO 9001:2015, which characteristic is NOT required for quality objectives?

    Answer: Approved by a third-party auditor

    ISO 9001:2015 Clause 6.2 requires objectives to be measurable, monitored, communicated, and consistent with policy — third-party approval is not required.

  4. During QMS deployment, a plant decides to exclude 'Design and Development' (Clause 8.3) from its scope. Under what condition is this exclusion permitted?

    Answer: If the plant does not perform design activities and the exclusion does not affect conformity

    ISO 9001:2015 allows exclusion of requirements that are not applicable to the organization's operations, provided this does not affect the ability to ensure product conformity.

  5. What is the primary purpose of a Process FMEA (Failure Mode and Effects Analysis) in a QMS?

    Answer: To proactively identify and prioritize potential process failure modes before they occur

    Process FMEA uses Risk Priority Numbers (RPNs) to rank failure modes by severity, occurrence, and detectability so resources target highest-risk items first.

  6. In ISO 9001, what is meant by 'continual improvement' versus 'continuous improvement'?

    Answer: Continual improvement allows for periodic step-changes, while continuous implies uninterrupted incremental progress

    ISO 9001 uses 'continual improvement' intentionally, acknowledging that improvements may occur in discrete steps or projects rather than as an unbroken stream.

  7. Which of the following BEST supports the 'process approach' required by ISO 9001:2015?

    Answer: Mapping end-to-end processes with defined inputs, outputs, owners, and performance metrics

    The process approach requires understanding interrelated activities as a system, with each process having clear inputs, outputs, owners, and measurable performance indicators.