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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. What is the purpose of a 'scope statement' in an ISO 9001 QMS?

    Answer: To define the boundaries and applicability of the QMS

    The scope statement defines what products, services, locations, and processes are covered by the QMS, setting its boundaries.

  2. During an ISO 9001 internal audit, the auditor finds no documented evidence of management reviews for 18 months. This constitutes a:

    Answer: Major nonconformity

    Failure to conduct management reviews at planned intervals is a major nonconformity because it violates a mandatory ISO 9001:2015 Clause 9.3 requirement.

  3. Which of the following BEST describes 'documented information' as used in ISO 9001:2015?

    Answer: Information required to be controlled and maintained by the organization

    ISO 9001:2015 uses the term 'documented information' to cover both documents (maintained) and records (retained), in any medium or format.

  4. A plant experiences a recurring defect rate spike every Monday morning. What QMS tool is BEST suited to identify the root cause?

    Answer: Fishbone (Ishikawa) diagram

    A fishbone diagram systematically explores all potential causes (people, methods, machines, materials, environment, measurement) tied to a specific effect.

  5. In ISO 9001:2015, 'interested parties' (stakeholders) are addressed in which clause?

    Answer: Clause 4.2

    Clause 4.2 requires organizations to determine relevant interested parties and their requirements relevant to the QMS.

  6. Which metric is MOST directly used to measure customer satisfaction under ISO 9001?

    Answer: Net Promoter Score or customer complaint rate

    ISO 9001 Clause 9.1.2 requires monitoring customer perception, commonly measured via surveys, NPS, or tracking complaint frequency and resolution.

  7. What is the key difference between 'correction' and 'corrective action' in ISO 9001 terminology?

    Answer: Correction addresses the immediate nonconformity; corrective action eliminates the root cause

    A correction fixes the specific nonconforming item (containment), while corrective action investigates and eliminates the underlying root cause to prevent recurrence.