DQM Core Units

Quality Management System flashcards

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Complete Flashcard Reference

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How do external issues differ from internal issues in an organisation's context?

External issues are factors outside the organisation's control: the regulatory environment, market competition, technology change and the wider economy. Internal issues are factors within the organisation: its culture, resources, knowledge and existing performance.

What are the seven quality management principles?

1. Customer focus 2. Leadership 3. Engagement of people 4. Process approach 5. Improvement 6. Evidence-based decision making 7. Relationship management

What are the five classes of quality management documents?

Quality policy: the top-level statement of intent and direction on quality. Quality manual: the scope and structure of the system as a whole. Procedures: how a specific process is carried out. Work instructions: detailed, step-by-step guidance for a specific task. Records: evidence that an activity was carried out or a result achieved.

Who are the interested parties of an organisation's quality management system?

Customers, who receive its products or services. Employees, who deliver the work the system governs. Suppliers, who provide the inputs it depends on. Regulators, who set legal and compliance requirements. Owners and investors, who bear the financial stake. The wider community, affected by its operations.

What are the four steps of the Plan-Do-Check-Act cycle?

Plan: what the process should achieve. Do: carry it out. Check: compare the results against what was planned. Act: correct or improve based on what was found. Then the cycle repeats.

How is a procedure handled differently from a record?

A procedure (or work instruction) is maintained: kept current and revised as needed. A record is retained: a fixed, dated piece of evidence that is never revised after the fact, because revising it would destroy its value as evidence.

What are the four stages in the evolution of quality, in order?

1. Inspection: checking finished output and rejecting what fails. 2. Quality control: monitoring the process during production. 3. Quality assurance: planned, systematic activities before and during production. 4. Total Quality Management: quality as everyone's responsibility across the organisation.

What does a quality management system's scope statement define, and why must it be clearly bounded?

It defines which products, services, sites and processes the system actually covers, taking into account the issues and interested parties' requirements identified. A clearly bounded scope is what makes the system auditable and its claims credible.

What are the three categories of processes in a quality management system?

Management processes: set direction, policy and objectives for the system. Core (realisation) processes: directly produce the product or service. Support processes: enable the core processes, such as HR, IT, maintenance and procurement.

Which ISO 9001 clauses do the unit's three elements map onto?

Establish the business context: clause 4 (context). Establish quality management processes: clauses 4.4 and 8 (processes). Establish quality management documentation: clause 7.5 (documented information).

Why does building a quality management system start with understanding the business context?