Points of attention - checklist ISO 9001:2015 |
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Lawsuit |
Sub-processes |
New aspects |
Management process |
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- Context of the organization
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- Leadership (does the board play a leading role in the management system?)
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- Context of the organization (What are the most important aspects and developments?)
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- Objectives and actions (improvement process at company level)
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- Risks and opportunities (at the company level and based on context)
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- Objectives and actions (SMART and with global elaboration, resources and timing actions)
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- Monitoring and measurement (Key KPIs at the company level, including analysis and action)
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- Knowledge (strategic and future-oriented)
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Product development process |
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- Sales (determine requirements for the product and context)
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- Context of the organization (Included in specification)
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- Product development and product change
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- Risks and opportunities (with regard to product, process and project)
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- Process development (sections 6.6 and 8.1)
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- Monitoring and measuring (Process KPIs, Product measurements)
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- Knowledge (Critical technological knowledge, now and in the future; lessons learned)
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- Documentation (of the development process and of products and processes)
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- Objectives and actions with regard to the process (SMART and with elaboration resources and timing actions)
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Production, export service |
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- Context of the organization (Included in specification)
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- Risks and opportunities (only in case of changes)
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- Monitoring and measuring (Process KPIs, Product measurements)
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- Knowledge (Critical process and product knowledge, now and in the future)
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- Documentation (process description, instructions, etc.)
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- Objectives and actions with regard to the process (SMART and with elaboration resources and timing actions)
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HRM |
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- Context of the organization (Labor market)
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- Risks and opportunities (Availability of personnel)
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- Competency management (usually in the assessment cycle)
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- Monitoring and measuring (Process KPIs)
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- Managing critical functions
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- Knowledge (Personnel planning, including succession; contacts with colleges and universities)
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- Documentation (process description, instructions, etc.)
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- Objectives and actions with regard to the process (SMART and with elaboration resources and timing actions)
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Change process |
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- Process and organizational changes
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- Context of the organisation (Possible reason for changes)
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- Changes to assets and facilities
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- Risks and opportunities (In the event of changes with substantial risks to service/product)
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- Monitoring and measuring (Possible changes to process KPIs)
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- Knowledge (Continuity in critical knowledge)
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- Documentation (of change process and new situation)
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- Objectives and actions with regard to changes (SMART and with elaboration of resources and timing actions)
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- Continuity of delivery/service during the change
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Facilities and means of production |
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- Risks and opportunities (with regard to availability and continuity)
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- Monitoring and measuring (KPIs if process is critical for product/service quality)
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Described management system |
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- Risks and opportunities (Degree of documentation depends on risk. Is this also the practice?)
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- Standard sets minimum requirements for documentation and registrations (Are they met?)
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- Changes have been made, such as redefinition of scope and lapsed management representative
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