4.4 Quality management system and its processes 4 Quality management system 4.1 General requirements Process inputs / outputs & KPIs Many QMS already cover this 5 Leadership 5 Management responsibility 5.1 Leadership and commitment 5.1 Management commitment Increased Focus, More hands on direction More frequent management reviews, or in management meetings 5.1.1 General 5.1 Management commitment Demonstrate commitment 5.1.2 Customer focus 5.2 Customer focus Determine statutory and regulatory requirements Risks Contract Review New product launch process Risks (Process could be documented – see 6.1) 5.2 Quality policy 5.2.1 developing the quality policy 5.2.2 communicating the quality policy 5.3 Quality policy Documented Available to relevant interested parties as applicable communicated and understood Training & Postings, covered regularly 5.3 Organizational roles, responsibilities and authorities 5.5.1 Responsibility and authority 5.5.2 Management representative Mgmt Rep implied, may be distributed – more open & updated language
5.4.2 quality management system planning More on Management of Change (MOC) – See Below 8.5.6 6 Planning 5.4.2 Quality management system planning 6.1 Actions to address risks and opportunities 5.4.2 Quality management system planning 8.5.3 Preventive action Significant New Requirement – Risk Not a full ISO 31000 risk management program – more risk management light Continual Improvement & Preventive action process – Now a Risk Analysis and Continual Improvement process Create Procedure / Process (Documented is not req, but may be helpful) 6.2 Quality objectives and planning to achieve them 5.4.1 Quality objectives objectives to be planned & measurable Define what is to be done (Like ISO 14001 – Project Plan / mgmt. Many systems largely cover this - may need more action plans – or actions covered in mgmt. meetings. Dashboard covered in meetings with action items 6.3 Planning of changes 5.4.2 Quality management system planning Risks to the integrity of the QMS More detailed steps to take Also in section 8.5.6 – see this section for details. ECN / PCN process, Risk process… 7 Support 6 Resource management 7.1 Resources 6 Resource management
7.1.1 General 6.1 Provision of resources Internal vs external resources Policy Manual Contract review New product launch… Purchasing / supplier processes 7.1.2 People 6.1 Provision of resources 7.1.3 Infrastructure 6.3 Infrastructure 7.1.4 Environment for the operation of processes 6.4 Work environment 7.1.5 Monitoring and measuring resources 7.1.5.1 General 7.1.5.2 measurement traceability 7.6 Control of monitoring and measuring equipment Language Changes – No really new requirements 7.1.6 Organizational knowledge New Organizational Knowledge - how much documentation is needed Training Process, TGRTGW, Design Process… Determine how many / detailed work instructions 7.2 Competence 6.2.1 General 6.2.2 Competence, training and awareness 7.3 Awareness 6.2.2 Competence, training and awareness Like ISO 14001 – Staff Aware of Objectives, implications of nonconformity… Training Process Postings and Meetings
7.4 Communication 5.5.3 Internal communication Like ISO 14001 – Communication to external parties (Contractors / customers) Training Process, Postings, Meetings Supplier Manuals… 7.5 Documented information 4.2 Documentation requirements Language Changes – No really new requirements – Records and Documentation More open language 7.5.1 General 4.2.1 General 7.5.2 Creating and updating 4.2.3 Control of documents 4.2.4 Control of records New Section – No real new requirements 7.5.3 Control of documented Information 4.2.3 Control of documents 4.2.4 Control of records 8 Operation 7 Product realization 8.1 Operational planning and control 7.1 Planning of product realization Includes outsources processes 8.2 Determination of requirements for products and services 7.2 Customer-related processes 8.2.1 Customer communication 7.2.3 Customer communication Customer Property Contingency plans were relevant Reference Contingency Plan 8.2.2 Determination of requirements related to products and services 7.2.1 Determination of requirements related to the product
8.4 Control of externally provided products and services 7.4.1 Purchasing process Increased focus on outsources processes Purchasing Process, Supplier Quality Processes… 8.4.1 General 7.4.1 Purchasing process 8.4.2 Type and extent of control (of external provision) 7.4.1 Purchasing process 7.4.3 Verification of purchased product Dependent on risks – Verification records Need to justify control based on risk – No documentation specifically req 8.4.3 Information for external providers 7.4.2 Purchasing information Language Changes – No really new requirements 8.5 Production and service provision 7.5 Production and service provision 8.5.1 Control of production and service provision 7.5.1 Control of production and service provision Language Changes – No really new requirements 8.5.2 Identification and traceability 7.5.3 Identification and traceability 8.5.3 Property belonging to customers or external providers 7.5.4 Customer property 8.5.4 Preservation 7.5.5 Preservation of product Language Changes – more emphasis on “Process outputs” 8.5.5 Post-delivery activities 7.5.1 Control of production and service provision New – but will not affect most companies Servicing…
8.5.6 Control of changes 7.3.7 Control of design and development changes, 4.2.3 & 5.4.2 New & increased emphasis, but largely covered by most systems ECN, Process Changes, document control… 8.6 Release of products and services 8.2.4 Monitoring and measurement of processes 7.4.3 Verification of purchased product 8.7 Control of nonconforming process outputs 8.3 Control of nonconforming product Language Changes – No really new requirements Update defined processes 9 Performance evaluation 8 Measurement, analysis and improvement 9.1 Monitoring, measurement, analysis and evaluation 8 Measurement, analysis and improvement Language Changes – More details 9.1.1 General 8.1 General 8.2.3 monitoring and measurement processes 9.1.2 Customer satisfaction 8.2.1 Customer satisfaction 9.1.3 Analysis and evaluation 8.4 Analysis of data More evidence of analysis of data 9.2 Internal audit 8.2.2 Internal audit Language Changes – More details Additional internal audit inputs