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It outlines ISO 9001:2015 content from scope and context of the organization through leadership, planning, support, operation, performance evaluation, and improvement. 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It enforces a common framework, standardized text, shared clauses and titles, and consistent terms and definitions.","Answer",{"name":111,"@type":106,"acceptedAnswer":112},"How do you determine the context of an organization for ISO 9001:2015?",{"text":113,"@type":109},"Determine the internal and external factors that can affect strategic objectives and the planning of the quality management system. This includes factors that can influence customer satisfaction and the delivery of quality products and services.",{"name":115,"@type":106,"acceptedAnswer":116},"Which tools are referenced for context analysis, and how are they used?",{"text":117,"@type":109},"The presentation references PESTLE analysis to classify influencing factors, including opportunities and threats in a SWOT analysis. 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EN ISO 9001:2015  \nMr . John Tighe Lead Auditor, NSAI  \nCONTENT  \n• High Level Structure (HLS)  \n• Context Of the Organisation  \n• Interested Parties  \n• Scope of the QMS  \n• Process Approach  \n• The emphasis on Leadership  \n• The focus on Risk-based thinking  \n• Quality Objectives  \n• How Change is addressed  \n• Externally provided Processes, Products, Services  \n• QMS Questionnaire  \n• Process Clause Matrix  \nHigh Level Structure  \nThe High Level Structure (HLS) is a standardized way of drafting future ISO management system standards  \nAll new standards should respect and share a common consistent core:  \n• A common framework (table of contents, chapters, etc.)  \n• Standardised text  \n• Shared clauses and titles  \n• Common terms and definitions  \nWhilst the high level structure cannot be changed, sub-clauses and discipline-specific text can be added.  \nWith the new structure applicable to all new ISO management systems standards it will be much easier to implement multiple, integrated management systems  \nISO 9001:2015 Contents  \n1. Scope  \n2. Normative references  \n3. Terms and definitions  \n4. Context of the organization  \n• Understanding the organization and its context  \n• Understanding the needs and expectations of interested parties  \n• Determining the scope Of QMS  \n• Quality management system and its processes  \n5. Leadership  \n• Leadership and commitment  \n• Quality Policy  \n• Organizational roles, responsibilities and authorities  \n6. Planning  \n• Actions to address risks and opportunities  \n• Quality objectives and planning to achieve them  \n• Planning of changes  \n7. Support  \n• Resources  \n-Organizational knowledge  \n• Competence  \n• Awareness  \n• Communication  \n• Documented information  \n8. Operation  \n••  \n•  \n•  \n•  \n••  \nOperational planning and control Requirements for products and services  \nDesign and development of products and services  \nControl of externally provided processes, products and services Production and service provision-Post Delivery, Control of change Release of products and services Control of nonconforming outputs  \n9. Performance evaluation  \n• Monitoring, measurement, analysis and evaluation  \n• Internal audit  \n• Management review  \n10. Improvement  \n• General  \n• Nonconformity and corrective action  \n• Continual improvement  \nBlack: core MS requirements Red: new MS requirements  \nGreen: ISO 9001 specific  \nContext of the organisation  \n• An organisations context is influenced by its business environment that characterises each sector or industry; the customers and their needs, the required knowledge and technologies, the materials, services and systems that are required for producing the product or service, legal, regulatory, cultural constraints and the application and interfaces between them.  \n• To determine context means to identify the internal and external factors that can impact the organisations strategic objectives and the planning of the quality management system.  \n• Focus on factors that can affect customer satisfaction and delivery of quality products and/or service.  \n• The context will influence the type and complexity of the quality management system needed.  \nContext of the Organisation  \nInternal context:  \n• Performance factors: products and service offerings, financial results, regulatory requirements  \n• Resource factors: including infrastructure, environment for the operation of the processes, organizational knowledge, assets, capabilities, information systems  \n• Human factors: such as competence of personnel, organizational behaviour & culture, relationships with unions, suppliers & partners  \n• Operational factors: such as process or production and service provision capabilities, performance of the quality management system, monitoring customer satisfaction  \n• Factors in the governance of the organization, such as its rules and procedures for decision making or organizati","cbCaivDJD5qwm8WC","https://ap.wps.com/l/cbCaivDJD5qwm8WC","pdf",1486578,127,"English","# High Level Structure (HLS)\n## Common framework and shared clauses\n# ISO 9001:2015 Contents\n## Scope, normative references, terms\n## Leadership\n## Planning\n## Support\n## Operation\n## Performance evaluation\n## Improvement\n# Context of the Organisation\n## Internal context factors\n## External context factors\n## Context analysis approaches (PESTLE, SWOT, Porter)","[{\"question\":\"What is the High Level Structure (HLS) and what does it standardize?\",\"answer\":\"HLS provides a standardized way to draft future ISO management system standards. It enforces a common framework, standardized text, shared clauses and titles, and consistent terms and definitions.\"},{\"question\":\"How do you determine the context of an organization for ISO 9001:2015?\",\"answer\":\"Determine the internal and external factors that can affect strategic objectives and the planning of the quality management system. This includes factors that can influence customer satisfaction and the delivery of quality products and services.\"},{\"question\":\"Which tools are referenced for context analysis, and how are they used?\",\"answer\":\"The presentation references PESTLE analysis to classify influencing factors, including opportunities and threats in a SWOT analysis. It also mentions Porter’s five forces model as another method to understand industry fit within the environment.\"}]","ISO 9001:2015 & ISO 14001:2015 ‘An Organisations View’ - Roadshow Presentation | PDF",1789231542,44]