ISO 9001:2015 & ISO 14001:2015 ‘An Organisations View’ - Roadshow Presentation

Sep 12, 2026

Roadshow presentation covering the High Level Structure (HLS) introduced for future ISO management system standards, explaining the common framework, standardized text, shared clauses, and consistent terminology. It outlines ISO 9001:2015 content from scope and context of the organization through leadership, planning, support, operation, performance evaluation, and improvement. The session focuses on how to identify internal and external issues impacting strategic objectives and quality management system planning, including interested parties and the practical role of risk-based thinking, with context analysis examples using PESTLE, SWOT, and Porter’s five forces.

LanguageEnglish

CategoryPresentations

FormatPDF

Pages127

Reading Time44 min

AccessFree to download

High Level Structure (HLS)

Common framework and shared clauses

ISO 9001:2015 Contents

Scope, normative references, terms

Leadership

Planning

Support

Operation

Performance evaluation

Improvement

Context of the Organisation

Internal context factors

External context factors

Context analysis approaches (PESTLE, SWOT, Porter)

ISO 9001:2015 & ISO 14001:2015 ‘An Organisations View’ February & March 2017 I.S . EN ISO 9001:2015 Mr . John Tighe Lead Auditor, NSAI CONTENT • High Level Structure (HLS) • Context Of the Organisation • Interested Parties • Scope of the QMS • Process Approach • The emphasis on Leadership • The focus on Risk-based thinking • Quality Objectives • How Change is addressed • Externally provided Processes, Products, Services • QMS Questionnaire • Process Clause Matrix High Level Structure The High Level Structure (HLS) is a standardized way of drafting future ISO management system standards All new standards should respect and share a common consistent core: • A common framework (table of contents, chapters, etc.) • Standardised text • Shared clauses and titles • Common terms and definitions Whilst the high level structure cannot be changed, sub-clauses and discipline-specific text can be added. With the new structure applicable to all new ISO management systems standards it will be much easier to implement multiple, integrated management systems ISO 9001:2015 Contents 1. Scope 2. Normative references 3. Terms and definitions 4. Context of the organization • Understanding the organization and its context • Understanding the needs and expectations of interested parties • Determining the scope Of QMS • Quality management system and its processes 5. Leadership • Leadership and commitment • Quality Policy • Organizational roles, responsibilities and authorities 6. Planning • Actions to address risks and opportunities • Quality objectives and planning to achieve them • Planning of changes 7. Support • Resources -Organizational knowledge • Competence • Awareness • Communication • Documented information 8. Operation •• • • • •• Operational planning and control Requirements for products and services Design and development of products and services Control 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 9. Performance evaluation • Monitoring, measurement, analysis and evaluation • Internal audit • Management review 10. Improvement • General • Nonconformity and corrective action • Continual improvement Black: core MS requirements Red: new MS requirements Green: ISO 9001 specific Context of the organisation • 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. • 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. • Focus on factors that can affect customer satisfaction and delivery of quality products and/or service. • The context will influence the type and complexity of the quality management system needed. Context of the Organisation Internal context: • Performance factors: products and service offerings, financial results, regulatory requirements • Resource factors: including infrastructure, environment for the operation of the processes, organizational knowledge, assets, capabilities, information systems • Human factors: such as competence of personnel, organizational behaviour & culture, relationships with unions, suppliers & partners • Operational factors: such as process or production and service provision capabilities, performance of the quality management system, monitoring customer satisfaction • Factors in the governance of the organization, such as its rules and procedures for decision making or organizati

FAQs

What is the High Level Structure (HLS) and what does it standardize?

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.

How do you determine the context of an organization for ISO 9001:2015?

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.

Which tools are referenced for context analysis, and how are they used?

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.

Sep 12, 2026

Upload by Aria Callaghan