Rina Services

Select Country

Skip Navigation LinksRINA Services >> keytopics >> ISO 9001 and ISO 14001 Revision >> ISO 9001:2015

ISO 9001 2015: elements of change

  1. Context of the organization
    • The organisation must identify and analyse internal and external factors:
      • that are significant for its strategic objectives
      • that influence its capacity to achieve the results expected of the quality management system.
      Defining these factors is essential for reasoning in terms of a Risk-Based Approach and for organising the quality management system accordingly.
    • Objectives: to raise the level of the organisation's strategic vision in planning the quality management system, taking the context in which it operates into account.
    • A knowledge of:
      • context
      • expectations of the interested parties
      • products and services offered by the organisation
      is essential for defining the quality management system's field of application, which constitutes the conditions under which the normative requirements are applied.
  2. Leadership:
    • Emphasis on Management's responsibilities and its role, in terms of support and motivation in relation to human resources, when it comes to implementing the quality management system.
    • The new standard no longer speaks about a Management Representative, but explicitly involves Top Management ("A person or group of people who directs and controls an organisation at the highest level").
    • Involvement of the company's Management is essential for effective implementation of the quality management system and to improve its integration into the "company system".
  3. Planning
    • Risk-based thinking: essential for planning the quality management system, it goes across all standard and implies new responsibilities for the organisations:
      • analysing risks and opportunities and classifying them in relation to the seriousness of the consequences,
      • planning actions to deal with the risks (elimination and/or mitigating the same),
      • implementing these actions,
      • checking their efficacy,
      • learning from experience, with a view to continuous improvement.
    • Organisations are to determine the best way of assessing risks and opportunities, in a manner that is in line with the complexity of the organisation itself and its processes.
  4. Support:
    • A new point that includes all the support requirements, that is: resources, skills, awareness, communication and documented information.
    • Awareness is elevated to requirement status.
    • Documented information:
      • This is the real new element (common to all standards subject to HLS).
      • Replaces the terms "procedures" and "records".
      • Can be drawn up and kept in the form the organisation deems most adequate in relation to its needs, risks and opportunities.
      • Must not be interpreted as downgrading of the obligation - on the part of organisations - to develop, maintain and record what is required in terms of the system.
  5. Operational activities:
    • The process-based approach is made more explicit.
    • The aim of the processes is to generate trust in the organisation's capacity to:
      • satisfy customer requirements
      • provide products and services that conform to standard requirements.
    • Applicability to the "services" is made more explicit (in the previous edition, only the term "product" was used).
    • External provision (products and services supplied from outside):
      • replaces the terms "procurement / outsourcing",
      • stresses control of the same: the organisation must ensure that what is procured from outside conforms to the requirements.
  6. Performance evaluation:
    • Attention is shifted from monitoring the management system to planning product and/ or service monitoring activities.
    • The organisation must identify what monitored, how and when the results of monitoring must be analysed.
    • The monitoring, measuring and analysis activities are required to guarantee:
      • the effectiveness of the quality management system,
      • constant satisfaction of the requirements and objectives the organisation has set.
  7. Improvement:
    • Objectives: to determine and select opportunities for improving:
      • processes
      • products and services
      • results expected of the management system.
    • Continuous activity: whenever an opportunity for improvement is identified, the organisation must establish how to implement it and what resources to use.

First name
Last name *
E-mail *
Company *

Request information

Thank you for contacting us.