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A detailed look at the ISO 9001:2015 Quality Management Standard: Part 3

12th August 2016


Details the requirements for concepts of risk (and opportunity).

  • ACTIONS TO ADDRESS RISKS AND OPPORTUNITIES – The requirement to understand the risks and opportunities relevant to the scope of the organisation and determine actions, objectives and plans to address them.
  • The risks and opportunities use the inputs that the organisation has identified in understanding its context and the views from interested parties.
  • Options to address risks and opportunities can include:

    • Avoiding risk;
    • Taking risk in order to pursue an opportunity eliminating the risk source;
    • Changing the likelihood or consequences;
    • Sharing the risk; or
    • Retaining risk by informed decision.
  • Opportunities:

    • Can lead to the adoption of new practices:
    • Launching new products;
    • Opening new markets;
    • Addressing new clients;
    • Building partnerships;
    • Using new technology and other desirable and viable possibilities to address the organisation’s or its customers’ needs.
  • QUALITY OBJECTIVES AND PLANNING TO ACHIEVE THEM – The requirement for the organisation to set quality objectives at relevant functions, levels and processes needed for the quality management system.  These objectives must be SMART (Specific, Measurable, Achievable, Realistic and Timely) and can include:

    • Market position/growth;
    • Process effectiveness/efficiency;
    • Maintenance of present position;
    • Reduction in costs of quality;
    • Improvements in product conformity;
    • Reduction in defects/poor service;
    • Improved customer/client satisfaction.

    Objectives can be part of staff development/appraisals and records need to be kept on levels of achievement.

    • What will be done?
    • What resources will be required?
    • Who will be responsible?
    • When will it be completed?
    • How the results will be evaluated?

  • PLANNING OF CHANGES- The requirement is to ensure changes and the impact of changes are considered in terms of risk and are effectively planned, controlled and managed.


Details the requirement for the activities for People, Infrastructure, Environment for the Operation of Processes and Monitoring and Measurement Resources, Measurement Traceability, together with Organisational Knowledge Procedural Requirements of the quality management system.

  • RESOURCES –   The requirement for the resources needed for the establishment, implementation, maintenance and continual improvement of  the quality management, including the requirement for externally supplied resources.
  • PEOPLE – Determine and provide the persons necessary for effective implementation of the quality management system and for the operation and control of its processes.
  • INFRASTRUCTURE – Determine, provide and maintain the infrastructure necessary for the operation of its processes and to achieve conformity of products and services.
  • ENVIRONMENT FOR THE OPERATION OF ITS PROCESSES – Determine, provide and maintain the environment necessary for the operation of its processes and to achieve conformity of products and services.
  • These can be a combination of social, psychological and physical.
  • MONITORING AND MEASURING RESOURCES – The requirement to determine and provide the resources needed to ensure valid and reliable results when monitoring or measuring is used to verify the conformity of products and services to requirements.  Documented information as evidence of fitness for purpose of the monitoring and measurement resources are kept.
  • MEASUREMENT TRACEABILITY – When measurement traceability is a requirement, or is considered to be an essential part of providing confidence in the validity of measuring results, measuring equipment must be:

    • Calibrated, or verified, or both, at specified intervals, or prior to use, against measurement standards traceable to international or national measurement standards.  Where no standard exists the basis for calibration or verification must be documented.
    • Identified in order to determine their status
    • Safeguarded from adjustments that would invalidate the calibration status.
    • Where equipment is found to be unfit for its intended purpose then the validity of previous measurements must be reviewed.
  • ORGANISATIONAL KNOWLEDGE – Determine the knowledge necessary for the operation of its processes and to achieve conformity of products and services.   This knowledge must be maintained and be made available to the extent necessary.  
  • This knowledge can be from internal resources (e.g. intellectual property, knowledge specific to the organisation, gained from experience, lessons learned from failures and successful projects, capturing and sharing undocumented knowledge and experience, the results of improvements in processes, products and services).
  • External sources (e.g. standards, academia, conferences, gathering knowledge for customers or external providers).
  • COMPETENCE –  The requirement to determine the necessary competence of persons doing work under its control that affects the performance and effectiveness of the quality management system; where competence criteria are not met then the training required to acquire such competence.   There is a requirement to manage recruitment, induction and ongoing training and maintain documented information.
  • AWARENESS – The requirement to ensure that staff are made aware of the relevance of the quality policy, relevant quality objectives and their activities and how they contribute to the achievement of quality objectives.  Conversely the implications of not contributing to the specific and overall quality management system.
  • COMMUNICATION – The requirement for the organisation to determine the internal and external communications relevant to the quality management system including:

    • On what it will communicate?
    • When to communicate?
    • With whom to communicate?
    • How to communicate?
    • Who communicates?
  • DOCUMENTED INFORMATION – the requirement for documented information required by ISO 9001:2015 and documented information determined by the organisation as being necessary for the effectiveness of the quality management system.

There is no longer a requirement for mandatory documented procedures or manuals, but there is a requirement to maintain documented evidence of the system being operated.

In practice many organisations will maintain manuals and procedures to act as a guide and ensure operations are carried out effectively and efficiently.     
Documents, documented information can be in any format.                                           

  • CREATING AND UPDATING – When creating and updating documented information the following must be observed;

    • Identification and description (e.g. Title, date, version, author, or reference number).
    • Format (e.g. language, software version, graphics) and media (e.g. Paper or electronic).
    • Review and approval for suitability and adequacy.
  • CONTROL OF DOCUMENTED INFORMATION –  Documented information required by the quality management system and by ISO 9001:2015 must be controlled to ensure:

    • It is available and suitable for use, where and when it is needed;
    • It is adequately protected (e.g. from loss of confidentiality, improper use, or loss of integrity).

  • The following activities must be addressed, as appropriate:

    • Distribution, access, retrieval and use;
    • Storage, preservation, including preservation of legibility;
    • Control, of changes (e.g. version control);
    • Retention and disposition.

Documented information of external origin determined by the organisation to be necessary for the planning and operation of the quality management system is identified, as appropriate and controlled.

Documented information retained as evidence of conformity is protected from unintended alterations.

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