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The Resources Required to Execute ISO 9001:2015

ISO 9001-2015 Requirement: To be a truly effective quality management system, ISO 9001 2015 cites specific areas to which resources must be allocated.

Primary Section(s): 7.1, 7.2, 7.3, 7.4,7.5

Secondary Section(s): 0.1,4.4, 5.1.1,6.2.6.3,8.3,8.5,9.3

Key Requirements:

Implementation Tools:

Section 7 Resources

Section 7.1: Monitoring, Measurement, Analysis and Evaluation

This section takes a broad view of items needed to realize the requirements of ISO 9000 2015, specifically calling for support in these critical areas:

    • What resources on hand vs. what need to be procured including:
      • labor/skills
      • plant or office facilities/utilities
      • information technology/communications
      • transportation/logistics
      • equipment
      • working conditions/environment (including physical and interpersonnel emotional, intellectual, and motivational issues)
    • Measuring the type, level, scope, continuity and suitability of resources including ongoing justification of the need for these, and recording the results of this tracking
    • Addresses automated measurement for areas such as production data acquisition, asking that its accuracy be verified, documented, made tamper-proof and secure
  • What information is needed by the organization to maintain quality output including that a plan be made on how information (i.e. data, procedures/approaches, etc.) be categorized, preserved and shared – and that any gaps in knowledge be understood and addressed.

Section 7.2: Competence

The aptitude of those who implement the quality plan needs to be assessed against the requirements for the tasks, and any deficiencies be addressed through personnel training, exposure, outsourcing or reassignment.

Section 7.3: Awareness

The standard requires that everyone, not just those who administer the QMS, become familiar with its policies and objectives and know what they must do to achieve its goals, including what happens if they don’t adequately meet these requirements.

Section 7.4: Communication

A formal plan and activies for informing the organization about the QMS needs to include:

  • Who needs to know about each specific plan element
  • How and when that communication will take place
  • And who is responsible for the information being transmitted

Section 7.5: Documented Information

The nature of documentation has been expanded in order to both meet that which is required by the standard, but also what is needed by the organization itself to practically implement the QMS. It notes that the extensiveness of that documentation will vary based on a variety of factors (i.e. size, mission, products, services, sophistication, etc.). It does provide these specific documentation criteria:

  • It must include a means for proper description including its source, purpose, change history, review/approvals and the method of communicating (text, audio, video, pictorial, multimedia, interactive, etc.)
  • A means must be provided to formally manage the documentation, balancing the need for access versus security
  • Going further, there must be a plan and approach governing documentation dissemination (what, when, and where documentation can be accessed and by whom), integrity/validation, revision, approval, storage and destruction (if applicable)

Please note that certain text from the ISO 9001 standard is only used for instructional purposes. Standard Stores recognizes and respects the International Organization for Standardization (ISO) copyright and intellectual property guidelines.

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