Jun 2016 | ISO 9001:2015 Requirements Met By impi! Solutions

ImageImpi! founder Pierre Bienvenüe shares his analysis of ISO 9001:2015 requirements based on lessons learned working with one of his clients since July 2015 under the guidance of one of the contributors to the new version of the standard. He uses the impi! model to document mappings from sub-clauses of the impi! solution model to ISO 9001:2015 requirements, and from ISO clauses and sub-clauses to solution capabilities.

Pierre writes: "Since July 2015, I've had the privilege to contribute to the ISO 9001:2015 implementation at one of my clients (my official guinea pig!) under the guidance of one of the contributors to the new version of the standard. impi! has proven itself to be a solid and flexible platform to work through the implementation and manage the required documentation. As a result, the current impi! solutions are supportive of the new standard."

"All impi! solutions are built on TeamPage on a wiki space and are standard documents. Every solution starts with a Policy (the why) and a Standard Operating Procedure (the how). The SOP is the hub that links all the other documents (the spokes). The templates used for these documents are the same that the client can use for their own controlled documentation in their own wiki space called “Knowledge Central”. Two outputs of every improvement projects are a) an operational improvement and b) documentation in Knowledge Central. The project templates used to run improvement projects comprise standard articles that will naturally become elements of the BOP (e.g. SIPOC, business process maps). When the project leader reaches the Control or Adjust part of the project, large chunks of the documentation would have been written. Using the capability of TeamPage simplifies the linking and tagging of documents. The organisation steadily builds its very own Wikipedia, and it’s ISO 9001 compliant. The risk of deadwood documentation is reduced: team members create their own documentation, hyperlinking contextualises the documentation and tagging and search capability ease retrieval of information."

"Of course we apply this model to definition and development of our own impi! solutions! I'm happy to share my mapping of imp! Solution clauses to ISO 9001:2015 requirements - and the inverse mapping from ISO 9001:2015 to imp! solution clauses. This is a living document that guides definition and development of TeamPage solutions developed by impi! and Traction Software."

Pierre Bienvenüe is founder of impi Business Improvement Solutions Pty, a South African business improvement firm and TeamPage solution partner since 2012. See Introducing impi! for contact information and background. See Quality Management, Signature Requirements for more about Traction Software's Quality Management option. Please contact us for Quality Option details.

Solutions application ⇒ ISO 9001:2015 reference


Sub-clause Solution Application by the solution

4. Context of the Organisation

4.1 Understanding the organization and its context

Managing Long Range Planning

  • Analysis of external factors (STEEP)
  • Identification of beneficial/harmful and internal/external factors (SWOT)
  • Performing risk assessments of key processes at functional levels

4.2 Understanding the needs and expectations of interested parties

Managing Long Range Planning

  • Mapping of key processes at functional levels using a SIPOC model that names the affecting (Suppliers) and affected parties (Customer)

4.4 Quality management system and its processes

Managing Long Range Planning

  • Map of the organisation process model
  • Map of key process model at functional level

4.4 Quality management system and its processes

Management of Improvement Projects

  • A structure is established to manage the implementation of improvement opportunities
  • Improvement projects are process centred and include risk assessment and change management

5. Leadership

5.1 Leadership and commitment

Managing Long Range Planning

  • Leadership establishes and manages the process of Long Range Planning (LRP)
  • The LRP process is an enabler for:
    • engagement and communication;
    • process, risk and improvement based thinking;
    • establishing clear policy direction and responsibilities.

5.2 Policy

Managing Long Range Planning

  • The LRP process enables the adjustment and communication of the quality policy
  • Vision, mission and values are adjusted for the organisation

5.3 Organisational roles, responsibilities and authorities

Managing Long Range Planning

  • Adjustment of the organigram and the MBU structure
  • Heads of department are responsible for the roll out the MBU structure (including KPI management) as well as the management of IPs
6. Planning

6.1 Actions to address risks and opportunities

Managing Long Range Planning

  • List of IOs is updated

6.2 Quality objectives and planning to achieve them

Managing Long Range Planning

  • Breakthrough Objectives and annual objectives are decided for BU 4
  • Annual objectives are decided for BU 3

6.2 Quality objectives and planning to achieve them

Establish and Run Mini Business Units

  • Roll out of Key Performance Indicator (KPI) usually following on the management review

6.2 Quality objectives and planning to achieve them

Management of Improvement Projects

  • IOs are triggered with the view of improving measurable outputs that are aligned with the organisation's breakthrough objectives. Improvement measures are reported in the project reviews of IPs
  • Changes to processes are managed through IPs. Responsibilities and Resources are identified during the project and deployed.
  • Change management forms part of the IP

7. Support

7.1.6 Documentation. Organisational knowledge

Management of Improvement Projects

  • Knowledge Central is a moderated space configured to organise and retrieve internal and external knowledge.

7.3 Awareness

Establish and Run Mini Business Units

  • The change management and communication is planned to ensure the organisation's employees are communicated the structural and strategic changes, the Vision, Mission, Value Statement, breakthrough and annual objectives.

7.3 Awareness

Management of Improvement Projects

  • Alignment of KPIs and their regular review ensures that every person in the organisation understand the value of their contribution to the effectiveness of the quality management system
  • Standard meetings are regular forums where non-conformance and improvement are managed in the relevant MBUs.

7.4 Communication

Managing Long Range Planning

  • The change management and communication is planned to ensure the organisation's employees are communicated the structural and strategic changes, the vision, mission, values, breakthrough and annual objectives.

7.5.2 Documentation. Creating and updating

Management of Improvement Projects

  • An IP is only completed when the relevant personnel is deemed competent and standard documentation is published in Knowledge Central

9. Performance Evaluation

9.3 Management review

Managing Long Range Planning

  • The management review is integrated in the LRP process

10. Improvement

10.1 General

Establish and Run Mini Business Units

  • Every MBU is responsible to manage corrective (problem solving) and improvement activities

10.1 General

Management of Improvement Projects

  • The management system for improvement projects is established to improve the quality management system focussing on process changes using lean-six sigma concepts and methods
  • IOs are managed, prioritised and converted into IPs

10.3 Continual improvement

Managing Long Range Planning

  • Improvement Opportunities (IOs) and Improvement Projects (IPs) are identified during the various milestones of the LRP process. They are then prioritised and responsibilities are allocated

10.3 Continual improvement

Management of Improvement Projects

  • Operational, systemic and strategic improvement projects are managed through the IP system.

ISO 9001:2015 reference ⇒ solutions application


ISO Clause Sub-clause Application by the solution

Goal Alignment - Managing Long Range Planning

Context of the Organisation

4.1 Understanding the organization and its context

  • Analysis of external factors (STEEP)
  • Identification of beneficial/harmful and internal/external factors (SWOT)
  • Performing risk assessments of key processes at functional levels

Context of the Organisation

4.2 Understanding the needs and expectations of interested parties

  • Mapping of key processes at functional levels using a SIPOC model that names the affecting (Suppliers) and affected parties (Customer)

Context of the Organisation

4.4 Quality management system and its processes

  • Map of the organisation process model
  • Map of key process model at functional level

Leadership

5.1 Leadership and commitment

  • Leadership establishes and manages the process of long range planning.
  • The LRP process is an enabler for:
    • engagement and communication;
    • process, risk and improvement based thinking;
    • establishing clear policy direction and responsibilities.

Leadership

5.2 Policy

  • The LRP process enables the adjustment and communication of the quality policy
  • Vision, mission and values are adjusted for the organisation

Leadership

5.3 Organisational roles, responsibilities and authorities

  • Adjustment of the organigram and the MBU structure
  • Heads of department are responsible for the roll out the MBU structure (including KPI management) as well as the management of IPs

Planning

6.1 Actions to address risks and opportunities

  • List of IOs is updated

Planning

6.2 Quality objectives and planning to achieve them

  • Breakthrough and annual objectives are decided for BU 4
  • Annual objectives are decided for BU 3

Support

7.3 Awareness

  • The change management and communication is planned to ensure the organisation's employees are communicated the structural and strategic changes, the vision, Mission mission, values, breakthrough and annual objectives.

Support

7.4 Communication

  • The change management and communication is planned to ensure the organisation's employees are communicated the structural and strategic changes, the vision, mission, values, breakthrough and annual objectives.

Performance Evaluation

9.3 Management review

  • The management review is integrated in the LRP process

Improvement

10.3 Continual improvement

  • Improvement Opportunities (IOs) and Improvement Projects (IPs) are identified during the various milestones of the LRP process. They are then prioritised and responsibilities are allocated
Goal Alignment - Establish and Run Mini Business Units: SOP

Planning

6.2 Quality objectives and planning to achieve them

  • Roll out of Key Performance Indicators (KPIs) usually following on the management review

Support

7.3 Awareness

  • Alignment of KPIs and their regular review ensures that every person in the organisation understand the value of their contribution to the effectiveness of the quality management system
  • Standard meetings are regular forums where non-conformance and improvement are managed in the relevant MBUs.

Improvement

10.1 General

  • Every MBU is responsible to manage corrective (problem solving) and improvement activities
Management of Improvement Projects

Context of the Organisation

4.4 Quality management system and its processes

  • A structure is established to manage the implementation of improvement opportunities
  • Improvement projects are process centred and include risk assessment and change management

Planning

6.2 Quality objectives and planning to achieve them

  • IOs are triggered with the view of improving measurable outputs that are aligned with the organisation's breakthrough objectives. Improvement measures are reported in the project reviews of IPs
  • Changes to processes are managed through IPs. Responsibilities and Resources are identified during the project and deployed.
  • Change management forms part of the IP

Support

7.1.6 Documentation. Organisational knowledge

  • Knowledge Central is a moderated space configured to organise and retrieve internal and external knowledge.

Support

7.5.2 Documentation. Creating and updating

  • An IP is only completed when the relevant personnel is deemed competent and standard documentation is published in Knowledge Central

Improvement

10.1 General

  • The management system for improvement projects is established to improve the quality management system focussing on process changes using lean-six sigma concepts and methods
  • IOs are managed, prioritised and converted into IPs

Improvement

10.3 Continual improvement

  • Operational, systemic and strategic improvement projects are managed through the IP system.

Related

Introducing impi! - Pierre Bienvenüe - Concepts impi! uses to build business management systems. Convergence of Quality Assurance and Continuous Improvement.

Dec 2015 | Quality Management, Signature Requirements - The TeamPage Quality Management module adds Feedback, Non-Conformance, and Corrective Action forms and dashboards to TeamPage's standard support for authoring, delivery, and tracking of quality and compliance documentation

TeamPage Solutions: Quality Management - Author, version, and share quality procedures using TeamPage

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