Every day we get quality professionals asking us how they can use EQMS to meet the requirements of ISO 9001, ISO 14001, and other management system standards.
Below we have broken down many of the main requirements for ISO 9001 and provided a small example of how EQMS will help manage each of these requirements.
Please use the below guide to get a taster of how EQMS can help you to manage your ISO 9001:2015 requirements. In no way is this an exhaustive list of all the ISO 9001 requirements, nor does it share all of the functionality of EQMS, but it should help you visualise how quality management software can help you achieve ISO 9001:2015 compliance.
|Clause||Requirements||Example how EQMS helps|
|4. Context of the organisation|
|4.1 Understanding the context of the organisation||Identify, monitor, and review external and internal issues that are relevant to its purpose and strategic direction.||
Issues and risks relevant to the strategic direction of the organisation can be identified, monitored, and reviewed in EQMS to help understand the Context of the Organisation.
Image: Example risks in EQMS
|4.2 Understanding the needs and expectations of interested parties||The organisation is required to determine the relevant requirements of relevant interested parties. It must then monitor and review the information about these parties and their requirements.||
The relevant requirements of interested parties can be monitored and reviewed in EQMS. For example, EQMS Training Records Manager can be used to assess training requirements and any gaps in performance.
Image: Example training matrix in EQMS
|4.3 Determine the scope of the quality management system||The scope of the quality management system must be made available and maintained as documented information.||
The scope of the quality management system can be stored in EQMS and communicated to the whole organisation and versions are easily controlled. All changes can be viewed using the audit trail.
Image: Example Document Navigator Tree in EQMS
|4.4 Quality Management System and its processes||
The organisation must establish a process-based quality management system.
Once in place, the QMS needs to be maintained and continually improved.
EQMS ensures all processes can be managed, monitored, and evaluated - at the click of a button.
Performance-related indicators are viewed either through the EQMS KPI Dashboard or via customised reports.
|5.1 Leadership and commitment||
Leadership must ensure that their quality policy and objectives are consistent with the strategic direction of the organisation.
Leadership must promote awareness and adoption of the process approach and risk based thinking.
EQMS ensures leadership are able to easily have a "hands on" approach.
The EQMS Dashboard ensures there is one single source of truth for all activity across the organisation, enabling the leadership team to get more visibility, promote awareness and know how the business is performing.
Image: Example KPI Dashboard in EQMS
|5.2 Policy||Top management must establish a quality policy that is appropriate to the purpose and strategic direction of the organisation.||
EQMS makes it easy for top management to implement and systematically maintain the quality policy and ensure it is applied throughout the organisation. For example, EQMS Document Manager ensures all employees have read and acknowledged required documents.
Image: Example document acknowledge in EQMS
|5.3 Organisational roles, responsibilities and authorities||Top management needs to ensure assignment of the necessary responsibilities and authorities to the organisational roles within the organisation to carry out quality-related objectives.||
EQMS has customisable workflows built into the framework to ensure that necessary responsibility and authorities are completed within required timeframes.
Image: Example workflow
|6.1 Actions to address risks and opportunities||The organisation must determine the risks and opportunities that need to be addressed for its given context.||
EQMS Risk Manager enables organisations to employ ISO 31000, COSO, SOX, Basel, AS/NZS 4360 or your own unique control framework to identify, quantify, and prioritise risks and opportunities.
Image: Example risk categories in EQMS Risk Manager
|6.2 Quality objectives and planning to achieve them||The organisation must set quality objectives for relevant functions, levels and processes within its quality management system.||
EQMS enables organisations to set quality objectives and monitor progress against the achievement of objectives.
|6.3 Planning of changes||When the organisation determines there is a need to change the quality management system, it must be carried out in a planned and systematic manner.||
With EQMS, any changes to the quality management system are managed through a workflow, enabling the organisation to assess whether the integrity of the quality management system could be compromised.
Image: Example changes paths in EQMS
|7.1 Resources||The organisation must determine and provide all the resources necessary to establish, implement, maintain, and improve the quality management system.||
EQMS enables you to document all of the necessary resources for a management system, including people, infrastructure, the environment for the operation of processes, monitoring and measuring resources, and organisational knowledge.
Image: Plan resource requirements in EQMS
|7.2 Competence||The organisation must determine the competency requirements for those people performing work under its control.||
EQMS Training Records Manager enables organisations to identify competency issues with quick and easy overviews or drill-down records.
Image: Run 100s of different custom reports about training records in EQMS
|7.3 Awareness||The organisation must ensure that all people doing work under the organisation's control are aware of the quality policy and objectives, and how they are contributing to the effectiveness of the QMS.||
EQMS makes it easy to ensure that anyone who is working under the organisation's control is aware of the implications of not conforming to the quality management system.
For example, a new employee can be sent the quality policy and the objectives. They can then acknowledge that they have read and understood the implications of not conforming to the quality management system.
Image: How to acknowledge quality policy in EQMS
|7.4 Communication||The organsation must determine the quality management system related matters on which it wishes to communicate.||
EQMS makes it easy to communicate quickly and effectively with stakeholders. Emails and push notifications can be sent to staff when they wish to communicate quality management system related matters, or staff can view activity on their 'To Do' list.
Image: To do list in EQMS
|7.5 Documented information||The organisation must document information required for ISO 9001:2015 and for the effective operation of its quality management system.||
EQMS makes it easy to control documented information to ensure it is available where and when needed, and that it is suitable for use. All documented information is controlled within EQMS, with unique identifiers, authors, reference numbers etc.
Image: Documented information follows a best practice approach in EQMS
|8.1 Operational planning and control||The organisation must plan, implement, and control processes to meet the requirements for product and service delivery.||
EQMS makes it easy to plan, implement and control processes.
Image: View all activity related to a process on one screen.
|8.2 Requirements for products and services||Organisations must be able to determine and review requirements for products and services, and document customer communication and feedback.||EQMS Issues Manager makes it easy to log and manage customer feedback. Any user can raise an issue, so an organisation has an up-to-date real-time overview of customer communication issues at any point.|
|8.3 Design and development of products and services||Organisations must establish, implement, and maintain a design and development process.||
EQMS enables organisations to apply controls to its design and development process. For example, even complex CAD drawings can be annotated and controlled with EQMS. All changes can be viewed through the audit trail.
|8.4. Control of externally provided processes, products and services||The organisation must ensure that externally provided processes, products or services meet requirements.||
EQMS provides a framework to monitor the performance of external providers and to have the results of the evaluation, any further re-evaluation, and any necessary actions as documented information.
|8.5 Production and service provision||The organisation must control the way in which they produce their products and services.||
EQMS ensures monitoring and measuring activities will be undertaken at appropriate points. It enables organisations to verify processes are being controlled and that outputs, products, and servcies are meeting their acceptance criteria.
The integrated EQMS modules make it easy to understand control changes.
|8.6 Release of products and services||The organisation must carry out predetermined arrangements at appropriate stages of the production / service delivery in order ro verify that products and services meet all requirements.||By using EQMS to plan, manage, and control workflows, it becomes easy to retain documented information. Internal audits are made quick and easy with EQMS Audit Manager, and audits can be scheduled to recurr at any frequency required.|
|8.7 Control of nonconforming ourtputs||The organisation is required to identify any outputs that do not conform to their intended requirements and controls need to be established and implemented to ensure that these non-conforming outputs are not delivered to the customer or their unintended use is prevented.||
EQMS Issues Manager ensures that any changes are managed and controlled prior to being released to customers. Authorities deciding the action can be predefined using the EQMS workflows.
Image: EQMS Issues Manager enables easy change management
|9. Performance Evaluation|
|9.1 General||Requires the organisation to determine what it needs to monitor and measure.||EQMS consolidates all information providing a plethora of different custom report types, making it easy to adapt the quality management sysrtem to the changing requirements e.g. customer satisfaction can be measured through the number of complaints/ time to respond to issues. EQMS provides many analysis and evaluation options to manipulate the data.|
|9.2 Internal audit||The organisation must carry out internal audits at planned intervals.||
EQMS Audit and Inspection Manager makes it easy to schedule, plan and manage audits. Any non-conformities or issues raised can then trigger a workflow.
The integrated modules makes it easy to wholistically manage audits from the planning phase.
Image: iEQMS Audit Manager app allows audits on-the-go without the need for duplication of effort.
|9.3 Management review||Top management must undertake reviews at planned intervals to ensure the quality management system's continuing suitability, adequa,cy and effectiveness.||
EQMS Audit and Inspection Manager has predefined checklists and audits which makes it easy to determine the effectiveness of the quality management system.
Image: Quickly review using visual reports
|Organisations must actively seek out and realise improvement opportunities that will better enable the organsiation to meet customer requirements and enhance their customers' satisfaction.||
EQMS ensures risk-based thinking is embedded into all processes. Permissions controls in EQMS Document Manager ensure security of information without detriment to business performance. Ongoing commitment to improvement can easily be carried out using EQMS Audit Manager to schedule and conduct internal and supplier audits.
Image: EQMS Audit Manager lets you schedule repeated audits with ease
10.2 Non-conformity and corrective action
|The organisation must set out how it acts when a nonconformity occurs.||Processes for following non-conformances can be documented in EQMS Document Manager. In addition, EQMS Issues Manager has customisable automated trigger workflows to ensure clear corrective action paths are taken.|
10.3 Continual improvement
|The organisation must use the outputs from analysis and evaluation and from management revview to determine areas of underperformance and to identify any opportunities for improvement.||EQMS KPI reporting enables management to view real-time reports with a range of custom widgets. Continuous monitoring of activity within EQMS and its reports enables the organisation to commit to ongoing improvement with regular performance reviews.|
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