Governance, Risk and Compliance Blog

Quality management software for ISO 9001:2015 – clause by clause

Posted by Emily Hill on Fri, Feb 24, 2017

Quality Management Software for ISO 9001:2015

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 brief examples of how EQMS will help manage each of these requirements. 

Hopefully this guide gives you a taster of how EQMS can help you manage your own 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 fully comply with ISO 9001:2015.

 

Clause  Requirements  Example of how EQMS helps 
4. Context of the organisation    
4.1 Understanding the organisation and its context Identify, monitor, and review external and internal issues that are relevant to its purpose and strategic direction. 

You can use EQMS Risk Manager to identify, monitor and review issues and risks relevant to your organisation's strategic direction.

Identify and monitor risks with EQMS

Image: Example risks in EQMS

4.2 Understanding the needs and expectations of interested parties The organisation must determine the relevant requirements of relevant interested parties. It must then monitor and review the information about these parties and their requirements. 

You can monitor and review interested parties' relevant requirements in EQMS. For example, you can use EQMS Training Records Manager to assess training needs and any gaps in performance. 

Monitor and review training with EQMS

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. 

You can store the scope of the quality management system in EQMS Document Manager and communicate it to the whole organisation. Versions can be easily controlled. You can use the audit trail to view all changes that have been made. 

Control and manage documents

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.  

 

With EQMS, you can manage, monitor and evaluate all processes at the click of a button

Learn more about a process-based quality management system here. 

You can view performance-related indicators either through the EQMS KPI Dashboard or via customised reports.

5. Leadership    
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 can easily take a "hands on" approach.

Learn how Sodexo's leadership communicates policies with EQMS here. 

The EQMS KPI 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. 

EQMS KPI Dashboard

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 the required documents.  

Employees read and acknowledge documentsImage: Example document acknowledge in EQMS

5.3 Organisational roles, responsibilities and authorities  Top management needs to ensure the necessary responsibilities and authorities are assigned to the roles within the organisation designated to carry out quality-related objectives. 

EQMS has customisable workflows built into its framework to ensure that necessary responsibility and authorities are completed within required timeframes. 

Customised workflows for assigning roles

Image: Example workflow

6. Planning

   
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 allows you to employ ISO 31000, COSO, SOX, Basel, AS/NZS 4360 or your own unique control framework to identify, quantify, and prioritise risks and opportunities. 

 Identify and prioritise risk with EQMS

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 allows you to set quality objectives and monitor your progress in achieving those objectives. 

See KPIs with EQMS.

6.3 Planning changes  When the organisation determines there is a need to change the quality management system, the change must be carried out in a planned and systematic manner. 

With EQMS Change Manager, you can manage any changes to your quality management system through a workflow. This allows you to assess whether the integrity of your quality management system could be compromised. 

Use EQMS to manage changes to your system

Image: Example changes paths in EQMS

7. Support    
7.1 Resources  The organisation must determine and provide all the resources needed to establish, implement, maintain, and improve the quality management system.

EQMS Document Manager allows you to document all the resources needed for a management system, including people, infrastructure, the environment for the operation of processes, monitoring and measuring resources, and organisational knowledge. 

Plan resources with EQMSImage: 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 allows you to identify competency issues with quick and easy overviews or drill-down records.

Identify competency issues with EQMS

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 its 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.

Make staff aware of quality policy

Image: How to acknowledge quality policy in EQMS

7.4 Communication  The organisation 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. You can send emails and push notifications to staff when you need to communicate quality management system-related matters, or staff can view activity on their 'To Do' list. 

Easy communication with stakeholdersImage: 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. 

 

Control documents as best practice

Image: Documented information follows a best practice approach in EQMS

8. Operation     
8.1 Operational planning and control  The organisation must plan, implement and control processes to meet the requirements for delivering products and services. 

EQMS makes it easy to plan, implement and control processes. 

Plan and control processes easily

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, meaning your organisation always has an up-to-date, real-time overview of any issues relating to customer communication.
8.3 Design and development of products and services  Organisations must establish, implement and maintain a design and development process.

EQMS allows you to apply controls to your design and development process. For example, you can annotate and control even complex CAD drawings, and view all changes through the audit trail.  

 

8.4. Control of externally provided processes, products and services  The organisation must ensure that processes, products or services provided externally meet requirements. 

EQMS provides a framework to monitor external providers' performance and have the results of that monitoring, any further re-evaluation, and any necessary actions as documented information. 

Monitor and assess supplier performance

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 carried out at appropriate points. It allows you to verify that processes are being controlled and that outputs, products, and services 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 to verify that products and services meet all requirements.  By using EQMS to plan, manage and control workflows, it becomes easy to retain documented information. EQMS Audit and Inspection Manager makes internal audits quick and easy, and allows you to reschedule audits as frequently as you need.
8.7 Control of nonconforming ourtputs  The organisation must identify any outputs that do not conform to its intended requirements and establish and implement controls to ensure that these non-conforming outputs are neither delivered to the customer nor used unintentionally. 

EQMS Issues Manager ensures that any changes are managed and controlled before they are released to customers. You can use the EQMS workflows to predefine who will decide what action is taken. 

Easily manage issues and changes

Image: EQMS Issues Manager allows changes to be easily managed

9. Performance evaluation    
9.1 General  The organisation must determine what it needs to monitor and measure.  EQMS brings all information together to provide an extensive range of custom reports, making it easy for you to adapt your quality management system to your changing requirements (for example, you can measure customer satisfaction through the number of complaints, or the time taken to respond to issues). EQMS gives you many options to analyse, evaluate and 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 make it easy to manage audits from the planning phase. 

Schedule, plan and manage audits

Image: The iEQMS Audit Manager app allows audits on-the-go without duplicating any effort.

9.3 Management review Top management must carry out reviews at planned intervals to ensure the quality management system continues to be suitable and effective. 

EQMS Audit and Inspection Manager has predefined checklists and audits, making it easy for you to determine the effectiveness of your quality management system. 

Review QMS with visual reports

Image: Use visual reports to quickly review your QMS

10. Improvement    

10.1 General 

Organisations must actively seek and take opportunities to improve so they can better meet customers' requirements and generate greater customer satisfaction. 

EQMS ensures risk-based thinking is embedded in all processes. Permissions controls in EQMS Document Manager protect the security of your information without harming your business's performance. You can commit to ongoing improvement by using EQMS Audit Manager to schedule and carry out internal and supplier audits.

Schedule audits with EQMS

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 non-conformity occurs.  You can use EQMS Document Manager to document processes for following non-conformities. Also, EQMS Issues Manager has customisable and automated trigger workflows to ensure clear corrective action is taken.

10.3 Continual improvement

The organisation must use the outputs from analysis and evaluation and from management reviews to determine areas of underperformance and to identify any opportunities for improvement.  EQMS's KPI reporting enables management to view real-time reports with a range of custom widgets. Continuous monitoring of activity within EQMS and its reports allows you to commit to ongoing improvement with regular performance reviews.


What you should do now

Download the ISO 9001:2015 toolkit for more information on how your organisation can fully comply with the requirements. 

 

ISO 9001:2015 Toolkit

  

Tags: ISO 9001:2015