ISO 9001 Software

How can Effivity help you on your journey to optimise your ISO 9001 QMS?

The implementation of an ISO 9001 Quality Management System needs to be a strategic initiative. The developed QMS must merge seamlessly with the existing business processes of your organisation to satisfy the needs and expectations of all interested parties. The Effivity – QMS module enables organisations to plan, implement, maintain and improve their QMS. Effivity is a comprehensive Compliance Management Software that helps in simplifying your organisation’s Quality and Compliance Management modules. Effivity is recognised as one of the best enterprise solutions with the highest client satisfaction. It is cloud-based, hence state-of-the-art, and scalable so you need not spend large amounts of time on QMS every time your business expands. It’s configurable so features can be customised as per the compliance requirements of your organisation. It is the best way of managing, tracking, and implementing the ISO 9001 standards in your business environment.

Effivity - QMS, the sure shot key to success

Your customers, clients and channel partners need to have confidence in your processes, products, services and projects to maintain a sustainable competitive advantage. Since the complexity of business processes may result in poorly defined QMS, the resultant benefits may not be evident. Effivity addresses this problem by providing a robust, globally proven and effective quality management implementation software to address the requirements of the ISO 9001:2015 standard in the most comprehensive manner.

Effivity - QMS helps in achieving QMS certification so you can manage regulations and standards effectively. Our workflow-driven software enables organisational compliance management and corporate governance organisation. As the focus on quality management increases worldwide, you can’t ignore it. QMS certification allows for visibility and control. You need software capable of offering the control, reporting features, and documentation processing to get certified with the utmost ease and convenience.

Our software offers a comprehensive set of tools and capabilities to manage quality management issues quite easily. It is a powerful solution that can help you pass the stringent quality standards. We assure that the auditors will be fully satisfied with your quality standards.

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ISO 9001 modules covered by Effivity - QMS

Our software covers all the modules necessary to help you achieve QMS certification.

Context of the Organisation

  1. Define the context of the organisation by establishing the aim of the organisation, the nature of the business and the benefits of the business. Also establish strengths and weaknesses of, threats to, and opportunities for your business.
  2. Define the different external issues that may affect your organisation, like competition, cultural and economic considerations, and determine the risks associated with each external issue.
  3. Define the different internal issues that may affect your organisation, such as competence, cultural considerations, and values, and determine the risks associated with each internal issue.
  4. Define who your stakeholders and interested parties are. Detail what you expect and need from them and how they impact your organisation and determine the risks associated with your stakeholders and interested parties.
  5. The risks associated with the internal and external issues related to your organisation as well as the concerns of interested parties will be captured in the Risk and Opportunity module, where you can act to control risks.
  6. Define the scope of the QMS for which your organisation needs certification and determine which clauses are not applicable.
  7. Provide justification for the non-applicable and thus excluded clauses.
  8. Flow charts, procedures and forms related to your organisational context can be captured in the Documented Information module.

Risk and Opportunity

  1. Define the applicable risk and opportunity types whether derived from context, process, or products and services.
  2. Define the activity and source from where the risk or opportunity may originate.
  3. Define to which category the identified risk belongs from a predefined list of categories.
  4. Describe the risk in a detailed manner.
  5. Define how the level of impact and the probability of occurrence.
  6. Define your plan to treat the risk from a predefined list of solutions.
  7. Define the suitable action to treat the risk.
  8. Define the opportunity and describe the proposed action.
  9. Procedures and forms related to risk and opportunity can be captured in the Documented Information module.

Human Resources

  1. Define the organisational structure, create employees and departments, and assign roles and designations.
  2. Define role, responsibility and authority.
  3. Define ideal competence.
  4. Compare existing competences to ideal competences and identify competence gaps via competence evaluation.
  5. Identify training needs and create a training calendar.
  6. Capture training records.
  7. Carry out training effectiveness evaluation.
  8. Upload and manage HR-related policies and procedures using the Documented Information control module.
  9. Define, plan and track HR objectives.


  1. Capture customer enquiries and contact details.
  2. Record follow-up on each enquiry.
  3. Define internal proposals and send to technical teams for review.
  4. Update the status of enquiries.
  5. Create a work order when the status of an enquiry changes to won.
  6. Send predefined customer feedback to customers.
  7. Update responses once you receive feedback from customers.
  8. Define a plan to track marketing objectives.
  9. Procedures, forms, and flow charts can be captured in the Documented Information module.


  1. Register suppliers by entering contact details and product or service details.
  2. A list of approved suppliers is available in a read-only version.
  3. Record the re-evaluation details of each supplier by providing values to predefined parameters.
  4. Define the criteria for outsourced process.
  5. Update details for original purchase orders.
  6. Define, plan and track purchasing objectives.
  7. Procedures and forms related to purchasing can be captured in the Documented Information module.

Design and Development

  1. Identify project design and development.
  2. Define a plan for the identified design and development project.
  3. Define inputs for the identified design and development project.
  4. Define outputs for the identified design and development project.
  5. Record the review and verification details of the identified design and development project.
  6. Define validation for the identified design and development project.
  7. Define changes necessary to the identified design and development project.
  8. Define, plan and track your design and development objectives.
  9. Procedures and forms related to design and development can be captured in the Documented Information module.


  1. Establish a quality policy.
  2. Define quality objectives for each department.
  3. Define achievement plan for each objective.
  4. Define tracking for each objective.
  5. Define incoming inspection quality plans for raw materials and/or purchased products or services.
  6. Capture incoming inspection quality records for all purchased products and purchase orders.
  7. Define in-process inspection quality plans for processes.
  8. Capture in-process inspection quality plans for processes and work orders.
  9. Define final inspection quality plans for final products and/or services.
  10. Capture final inspection quality records for final products and work orders.
  11. Define improvement activities.
  12. Procedures and forms related to quality can be captured in the Documented Information module.


  1. Define raw materials.
  2. Define product and services.
  3. Create a detailed work order and determine the person responsible for the work order.
  4. Establish operation plans for each product by defining the required processes and resources.
  5. Determine processes by defining input, working, output, and process effectiveness and the associated risks.
  6. The risks associated with your processes will be captured in the Risk and Opportunity module and implemented actions can also be addressed in the Risk and Opportunity module.
  7. Establish process validation where process output can’t be measured.
  8. Prepare execution plans for work orders.
  9. Define equipment.
  10. Schedule equipment for calibration.
  11. Update equipment calibration details after calibration.
  12. Schedule equipment for preventive maintenance.
  13. Update preventive maintenance details after preventive maintenance.
  14. Capture breakdown details.
  15. Capture customer-owned property.
  16. Define what to monitor and when.
  17. Procedures and forms related to operations can be captured in the Documented Information module.


  1. Define the non-conformance.
  2. Define non-conformance type.
  3. Define appropriate correction.
  4. Define root cause analysis.
  5. Define proposed corrective action.
  6. Define actual corrective action.
  7. Define verification taken.
  8. Define effectiveness of corrective action.

Internal audit

  1. Define internal audit master schedule for each department.
  2. Define internal audit schedule.
  3. Define internal audit report.
  4. Non-conformances captured here will be reflected in the Non-Conformance module, where you can act.
  5. Procedures and forms related to internal audits can be captured in the Documented Information module.

Management Review

  1. Define management review agendas and notify attendees via email.
  2. Outline the discussion minutes against each agenda.
  3. Record the actions planned during meetings.
  4. Procedures and forms related to Management Review can be captured in the Documented Information module.

Documented information

  1. Define retention and disposal mechanisms for forms and checklists.
  2. Create a change request for any document.
  3. Define external documents by providing details like document name, department, revision number, and revision date.

Why Effivity – QMS is your best choice for ISO 9001 implementation, maintenance and certification

  • Get ISO 9001 certified as fast as possible.
  • We make it a cost-effective affair. Our prices are affordable and competitive. Pay per user and no initial IT infrastructure expenses required.
  • Effivity - QMS is the one and only ISO 9001 implementation software that offers more than ever expected from a typical QMS module. Seasoned ISO specialists designed and developed the software, and they have implemented it across various industries.
  • Everything is electronic, so you don't have to struggle with piles of papers. A smart way of implementing ISO 9001 indeed.
  • Cloud-based technology increases accessibility, reliability and cost-efficiency.
  • User-friendly interfaces for everyone.
  • Our approach is technology-driven. Manage complete process documentation to international benchmarks.
  • We bring down costs and the time required to achieve certification.
  • Post-certification, manage compliance effortlessly, easily and in real-time.
  • Our backend team is available to you round-the-clock to assist and manage everything regarding process documentation, standardisation, auditing, and compliance.

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