Complying with the ISO 9001 standard is more relevant than ever. All organizations need Quality Management to ensure they consistently deliver quality products and services to their customers.
However, the ‘one-size-fits-all’ solution for how to handle Quality Management, is a relic of the past. An individual approach and definition of the scope of how your organization works with Quality Management is necessary. At the same time organizations must document why and how the different choices in scope and method has been made.
Once up and running, continuous involvement of stakeholders and documentation of responsibilities, interactions and decisions are necessary. Organizations maintaining, or working towards, ISO 9001 compliance can benefit from the structure and facilitation of digital collaboration QualiWare provides. Read on to learn more about what the ISO 9001:2015 Standard entails and how QualiWare can help you get the most out of your Quality Management System.
The ISO 9001:2015 Standard guide organizations to tailor a Quality Management System that suit their specific needs. Having a well-functioning tailored Quality Management System is necessary for organizations if they want to survive the increasing complexity of their environments. The purpose of ISO 9001 is to ensure an organization’s efficiency and improve customer satisfaction. It enables the organization to demonstrate its ability to consistently provide products and services that live up to policies, regulations and customer requirements.
Complying with the ISO 9001:2015 standard entails:
- Having a clear understanding of the organization’s internal and external context
- Having a customer-centric process approach, employing the Plan-Do-Check-Act cycle
- Focusing on seeking improvement opportunities
- Integrating risk-based thinking, and creating control activities throughout the organization
- Aligning the Quality Management System’s policies and objectives with the organization’s strategy
- Engaging the organization’s leadership in the management system
- Focusing on relationship management
The potential benefits compliance includes:
- Improved results by focusing the organizations efforts on achieving planned results
- Improved risk control
- Improved customer satisfaction and loyalty
- Improved image, reputation and credibility
Plan, Do, Check & Act – Using the Process Approach
The process approach entails that an organization plans its processes and their interactions, focusing on the ‘customer’ for each process – whether the output is meant for external or internal delivery.
With the focus on the customer and the intended output, risks that might affect the planned result should be assessed. Controls to minimize probability and impact of the risks and maximize the utilization of opportunities should be put into place.
Using the process approach should enable your organization to understand how to consistently meet requirements, improve your processes based on evaluated data, achieve effective processes, and consider how your processes contribute value.
The elements needed in the Quality Management Systems can be divided into four groups that makes up a cycle:
1. Plan: Determine the organization’s context, scope, objectives, policies and processes. Map the sequence of the processes and determine who is accountable for them and owner of them. Document the needs and expectations of customers and other stakeholders. Establish what information needs to be documented and what interfaces, risks and activities the processes contain. Lastly, you must define the monitoring and measurement requirements.
2. Do: Implement the planned changes and determine the needed resources for operations and their support.
3. Check: Ensure the plan is working by monitoring and measuring the processes and products against their planned objectives and relevant requirements to evaluate performance.
4. Act: Implement change requests to improve risk handling, process performance and customer satisfaction.
The leadership of the organization is accountable of the effectiveness of the Quality Management System. Therefore, it has a prominent role in enabling the four steps by:
- Promoting the use of the process approach and risk-based thinking
- Actively engaging the organization in it and ensure that the customers’ requirements are in focus
- Ensuring the availability of the necessary resources
- Ensuring the organizational structure to support the Quality Management System is in place
QualiWare will support you – today and into the future!
To continually run and improve your processes and outcome is a tall order to handle for any organization. This is why QualiWare has tailored a solution for the organization that needs to obtain or maintain an ISO 9001 certification and get the most out of its Quality Management System.
By using the QualiWare Governance Risk and Compliance (GRC) solution, your organization will easier be able to achieve a broad range of benefits such as:
- Governance Management: Facilitating a secure and structured way for maintaining your information and processes. This includes facilitating the involvement of relevant stakeholders, letting the right people know when it is time for a review of information and models, and notify employees when changes relevant to them have occurred.
- Risk Management: Making risk visible in processes. Handling and reducing the risk within structured control activities. Providing financial overviews of risk activity costs.
- Compliance Management: Ensuring requirements for compliance are structured and communicated. Providing reports for analytics covering compliance, requirements and Quality Management System usage statistics of your organization.
- Context Mapping: Modelling your organization’s context and relationships, for example with a Business Operating Model, Business Eco System diagrams and stakeholder models.
- Process Management: Mapping processes and documenting their contribution to stakeholders and the organization’s objectives.
- Engaging the organization: Involving employees and leadership through a collaboration platform where all approved information is published and easily accessible. Below, you can see an example of how the Collaboration platform can look:
By maintaining your Quality Management System in QualiWare, you will have all the information saved in one place – easy to access for all employees and easy to maintain by the quality management team.
Many organizations have most of their documentation in text files. Such a set-up typically creates small islands of knowledge where information is scattered throughout the organization without any structure. It is much easier for the employees if the information is visualized – and that is also more easily maintained and accurately governed.
QualiWare would like to help you take the step to go from documents to diagrams and enable you to get the most out of your Quality Management System. You can read more about why you should document your information in models here, and learn more about how to go from documents to diagrams here
To learn more about the ISO 9001:2015, you can visit iso.org: https://committee.iso.org/sites/tc176sc2/home/projects/published/iso-9001-2015.html