ISO 9001:2015 is the quality management system (QMS) standard developed by the International Organization for Standardization (ISO) to help organizations, of any size in any industry, increase the consistency of quality products and services while improving customer satisfaction and reducing risks. The ISO 9001 QMS standard does not outline requirements that specific products and services should conform to. Instead, ISO 9001 specifies the requirements for good management practices that should be followed to achieve quality, regardless of product or service. An ISO 9001 QMS provides a formalized and systematic approach to achieving organizational objectives.
• Context of the Organization – To concisely define who is affected by an organization’s work, as well as their expectations, the overall context of the organization or business must be assessed.
• Leadership and Commitment – In order for an organization or business to move beyond commitment Top Management should proactively engage employees and demonstrate leadership for the quality management system. Organizations and businesses will need to establish more of an emphasis on the people that provide the products and services.
• Quality Policy and Objectives – Organizations must establish a documented quality policy with measurable Quality Objectives and include a clearly defined method to achieve them.
• Risk-Based Thinking – Implementing preventive actions and establishing contingency plans in the event the mitigation controls fail discourages the probability of negative impacts on an organization’s products or services.
• People and Infrastructure – A critical part of any organization or business is the people. Motivated, competent and well-trained personnel play a key role in achieving goals. The need for personnel should be evaluated at regular intervals as it can change over time. Organizations and businesses are required to determine what infrastructure is required and then provide and maintain said infrastructure so there are no obstacles preventing a smooth execution of any operations. Infrastructure includes but is not limited to instruments, equipment, hardware, utilities, software, transportation facilities and communication, etc.
• Organizational Knowledge – Organizations and businesses are required to take steps to capture and preserve knowledge. Organizational knowledge needs to be kept current, and, if it is found to be insufficient, then steps will need to be taken by management to enhance it. These steps are necessary to ensure informed decisions are being made with respect to any updates to the quality management systems.
• Training and Competency – Organizations and businesses can ensure personnel is properly trained by requiring staff to demonstrate competency through tests or observations.
• Control of Documented Information – Businesses and organizations are required to determine the necessary documented information to demonstrate planning, operation, control, implementation, and the continual improvement and effectiveness of their QMS.
• Operational Planning and Control – It is important for organizations and businesses to ensure the planning and control of operational activities have established processes and documentation. All activities including sales, design and development, delivery, servicing and manufacturing are within this scope.
• Design and Development – Design and development processes must be established, implemented and maintained for businesses and organizations responsible for design and development. Determining how to manage design and development changes as well as the required planning, inputs, controls, and outputs are an essential part of the process.
• Management of Change – Potential changes that can impact an organization or a business’s QMS will need to be controlled in a planned manner. Once a change has been requested, it will be reviewed and approved. If there is a risk associated with the introduction of the change it should be identified prior to implementation and addressed.
• Control of Nonconforming Outputs – Processes will need to be established, implemented and maintained to determine and manage non-conformities. Nonconforming services, products and outputs will need to be included. Businesses and organizations should not only focus on the final output but on the process for the output.
• Customer Satisfaction – Customer requirements should be determined and focused on to ensure customer satisfaction is achieved. Organizations and businesses should focus on customer satisfaction and work to receive customer feedback to drive continual improvement.
• Management Review – To ensure a management system’s continuing suitability, adequacy, and effectiveness it should be reviewed by top management to access the possible need for changes to policies, objectives, or any other elements of the management system.
• Corrective Actions – A thorough root cause analysis should be conducted to ensure corrective actions that address the root symptoms of issues are implemented.
• Internal Audit Planning and Program – The goal of internal audits is to determine if the management system meets the requirements of the standard and if it has been effectively implemented and maintained. Internal audits will need to be conducted in planned time frames throughout the year.
ISO 9001:2015 can be utilized to become more efficient, improve operations and increase profitability. By implementing an ISO 9001 QMS, organizations have the ability to focus on continual improvement and improve customer satisfaction, which in turn may mean repeat clients and increased business. To learn about becoming certified you can read our article Becoming ISO 9001:2015 Quality Management System Certified or contact us today to find out more about how the ISO Certifications Group can assist your organization or business with achieving its ISO 9001 certification goals. Check out additional news articles here.
