The ultimate benchmark for your Quality Management System (QMS)
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To implement the ISO 9001 standard, you need to first understand the requirements that are underlined by the standard. The requirements are put out in seven sections, known as ‘clauses’.
This clause needs the organizations to determine the purpose, objectives, strategic direction and scope of their QMS. To determine them, they need to consider both external agents and internal factors of their business that have an influence on the quality aspect. Therefore, you need to know about the processes that directly impact the quality, needs and wants of the customers and the interests of your business’s stakeholders.
The standard clearly laid out is the commitment and role of the leaders/senior management in establishing the QMS in this clause. The senior managers should be fully responsible for creating the QMS and making it effective in its purpose. They should create the structure and functionalities of the QMS depending on the scope, set definite quality policies, and determine the attainable objectives. Leadership is extremely important because the leaders are the only persons who can communicate the objectives, policies, importance of QMS, etc. to everyone in the organization and make them work together towards the same goal. The senior management team’s involvement is also required to conduct annual reviews.
In this clause regarding planning, it is stated that the QMS must operate based on risk-based thinking, which means it must put measures to identify the potential risks and assess their severity and frequency of occurrence. Risk identification is necessary to prevent any undesirable impact on the processes or quality of the final products. Besides the risks, the opportunities which lead to further improvements in the QMS also must be looked into.
4. Resource Support:
This clause mentions the need for adequate resources to make the implementation and operation of the QMS. Some of the key resources that are specifically mentioned are infrastructure and efficient work environment, technology support, training, and skilled human resources.
This is an important clause that states the processes or works that an organization’s employees must undertake to effectively operate the QMS and deliver good-quality products or services. The key processes will determine the customer requirements and quality expectations of the customers, documents to be created and recorded, resources needed by the employees, and monitoring and testing methods to ensure quality.
6. Evaluation of Performance:
This clause emphasizes analyzing the performance of the processes put forth by the QMS periodically and assuring their conformity with ISO 9001 requirements. Your organization must ensure that every aspect of the QMS is in line with the standard’s requirements. This clause hence supports the improvement of your quality management approach, making the way to deliver better quality products or services every time.
7. Continual Improvement:
The final clause puts specific stress on the continuous improvement of your QMS as well as the processes of your business. It states that there should be specific measures in practice to ensure improved services or products from time to time to match the evolving needs of customers. It also means your organization should identify the processes that are underperforming and make modifications to them to increase their efficiency.
ISO 9001 is the world’s best-known and most implemented standard for Quality Management Systems (QMS). It gives organizations of all types, sizes, and scales a set of principles to follow to produce and deliver quality-assured services/products. The principles of the standard are intended to help organizations implement a QMS framework that continuously ensures delivery of super-quality products or services that satisfy customer needs. Organizations achieving the certification therefore verify that they meet those principles and can deliver high-quality output consistently.
This ISO standard for a QMS also outlines necessary practices, procedures, and infrastructure that help businesses to improve their overall operational efficiency, client service, and employee performance over time.
Despite being a core management standard, ISO 9001 does not mandate specifics for how businesses should manage their operations for quality output. Instead, it provides them with a feasible and flexible framework for a management system that they can establish to improve the quality of their output.
ISO 9001 stands for a robust framework for quality management. The standard sets out the requirements to build a QMS framework that helps organizations to meet the needs of both customers and other interested trade parties. At the heart of ISO 9001 is a well-defined quality policy, principles, and practices which together help the business to achieve its objectives, customer loyalty, and market goals.
Being a standard for quality management, the practices and principles apply to all processes from start to finish in the business. The processes include designing or conceptualizing, development, production, validation, packaging, distribution, installation, servicing, and other activities related to the creation of products/services.
To get the ISO certification, an organization needs to successfully implement the QMS or transition its existing system to an ISO 9001 QMS. Following that, they need to pass the two phases of the Certification Audit. The audit has to be conducted by an accredited certification body (i.e., a third-party body). In the audit process, you need to prove that your implemented QMS has been effective, operative for minimum of three months, and meets ISO 9001 requirements. They auditors also check whether your QMS has been continually improved through internal audits and periodic management reviews.
Most organizations lack technically skilled quality managers or expertise to implement the QMS adhering to the principles provided by the ISO standard. It is here the role of ISO 9001 certification consultants comes forth! They can guide you through the methodical approach to implement the QMS and ensure that you meet all requirements of the standard. They also can assist you in writing the QMS documentation, which helps to make employees aware of the planned procedures of quality control.
To achieve the certification, a business first must have a robust QMS or implement one if it does not. If there is no definite QMS present in their organization, they must have a methodical approach to implement it. The implementation of the QMS is based on 8 key principles:
International experts explain that adhering to these principles in the QMS is necessary for driving operational excellence.
Obtaining the certification is not obligatory for any business. However, achieving it helps you to focus on improving your customer experiences. The ISO 9001 quality management standard empowers your business with a robust approach to meet customer needs, improve operational efficiency, and boost sales. When properly implemented, the ISO certified QMS transforms your business making it more customer-centric. It eventually can boost your profitability and sustainability.
The implementation of a standardized QMS that maintains documentation gives much clarity to employees regarding the focus on customer satisfaction. It encourages them to perform better while working on the internal processes as well as delivering the customer service.
The cost of getting ISO 9001 certified depends on several factors such as the complexity of your business processes, size of organization, risks evaluated, time needed for auditing, and what the gaps against the standard exist before implementing the QMS. Apart from the primary costs, there are some external expenses which include the fees of the ISO 9001 certification consultants.
The benefits of getting your business ISO 9001 certified are numerous. It primarily helps you to produce high-quality and reliable products/services. However, there are several other benefits that gradually your business can realize over time such as operational efficiency, reduction of risks, higher customer loyalty, increased profitability, and greater competitive advantage.
After achieving the ISO certification, you are also required to maintain it for your organization since the validity of the certification is three years. You need to conduct surveillance audits yearly (or after six months if required) throughout the three-year period. The audits can be performed by appointing expert ISO auditors from a third-party certification agency or consultancy. They will thoroughly check and assess your QMS to make sure it is has been made better with time to meet the evolving quality expectations of customers.
When the certification completes three years, you need to undergo a re-certification audit by any accredited body to ensure that your QMS still complies with requirements of ISO 9001. Many times, the standard goes through updates and changes. Through the recertification audit, the auditors check whether your QMS has incorporated the changes of the latest versions appropriately and has also documented them.
The time required by an organization to get certified will vary. It depends on several factors such as the size of organization, number of processes, complexities of processes, size of workforce, and so on. It also depends on the preparedness of the organization regarding the QMS, i.e., whether they have an existing QMS (which is not ISO compliant and hence needs to improve), or needs to freshly implement a robust QMS. The time required also depends on the resources available and participation level of the employees in the organization.
Depending on these factors, it can take 30 to 90 days! Even if you complete the implementation of QMS quickly with unwavering guidance and support from the ISO consultants, some more time is required to let the QMS mature and produce relevant records of quality success, proving that it is working effectively. Therefore, on an average, it may take 2-3 months.
Your organization can apply for the certification by following the simple steps which include: