ISO 9001

The ultimate benchmark for your Quality Management System (QMS)

Our unique method can get you ready for ISO certification in as quick as 30 days with no compromises.

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ISO 9001- Quality Management Standard
Why Achieve the ISO 9001 Certification for Your Business?
Best practices that the ISO 9001 Standard promotes are:
How to Get Started with ISO 9001? Our ISO Certification Consultants Can Help!
Why Hire the ISO 9001 Certification Consultants from Compliancehelp Consulting LLC?
Looking to implement the ISO 9001 Quality Management System? Do not know how to start? Speak to our expert ISO consultants!
To find more about ISO 9001, check out our section of Frequently Asked Questions (FAQs).
FAQs about ISO 9001

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:

  • Customer focus
  • Leadership
  • Engagement of people
  • Process approach
  • Continual improvement
  • Factual decision making
  • Relationship management

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:

  • Preparation – You need to perceive the requirements of the standard and decide how to meet them with your QMS. ISO quality consulting services can help you in the preparation stages.
  • Documentation – You need to write down everything such as the quality policy, scope, objectives, procedures you’re deciding to implement, process flowcharts, work instructions for employees, and other additional forms that the QMS may require.
  • Implementation – The documentation is followed by the employees and supervised by managers implementing the QMS in place.
  • Internal audit – The QMS is meticulously assessed by experienced internal auditors to assure it is working efficiently as well as meeting the ISO 9001 requirements.
  • Certification – Select a certification body which will perform an external certification audit and grant the ISO 9001 certificate when they observe that you are adhering to the standard.
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