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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.

ISO 9001- Quality Management Standard

ISO 9001 is the most sought-after and internationally acclaimed management system standard.

Internally, the ISO 9001 Quality Management Standard helps to improve operational and management efficiency and effectiveness.

ISO 9001 is not only a Quality Assurance Standard or a degree of excellence; it is a way to ensure that customer requirements are met with consistency. Attaining the ISO 9001 certification helps to drive the success of your business by boosting customer satisfaction, marketability, and profit potential.

The certification makes your business more valuable. It lets others know that your organization is committed to continually improving systems to better ensure customer satisfaction. Other organizations are more likely to engage with ISO 9001 certified companies. Moreover, ISO 9001 Quality Assurance Certification demonstrates credibility.

Why Achieve the ISO 9001 Certification for Your Business?

More than 1 million organizations have implemented ISO 9001 in more than 75 countries.

While there were earlier standards for quality management systems, the International Organization for Standardization, or ISO, released its 9001 standard in 1987 for the first time. The standard has been revised several times in 1994, 2000, 2008, and the current version in 2015.

An internationally and diverse selection committee developed the framework of the ISO 9001 Quality Management System Standard to help all types of organizations (including commercial businesses, governments, non-profit organizations, etc.) adopt “good management practices.”

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ISO 14001 Standard discussion

Best practices that the ISO 9001 Standard promotes are:

  • A policy statement (or mission statement)
  • A detailed understanding of customer requirements
  • Management reviews
  • Objectives and plans
  • A way of determining customer satisfaction
  • Risk based thinking
  • Competent human resources
  • Effective supplier management
  • Strategic management
  • Internal auditing
  • Data collection and analysis
  • Management of documents and records
  • Control of non-conformances and consideration of the corrective actions etc.
  • A written management system (or policies and procedures) to confirm that the management system is approved, available, and up to date

By attaining the ISO 9001 certification, your business may see the following potential benefits:

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’.

1.Organizational Context:

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.

2. Leadership:

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.

3. Planning:

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.

5. Operation:

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.

By attaining the ISO 9001 certification, your business may see the following potential benefits:

By attaining the ISO 9001 certification, your business may see the following potential benefits:

Higher customer satisfaction:

You can offer products or deliver services that satisfy the expectations of customers and persuade them to come back for repeat purchases.

Reduction in operational costs:

An ISO 9001 QMS drives continuous improvement in your organizational processes resulting in cost savings.

Better stakeholder relationships:

The ISO certification proves the credibility of your business which improves the perception of stakeholders and can strengthen your relationship with them.

Enhanced risk management:

A compliant QMS helps improve the traceability of processes, services, or products which helps in identifying risks and rectifying them early.

Ability to win contracts:

The certification is a crucial procurement specification and can open a gateway of opportunities for your business to win tender contracts.

Assurance of legal compliance:

It assures that your organization understands other statutory or regulatory obligations, be it regional or national, and meets them.

By attaining the ISO 9001 certification, your business may see the following potential benefits:

Our consulting services can help you through the process of preparation for achieving the ISO 9001 standard. Our specialist consultants can do on-site inspections, risks and opportunity assessments, and employee interviews to get an overall view of your quality management program.

We, at Compliancehelp Consulting LLC offer leading ISO quality consulting services to help you develop a fully compliant QMS. We will help you through a 5-step process.

1.Premium Consultation

Our services start with premium consultation where we help you to understand the specifications of the ISO 9001 standard, the need for a quality policy and defined objectives, crucial documentation requirements, and the QMS implementation process.

2. Gap Analysis

Then, we do a gap analysis or pre-assessment of your existing quality management system to discover any shortcomings against the ISO 9001 requirements.

Subsequently, we provide you with recommendations and necessary assistance to amend the shortcomings and implement an improved QMS that is 100% ready for ISO certification.

3. Implementing the QMS

This step starts with documentation of the procedures of QMS and your work processes in detail. The documentation will establish how they will be executed from now onwards to achieve compliance with the standard. Following that, the implementation process starts. Our consultants will help you to plan the steps for implementation, provide training to your employees, get the necessary resources, and work according to the plan. We would assist you through the entire implementation of the QMS.

4. Certification Readiness

We also provide a certification readiness review. This is especially beneficial for organizations that have already established the ISO 9001 quality management standard and are ready with documentation requirements but would like to get a final assurance from experts. Our ISO consultants perform a final assessment of their QMS and confirm its compliance and readiness for the certification.

5. Internal Audit

Our ISO certification consultants also assist in conducting thorough internal audits at periodic intervals to ensure that your QMS procedures and its comprehensive documentation are continually ISO compliant. We also provide remote auditing services for organizations that need to get certified quickly.

Our consultation and dedicated support are intended to get your business ISO 9001 certified within the determined time period and in the most cost-effective way. Our ISO consultants strive to make your journey as uncomplicated as possible with a customized approach. We not only help you to achieve the certification painlessly but also make sure that your business derives maximum benefits from it.

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Why Hire the ISO 9001 Certification Consultants from
Compliancehelp Consulting LLC?

Lowest cost

We deliver a lean, custom fit ISO compliant management system, saving significantly on the often overlooked, but usually most expensive part of ISO compliance- the implementation stage.

Speed

Everybody knows how lengthy an ISO certification process is! It is difficult to be motivated and focused if certification takes too long. Don’t worry! We can help you gain certification within 90 days, or often in less time than that!

Resources to obtain and maintain certification

ISO compliance does not need to cost a lot to maintain! We minimize the need for internal resources with a lean and compliant ISO quality consulting approach.

Ongoing support

Compliancehelp Consulting LLC can help you manage ongoing compliance on your own, or you can team up with us. Our personalized ISO certification services include monitoring and internal audits as well. Our experts can monitor your Quality Management System to ensure consistency, improvement, and compliance. We can also help in making it compliant with future updates to the ISO standard a cinch.

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Frequently Asked Questions

What is the ISO 9001 standard?

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.

What does ISO 9001 stand for?

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.

How do you get the ISO 9001 certification?

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.

What is required for the ISO 9001 certification?

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.

Why is the ISO 9001 certification important?

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.

How much does it cost to get the ISO 9001 certification?

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.

What are the benefits of ISO 9001?

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.

How do you maintain ISO 9001 compliance?

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.

How long does it take to get ISO 9001 certified?

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.

How to apply for the ISO 9001 certification?

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.