ISO Standards  >  ISO 9001 Compliance and ISO 9001 Implementation

ISO 9001 Compliance and Implementation

ISO 9001 compliance

What is ISO 9001? How compliance drives operational excellence?

Explore what are ISO 9001 Standards and why companies need ISO 9001

ISO 9001 Compliance
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What is ISO 9001 standard?

ISO 9001 is a standard that facilitates the incorporation of best practices into an enterprise’s Quality Management System (QMS). Compliance to ISO 9001 needs automation and digital technology like ComplianceQuest’s holistic QHSE system. Our system is mapped to the ISO 9001 requirements for enabling businesses to become compliant and thereby make their quality management system efficient and effective. With ComplianceQuest you can implement proven workflows as per quality management best practices and, when required, it is easily configurable to custom design workflows in case of a special use case. It even catalyzes new thinking and innovation.


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Ensure ISO 9001 Compliance with ComplianceQuest’s QHSE

  • Faster business growth with improved efficiency and customer satisfaction
  • Track all quality and safety metrics across the organization
  • Risk based approach to assess your supplier chain
  • Simpler, easier and better automation process with a next-gen software solution

With ComplianceQuest QHSE you can drive a culture of quality in your organization and at the same time embrace a safe and healthy workplace for the employees as well as the environment. Sign up for an online demo now.

Ensure ISO 9001 Compliance

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How ISO 9001 Compliance with ComplianceQuest QHSE Helps Business Efficiency

ComplianceQuest is a 100% cloud based Quality, Health, Safety and Environmental (QHSE) Solution Suite to help you drive quality excellence which leads to business growth while at the same time you can embrace a culture of health and safety to reduce costs of accidents or non-conformance. It is built natively on the Salesforce.com platform, one of the leading business cloud platforms, ensuring high security, future readiness and scalability to the system. Aligning your organization with our ISO 9001 compliance software helps you notch up your business efficiency and customer satisfaction.

Improved Processes

Improved Processes

ISO 9001 promotes process-based QMS (Quality Management System), integrating interrelated processes at the enterprise level. This holistic approach ensures greater effectiveness and better integrated processes that can minimize waste and thereby reduce costs.

Improved Decision-Making

Improved Decision-Making

Businesses need to be able to take timely decisions that can improve the chances of their success. For this, they need data that can help them make informed decisions. A well-implemented ISO 9001 aims to achieve just that.

Improved Productivity

Improved Productivity

ISO 9001 compliance effects greater productivity and employee performance over time. Better documentation and predictive analytics enable timely response to challenges and improved employee engagement.

Improved Supply Chain Quality

Improved Supply Chain Quality

Provide detailed requirements to the suppliers to ensure quality of products and services supplied. Ensure these processes are functioning optimally every time you conduct your internal ISO 9001 audit check.

  • Improved Processes

    Improved Processes

    ISO 9001 promotes process-based QMS (Quality Management System), integrating interrelated processes at the enterprise level. This holistic approach ensures greater effectiveness and better integrated processes that can minimize waste and thereby reduce costs.

  • Improved Decision-Making

    Improved Decision-Making

    Businesses need to be able to take timely decisions that can improve the chances of their success. For this, they need data that can help them make informed decisions. A well-implemented ISO 9001 aims to achieve just that.

  • Improved Productivity

    Improved Productivity

    ISO 9001 compliance effects greater productivity and employee performance over time. Better documentation and predictive analytics enable timely response to challenges and improved employee engagement.

  • Improved Supply Chain Quality

    Improved Supply Chain Quality

    Provide detailed requirements to the suppliers to ensure quality of products and services supplied. Ensure these processes are functioning optimally every time you conduct your internal ISO 9001 audit check.

Embrace quality efficient business operations by ensuring ISO 9001 compliance. ComplianceQuest QHSE suite can drive the ISO 9001 compliance for you. Contact us for a demo!

ISO 9001 - Modern EQMS

Using a Modern EQMS to Automate ISO 9001 Processes & Improve Quality Performance

ComplianceQuest QHSE Features that ensures ISO 9001 Compliance

The ComplianceQuest QHSE solution suite provide you with the four critical areas for ISO 9001 compliance of EDMS, QMS, Supplier Quality Management and Complaints/Field Service Quality. Along with this there are other safety & quality modules to manage Audit, Risk, Training, Conformance, Inspection, Incident, Health and Safety, Sustainability and more that also integrate seamlessly together.

Some features that ensure ISO 9001 compliance and which will drive operational excellence are:

Powerful dashboards built into the solution provide reports and insights based on the role of the user, the function, the region or at the corporate level.

System provides user-level customizations and access, ensuring privacy and security.

With the help of data, analytics and AI, the ComplianceQuest solution can help with root cause analysis in case of any incidents or accidents, identify and recommend the next best action.

Integrates well with the existing ERP, CRM, PLM, LIMS, HRMS and other critical systems.

ISO 9001 Compliance Improves Quality & Safety Management Across Your Organization

As you become ISO 9001 compliant, many quality & safety management systems get implemented across your organization boosting process efficiency, employee productivity and reducing customer complaints. Some of these systems include:

  • Document Management

    The ISO 9001:2015 standard emphasizes documentation, capturing procedures, forms, and work instructions. Streamlining documentation becomes more convenient through improved version control, collaboration, and accessibility during auditing processes.

  • Collaboration

    Drive collaboration of teams across geographies and departments and enable version control of documents.

  • Automation

    Automation enhances internal audit, document management, corrective and preventive action (CAPA), and other quality processes. Organizations can optimize these processes by implementing automated systems, reducing manual effort, and improving efficiency.

    Once the ISO 9001 processes are fully implemented, evaluating internal conformance to the standard is essential. This evaluation can be conducted by trained employees or outsourced to a subcontractor. It is important to note that the audit should not be a one-time event but carried out periodically to ensure ongoing compliance and continuous improvement.

  • Supplier Management

    Provide detailed requirements to the suppliers to ensure quality of products and services supplied. And ensure that these standards are met by all suppliers.

  • Customer Complaints

    An enterprise-wide quality culture looks at the entire lifecycle of an organization across suppliers, internal processes, and all customer-related workflows thus improving customer experience many folds.

Contact us today to understand the next steps to ISO 9001 compliance for your organization.

5 Steps for ISO 9001 Implementation

ISO 9001 implementation is essential to an organization’s growth strategy across industries. An organization that is ISO 9001: 2015 compliant is shown to have clarity and compatibility with other management system standards. ISO 9001 implementation is driven by the need to meet international quality regulations, deliver customer delight, and effect continuous improvement in quality management in an organization. Before starting with the implementation process, it is crucial to perform a gap analysis or needs assessment to understand the compliance requirements of the business. Once there is an understanding of the requirements, follow these five steps as part of the implementation process:

  • Create a detailed plan that includes the actions to be taken, roles and responsibilities of people involved, time taken to complete the implementation, and implementation milestones
  • System design
  • System implementation includes using the QHSE system to automate certain quality processes and remain compliant
  • Audits, review, and improvement to ensure the processes have met the core objective of the process
  • Certification is the final step in the ISO implementation process as it showcases that the company has met all the quality requirements per the standard
ISO 9001 Implementation methods


Success story of three manufacturing companies

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Success Story of Three Manufacturing Companies Using the CQ EQMS Solution to Modernize Quality Processes

Success story of three manufacturing companies
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5 Things to Make Your ISO 9001 Implementation A Success

ISO 9001 implementation has become an essential part of many organization’s growth strategy. It is impelled by the need to deliver customer delight, meet international quality requirements and effect continuous improvement (in terms of quality management) in one’s own organization.

At ComplianceQuest, we’ve helped customers at 1000+ locations around the world implement an automated workflow for quality control. We believe that the following five factors will determine how well ISO 9001 will be implemented in your enterprise.

5 Things to Make ISO 9001 Implementation Success

  • Commitment from the Top: The effort has to be driven from the top, with the senior management completely committed to achieving compliance to ISO 9001 requirements. Sometimes, the management may sign on the dotted line and kickstart the initiative, but if it does not follow through by being involved in theactual process, then it can set a bad example that comes in the way of creating a culture of quality. The top management’s lack of commitment can be a result of the following three reasons:
    • Lack of awareness
    • High turnover at the top – leading to lack of continuity of vision
    • Low dedication to quality-related metrics due to other business priorities

    However, compliance will in fact create confidence in the customers about the business’ commitment to quality and efficiency. It will be the driving force behind the company’s quality policy as well as implementation. A well-implemented ISO 9001 process will, in fact, make life much easier for your entire workforce. When the ISO 9001 workflow is automated, it’ll also help your people develop an inherent quality culture.

  • Employee Motivation: Taking care of day-to-day operations and meeting deadlines may seem more important to your employees than introducing quality related documentation and procedures. Resistance to change is a known human failing and lack of clear understanding of the processes as well as the need for and impact of change can lead to a failure of ISO 9001 implementation. Clear communication and employee buy-in are crucial to its success. It is crucial that your on-ground team is involved in the ISO 9001 implementation process from the very beginning. Co-create and collaborate with your on-ground team to ensure the implementation is successful.
  • Knowledge Sharing: It can be inferred from the above two points that proper knowledge regarding ISO compliance and implementation is an essential factor for its implementation to bear results. It begins by understanding the following:
    • What ISO 9001 implementation requires
    • Where the organization currently is in terms of its quality efforts
    • Gap analysis
    • Developing a plan to overcome those gaps by adhering to a quality standard like ISO 9001

  • Planning: Lack of planning has caused many ISO 9001 implementation projects to fail. Devise a strategy that has the following:
    • Realistic timelines
    • Allocation of resources
    • Assessment of risks and opportunities
    • Set periodic audits
    • Measure progress and take corrective action in case of deviations

  • Allocate Budget: ISO 9001 implementation needs financial support for consultants, training, quality resources, to pay auditors and pay for the certification. If a business is new to ISO or any quality standard in general, going alone can be daunting and require a steep learning curve. Also, automating the quality adoption process and the entire quality effort can help the organization experience the true benefits of ISO 9001 implementation.

ComplianceQuest, a 100% modern cloud-based Enterprise Quality & Safety Management System (QHSE) goes above and beyond the requirements for ISO 9001:2015 while automating your entire quality management system requirements. Our product and automation features significantly reduce the efforts involved in maintaining your ISO 9001:2015 Quality System. The product is designed to deliver flexibility, scalability, customizations and data visibility.

In addition, it provides a complete view of your organization’s data – a key aspect to drive continuous improvement of your quality management process.

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We are still getting started and have only just implemented Document Management. We are very excited about the potential for managing our QMS and can’t wait to move onto the other ComplianceQuest modules with the help of Amit.

Karen Bligh,
Australian Dental Manufacturing

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ADM testimonial for iso 9001 implementation

6 Steps to Becoming ISO 9001 Certified

Congratulations! If you have reached this page, then it shows you are seriously contemplating pursuing your ISO certification and are wondering how to go about it. Getting an ISO certification is no walk in the park but it is well worth the effort.

In this post, we keep it simple and deliver a 6-step guide to becoming ISO 9001 certified.

6 steps for ISO 9001 certification

Step 1: Set the Goals for Your Business

There is no one size fits all when it comes to setting the objectives for an ISO 9001 certification. You will have to first identify the results of your past quality efforts, do a gap analysis with regardto ISO requirements and delineate the right approach suited to your company’s culture and requirements. This will determine whether your effort is led by:

  • An employee, typically the quality manager
  • A hands-on consultant who can speed up the process though at a higher cost
  • A hands-off consultant who can prove costly but will also align the internal team to the process
  • Use a certification kit where internal efforts as well as the cost are low

Whichever approach you take, training and awareness programs will play a key part in realizing the benefits of the implementation better. Planning your project well for its successful completion is also essential.

Step 2: Document Management

ISO 9001:2015 standard lays stress on documentation capturing procedures, forms and work instructions. Documentation is important to maintain business continuity, affecting operations, efficiency and profitability, and is required during audits. It should describe workflows and processes lucidly – enabling readers to understand it well.

Step 3: Collaborative Mindset for Implementation

Implementation of ISO 9001 quality management system across the business should align with your documentation. It must clearly list out new requirements, if any, that came up during the gap analysis. Communicating the new requirements to the employees to help them understand the new way of working as well as its benefits is essential for its successful implementation.

Step 4: Automation of Internal Audit, Document Management, CAPA, etc.

On completing the implementation of ISO 9001 processes, evaluate the conformance to ISO 9001 internally. Trained employees or a subcontractor can do the audit, which is not a one-time affair but should be conducted periodically. The key to conducting internal audits efficiently is an automated workflow. ComplianceQuest’s QHSE built on the Salesforce.com is flexible, scalable and customizable and will work well for a range of organizations. Automation will enable a range of processes – document management, audit management, CAPA, incident reporting, compliant management, among others. The key point to note here is that getting an ISO certification is only the first step. It needs continuous improvement and monitoring. It needs an enterprise-wide buy-in from stakeholders across the lifecycle of a business.

Step 5: Getting Certified

Once you are sure that ISO 9001:2015 has been implemented as per the documentation you will need an independent, third-party ISO 9001 audit to achieve the certification. The ideal time is two months after the implementation process so that you have records proving your ISO 9001 compliance.

Step 6: Re-certifying

When you obtain the ISO 9001 certification, you have just begun the journey as it is not a one-time event. It is essential to continue to be vigilant since a surveillance site audit will be conducted once or twice a year in order to ensure your continued compliance and improvement.You will have to be recertified every three years to remain certified.


ISO 9001:2015 lays stress on a quality management system as that can smoothen your implementation and continued compliance. A QMS tool such as the one from ComplianceQuest,built on the scalable cloud platform Salesforce.com, is aligned with the ISO requirements and a natural fit. From design, documentation to training and implementation, it can make the ISO implementation process intuitive and easy. If you are embarking on your journey on ISO 9001:2015 implementation or recertification and want to automate your processes, contact us here: contact-us

ISO 9001 implementation supports the growth of your organization, enables compliance with international quality standards, and fosters ongoing improvement within your own organization

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Frequently Asked Questions

  • A generic standard, the 2015 update impacts almost every industry and it’s standards (AS9100D:2016, IATF 16949:2016, etc.). ISO 9001:2015 requires businesses to design their QMS specific to their industry. More than one million organizations in over 170 countries certified in ISO 9001 have upgraded to ISO 9001:2015 to meet this new requirement.

  • Once you are sure that ISO 9001:2015 has been implemented as per the documentation you will need an independent, third-party ISO 9001 audit to achieve the certification. The ideal time is two months after the implementation process so that you have records proving your ISO 9001 compliance.

  • When you obtain the ISO 9001 certification, you have just begun the journey as it is not a one-time event. It is essential to continue to be vigilant since a surveillance site audit will be conducted once or twice a year in order to ensure your continued compliance and improvement. You will have to be recertified every three years to remain ISO 9001 certified.

  • Compliance to ISO 9001, which can be through voluntary auditing or third party registration, can improve the efficiency of the business, improve customer satisfaction and lead to faster growth.

    Typically, the ISO 9001 standard is adopted by a company either because customers mandate it as part of the contract; governments require the certification to allow trading; or when a business wants to improve its products and customer satisfaction.

  • By complying with ISO 9001, enterprises can:

    Provide consistent quality of products and services that meet customer requirements and comply to applicable regulations

    • Improve customer satisfaction through the effective application of the system

    • Implement processes that effect continuous improvement of the system

    Have a unified quality and EHS system by integrating ISO 9001 with ISO 14001 (Environmental), ISO 45001 (Occupational Health and Safety), etc.

    • Provide enterprise-wide view of causal relationships and assign responsibilities

    • Set goals and create a roadmap for growth

    • Expand into new markets

    • Assess and analyze risks within the organization

    • Improve productivity and efficiency effectively

    • Lower costs of production and quality

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