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  ISO Standards  >  ISO 9001 Certification

ISO 9001 Certification

iso 9001 certification
iso 9001 certification
iso 9001 certification video

Introduction to ISO 9001 Certification

ISO 9001 is the international standard for the quality management system (QMS). This certification showcases the organization’s commitment to providing products or services that meet customer and regulatory requirements and shows continuous improvement. In some industries, ISO 9001 certification is mandatory. To become ISO 9001 standard certified, the organization must adhere to the requirements set forth in the standard.

What is ISO 9001:2015 quality management system?

ISO 9001:2015 replaced ISO 9001:2008. The latest iteration acts as guiding principles that are used to create efficiency within an organization by aligning and streamlining processes. The seven quality management principles of ISO 9001:2015 are

  • Customer focus
  • Leadership
  • Engagement of people
  • Process approach
  • Improvement
  • Evidence-based decision making
  • Relationship management

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Objectives of ISO 9001 Certification

The ISO 9001 standard allows businesses to organize processes, improve process efficiency, and continually improve products and services. Having an ISO 9001:2015 certification means that an organization:

  • Maintains documentation
  • Follows the guidelines of the regulated ISO 9001 standard
  • Meets statutory and regulatory requirements
  • Fulfills its own requirements
iso 9001 certification objective

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What are the benefits of being ISO 9001 certified?

Having ISO 9001 certification is globally recognized and assures the stakeholders that the management systems are consistently assessed and approved. The certificate also offers other benefits such as:

  • Globally recognized standard

  • Suitable for both small and large organizations

  • Better internal management

  • Minimizes wastage

  • Improves efficiency, productivity, and profit

  • Enhanced customer retention and acquisition

  • Helps achieve consistent outcomes

  • Compatible with other ISO standards

ISO 9001 Modern EQMS

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

iso 9001 certification best practices

Best Practices For ISO 9001 Certification

To ensure a successful implementation of ISO 9001, follow these five focus points diligently:

  • A well-implemented ISO 9001 process will have to be driven from the top, with the senior management completely committed to achieving compliance with ISO 9001 requirements
  • Co-create and collaborate with the on-ground team to keep up morale and motivation as lack of clear understanding of the processes as well as the need for and impact of change can lead to a failure of ISO implementation
  • Proper knowledge regarding ISO compliance and implementation is an essential factor for its implementation to bear results
  • Plan a strategy that has realistic timelines, allocate resources, assess risks and opportunities assessment, conduct periodic audits, and track progress
  • ISO implementation requires an allocation of budget for consultants, training, quality resources to pay auditors and pay for the certification

How do I get ISO 9001 certified?

  • Step 1: Set the Goals for the Business
    Identify the results of past quality efforts using a gap analysis with regard to ISO requirements, and delineate the right approach suited to the company’s culture and requirements.
  • Step 2: Document Management
    ISO 9001:2015 standard focuses on documentation as it helps maintain business continuity, operations, efficiency, and profitability. The documentation should detail workflows and processes.
  • Step 3: Collaborative Mindset for Implementation
    A successful implementation process includes communicating the new requirements to the employees to help them understand the new way of working.
  • 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.
  • Step 5: Getting Certified
    Upon completion of the documentation process, the organization must have a third-party ISO 9001 audit to achieve the certification within two months of the implementation process.
  • Step 6: Recertifying
    ISO certification is not a one-time process and organizations must get recertified every three years to remain certified.
iso 9001 certification steps


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Biotech Company Partners with ComplianceQuest, Automates Quality Management Processes

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Requirements For ISO 9001 Certification

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. Simply put, ISO certification assures customers and other vendors that the company can be trusted as the certification is focused on quality.

The ISO 9001 requirements for certification are mandated by ISO in ten clauses. These clauses follow a Plan-Do-Check-Act cycle as mentioned below:

iso 9001 certification plan

Plan

Clause 1: Document the scope detailing the various aspects of the business such as product, regulatory requirements, remote locations, activities


Clause 2: Prepare a list of normative references, including concepts, principles, and definitions that should be understood and applied as defined in ISO 9000


Clause 3: Identify the various terms and definitions defined in the ISO 9001:2015 standard that will help the organization during the implementation process


Clause 4: Determine the context of the organization focusing on both internal and external issues that will have an impact on the strategic objective, purpose, and direction of the organization.


Clause 5: Outline the commitment requirements from the leadership and top management on various issues such as customer focus, quality policy, defined QMS related responsibilities, and authorities


Clause 6: Align the quality policy with risks, opportunities, and quality objectives

iso 9001 certification system

Do

Clause 7: Create a support system that includes people, infrastructure, knowledge base, communication, and documented information to operate the QMS


Clause 8: Focus on operational planning and control, to help uncover customer requirements, review design, delivery, and post-delivery support.

iso 9001 certification check

Check

Clause 9: Prepare a performance evaluation that helps assess data related to customer satisfaction, internal audits, process performance evaluation, analysis, and management review.

iso 9001 certification act

Act

Clause 10: Address nonconformity and process improvement requirements through corrective actions and continual improvement actions.

  • iso 9001 certification plan

    Plan

    Clause 1: Document the scope detailing the various aspects of the business such as product, regulatory requirements, remote locations, activities


    Clause 2: Prepare a list of normative references, including concepts, principles, and definitions that should be understood and applied as defined in ISO 9000


    Clause 3: Identify the various terms and definitions defined in the ISO 9001:2015 standard that will help the organization during the implementation process


    Clause 4: Determine the context of the organization focusing on both internal and external issues that will have an impact on the strategic objective, purpose, and direction of the organization.


    Clause 5: Outline the commitment requirements from the leadership and top management on various issues such as customer focus, quality policy, defined QMS related responsibilities, and authorities


    Clause 6: Align the quality policy with risks, opportunities, and quality objectives

  • iso 9001 certification system

    Do

    Clause 7: Create a support system that includes people, infrastructure, knowledge base, communication, and documented information to operate the QMS


    Clause 8: Focus on operational planning and control, to help uncover customer requirements, review design, delivery, and post-delivery support.

  • iso 9001 certification check

    Check

    Clause 9: Prepare a performance evaluation that helps assess data related to customer satisfaction, internal audits, process performance evaluation, analysis, and management review.

  • iso 9001 certification act

    Act

    Clause 10: Address nonconformity and process improvement requirements through corrective actions and continual improvement actions.

ComplianceQuest and Salesforce
– a winning combination

ComplianceQuest pairs the user-friendly tools of SalesForce with a very capable and responsive development / support team resulting in a full QMS application that was adapted to our processes and very easy to implement. Our large, global organization is not an easy group to please. From their patient participation in our configuration workshops to their quick responses to every email and crazy request, the CQ team has proven to be a true partner in our implementation. Their website and demos show how user-friendly and well integrated the modules are. The REAL win is getting this functionality with a team who is truly invested and has gone over and above to make our implementation a success!

Melanie Lees,
Quality Director

continental contitech
continental contitech

Steps to get ISO 9001 Certification With ComplianceQuest

Using ISO 9001:2015 helps ensure that customers receive consistent, high-quality products and services, which in turn brings many business benefits. ComplianceQuest – A 100% modern cloud Enterprise Quality & Safety Management System (QHSE) – goes above and beyond the requirements for ISO 9001:2015 while automating your entire ISO 9001 Quality Management System requirements. The QMS solution from ComplianceQuest is mapped to the ISO requirements for enabling businesses to become compliant and thereby make the Quality Management System efficient and effective. ComplianceQuest’s main goals when embarking on ISO certification are:

  • Providing a secure, homogeneous, and repeatable internal process execution
  • Creating a platform for consistency during expansion and growth
  • Improving client delivery services and customer satisfaction

CQ significantly reduces the effort involved in maintaining your ISO 9001:2015 Quality System by making the required processes automated while maintaining full traceability. In addition, it provides a complete view of your organization’s data concerning the performance and effectiveness of your quality and compliance management system. Some of the features include:

If you're ready to take your organisation to the next level and achieve ISO 9001 certification, you're in the right place!

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Related Checklists

Quality-centric Companies Rely on CQ QMS

  • affinivax
  • verily
  • 3m logo
  • Tupperware
  • Qorvo
  • Continental
  • Vyaire
  • Lifescan
  • Lundbeck
  • CDC
  • Qlik
  • CSA Group
  • Impossible
  • Fluence

Frequently Asked Questions

    • ISO 9001 promotes process-based QMS by integrating interrelated processes at the enterprise level, thus ensuring greater effectiveness and better-integrated processes to minimize waste and reduce costs.

    • A well-implemented ISO 9001 helps businesses make informed decisions as its framework for quality management focuses on facts and data.

    • Being process-oriented with quality as the motivating force, a business can deliver a better quality of products in a timely manner, earning customer loyalty and repeat business.

    • By implementing ISO 9001 first, businesses can deploy and manage other standards such as ISO 14001 (environmental management), ISO 20000 (IT service management), ISO 13485 (medical devices), or ISO/TS 16949 (automotive industry) easily.

    • ISO promotes productivity and employee performance as better documentation and predictive analytics enable timely response to challenges and improve employee engagement.

  • Without a robust QMS to support the operations, businesses can face several challenges such as:

    • Lack of control on the quality of inputs, manufacturing, or even distribution

    • Inability to enforce processes and procedures on third-party vendors

    • Lack of visibility into the processes followed by the vendors except through a few inspections

    • Inability to meet customer expectations in terms of quality of products and services

    • Inability Increasingly stringent regulatory bodies that require businesses to conform to the standards and regulations stipulated specific to their industry

    • Non-compliance with mandatory quality management


    Overall, digital transformation and automation are the key to quality management and ISO 9001 compliance. Without automation and digital technologies like AI, data analytics, and the cloud, it’ll be impossible to build an enterprise-wide culture for quality management.

  • ComplianceQuest’s Next-Gen QHSE has been built on our five guiding design principles:

    • Principle #1: Core Quality Promise that enables critical business decision making

    • Principle #2: Simple, seamless and consistent user experience

    • Principle #3: Single source of Data at its Core

    • Principle #4: Modular, cloud-based, best practices through Standardization and Flexibility

    • Principle #5: Continued Improvement across quality, business process, systems, design and people

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