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ISO 9001 Quality Management System

ISO 9001:2015 certification guarantees the quality of products and services

iso 9001 quality management system
iso 9001 quality management system
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What is ISO 9001?

ISO 9001 is an international standard for quality management systems (QMS) that acts as a framework for organizations to implement processes and procedures that ensure consistent product or service quality. The ISO 9001 standard sets out various requirements for a quality management system, including the organization's internal and external context, leadership commitment, systematic approach to setting objectives, providing the necessary support, planning and controlling operational processes, and continually improving the QMS. Implementing ISO 9001 shows that organizations are committed to enhancing customer satisfaction, improving internal processes, increasing efficiency, and driving continual improvement. It is a globally recognized standard, and many companies choose to become ISO 9001 certified to demonstrate their commitment to quality management practices.

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Implementing ISO 9001 QMS helps improve overall efficiency and productivity while boosting employee morale. A part of the ISO 9000 family of standards, ISO 9001 defines requirements for a Quality Management System (QMS). Organizations comply with standards like ISO 9001 to showcase their competence in offering products and services of good quality and comply with the government’s laws and regulations. One of the main requirements of ISO 9001 is “continuous improvement”. It refers to continuously tracking and improving an organization’s products, processes, services, and satisfaction levels. It also refers to the continuous improvement of the organization’s QMS.

Getting certified in ISO 9001 involves preparing an organization for certification, performing an internal audit, and, lastly, performing an external audit. This external auditor will be an accredited certifier or registrar who audits the QMS against ISO 9001 specified requirements. It is a comprehensive check of the QMS that the organization implements.

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Define ISO 9001 Quality Management System

ISO 9001 Quality Management System is defined as the international standard that details QMS requirements. It is the only standard in the series to which organizations can certify. Organizations use the ISO 9001 standard to demonstrate their ability to consistently provide products and services that meet customer and all regulatory requirements. Implementing a ISO 9001 Quality Management System affects every aspect of an organization’s performance, including:

Increase efficiency

Increasing efficiency, boosting revenue, improving customer satisfaction and retention

better credibility

Facilitating supplier onboarding for better credibility

Enhance customer satisfaction

Enhancing customer satisfaction by understanding your customers’ needs and mitigating errors

greater operating efficiency

Achieving greater operating efficiency by following industry best-practice and focusing on quality

effective decision-making

Creating an effective decision-making process by detecting and identifying problems to prevent repeating the mistakes in the future

improve employee engagement

Improving employee engagement and productivity by focusing on internal communications and involving employees in the designing a process

Establis effective process

Establishing effective process integration to see improvements in efficiency more easily

Create a systematic approach

Creating a systematic approach to identify and exploit opportunities to improve

how iso 9001 quality management system evolved

How has the ISO 9001:2015 – Quality Management System evolved over the years?

Originally published in 1987, ISO 9001 underwent significant revisions in 1994, 2000, and 2008. In 2015, the latest revision was published. ISO 9001:2015 replaced ISO 9001:2008.

  • ISO 9001:1994 included changes to improve the design and development clause control and provide other clarifications. The 1994 series also modified the role of ISO 9002 and 9003.
  • The ISO 9001:2008 revision clarified issues that arose during the application of ISO 9001:2000.

ISO 9001:2008 was an international standard for quality management systems. The ISO 9001:2008 version -

  • Provided a framework for organizations to establish and maintain processes that ensured consistent product and service quality.
  • Emphasized customer satisfaction, continuous improvement, and a process-oriented approach.
  • Included requirements for documentation, management commitment, resource allocation, and performance measurement.

ISO 9001:2008 was widely adopted across industries globally, helping businesses enhance their operations, reduce errors, and meet customer expectations.

However, it was replaced by ISO 9001:2015, which introduced a more risk-based approach and emphasized leadership and stakeholder engagement, making it more relevant to contemporary business practices.

Changes introduced in the 2015 ISO 9001 revision were intended to ensure that ISO 9001 standard continues to adapt to the changing environments. Some of the significant updates in ISO 9001:2015 include:

  • The introduction of new terminology
  • Improved applicability for services
  • An emphasis on risk-based thinking to create a process approach
  • Restructuring some of the information
  • Increased leadership requirements

The latest iteration is considered guiding principles to create efficiency within an organization by streamlining the processes. ISO 9001:2015 is based on seven quality management principles. They are:

  • Customer focus
  • Engagement of people
  • Leadership
  • Process approach
  • Evidence-based decision making
  • Improvement
  • Relationship management
ISO 9001 EQMS Processes

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

Is it necessary to get an ISO 9001 Certification?

While not mandatory, an ISO 9001 certification can significantly benefit an organization. Here are a few benefits

  • Certification enhances credibility and trust among customers and stakeholders, demonstrating that the organization follows best practices in quality management and is consistently dedicated to meeting customer requirements.
  • ISO 9001 certification helps improve internal processes and efficiency by promoting a systematic approach to quality management, ensuring standardized processes, clear responsibilities, and continuous improvement.
  • Being certified can expand business opportunities as many clients and partners prefer or require ISO 9001-certified suppliers, thus offering a competitive edge in the market.
  • Getting ISO 9001 certification fosters a culture of quality and customer satisfaction within the organization. It promotes employee engagement, better communication, and a focus on meeting customer needs, leading to improved performance and customer retention

Certification to the ISO 9001 standard enhances an organization’s credibility as it shows the customers that its products and services meet expectations. The certification process typically includes implementing the requirements of ISO 9001:2015 and completing a successful registrar’s audit that confirms that the organization met those requirements. In some industries, certification is required or legally mandated.

The ISO 9001 standard allows organizations to organize processes, improve process efficiency, and offer quality products and services. With an ISO 9001:2015 certification, organizations are confirming that they:

  • Maintain documentation
  • Follow the guidelines of the regulated ISO 9001 standard
  • Meet statutory and regulatory requirements
  • Fulfill compliance requirements

What are the advantages of getting ISO 9001 Certified?

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

  • Globally recognized standard
  • Minimizes wastage
  • Suitable for both small and large organizations
  • Better internal management
  • Enhanced customer retention and acquisition
  • Improves efficiency, productivity, and profit
  • Compatible with other ISO standards
  • Helps achieve consistent outcomes
advantages of iso 9001 certification

How long does ISO 9001 certification last?

ISO 9001 certification does not have a fixed duration or expiration date. Once an organization is certified, it is valid until it decides to let it lapse or seek recertification. However, it's important to note that ISO 9001 certification requires ongoing compliance and periodic audits to maintain validity. Certification bodies typically conduct surveillance audits at regular intervals (usually annually or every three years) to assess whether the organization continues to meet the requirements of the ISO 9001 standard. If an organization fails to address significant non-conformities or does not meet the ongoing requirements of the ISO 9001 standard, the certification may be suspended or revoked.



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Step by Step Certification Process of CQ’s ISO 9001 Quality Management System

ISO certification assures customers and vendors that the company can be trusted as the ISO 9001 certification focuses on quality. Typically, the ISO 9001 Quality Management System standard is adopted by a company because

  • customers mandate ISO 9001 standard as part of the contract,
  • governments require the certification to allow trading,
  • business wants to improve their products and, in turn, customer satisfaction

The six steps to getting ISO 9001 certified are explained below:

  • Step 1: Set the Goals for the Business

    Using gap analysis, identify the results of past quality efforts concerning ISO requirements, and draft the right approach suited to meet the organization’s culture and requirements.

  • Step 2: Document Management

    Document management is critical to the process as it helps maintain business continuity, efficiency, operations, and profitability. The documentation should detail workflows and processes.

  • Step 3: Collaborative Mindset for Implementation

    A successful implementation process involves communicating the new requirements to the employees to ensure they understand the new way of working.

ISO 9001 Step by Step Certification Process

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

    Once ISO 9001 processes implementation is complete, evaluate the conformance to ISO 9001 internally. This internal audit should be conducted periodically. Trained employees or subcontractors can do the audit.

  • Step 5: Getting Certified

    Upon completing the documentation process, the organization must invite a third-party ISO 9001 auditor to complete the audit process. This must be done to achieve the certification within two months of the implementation process.

  • Step 6: Recertifying

    Since ISO certification is not a one-time process, organizations must get recertified every three years to remain compliant.

What are the best practices for implementing the ISO 9001 quality management system?

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

  • Drive ISO 9001 process from the top, with the senior management committed to achieving compliance with the requirements of the certification.

  • Collaborate with the on-ground team to keep up morale and motivation to prevent failure of ISO implementation.

  • Have proper knowledge about ISO compliance and implementation

  • Plan a strategy with realistic timelines, assess risks and opportunities assessment, allocate resources, conduct periodic audits, and track progress

  • ISO implementation requires an allocated budget for consultants, training, auditors, and pay for the certification

What are the five areas that business can improve with the latest ISO 9001 standard?

ISO 9001:2015 applies to any organization, irrespective of the size or industry. Organizations in the manufacturing, engineering, food and beverages, and construction find that by using the ISO 9001 standard, they get the following benefits:

  • ISO 9001 qms Process

    Improved Processes

    ISO 9001 promotes process-based Quality Management systems by integrating interrelated processes at the enterprise level, thus minimizing waste and costs.

  • QMS Descision Making

    Improved Decision-Making

    A well-implemented ISO 9001 aims to enable management to make decisions on facts and data more than anything else.

  • ISO 9001 Growth

    Improved Brand Perception and Growth Prospects

    When organizations become process-oriented with quality as the driving force, businesses can deliver better quality products in a timely manner. This helps win customer loyalty and increase revenues.

  • ISO 9001 Standard

    Improved Compliance to Industry-Specific Standards

    ISO 9001:2015 has been designed to lay the foundation for other industry-specific standards in the ISO family, including ISO 14001 (environmental management), ISO/TS 16949 (automotive industry), ISO 20000 (IT service management), and ISO 13485 (medical devices). By implementing ISO 9001 first, organizations can bring down the cost and time of compliance.

  • Improved Quality

    Improved Productivity

    With time, ISO affects greater productivity and employee performance. By using predictive analytics and better documentation, organizations can enable timely responses to challenges and improve employee engagement.

Cloud-Based Platform with Increased Agility, Efficiency and Speed

Everything is automated and fast; we can generate reports for information, strategic, and planning purposes, which makes a huge impact on our productivity and efficiency. The support and communication at ComplianceQuest have been top-notch, even on days when there was a lot of pressure. All of this and more was achieved when we picked ComplianceQuest as our EQMS. I’ve rarely seen anyone hit a target like that as quickly as we did, especially with the number of documents to migrate (3,000) and customization’s to Corrective Action and Preventive Action application.

Kippy Hillhouse,
Quality Engineer, YKK

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How does ComplianceQuest QMS Help to Comply with ISO 9001 Standard?

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

CQ reduces the effort involved in maintaining ISO 9001:2015 Quality System by automating the required processes while maintaining complete traceability. Also, CQ QMS provides a complete view of the organization’s data related to the performance and effectiveness of the quality and compliance management system. Some of the features of CQ QMS include:

iso 9001 quality management system benefits

Benefits of Using CQ’s ISO 9001 Quality Management System for Business Growth

An ISO 9001 Quality Management System can streamline business processes, minimize errors, unleash valuable management time, and improve internal communications. By adopting this approach, companies can get benefit from enhanced employee morale, better customer retention, and greater revenues. Here are the key benefits of iso 9001 quality management system framework:

Determine risks and opportunities in a structured way to ensure better planning, fewer surprises, efficient decision-making, and better relationships with suppliers, customers, and employees.

Avoid problems from recurring by maintaining records of problems, identifying their root causes, and creating permanent solutions.

Improve employee morale by communicating quality policies to employees

Improve control over the business by continuously monitoring, measuring, analyzing, and evaluating the effectiveness of the quality management system.

A 100% modern cloud Enterprise Quality & Safety Management System (QHSE) focuses on the requirements for ISO 9001:2015 while automating the entire ISO 9001 Quality Management System requirements. CQ QMS significantly reduces the effort involved in maintaining the ISO 9001:2015 Quality System by automating the required processes while maintaining full traceability. Also, CQ Quality System provides a complete view of the organization’s data concerning the performance and effectiveness of the quality and compliance management system.

CQ’s-QMS Professional Certifications

The QMS solution from ComplianceQuest is mapped to the ISO requirements to enable businesses to become compliant and ensure that the quality management system is efficient and effective. The ISO 9001:2015 certification proves that ComplianceQuest has an actionable, clear, and thorough approach to the essential components of a successful Customer-First organization and corporate growth. When embarking on ISO certification, ComplianceQuest focuses on:

  • Creating a platform that supports expansion and growth
  • Providing a secure internal process execution
  • Improving client delivery services and customer satisfaction
cqs qms iso 9001 certification

Manage your entire QMS processes with ComplianceQuest's ISO 9001 Quality Management System to ensure products and services meet customers and all regulatory requirements. 

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Frequently Asked Questions

  • Some of the ComplianceQuest QMS that ensure ISO 9001 compliance and which will drive operational excellence are:

    • Powerful dashboards built into the solution give reports and insights based on the user’s role.

    • Using data, analytics, and AI, the ComplianceQuest QMS solution can help with root cause analysis of any incidents, identify and recommend the next best action.

    • The system provides user-level customizations and access, ensuring privacy and security.

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

  • To become ISO 9001 certified, organizations need planning, commitment, and resources. QMS ISO advises a simple 3-step process:

    • Gap Analysis: A consultant must review and document the current processes and procedures list any areas that do not meet the requirements of the standard

    • Implementation: Track the impact of any changes that have been made to the existing processes and procedures

    • Certification: An auditor to annually check and ensure that all of the documented processes are being followed

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