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ISO 9001 Quality Management System

ISO 9001 Quality Management System

ISO 9001:2015 certification guarantees the quality of products and services
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Implementing QMS ISO 9001 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.
ISO 9001 Quality Management System
ComplianceQuest QMS Quality Management System

Define ISO 9001 Quality Management System

ISO 9001 is defined as the international standard that details Quality Management System (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 QMS affects every aspect of an organization’s performance, including
  • Increasing efficiency, boosting revenue, improving customer satisfaction and retention
  • Facilitating supplier onboarding for better credibility
  • Enhancing customer satisfaction by understanding your customers’ needs and mitigating errors
  • Achieving greater operating efficiency by following industry best-practice and focusing on quality
  • Creating an effective decision-making process by detecting and identifying problems to prevent repeating the mistakes in the future
  • Improving employee engagement and productivity by focusing on internal communications and involving employees in the designing a process
  • Establishing effective process integration to see improvements in efficiency more easily.
  • Creating a systematic approach to identify and exploit opportunities to improve

Manage your entire QMS processes with ComplianceQuest’s quality management software for flexible, scalable and configurable workflow.

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.

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 9001:2015 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:

  • Improved Processes: ISO 9001 promotes process-based Quality Management systems by integrating interrelated processes at the enterprise level, thus minimizing waste and costs.
  • Improved Decision-Making: A well-implemented ISO 9001 aims to enable management to make decisions on facts and data more than anything else.
  • 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.
  • 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 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.
ISO 9001 Quality Management System

Is it necessary to get an ISO 9001 Certification?

Within the ISO 9000 series, ISO 9001 is the only standard to which organizations can get certified. If an organization has ISO 9001:2015 certification, it means that it has demonstrated the following:
Meets customer, statutory, and regulatory requirements
Follows the guidelines detailed in the ISO 9001 standard
Fulfills its own requirements
Maintains documentation

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 is implemented by the organization.

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
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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 standard is adopted by a company because
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customers mandate ISO 9001 standard as part of the contract,
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governments require the certification to allow trading,
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business wants to improve their products and, in turn, customer satisfaction
The six steps to getting ISO 9001 certified are explained below –
ISO 9001 Quality Management System Certification steps - 1

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.

ISO 9001 Quality Management System Certification steps - 2

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.

ISO 9001 Quality Management System Certification steps - 3

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 Quality Management System Certification steps - 4

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.

ISO 9001 Quality Management System Certification steps - 5

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.

ISO 9001 Quality Management System Certification steps - 6

Step 6: Recertifying

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

ISO 9001 Quality Management System
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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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ISO 9001 Quality Management System

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

An ISO 9001 QMS 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 using the ISO 9001 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 QS 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

Quality-centric companies rely on CQ QMS

Frequently Asked Questions

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

What are the best practices for ISO 9001 certification?
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 some of the features of ComplianceQuest QMS that ensure ISO 9001 compliance?
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
What is the process of getting an ISO 9001 certification?
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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