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ISO 9001

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What is ISO 9001?

ISO 9001 is a globally recognized standard for quality management. It helps organizations of all sizes and sectors to improve their performance, meet customer expectations and demonstrate their commitment to quality. Its requirements define how to establish, implement, maintain, and continually improve a quality management system (QMS).

Structure of the ISO 9001:2015

The ISO 9001:2015 standard is structured into several clauses that outline the requirements for a quality management system. Here’s a brief overview of the structure by clause:

  1. Scope (Clause 1): Defines the scope of the standard, outlining what the standard covers and excludes.
  2. Normative References (Clause 2): Lists any referenced standards or documents essential for understanding and implementing ISO 9001.
  3. Terms and Definitions (Clause 3): Provides definitions of key terms used throughout the standard to ensure common understanding.
  4. Context of the Organization (Clause 4): Requires organizations to determine the external and internal issues relevant to their purpose and strategic direction and the interested parties affected by the organization’s QMS.
  5. Leadership (Clause 5): Focuses on the commitment of top management to the QMS, including leadership and commitment, the establishment of a quality policy, roles, responsibilities, and authorities.
  6. Planning (Clause 6): Covers actions to address risks and opportunities, quality objectives and planning to achieve them, and planning of changes.
  7. Support (Clause 7): Addresses resources, including competent people, infrastructure, monitoring and measuring resources, organizational knowledge, and the documented information necessary for the QMS.
  8. Operation (Clause 8): Includes operational planning and control, determining requirements for products and services, design and development (if applicable), controlling externally provided products and services, production and service provision, release of products and services, and control of nonconforming outputs.
  9. Performance Evaluation (Clause 9): Covers monitoring, measurement, analysis, and evaluation, internal audit, and management review.
  10. Improvement (Clause 10): Deals with nonconformity and corrective action and continual improvement.

Stages of ISO 9001:2015

  1. Stage One Audit: A preliminary audit to evaluate your preparedness for the certification audit. This includes a review of your quality management system documentation and initial identification of potential non-conformities.
  2. Stage Two Audit: An on-site audit to assess the implementation and effectiveness of your quality management system. This involves interviews, observation of activities, and review of records to ensure compliance with ISO 9001:2015 requirements.
  3. Addressing Non-Conformities: Identification and resolution of any non-conformities discovered during the audit. Our auditors will provide detailed feedback and work with you to develop corrective actions to address any issues.
  4. Certification Decision: Upon successful completion of the audit and resolution of any non-conformities, Guardian Assessment Private Limited will make a certification decision and issue the ISO 9001:2015 certification. This certification demonstrates your organization’s commitment to quality excellence and regulatory compliance.
  5. Surveillance Audits: Regular audits are conducted annually to ensure ongoing compliance and continuous improvement. These audits help to maintain the integrity of your quality management system and identify areas for improvement.
  6. Recertification Audit: Conducted at the end of the certification cycle (typically three years) to ensure continued conformity with ISO 9001:2015 standards and to renew the certification. This involves a comprehensive review of your quality management system to confirm its ongoing effectiveness and compliance.

Benefits of ISO 9001:2015 Certification

ISO 9001:2015 certification offers numerous benefits to organizations:

  • Improved Quality Management: ISO 9001:2015 certification provides a framework for consistently delivering high-quality products and services, leading to enhanced customer satisfaction and reduced defects
  • Improved Operational Efficiency: Streamlining processes and reducing inefficiencies helps organizations operate more effectively, reducing costs and improving overall productivity.
  • Improved Employee Engagement: Implementing ISO 9001:2015 involves staff in quality management practices, increasing their awareness and involvement, which enhances engagement, motivation, and productivity.
  • Enhanced Customer Trust and Loyalty:Demonstrating a commitment to quality through certification helps build trust with customers, leading to stronger relationships and increased repeat business.
  • Cost Savings and Increased Profitability: By minimizing errors, improving resource allocation, and enhancing process efficiency, ISO 9001 certification contributes to reduced costs and improved financial performance over time.
  • Global Recognition: As an internationally recognized standard, ISO 9001:2015 certification enhances your organization’s credibility and reputation on a global scale, facilitating international business and demonstrating a commitment to global quality standards.

What are the Documents and Records an organisation should maintain for ISO 9001:2015 Certification?

Mandatory Documents:

  1. Scope of the Quality Management System (Clause 4.3)
  2. Quality Policy (Clause 5.2)
  3. Quality Objectives (Clause 6.2)
  4. Criteria for Evaluation and Selection of Suppliers (Clause 8.4.1)
  5. Documented Information Required by the Standard (Clause 7.5.1)

Mandatory Records:

  1. Records of Monitoring and Measurement Equipment Calibration (Clause 7.1.5.1)
  2. Records of Training, Skills, Experience, and Qualifications (Clause 7.2)
  3. Product/Service Requirements Review Records (Clause 8.2.3.2)
  4. Records of Design and Development Outputs (Clause 8.3.5)
  5. Records of Design and Development Changes (Clause 8.3.6)
  6. Supplier Evaluation and Re-evaluation Records (Clause 8.4.1)
  7. Records of Control of Nonconforming Outputs (Clause 8.7.2)
  8. Results of Monitoring and Measurement of Product/Service (Clause 9.1.1)
  9. Internal Audit Program and Results (Clause 9.2)
  10. Management Review Minutes (Clause 9.3)
  11. Records of Corrective Actions (Clause 10.2)

Non-Mandatory Documents (Examples):

  1. Procedure for Control of Documented Information
  2. Procedure for Internal Audits
  3. Procedure for Control of Nonconforming Outputs
  4. Procedure for Corrective Actions
  5. Procedure for Preventive Actions

Integration of ISO 9001:2015 with Other Standards

An integrated management system (IMS) combines all related components of a business into one system for easier management and operations. Information security, privacy, quality, environmental, safety, and various specialized management systems are often combined and managed as an IMS. An IMS integrates all of an organization’s systems and processes into one complete framework, enabling the organization to work as a single unit with unified objectives. ISO 9001:2015 can be integrated with standards such as:

  • ISO 27001:2022 (ISMS) – Information Security Management System
  • ISO 14001:2015 (EMS) – Environmental Management System
  • ISO 45001:2018 (OHSMS) – Occupational Health and Safety Management System
  • ISO 13485:2016 (MD-QMS) – Medical Devices Quality Management System
  • ISO 22000:2018 (FSMS) – Food Safety Management System
  • ISO 27701:2019 (PIMS) – Privacy Information Management System
  • ISO 20000-1:2018 (IT-SMS) – Information Technology Services Management System
  • ISO 41001:2018 (FMS) – Facility Management – Management System
  • ISO 21001:2018 (EOMS) – Educational Organizations Management System
  • ISO 37001:2016 (ABMS) – Anti-Bribery Management System
  • ISO 50001:2018 (EnMS) – Energy Management System
  • ISO 55001:2014 (AMMS) – Asset Management System