BASIC INTRODUCTION OF QUALITY MANAGEMENT SYSTEM: ISO 9001:2015

ISO 9001:2015 certification establishes criteria for a quality management system (QMS) that enhances customer satisfaction by meeting customer and regulatory requirements. It helps organizations streamline operations, improve efficiency, and continually enhance processes. Certification demonstrates commitment to quality and enables access to new markets and opportunities. Key principles include customer focus, leadership engagement, and continual improvement. Through systematic audits and management reviews, ISO 9001 ensures ongoing conformity and effectiveness of the QMS, fostering a culture of excellence and accountability within organizations globally.

Structure of the ISO 9001:2015 Standard

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. Each clause contains specific requirements that organizations must meet to achieve ISO 9001:2015 certification. This structure helps ensure that the quality management system is robust, effective, and aligned with organizational goals and customer expectations.

Benefits of ISO 9001:2015 Certification

ISO 9001:2015 certification offers numerous benefits to organizations:
•Enhanced Customer Satisfaction: By focusing on meeting customer requirements consistently, organizations can enhance customer satisfaction, leading to increased loyalty and positive word-of-mouth.
•Improved Operational Efficiency: Streamlining processes and reducing inefficiencies helps organizations operate more effectively, reducing costs and improving overall productivity.
•Access to New Markets: ISO 9001:2015 certification is often a prerequisite for entering new markets and attracting potential customers who prioritize quality and reliability.
•Enhanced Organizational Reputation: Certification demonstrates commitment to quality management practices, boosting organizational credibility and trust among stakeholders.
•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.

Eligibility Criteria for ISO 9001:2015 Certification

To achieve ISO 9001:2015 certification, an organization must meet several key criteria. These include having a documented Quality Management System (QMS), showing commitment from top management, focusing on customer satisfaction, and implementing risk-based thinking. Additionally, the organization must commit to continual improvement, ensure the competence and training of personnel, maintain documented information, manage resources effectively, and comply with legal and regulatory requirements.
Key points:
1. Documented Quality Management System (QMS)
2. Management commitment and customer focus
3. Risk-based thinking and continual improvement
4. Competence, training, and legal compliance

Who should establish the requirement for ISO 9001:2015 Certification

The requirements for ISO 9001:2015 Certification should be established by any organization, regardless of its industry, seeking to implement a Quality Management System (QMS) to demonstrate its ability to consistently provide products and services that meet customer and regulatory requirements. ISO 9001 is applicable across various industries, including manufacturing, healthcare, information technology, construction, food and beverage, retail, and financial services. By adopting ISO 9001 standards, these industries can achieve significant benefits such as improved product quality, enhanced operational efficiency, reduced waste, and increased customer satisfaction. For instance, manufacturing companies can ensure consistent product quality, while healthcare providers can enhance patient care and comply with regulatory standards. IT companies can maintain high service delivery standards, and construction firms can improve project management and safety. Additionally, food and beverage companies can ensure product safety and compliance, retail businesses can improve inventory management and customer service, and financial institutions can enhance service quality and risk management. Overall, ISO 9001 helps organizations build trust with consumers, drive continuous improvement, and achieve long-term success by meeting customer and regulatory requirements effectively.

Step for Obtaining ISO 9001:2015 Certification

Obtaining ISO 9001:2015 certification involves several key requirements and steps:
1. Establishing a QMS: The organization needs to establish a Quality Management System (QMS) that meets the requirements of ISO 9001:2015. This involves defining processes, procedures, and policies that ensure consistent delivery of products or services that meet customer and regulatory requirements.
2. Documentation: Develop the necessary documentation for the QMS, including a Quality Manual, documented procedures, work instructions, and records required by the standard.
3. Implementation: Implement the QMS across the organization, ensuring that all relevant personnel are aware of their roles and responsibilities in maintaining quality standards.
4.Internal Audit: Conduct internal audits to assess the effectiveness of the QMS and identify areas for improvement.
5.Management Review: Hold management reviews to evaluate the QMS's performance, suitability, adequacy, and opportunities for improvement.
6.Pre-assessment (Optional): Some organizations choose to conduct a pre-assessment or gap analysis to identify any areas where the QMS does not meet ISO 9001 requirements before proceeding to formal certification.
7.Certification Audit: Engage an accredited certification body to conduct a certification audit. This audit will assess the organization's QMS against ISO 9001 requirements to determine compliance.
8.Corrective Actions: Address any non-conformities identified during the certification audit and implement corrective actions as necessary.
9.Certification: Upon successful completion of the certification audit and resolution of any non-conformities, the certification body will issue ISO 9001:2015 certification.
10.Surveillance Audits: Maintain the QMS and undergo periodic surveillance audits by the certification body to ensure ongoing compliance with ISO 9001 requirements.

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

What is the process for ISO 9001:2015 Certification?

The certification process with TNV involves several systematic steps to ensure thorough evaluation and compliance with ISO 9001:2015 standards:
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, TNV 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.

What is the Cost of ISO 9001:2015 Certification?

This is most critical question for a certification body, there is no definite charges for any ISO Certification, Expenses for Certification are widely depend on the various factors like size, location, complexity of operations, processes, their inter-relevance and state of the implementation of the requirement. For a small size organisation, charges may be lower whereas for large scale organisation, charges may be higher. Charges for the certification mainly depend on the three main factors, fist status of the implementation of the system in the organisation, Audit Duration and registration Fees which is usually called as Certification fees. TNV provides quotation considering all the factor which may be important. Client organisation need to submit information of client organisation in the specific form that F-01 and this form is available on the official portal in download section. You are advised to please write to us via email at info@isoindia.org or click on Contact us on the portal and submit the inquiry.

Importance of accreditation of ISO 9001:2015 when you choose Certification Body

Choosing an certification body for ISO 9001:2015 is most critical task and selection of a valid and accredited Certification body ensures your certification is credible and globally recognized but if you choose a wrong certification body, you may miss the benefit of the certification and your certification may be challenged at several points. Accredited Certification bodies have established a proper system and they have qualified auditors and robust processes, leading to consistent and high-quality audit outcomes which result into legit and accredited Certification. This enhances your organization’s market reputation and can open up new business opportunities, as many customers and partners prefer accredited certification. Additionally, it aids in regulatory compliance and reduces the risk of certification being questioned. Overall, accreditation ensures your certification supports continuous improvement and customer satisfaction, facilitating smoother entry into international markets. In case of ISO Certification, Accredited mean it should be accredited and recognised by IAF. IAF is the only way to offer global recognition. IAF offer a global directory of Certified client and all kind of organisation say Certified organisation, Certification body and Accreditation board which is involved in the Management System Certification are duly listed on the IAF portal, i.e. www.iafcertsearch.org. TNV is an accredited Certification body within IAF and certificate issued by IAF are accepted worldwide. Validity of all accredited certification, certification body, Accreditation board can be verified on IAF portal i.e. www.iafcertsearch.org.

Recognition through UAF Accreditation

TNV Certification Pvt. Ltd. is accredited by the United Accreditation Foundation (UAF), a globally recognized accreditation body. This UAF accreditation ensures that our certification services adhere to the highest standards of competence, impartiality, and performance. Achieving certification through TNV provides your organization with international recognition and credibility. UAF accreditation guarantees that your ISO 9001:2015 certification is recognized and respected worldwide, enhancing your organization’s reputation and facilitating market access. UAF is an IAF member and MLA signatory that offers global recognition to all Certified Clients. TNV is accredited by UAF for wide range of the series of the standard like ISO 9001, ISO 14001, ISO 45001, ISO 22000, ISO 13485, ISO 21001, ISO 20000-1, ISO 27001, ISO 27701, ISO 37001, ISO 41001, ISO 50001, ISO 55001 and this makes TNV a largest Certification body in India who offers such wide range of the series of the standard. This wide services range enable our clients to avail all the accredited Services under one roof.

Importance of Updating Certified Organizations on www.iafcertsearch.org

Maintaining an up-to-date record of your ISO 9001:2015 certification on the IAF CertSearch database is crucial for several reasons, IAF portal for Global database is www.iafcertsearch.org and anyone may access and check the recognition of Client, Certification body and accreditation board. IAF is the only method to check the validity of the Check and recognised Certificate:
1.Visibility: Enhances the visibility and credibility of your certification to stakeholders worldwide. It allows potential clients and partners to verify your certification status easily.
Verification: Allows clients, regulatory bodies, and other interested parties to verify the authenticity and validity of your certification. This transparency builds trust and confidence in your organization.
Market Access: Facilitates access to global markets by demonstrating compliance with international standards. Many international clients and regulatory bodies refer to the IAF CertSearch database to verify certifications.
Trust: Builds trust with customers, suppliers, and partners by showcasing your commitment to quality and regulatory compliance. An updated certification record signals that your organization is dedicated to maintaining high standards.

Apply for ISO 9001:2015 Certification

If you plan to pursue ISO 9001:2015 certification, request a quotation by providing your organization’s information in the application form. You can download the inquiry form from our website or submit your inquiry through the Apply Now button. Alternatively, send your inquiry via email to info@isoindia.org or click on Contact us. You have option to choose more than one standard and if you consider that other standard may help your organisation, you may integrate the standards within the accredited certification range and may apply for the certification for ISO 9001, ISO 14001, ISO 45001, ISO 22000, ISO 13485, ISO 21001, ISO 20000-1, ISO 27001, ISO 27701, ISO 37001, ISO 41001, ISO 50001, ISO 55001.

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. Quality, Environmental, and Safety 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 14001:2015 (Environmental Management Systems), ISO 45001:2018 (Occupational Health and Safety Management Systems), and ISO 27001:2022 (Information Security Management Systems), ISO 22000:2018 (Food Safety Management Systems), ISO 13485:2016 (Medical Devices - Quality Management Systems), ISO 21001:2018 (Educational Organizations Management Systems), ISO 20000-1:2018 (IT Service Management Systems), ISO 27701:2019 (Privacy Information Management Systems), ISO 37001:2016 (Anti-bribery Management Systems), ISO 41001:2018 (Facility Management Systems), ISO 50001:2018 (Energy Management Systems), ISO 55001:2014 (Asset Management Systems) to enhance overall operational efficiency and effectiveness.