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What is ISO 9001:2015 certification?

ISO certification is a validation of a business's compliance with quality process standards defined by the International Standards Organization (ISO). ISO, a non-governmental organization, sets specifications for quality and efficiency in products, services, and systems.

What are the key principles of quality management outlined in ISO 9001?

The key principles of quality management outlined in ISO 9001 include:
  • Customer Focus: Organizations should understand and meet customer needs, ensuring satisfaction and loyalty.
  • Leadership: Effective leadership provides a clear vision, sets the direction, and fosters a positive organizational culture.
  • Involvement of People: Engaging and empowering employees at all levels enhances their contributions to the organization's success.
  • Process Approach: Managing activities as interconnected processes improves efficiency and effectiveness.
  • Systematic Approach to Management: A systematic approach enables consistent and thorough management of processes.
  • Continual Improvement: Organizations should continuously strive to enhance performance and processes.
  • Factual Approach to Decision Making: Data-driven decision-making ensures informed choices and better results.
  • Mutually Beneficial Supplier Relationships: Collaborating with suppliers fosters shared success and quality improvement.

Key requirements of obtaining ISO 9001 certification

The prerequisites for obtaining ISO certification can vary depending on the specific ISO standard, the type of organization, and its existing processes. However, there are some common prerequisites that apply to most ISO certifications:
  • Quality Management System (QMS) Implementation: The company must have an QMS, procedure manual, and other relevant checklists, forms, and formats in place. Implementing a QMS is a fundamental prerequisite for ISO certification. This system outlines the processes and procedures an organization follows to ensure quality in its products or services.
  • Compliance with ISO Standards: To get ISO certification, a company needs to make sure its everyday activities follow the specific rules of the ISO standard. This means checking how they currently do things and changing them if needed in different areas like HR, marketing, management, operations, and training.
  • Documented Processes: An organization is required to document its processes, procedures, and quality objectives. This documentation provides evidence of how the organization maintains and improves its QMS.
  • Internal Audits: Conducting regular internal audits is essential to identifying non-conformities and areas for improvement within the QMS. Corrective actions should be taken based on the audit findings. You need to ensure that if the internal auditor is an existing employee, he or she should not audit his or her own department.
  • Management Support: The top management of the organization must demonstrate commitment to the QMS and provide resources for its effective implementation and maintenance.
  • Training and Awareness: Employees at all levels should be aware of the QMS and receive appropriate training to carry out their roles effectively within the system. The company must arrange training for its employees from internal or external trainers to upgrade their knowledge and skills.
  • Data Collection and Analysis: Gathering data related to product or service quality, customer satisfaction, and process performance is crucial. Data analysis helps in making informed decisions and continuous improvement.
  • Corrective and Preventive Actions: Organizations must have procedures in place for addressing non-conformities, taking corrective actions, and implementing preventive measures to avoid similar issues in the future.
  • Customer Focus: ISO standards emphasize meeting customer requirements and enhancing customer satisfaction. Therefore, organizations should prioritize customer needs and feedback in their QMS. company needs to take regular feedback from customers, vendors or principals.
  • Risk Assessment: Identifying and addressing risks and opportunities within the QMS is an important aspect of ISO certification. Organizations should have a structured approach to managing risks effectively.

It's important to note that the specific prerequisites may vary depending on the ISO standard being pursued. Therefore, it's essential to contact consultant to ensure compliance with the specific requirements.

Why ISO 9001:2015 certification

There are many advantages to being an ISO 9001-certified company; some are listed below:
  1. Meeting Client Needs: Many businesses seek ISO 9001 certification to meet a single client's requirement, as this client exclusively deals with ISO 9001-compliant vendors. Obtaining ISO certification is crucial to securing their business.
  2. Expanding Revenue and Customer Base: ISO 9001 certification opens doors to new markets and opportunities. It allows you to engage with major corporations and secure government contracts, significantly boosting revenue.
  3. Enhancing Company and Product Quality: Implementing the ISO 9001 Quality Management System enhances your overall business processes and sets you on a path to superior quality.
  4. Boosting Customer Satisfaction: A well-functioning quality management system ensures you understand and meet customer expectations, leading to increased satisfaction and a reduction in customer complaints.
  5. Defining, Understanding, and Communicating Processes: ISO 9001 QMS streamlines and describes your business processes, improving their management and control. Quality objectives serve as the system's core.
  6. Fostering a Knowledgeable Culture and Higher Morale: Implementing ISO 9001 QMS empowers your staff with clear expectations, tools, and prompt feedback, leading to an improved company culture and more skilled employees.
  7. Enhancing Operational Consistency: Effective QMS implementation reduces process variation, ensuring consistent quality and meeting customer expectations every time.
  8. Sharpening Focus for Management and Employees: Proper objectives, metrics, and procedures enable better focus for management and employees. This ensures everyone remains aligned with what truly matters.
  9. Ensuring Quality Auditing and Feedback: ISO 9001 QMS requires regular quality audits, providing objective feedback to correct any deviations and maintain focus on organizational goals.
  10. Improving Efficiency, Reducing Waste, and Saving Money: A well-run QMS leads to process improvements, greater consistency, and more savings by reducing waste and inefficiency.
  11. Attaining International Quality Recognition: ISO 9001 is an internationally recognized standard across 120+ countries, making it the logical choice for organizations involved in international business or committed to quality.

Fee for obtaining ISO 9001:2015 Certification

The cost of obtaining ISO 9001:2015 certification can vary widely depending on factors such as the size and complexity of your organization, the number of locations to be included in the certification, and the chosen certification body. It typically includes fees for certification audits, documentation, consultancy, and ongoing surveillance audits. To get an accurate estimate, it's best to contact a Legal Babu business specialist for detailed pricing.

Stages Involved in Obtaining ISO 9001:2015 Certification

Application : The process starts with the application process, in which clients provide basic details about organizations along with their needs and expectations. This helps in understanding the client’s organization, its management system, size, and types of operations. Based on the information provided initially, objectives are defined for the assessment and/or certification, including applicable standards and specifications. Further Legal Babu will provide a detailed offer in a written contract specifying all relevant deliverables as well as applicable assessment and certification services tailored to individual client needs.

Pre- audit : A pre-audit will be carried out by Legal Babu; it will serve as an initial performance or gap analysis, identifying strengths and areas for improvement. For larger assessment and certification projects, a detailed project planning meeting with the lead assessor and client provides a valuable opportunity to develop a customized assessment plan for all functions and processes involved. A pre-audit helps top management understand the shortfall in existing processes and functions with respect to international standards.

Stage 1 audit : Stage 1 audits are carried out by the auditor appointed by the certification body. The scope of this stage extends to introductions and meetings with management and leadership. The discussion will revolve around confidential clauses and different grades of inspections while the audit is in progress. The assessment procedure involves the review and evaluation of system documentation, goals, results of management reviews, and internal audits. During this process, it is determined whether the client’s management system is adequately developed and ready for certification. The auditor will explain findings and highlight areas of improvement and major deficiencies, if any, that have to be addressed and closed within a specific period of time, typically within 3 months.

Stage 2 audit : During the stage 2 audit, the external auditor from a certification body is required to conduct an audit of the existing systems of quality compliance the company follows. Audits are done on a sampling basis. The audit is done according to QMS standards, and the company has to pass it positively. The reviews and inspections evaluate everything, from the employees to the products, services, and key support systems. If you are already employing best practices, the audit will yield positive results. Auditors will continue stringent tests that comprise further quality checks, like:

  • Cleanliness of workers, equipment and tools
  • Inventory check from storage of raw materials to finished products
  • Area of packaging
  • Dispatch of finished products
  • Training programs for workers

They may even speak to the managers who handle these sensitive areas to ascertain their methods and systems. Questions may be related to their objectives, maintenance, regulations, analysis, and continuous improvement.

Certificate : Following a successful audit, the auditor provides the audit report and suggests granting the QMS certification to the certification body. Upon receiving the audit report, the certification body conducts a comprehensive review of procedures and documents and secures final approvals from pertinent departments. During this stage, any identified technical issues or findings necessitating corrective actions are conveyed to the client. A draft certificate is then shared with the client for their review and potential amendments related to its content. Once the client approves it, a final certificate is issued, encompassing a certificate number, company name, address, and certificate validity.

Maintenance and Recertification : ISO 9001 certification is typically valid for three years. To maintain it, regular surveillance audits are conducted, and a recertification audit is required every three years.

What is the role of an ISO certification consultant?

An ISO certification consultant plays a crucial role in helping organizations achieve ISO certification. Their responsibilities include:
  • Assessment: Consultants assess the organization's existing processes and procedures to identify areas, also called gap analysis, that need improvement to meet ISO standards.
  • Guidance: They provide guidance on the specific ISO standard requirements and help the organization understand how to align their processes with these standards.
  • Documentation: Consultants assist in creating and maintaining the necessary documentation, including quality manuals, procedures, and records, required for ISO certification.
  • Training: They may provide training to employees to ensure they understand and can effectively implement the ISO standards within their roles.
  • Internal Audits: Consultants often conduct internal audits to identify non-conformities and areas for improvement before the official certification audit.
  • Corrective Actions: If any non-conformities are identified, consultants help the organization take corrective actions to address these issues.
  • Preparation for Certification Audit: They prepare the organization for the certification audit by the external certification body, ensuring all requirements are met.
  • Continuous Improvement: Consultants support ongoing improvement efforts, helping the organization maintain ISO certification over time.
  • Choosing the Right Standard: They assist in selecting the most suitable ISO standard for the organization's industry and goals.
  • Certification Body Liaison: Consultants may communicate with the certification body to schedule and coordinate the official certification audit.

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