ISO stands for the International Organization for Standardization. It is an independent, non-governmental international organization that develops and publishes voluntary, consensus-based, market-relevant International Standards. These standards provide requirements, specifications, guidelines, or characteristics that can be used consistently to ensure that materials, products, processes, and services are fit for their purpose.
ISO itself does not perform certifications. Instead, it develops the standards, and then external, independent certification bodies (also known as registrars) audit organizations to confirm that they meet the requirements of a particular ISO standard. If successful, the organization receives an ISO certification.
Purpose of ISO Certification
The main purpose of ISO standards and certification is to:
Ensure Quality and Consistency
Provide a framework for organizations to consistently deliver products and services that meet customer and regulatory requirements.
Enhance Efficiency
Streamline processes, reduce waste, and improve operational efficiency.
Increase Customer Satisfaction
Lead to higher quality products and services, fostering greater customer trust and loyalty.
Facilitate International Trade
Provide a common set of benchmarks that are globally recognized, making it easier for businesses to trade across borders.
Promote Best Practices
Encourage organizations to adopt internationally recognized best practices in various areas like quality management, environmental performance, information security, and occupational health and safety.
Manage Risks
Help organizations identify, assess, and mitigate risks effectively.
Achieve Regulatory Compliance
Support compliance with relevant laws and regulations.
Foster Continuous Improvement
Encourage organizations to regularly review and improve their systems and processes.
Key Types of ISO Standards and Certifications
There are over 24,000 ISO standards covering a vast range of industries and activities. Some of the most well-known and widely adopted ISO certifications include.
ISO 9001: Quality Management System (QMS)
- Purpose: The most popular ISO standard, it sets the criteria for a quality management system. It’s designed to help organizations ensure they meet the needs of customers and other stakeholders while meeting statutory and regulatory requirements related to a product or service.
- Focus: Customer satisfaction, process approach, leadership, engagement of people, continuous improvement, evidence-based decision making, and relationship management.
ISO 14001: Environmental Management System (EMS)
- Purpose: Provides a framework for organizations to manage their environmental responsibilities, including reducing waste, pollution, and energy consumption.
- Focus: Environmental performance, sustainable resource use, and compliance with environmental laws.
ISO 45001: Occupational Health and Safety Management System (OHSMS)
- Purpose: Specifies requirements for an occupational health and safety management system to prevent work-related injury and ill-health and to proactively improve OH&S performance.
- Focus: Worker safety, risk assessment, and hazard control.
ISO 27001: Information Security Management System (ISMS)
- Purpose: Provides a framework for managing information security, including sensitive company and customer information.
- Focus: Confidentiality, integrity, and availability of information, risk management for information assets.
ISO 22000: Food Safety Management System (FSMS)
- Purpose: A standard for food safety management that ensures food safety throughout the food chain, from farm to fork.
- Focus: Hazard analysis, critical control points (HACCP), and continuous improvement in food safety.
ISO 13485: Medical Devices – Quality Management System (QMS)
- Purpose: Specific to the medical device industry, it specifies requirements for a quality management system for organizations involved in the design, development, production, installation, and servicing of medical devices.
Benefits of ISO Certification for Businesses
Enhanced Credibility and Reputation
Globally recognized certification builds trust with customers, partners, and stakeholders.
Improved Customer Satisfaction
Consistent quality and focus on customer needs lead to happier clients.
Increased Operational Efficiency
Streamlined processes, reduced errors, and optimized resource use lead to cost savings.
Better Risk Management
Structured approaches to identify, assess, and mitigate risks.
Access to New Markets
Many tenders, contracts, and international markets require ISO certification.
Regulatory Compliance
Helps ensure adherence to relevant laws and regulations.
Continuous Improvement
Fosters a culture of ongoing enhancement and refinement of processes.
Improved Employee Morale and Engagement
Clear processes and a focus on quality can lead to a more organized and motivated workforce.
Competitive Advantage
Differentiates your business from competitors, especially in a crowded market.
How to Get ISO Certification in India (General Process)
The process of obtaining ISO certification involves several steps and typically takes a few months, depending on the size and complexity of your organization. ISO certification is a commitment to continuous improvement, and surveillance audits are conducted periodically to ensure ongoing compliance.
Identify the Relevant ISO Standard
Determine which ISO standard is most applicable to your organization’s business, industry, and goals (e.g., ISO 9001 for quality, ISO 14001 for environment).
Conduct a Gap Analysis
Assess your current processes, systems, and documentation against the requirements of the chosen ISO standard. This helps identify “gaps” that need to be addressed.
Develop and Implement the Management System
Based on the gap analysis, design and implement the necessary changes to your organization’s processes, policies, and procedures to align with the ISO standard’s requirements. This often involves:
- Documenting procedures and work instructions.
- Defining roles and responsibilities.
- Establishing performance metrics.
- Conducting employee training.
Internal Audit
Once the management system is implemented, conduct an internal audit to verify its effectiveness and identify any non-conformities before the external audit.
Management Review
Top management reviews the results of the internal audits, performance data, and other relevant information to ensure the system’s suitability and effectiveness.
Select an Accredited Certification Body
Choose an independent, third-party certification body (registrar) that is accredited by a recognized accreditation body (e.g., NABCB in India, IAF internationally) to perform the audit.
Certification Audit (Stage 1 & Stage 2)
- Stage 1 Audit (Document Review/Readiness Audit): The auditor reviews your documented management system to confirm it meets the standard’s requirements and assesses your readiness for the full audit.
- Stage 2 Audit (On-site Audit): The auditor conducts an on-site assessment to verify that your implemented management system is effectively operating in practice as per the standard’s requirements.
Address Non-Conformities
If any non-conformities are identified during the audit, you will need to take corrective actions to resolve them.
Receive ISO Certification
Upon successful completion of the audit and resolution of any non-conformities, the certification body will issue the ISO certificate.
Surveillance Audits
To maintain certification, the certification body will conduct periodic surveillance audits (typically annually) to ensure continued compliance and improvement. The certification is typically valid for three years, after which a re-certification audit is required.
Cost of ISO Certification in India
The cost of ISO certification in India is not fixed and varies significantly based on several factors:
Type of ISO Standard
Some standards (e.g., ISO 9001) might be less expensive than more specialized ones (e.g., ISO 22000 for food safety).
Size of the Organization
Larger organizations with more employees, departments, and complex processes will generally incur higher costs due to more audit days required.
Nature of Business/Industry
Industries with higher risks or more stringent regulatory requirements might have higher costs.
Complexity of Processes
Organizations with highly complex and interlinked processes may require more extensive auditing.
Number of Shifts
If an organization operates in multiple shifts, the audit scope might expand.
Level of Preparation
If your organization’s current systems are already close to ISO requirements, the cost of consultation and implementation might be lower.
Choice of Certification Body
Different accredited certification bodies may have different fee structures.
Consultant Fees (Optional)
Many organizations hire ISO consultants to help them prepare and implement the management system. These fees are separate from the certification body’s fees.
Travel and Accommodation
If the auditor needs to travel to your location, these costs may be borne by the client.
General Range (for initial certification, excluding major pre-implementation costs and depending on factors):
- For a small organization (e.g., 5-15 employees) seeking ISO 9001, the cost could range from ₹15,000 to ₹50,000 (this might include basic certification body fees, but excludes significant consultation fees).
- For medium to large organizations, or for more complex standards, the cost can range from ₹50,000 to several lakhs of rupees, factoring in audit fees, consultant fees, and internal resource allocation for implementation.
Given the complexities involved, especially in proceedings, it is highly advisable to consult with our experienced iso experts. They can guide you through the process, ensure compliance, and maximize the chances of successful registration.