Standards and Certification: Identifying Certifiable & Non-Certifiable Standards

In today's globalized and highly competitive world, standards play a crucial role in ensuring quality, safety, efficiency, and interoperability across industries. From manufacturing to IT services, healthcare, and environmental management, standards provide a structured framework that helps businesses, governments, and consumers trust products, services, and systems. Standards form the backbone of quality, safety, and regulatory compliance across industries. Some are mandated by regulatory authorities and must be followed to ensure legal compliance, while others are voluntary but widely adopted for business excellence. Understanding which standards require certification and which serve as best practice guidelines is essential for businesses, manufacturers, and service providers. Standards are developed by international organizations (ISO, IEC), national regulatory bodies (FDA, BIS, CDSCO), and industry groups.

This article explores the importance of standards, their applicability, and how to differentiate between certifiable and non-certifiable standards.

Ask Whether Your Standard is Certifiable or Not? Or Any Enquiry

Standard Number: Standard Title: Your Name:

What Are Standards?

A standard is a set of agreed-upon guidelines, specifications, or best practices developed by recognized bodies to ensure consistency, safety, quality, and efficiency. Standards can be international, national, or industry-specific, and they are used to regulate processes, materials, services, and products.

Types of Standards

Standards can be classified into different categories based on their purpose and applicability:

• Product Standards – Define requirements for physical goods (e.g.,  IEC 60601-1-25, IEC 60601-1-45).
• Process Standards – Focus on production and operational processes (e.g., ISO 14937, ISO 15001).
• Service Standards – Ensure quality in service delivery (e.g., ISO 20000 for IT service management, ).
• Management System Standards – Provide a framework for business operations and compliance (e.g., ISO 13485 for medical devices, ISO 9001 for quality management systems, ISO 14001 for environmental management).

Certifiable vs. Non-Certifiable Standards

Not all standards require certification. Understanding the difference helps businesses determine which standards they need to comply with.

Certifiable Standards

These are standards for which organizations can obtain official certification through third-party audits. Certification proves compliance and builds credibility. These are legally required standards enforced by governments or regulatory bodies. Non-compliance may result in legal penalties, product recalls, or restricted market access.

Examples of Certifiable Standards:

• ISO 9001 (Quality Management System)
• ISO 14001 (Environmental Management System)
• ISO 27001 (Information Security Management System)
• ISO 45001 (Occupational Health and Safety)

To obtain certification, organizations must undergo an audit by an accredited certification body.

• ISO 13485 – Mandatory for medical devices in many countries (e.g., EU MDR, India’s CDSCO).
• IEC 60601-1 – Required for electrical safety of medical devices.
• Good Manufacturing Practices (GMP) – Enforced by FDA, WHO, CDSCO for pharmaceuticals and medical devices.
• 21 CFR Part 820 (QSR) – U.S. FDA-mandated quality system regulations for medical devices.
• IS 15885 / IS 16102 – Mandatory for LED lighting products in India under BIS certification.

Implementation: Companies must undergo regulatory audits, submit technical documentation, and receive official approval from relevant authorities.

 Non-Certifiable Standards

These standards serve as guidelines or best practices but do not have a formal certification process. Organizations can adopt them voluntarily to improve operations. These are not legally required but widely adopted to demonstrate quality, efficiency, and competitiveness. They can be certifiable (allowing third-party certification) or non-certifiable (guidelines for best practices).

Examples of Non-Certifiable Standards:

• ISO 26000 (Social Responsibility)
• ISO 31000 (Risk Management)
• ISO 19011 (Guidelines for Auditing Management Systems)

Though non-certifiable, these standards are widely used to improve governance, risk management, and corporate responsibility. The standards which are meant for the adoption or enhancement of the process are majorly non-certifiable. Any standard which sets specification of any product is non certifiable until unless mandated by the Regulatory or Government Authority to be verified by the Laboratory established under any rules.

 

Which Standards Are Certifiable by Accredited Bodies?

Accreditation bodies certify testing and certification bodies only for specific types of standards, not all standards. The certifiability of a standard depends on whether it meets the criteria for third-party conformity assessment and aligns with recognized accreditation schemes.

Management System Standards (Certifiable)

Accreditation bodies grant certification for Management System Standards that require organizations to establish, implement, and maintain structured processes.

 Examples of Certifiable Management System Standards:

• ISO 9001 – Quality Management System (QMS)
• ISO 13485 – Medical Devices Quality Management System (MD QMS)
• ISO 14001 – Environmental Management System (EMS)
• ISO 45001 – Occupational Health & Safety (OHS)
• ISO 22000 – Food Safety Management System (FSMS)
• ISO 27001 – Information Security Management System (ISMS)

Non-Certifiable Management Guidelines:

• ISO 26000 – Social Responsibility (guidance only, no certification)
• ISO 31000 – Risk Management (framework, no certification)

Product Certification Standards (Certifiable)

Accreditation bodies certify products based on conformance to safety, performance, and quality requirements set by product-specific standards.

Examples of Certifiable Product Standards:

• IEC 60601-1 – Electrical Safety of Medical Devices
• BIS IS 15885 – LED Lighting Products (Bureau of Indian Standards)

Non-Certifiable Product Guidelines:

• ISO/TR 24971 – Risk Management Guidance for Medical Devices (support document, not certifiable)
• ISO 14971 – Medical Device Risk Management (linked to certification via ISO 13485)

Testing & Calibration Standards (Certifiable for Labs)

Laboratories conducting product testing or calibration must comply with accreditation schemes under ISO/IEC 17025 or related standards.

Examples of Certifiable Testing & Calibration Standards:

• ISO/IEC 17025 – General requirements for testing and calibration labs
• ISO 15189 – Medical Laboratory Accreditation (for clinical laboratories)

Non-Certifiable Testing Guidelines:

• ISO/IEC Guide 98-3 (GUM) – Guide to the Expression of Uncertainty in Measurement (used for guidance, not certification)

Inspection & Certification Body Accreditation (Certifiable)

Accreditation is granted to certification and inspection bodies under specific ISO standards.

Examples of Certifiable Standards for Certification/Inspection Bodies:

• ISO/IEC 17021-1 – Accreditation of management system certification bodies
• ISO/IEC 17065 – Accreditation of product certification bodies
• ISO/IEC 17020 – Accreditation of inspection bodies

Are There Guidelines for Inclusion of Standards for Accreditation?

Yes! Not all standards qualify for certifiable accreditation schemes. The accreditation body follows international guidelines to determine which standards can be included:

Must Require a Conformity Assessment

• The standard must include objective, measurable criteria that can be assessed and certified by a third party.
• Example: ISO 9001 has defined clauses and requirements that auditors can evaluate, making it certifiable.

Must Be Recognized by Accreditation Bodies

• Accreditation bodies follow frameworks like IAF (International Accreditation Forum) and ILAC (International Laboratory Accreditation Cooperation) to decide which standards qualify for certification.
• Example: ISO 45001 is part of IAF’s recognized schemes, so accredited certification is possible.

Cannot Be Purely a Guideline or Best Practice Framework

• Some standards, like ISO 26000 (Social Responsibility) and ISO 31000 (Risk Management), provide guidance but lack certification mechanisms.
• These are used for self-implementation rather than third-party certification.

Regional Regulations May Mandate Certain Certifications

• Some product safety and environmental standards become certifiable only if a country’s regulatory framework requires compliance.
• Example: CE Marking (Medical Devices, IVDs, Electronics, etc.) requires conformity to specific harmonized standards for certification.

Standards are essential for ensuring quality, safety, efficiency, and market competitiveness. Whether certifiable or non-certifiable, they help organizations improve processes, comply with regulations, and gain customer trust. Identifying and implementing the right standards can drive long-term success and sustainability.

By understanding their applicability, businesses can make informed decisions on adopting and certifying standards to enhance their operations and credibility.

Not all standards are certifiable — only those that meet conformity assessment requirements and are recognized under accreditation schemes. Accreditation bodies certify management systems, products, testing laboratories, and inspection bodies based on internationally accepted criteria. However, best-practice guidelines and advisory standards cannot be certified.