Conformity Assessment

The process of conformity assessment demonstrates whether a product, service, process, claim, system or person meets the relevant requirements. Such requirements are stated in standards, regulations, contracts, programmes, or other normative documents.

The most common process for conformity assessment includes but not limited to the following:

• Certification 
  
• Testing
  
• Inspection
  

1. Certification

Certification to management system standards is NOT a requirement. You can benefit from implementing the management system standards without being certified to them.

Certification is also known as third-party conformity assessment. ISO does NOT provide certification or conformity assessment. You’ll need to contact an external certification body for that.

Certification is the provision by an independent body of written assurance (a certificate) that the product, process, service, or system in question meets specific requirements. 

Certification can be a useful tool to add credibility, by demonstrating that your product or service meets the expectations of your customers. For some industries, certification is a legal or contractual requirement.

1.1 ISO does not perform certification

At ISO, we develop International Standards, such as ISO 9001 and ISO/IEC 27001, but we are NOT involved in their certification process, and do NOT issue certificates. This is performed by external certification bodies, thus a company or organization cannot be certified by ISO.

1.2 Choosing a certification body

When choosing a certification body, you should:

• Evaluate several certification bodies. Read more about how to find a certification body.
  

• Check if the certification body uses the relevant standards.
  

• Check if it is accredited. 

Accreditation provides independent confirmation of competence. Accreditation is not compulsory, and non-accreditation does not necessarily mean the certification body is not reputable. To find an accredited certification body, contact the national accreditation body in your country or visit International Accreditation Forum (IAF) CertSearch.

1.3 Displaying your certificate

Remember, when labelling a product or system as certified to an ISO standard:

Don't say: "ISO certified" or "ISO certification"

DO say: "ISO 9001:2015 certified" or "ISO 9001:2015 certification" (for example).

1.4 Certification process

The following diagram demonstrate the typical process flow for audit and certification process according to ISO/IEC 17021-1. 

Reference: 

[1] ISO/IEC 17000, Conformity assessment - Vocabulary

[2] ISO/IEC 17021-1, Conformity assessment — Requirements for bodies providing audit and certification of management systems — Part 1: Requirements

[3] ISO 19011, Guidelines for auditing management systems

2. Testing

Testing helps determine one or more characteristics of an object or product. The process is usually performed by a laboratory. For example, blood tests rely on the analysis of a number of characteristics such as the presence of a disease or genetic disorder. 

Reference: 

[4] ISO/IEC 17025 - General requirements for the competence of testing and calibration laboratories

3. Inspection

Inspection is the regular checking of a product to make sure it meets specified criteria. For example, fire extinguishers need regular inspections to ensure they are safe to use. 

4. Mutual Recognition

A Mutual Recognition Agreement or Arrangement (MRA) increases confidence in conformity assessment between countries as it formally recognizes the results of each other’s testing, inspection, certification or accreditation. Read more about MRAs in : ISO/IEC Guide 68.

5. International organizations in cooperation with ISO for accreditation

The International Accreditation Forum (IAF) is the world association of Conformity Assessment Accreditation Bodies and other bodies interested in conformity assessment in the fields of management systems, products, services, personnel and other similar programmes of conformity assessment.

The International Laboratory Accreditation Cooperation (ILAC) is the international organization for accreditation bodies operating in accordance with ISO/IEC 17011 and involved in the accreditation of conformity assessment bodies including:  

• calibration laboratories (using ISO/IEC 17025), 
• testing laboratories (using ISO/IEC 17025), 
• medical testing laboratories (using ISO 15189), 
• inspection bodies (using ISO/IEC 17020) and 
• proficiency testing providers (using ISO/IEC 17043).

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