In product certification, conformity assessment activities are used to demonstrate whether an object (which can be material, installation, process, system, person, body or product is fulfilling specified requirements.
Product
Product — The result of a process. There are four generic product categories are noted in ISO9000:2005 defined, namely service (e.g. transport), software (e.g. computer program, dictionary), hardware (e.g. engine, mechanical part) and processed materials (e.g. lubricant). Many products comprise elements belonging to different generic product categories. Whether the product is then called service, software, hardware or processed materials depends on the dominant elements (ISO/IEC 17000:2004, clause 3.3).
The three major activities used for conformity assessment are defined below:
-
Testing
Testing is the determination of one or more characteristics of an object of conformity assessment, according to a procedure. Testing can be applied to materials, products or processes.
Example: Determining the total lead content in a plastic toy material according to the test method CPSC-CH-E1002-08.1 (you are not required to know the details of this test method), to see whether the material fulfills the lead content requirement of the US Consumer Product Safety Improvement Act (CPSIA).
-
Inspection
Inspection is the examination of a product design, product, process or installation and determination of its conformity with specific requirements, or, on the basis of professional judgement, with general requirements.
Example: Examining the net weights of shampoo liquid in bottles (i.e. total weight – weight of bottle) from the same production batch to see whether they all contain 700 ml ± 20 ml of shampoo.
-
Certification
Certification is the issuance of a conformance statement by a third party (usually a certification body) that a product, process, system or person has demonstrated the fulfillment of specified requirements.
Example: An independent certification body conducted an audit on Company A and has concluded that the quality management system (QMS) of Company A fulfilled the requirements of ISO 9001.
Conformity assessment activities like testing and inspection can be conducted by first, second or third parties in a certification process. It is important to note that certification can only be conducted by a third party.
First party in a certification process
First party conformity assessment activities are performed by the person or organization that provides the object (i.e. object manufacturer or supplier). A typical example for first party conformity assessment activity is an internal quality control laboratory in a manufacturing plant which tests the product samples to see whether they pass the manufacturing specifications.
Second party in a certification process
Second party may refer to a person or organization which would like to purchase or use the object, or as a customer or the representative of a customer who shows interest in the object. Examples such as buyer's inspection audit to a manufacturer or colour test to an applicant's eyes during an employment interview are second party conformity assessment activities.
Third party in a certification process
Third party conformity assessment activities are performed by a person or body that is independent from either first or second parties. An independent laboratory which is owned by neither the toy manufacturer nor the buyer, conducting heavy metal testing for a sample produced by the toy manufacturer, can be classified as third party conformity assessment activity.
Table 1.1 provides an overview of different conformity assessment activities.
| Conformity assessment system or scheme | Management system | Party performing conformity assessment | Surveillance (when needed) | Result | ||
|---|---|---|---|---|---|---|
| First party | Second party | Third party | ||||
| Certification of products | ISO/IEC Guide 65 | × | × | o | o | Certificate |
| Certification of management systems | ISO/IEC 17021 | × | × | o | o | Certificate |
| Certification of persons | ISO/IEC 17024 | × | × | o | o | Certificate |
| Inspection | ISO/IEC 17020 | o | o | o | × | Report |
| Testing (for non-medical laboratory) | ISO/IEC 17025 | o | o | o | × | Report |
Can you identify any more examples of first, second, and third party conformity assessment activities?
Having discussed the conformity assessment activities, let's take a closer look at the quality management system (QMS) certification — which is the core of many product certification and laboratory accreditation practices.
- 3809 reads
