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ISO/IEC 17065 is the international standard titled “Conformity assessment: Requirements for bodies certifying products, processes and services”. The current edition is ISO/IEC 17065:2012. It defines how a certification body has to be organised and operated so that its certificates are impartial, consistent and reliable. With CE Danışmanı (CE Consultant) you prepare for ISO/IEC 17065 accreditation through a single point of contact for the whole process.
Who the standard is for
The standard is for bodies that evaluate whether a product, process or service conforms to specified requirements and issue a certificate for it. Such bodies work in many sectors, for example:
- Electrical appliances
- Construction products
- Food products
- Medical devices
- Toys
- Automotive parts
Bodies that certify management systems are covered by ISO/IEC 17021-1, inspection bodies by ISO/IEC 17020 and laboratories by ISO/IEC 17025.
What the standard requires
| Requirement | Content |
|---|---|
| Independence and impartiality | Certification activities are carried out impartially. Conflicts of interest are identified and removed. |
| Personnel competence | Enough personnel with the training, experience and expertise for the product areas in the scope. |
| Certification process | Defined procedures for application, evaluation, review, the certification decision and surveillance. |
| Management of the body | A management system that keeps the certification process under control. |
| Documentation and records | Records of all certification activities, so that each decision can be traced. |
| Continual improvement | The process is reviewed regularly to increase its effectiveness and reduce the risk of error. |
Why product certification bodies seek accreditation
- Confidence. Accreditation shows clients and other interested parties that the body works impartially and independently.
- International standards. The body’s procedures are evaluated against internationally accepted requirements.
- Demonstrated consistency. The same rules are applied to every client and every certificate.
- Market position. Clients and regulators give more weight to certificates issued under accreditation.
This also matters to manufacturers. In product schemes such as CE marking, certificates carry weight when the body behind them has demonstrated its competence. See conformity assessment.
Who grants the accreditation?
A product certification body is accredited by a national accreditation body. In Turkey that body is TÜRKAK. For the background see what accreditation is.
The process
- Preparation and evaluation. The current operation and management system are compared with the standard, and gaps and areas for improvement are identified.
- Training and awareness. Personnel learn the requirements and their role in meeting them.
- Application to the accreditation body, which reviews the application and the documentation.
- Assessment. The accreditation body assesses the management system and the certification activities.
- Corrective actions. Findings from the assessment are closed.
- Accreditation. The accreditation is granted for the defined scope and is followed by periodic assessments.
How CE Danışmanı helps
- Training for top management and a general work plan for the project
- Training for personnel so that they work within the system
- Internal auditor training
- Preparation and review of the body’s documents and supporting documents
- Defining the duties, authorities and responsibilities of each member of staff
- Internal audits before the accreditation assessment
- Guidance on follow-up actions and on the strategy of the working team
- Support during the TÜRKAK accreditation process
Tell us about your company and we will reply with our offer as soon as possible.
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