ISO/IEC 17065 Conformity Assessment: Requirements for Certification Bodies Certifying Products, Processes & Services
ISO (International Organization for Standardization) and IEC (International Electrotechnical Commission) make up the global specialized standardization system.
Along with their expert technical and conformity assessment committee (CASCO), the organization develops international standards and guides that benefit both the organization under compliance and its customers.
One of its widely-adopted accreditations is ISO/IEC 17065:2012.
The ISO 17065 certification ensures the competence of an accreditation body in providing certification for the quality of products, processes, and services.
What products, processes, and services do the accreditation refer to?
- Product: Includes a process result, such as software, hardware, or any service or processed materials.
- Service: An intangible result of at least one activity conducted in conjunction with a supplier and a customer.
- Process: Includes linked or interrelated activities that transform inputs into outputs. For example, manufacturing processes, welding engineering processes, and food production processes.
ISO/IEC 17065 accreditation builds trust and confidence among all interested parties in the quality of the product and its compliance with all regulatory standards. The certification is useful for different parties and organizations, including:
- Certification bodies’ clients
- Government authorities
- Customers of the organization being accredited
- Consumers and other public members
- Non-government organizations
In this article, we’ll review the ISO 17065 certification program and the steps to the accreditation process.
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Benefits of ISO 17065 Accreditation
ISO/IEC 17065 accreditation provides benefits to both the accredited organization and its customers. Some practical advantages of the certification include:
- The certification operation improves the efficiency, effectiveness, and productivity of the organization being accredited.
- It informs accreditation providers about their competence in performing compliance and issuing certificates.
- An increase in confidence in the certification body and the competency of the auditors responsible for certifying management systems.
- Its guidelines improve data analysis and record-keeping skills.
- Provides a competitive edge to the company by increasing its customers’ trust and confidence in the certification.
- It builds the reputation of the certification bodies and provides recognition and credibility in the global market.
- The accredited organization gains a distinct competitive advantage over its competitors.
ISO/IEC 17065 Accreditation Process
The ISO 17065 accreditation program provides standards for all conformity assessment activities, including accreditation bodies that certify services, products, and processes.
All the scheme owners or stakeholders, including regulatory authorities, industry associations, and conformity assessment bodies, must undergo a multi-step accreditation process before earning the certification.
Requirements of ISO 17065 Accreditation
- General Requirements: Includes legal and contractual matters, certification agreements, use of license and certificates, remarks of impartiality, non-discriminatory conditions, and confidentiality agreements.
- Structural Requirements: Here, organizations are required to provide information on the authorities and responsibilities of their personnel in different areas. Further, it also contains policies and principles to safeguard impartiality in certification activities.
- Resources Requirements: Requires organizations to provide information on the certification body personnel and their responsibilities and tasks during the accreditation processes.
Moreover, a certification body is required to meet all the requirements of applicable international standards, as mentioned by the certification scheme, while performing evaluation activities using internal or external resources.
The organizations shall follow the reference material/document of the following standards for the implementation of the compliance (wherever required or as notified by certification scheme owner):
- ISO/IEC 17025 for testing and calibration
- ISO/IEC 17020 for inspection
- ISO/IEC 17021 for auditing of the quality management system (QMS) or system certification
- Process Requirements: Includes requirements on certification schemes of the certification body, application requirements, review processes, evaluation, certification decision and documentation, surveillance, and complaints and appeals.
- Management System Requirements: Contains information on tasks required to maintain a quality management system (QMS) in the organization. It has requirements for management system documentation, control of documents and records, management review, and corrective and preventive actions.
Steps to ISO/IEC 17065 Accreditation
To earn an ISO 17065 accreditation, you need to go through the following steps:
- Fill In The Application Form: The organization seeking ISO 17065 accreditation should fill in an application form and pay the fees associated with it.
- Some essential documents and information needed for the accreditation process are:
- Application form for accreditation of certification bodies for systems and products
- Accreditation general requirements
- Accreditation requirements for multi-site conformity assessment bodies
- Usage requirements for accreditation symbol
- Perform Internal Audit: The organizations are required to perform an internal audit before applying for the on-site visit of the accreditation officers. Their expert team and staff should check for any non-conformities in their quality management system and correct any that are identified before official assessors arrive.
- On-site Visit of the Accreditation Officers: Assessors perform the assessment during the on-site visits to verify the applicant organization’s consistency, competence, and impartiality in operating its certification system in accordance with ISO/IEC 17065. Their activities during the assessment include:
- Document and file review
- Assessment of regional, central, and all other offices
- Performance review and proficiency testing
- Measurement and validation audits
- Witness tests, assessments, or examinations conducted by the applicant body
During the assessment process, the accreditation assessors consider the risks associated with the activities, locations, and personnel that will be assessed.
- Non-Conformities and Corrective Actions: After the visit, assessors create a report based on their on-site assessment and mention if all the standards are implemented correctly.
The report highlights the non-conformities (if any) in implementing the standards in the organization’s quality management system.
The organizations are required to take corrective actions towards all the major and minor non-conformities, which are later checked by the accreditation officers once again.
- Awarding ISO 17065 Accreditation Certification: The accreditation certification is granted to the organization if all standards are met and there are no remaining non-conformities and corrective actions.
Excedr Supports Labs Seeking Accreditations
ISO/IEC 17065 was developed by the CASCO committee that controls all conformity assessment activities. The standard guides accreditation bodies for certification of products, services, and processes with full competence, consistency, transparency, and zero impartiality.
In addition to demonstrating the competency of the accreditation bodies, the standard builds trust in consumers that the products and services fulfill all the specified scheme requirements.
Laboratory accreditation is a cumbersome process and requires complete focus and management of finance and the team to meet compliance standards.
Excedr’s custom and flexible lease program helps in the process of accreditation by providing labs with cutting-edge and high-throughput equipment that helps produce reliable, validated, and consistent results. Labs of all sizes can lease the right instrumentation, including clinical, imaging, and analytical equipment, for their lab without having to pay for expensive upfront payments.
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