Fundamentals of Conformity Assessment — Establishment and Implementation of Product Certification System, Management System Certification System, and Service Certification System

Product Certification System

Formulation of Product Certification System

The product certification system includes the rules, procedures, and management for implementing third-party product conformity assessment. The mandatory product certification (CCC certification) implemented in China has formulated a targeted product certification system in the form of "XXXX Product Certification Implementation Rules."

Establishment of Product Certification Scheme

A product certification scheme refers to the arrangement of the certification process and technical methods under the product certification system for specific product categories. These specific products may belong to a group of particular types with very similar characteristics, so the same set of rules and procedures can be applied under the same management to determine conformity with the same set of specified requirements.

The establishment of the scheme should be based on risk management thinking, considering the risks caused by nonconformities in the product quality management system, focusing on the possibility of products, services, etc., not meeting specified requirements, and also evaluating the relationship between these risks and certification costs (such as certification fees). Through specific certification schemes, products can be accepted by the market, major product nonconformities can be avoided, and the benefits should outweigh the direct and indirect costs of product certification, thereby promoting the healthy development of the product certification system.

Implementation of Product Certification Scheme

The implementation of the product certification scheme includes several functional stages: selection, determination, review and verification, and supervision.

The selection stage is to determine what requirements and methods to adopt, what information to select to carry out product evaluation, and how to determine the scope and objects of evaluation from the applied products.

The determination stage mainly refers to the further verification and confirmation by the certification body of relevant matters during the review of certification applications, testing and evaluation of product characteristics, quality process audits of production processes, evaluation of test or assessment reports, certification decisions, expansion of certification scope, and subsequent supervision of certification.

The review and verification stage runs throughout the entire certification process. Review evaluation activities exist during the review of certification applications, testing and evaluation of product characteristics, quality process audits of production processes, evaluation of test or assessment reports, certification decisions, expansion of certification scope, and subsequent supervision of certification.

The role of the supervision stage is to ensure that certified products continue to meet relevant requirements after certification.

Management System Certification System

Establishment of Management System Certification Scheme

Certification bodies need to develop management system audit schemes for specific specialties or organizations related to management system certification and are responsible for the design, application, management, and maintenance of the schemes. Certification bodies can operate management system audit schemes developed by other organizations (such as regulatory agencies, industry associations) through contracts or other formal agreements with the scheme developers. When two or more certification bodies jointly certify the same certified organization, multiple certification bodies can jointly establish an audit scheme and effectively execute the scheme through effective communication and collaboration.
 

Implementation of Management System Certification Scheme

The implementation of management system certification also involves the application of conformity assessment techniques such as selection, determination, review and verification, and supervision in certification activities. The audit scheme arranges activities of selection, determination, review and verification, and supervision at various audit stages for specific objects (specialties, organizations).

The selection in management system certification is to select specific audit objectives to evaluate the management system during the acceptance of certification applications and audit scheme planning.

The determination in management system certification is to determine the competency requirements for auditors meeting specific audit requirements, the specific audit workload (auditor days), audit methods, ways to obtain audit evidence, key audit processes, and important influencing factors during the application acceptance and audit scheme planning process.

Service Certification System

Service certification is the relevant third-party proof provided by applying conformity assessment techniques to whether the service and management of service providers meet related requirements.

With the increasing importance of the service industry in the national economy and the continuous development of new fields, new formats, and new models of the service industry supported by information technology, new and higher requirements have been put forward for service quality assurance, service standard development, and service performance evaluation. Service certification has emerged accordingly and has made significant progress in recent years.
 

Basic Requirements of Service Certification System

The service certification system or model provides technical means and services for applying conformity assessment functional methods to determine service characteristics and functions during the service certification process.

A service certification scheme is a description of the certification activities and arrangements planned for carrying out service certification or a special description of certification activities and arrangements planned for specific service certification.
 

Basic Requirements of Service Certification Scheme

Certification bodies should follow the conformity assessment functional methods given in GB/T27000 and the requirements of ISO/IEC17065 "Conformity assessment — Requirements for bodies certifying products, processes and services" to plan service certification schemes, including but not limited to:

Defining the scope of certification;

Determining certification criteria;

Determining applicable laws, regulations, and other requirements;

Determining the number of auditor days, professional competency requirements and allocation, as well as planning the formation of the certification inspection team; and planning and selecting the certification system, mainly including:

Selection planning;

Determination planning;

Review planning;

Supervision planning.

Planning and issuance of certification documents and markings (such as marks, logos, certificates).

Certification bodies should carry out determination activities for the services to be certified according to the provisions of the service certification scheme.