Conformity assessment—General requirements for accreditatioin bodies accrediting conformity assessment bodies
Some standard content:
ICS 03. 120.20
National Standard of the People's Republic of China
GB/T 27011—2005/IS0/IEC 17011:2004Abolishes GH/F154861995
Conformity assessment
General requirements for accreditation bodies
Conformity assessment-General reguirements for accreditation bodies accrediting conformity assessment bodies(S0/IFC 17011:2004, 1D)T)
2005-06-02 Issued
General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China Standardization Administration of China
2005-12-01 Implementation
GB/T27011—2005/ISO/IEC17011:2004 This standard is equivalent to ISO/IEC17011:2004 Conformity assessment - General requirements for accreditation bodies. The first edition of ISO/IEC 17011 cancels and replaces ISO)/IEC: Guide 68 "General requirements for the operation and recognition of accreditation systems for calibration and test laboratories", ISO/IEC Guide 61 "General requirements for accreditation bodies of certification bodies" and ISO/IEC Technical Report 17010 "General requirements for accreditation bodies of inspection bodies". From the date of implementation of this standard, GB/T15486--1995 will be abolished. This standard was proposed and coordinated by the National Technical Committee for Certification and Accreditation (SAC/TC261). Drafting units of this standard: National Certification and Accreditation Administration Committee, China National Accreditation Service for Conformity Assessment The main drafters of this standard: Bo Kenmin, Zhao Qinbo, Song Guilan, Li Yan, Zhang Mingmian, Fei Yang, Tu Lantai, Xie. GB/T27011—2005/ISO/IEC17011:2004ISO/IEC Foreword
The International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC) build a professional system for global standardization. The national member bodies of ISO or IEC participate in the formulation of international standards through the technical committees established by ISO or IEC for specific technical fields. The technical committees of ISO and IEC cooperate in areas of common interest. Other governmental and non-governmental international organizations that maintain contact with ISO and IEC also participate in the work. In the field of conformity assessment, the ISO Conformity Assessment Committee (CASC) is responsible for the formulation of international standards and guidelines.
The main task of the technical committee is to develop international standards according to the rules of ISO/IEC Part 2. The draft international standard adopted by the technical committee is submitted to the member bodies for voting. The draft international standard needs to be approved by at least 75% of the member bodies participating in the voting before it can be published as an international standard. Some of the contents of this standard may involve patent rights, which should be noted. ISO) shall not be responsible for identifying any such patent rights. ISO/IEC.1701) was prepared by the ISO Committee on Conformity Assessment (CASCO). The first edition of ISO)/IEC17011 cancels and replaces ISO/IEC: Guide 58, ISO/IFC. Guide 61 and ISO/IFC Technical Report 17010. Since many accreditation bodies have to follow the requirements of these two documents of the same nature and slightly different contents in very similar activities, they requested such a revision. Introduction
GB/T 27011-2005/ISO/IEC 17011:2004 In the mandatory field, the government adopts laws and regulations to approve products (including services) to ensure safety and health, protect the environment, prevent fraud and maintain market fairness. In the voluntary field, many industries have established a system of conformity assessment and approval in their economies and even around the world in order to achieve the most basic technical level, achieve comparability and ensure fair competition. A prerequisite for fair trade is that any product (including service) should be able to circulate in other economies as long as it is formally accepted in a certain economy without having to undergo a large number of repeated tests, inspections and certifications. Whether the product (including service) is fully or partially within the scope of the mandatory field, it should be the same. When the public society often needs products An objective statement of conformity of a product (including services) with specified requirements. Qualification assessment is the ability of a body to objectively make such a statement of conformity. The conformity assessment activities performed by a conformity assessment body include certification, inspection and testing, and in this standard also calibration. It is important for purchasers, regulatory authorities or bodies and the public to know that the conformity assessment body is competent to perform its work. Therefore, the need for impartial verification of the competence of conformity assessment bodies is increasing. This verification is made by an authoritative accreditation body (see Figure 1). Accreditation bodies are required to remain impartial in their relationship with conformity assessment bodies and their clients, and usually operate in a non-profit-sharing manner. Accreditation body
Audit competence
Conformity assessment body
Review of conformity||tt| |(but including services)
The accreditation body evaluates the capabilities of a conformity assessment body or a conformity assessment body, and can effectively promote the development of a better understanding of the relevant issues by promoting the recognition of the results of the accredited conformity assessment bodies. This promotion effect will be enhanced if the accreditation process has passed peer review and becomes a member of the relevant recognition agreement between accredited conformity assessment bodies.
Conformity assessment bodies evaluate the conformity of products, services and suppliers to specifications and/or requirements. Purchasers purchase products (including services) that conform to the specifications, or purchase suppliers that meet specific requirements. The regulatory department or agency sets the requirements for products and suppliers. Note: The term "supplier" refers to the provider of products [including services). Figure 1 Flowchart
Implementation of conformity assessment services by conformity assessment bodies The accreditation system should provide confidence to purchasers and regulatory authorities or bodies. As expected by trade regulators and trade organizations, this system should facilitate cross-border trade and ultimately achieve the goal of "one-stop" accreditation and "one-stop" conformity assessment. If both accreditation bodies and conformity assessment bodies operate in an equivalent manner according to globally recognized requirements and take into account the interests of all relevant parties, the system that promotes cross-border trade can work well. This standard specifies the general requirements for accreditation bodies. The established regional and international peer review mechanisms provide assurance that accreditation bodies operate in accordance with the standard: accreditation bodies can become members of relevant accreditation agreements after peer review and undergo regular re-evaluations to ensure their continued compliance with this standard.
Members of the mutual recognition agreement promote the realization of the "one-stop" goal by recognizing, promoting and accepting each other's recognized conformity assessment. This means that the conformity assessment bodies in an economy do not have to be recognized multiple times by different recognition bodies for indirect recognition. Scope
Conformity assessment
GB/T27011--2005/IS0/IEC 17011:2004 General requirements for accreditation bodies
This standard specifies the general requirements for accreditation bodies that review and accredit conformity assessment bodies. This standard can be used as a requirement document for peer review processes implemented for the purpose of signing mutual recognition agreements between accreditation bodies. Accreditation bodies operating in accordance with this standard do not have to provide accreditation for all types of conformity assessment bodies. Conformity assessment bodies referred to in this standard are organizations that provide the following conformity assessment services: testing, inspection, management system certification, personnel certification and product certification, and calibration is also included in this standard. Note: The general requirements for these conformity assessment bodies have been specified in various international standards and guidelines (for example, screening references, etc.) 2 Normative references
The provisions of the following documents become provisions of this standard through reference in this standard. For all dated referenced documents, all subsequent amendments (excluding errata) or revisions shall apply. Not applicable to this standard: However, parties to agreements based on this standard are encouraged to investigate whether the latest versions of these documents can be used. For any undated referenced documents, the latest versions apply to this standard. GB/T19000-2000 Quality Management System Fundamentals and Vocabulary (IDT IS09000:2000) IS0/1EC17000:2004 Conformity Assessment---Vocabulary and General Principles V1M:1993 International General Terms of Weights and Measures\3 Terms and Definitions
The following terms and definitions and the terms and definitions specified in ISO/1EC17000 apply to this standard. For terms and definitions not included in this standard and ISO/IFC17000, the terms and definitions of GB/T19000 or the International General Terms of Metrology (VIM) apply to this standard. If there are different definitions for specific metrological terms, the definitions in VIM shall prevail. 3.1
Accreditation & certifica
The formal proof that a conformity assessment body has the ability to carry out specific conformity assessment work. 3.2
Accreditation bodyaccreditatianhody
The authority to carry out accreditation.
Note: The authority of an accreditation body usually comes from the government. 3.3
Accreditation body logoaccreditationbodylogoThe logo used by the accreditation body to identify itself. 3.4
Accreditation certificateaccreditatlencertificateA document or a set of formal documents indicating that the scope of activities determined has been recognized. 3) Issued by the International Bureau of Weights and Measures (RIPM), the International Electrotechnical Commission (IEC), the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC), the International Organization for Standardization (ISO), the International Union of Pure and Applied Chemistry (IUPAC), the International Union of Theoretical and Applied Physics (IUFAP) and the International Organization of Legal Studies (OIMI).
GB/F 270 11--2005/IS0/IEC 17011:20043.5
Accreditation symbol
Accreditation symbol A symbol issued by an accredited assessment body to indicate its accreditation status. Note: "Nark" is a special term for the term 1-indicates the conformity of an entity with a group of requirements. 3.6
Appeal
A request for reconsideration made by a conformity assessment body against an adverse decision made by an accreditation body regarding its accreditation status. Note: A negative decision includes:
--refusal to accept the application;
--refusal to continue the assessment;
request for corrective action;
--change of accreditation scope;
--denial, suspension or withdrawal of accreditation: any measure that prevents the acquisition of accreditation. 3.7
assessmen
The process by which an accreditation body evaluates the competence of a conformity assessment body within the defined scope of accreditation, based on specific standards and/or other normative documents.
Note: The evaluation of the competence of a conformity assessment body is an evaluation of the overall operational competence of the conformity assessment body, including the competence of its personnel, the effectiveness of its assessment methods and the effectiveness of its conformity assessment results. 3.8
Assessor
Assessor
A person assigned by the accreditation body to conduct an assessment of a conformity assessment body, either alone or as a member of an assessment team. 3.9
Complaint
Dissatisfaction with the activities of an accreditation body or an accredited conformity assessment body, expressed to the accreditation body by any organization or individual, as distinct from a complaint, and in the hope of receiving a response.
Conformity Assessment Body (CAB) An organization that provides conformity assessment services and can be the subject of accreditation. NOTE: Unless otherwise specified, "conformity assessment body" in this standard refers to both conformity assessment bodies applying for accreditation and accredited conformity assessment bodies. 3.11 Consultancy Any activity of a conformity assessment body for the purpose of obtaining accreditation. Examples include: - participation in the registration or procedures of a conformity assessment body; - participation in the operation or management of a conformity assessment body system; - provision of specific advice or training on the establishment and implementation of a conformity assessment body's management system and/or the development and application of its capabilities; - provision of specific advice or training on the development and implementation of a conformity assessment body's operating procedures. 3.12 Expert Personnel A person assigned by an accreditation body who provides specialized knowledge and skills for the scope of accreditation being assessed. 3.13 Exlending accreditation The process of expanding the scope of accreditation. Stakeholders involved Partics parties with direct or indirect interests in accreditation, CB/T270F1--2005/IS0/IEC17011:2004 Note: Direct interests refer to the interests of the accredited party. Indirect interests refer to the interests of parties who have a direct or indirect interest in the accredited conformity assessment service. 3.15
Lead Assessor
The assessor who is fully responsible for a specific assessment action. 3.16
Reducing accreditation The process of canceling part of the scope of accreditation.
Scope of accreditation accreditation A specific conformity assessment service for which accreditation is sought or for which accreditation has been granted. 3.18
surveillance
A set of activities, other than re-assessment, to monitor that an accredited conformity assessment body continues to meet the requirements for accreditation. Note: Surveillance includes on-site surveillance assessments and other supervisory activities. Such as: a) communicating with the conformity assessment body on matters related to accreditation; b) reviewing the statements made by the conformity assessment body on the scope of accreditation; c) requesting the conformity assessment body to provide documents and records (such as acceptance reports, internal quality control results used to verify the effectiveness of the services provided by the conformity assessment body, records of complaints, and management review records); d) monitoring the performance of the conformity assessment body (such as the results of proficiency testing). 3.19
suspending accreditation The process of temporarily invalidating part or all of the scope of accreditation: 3.20
withdrawing accreditation accreditation The process of cancelling all accreditation.
witnessing
The observation of a conformity assessment body performing conformity assessment services within the scope of its accreditation. 4 Accreditation body
4.1 Legal responsibilities
The accreditation body shall be a registered legal entity. NOTE: A government accreditation body is considered a legal entity because of its government status. When a government accreditation body is part of a larger government entity, the government is responsible for establishing the accreditation body in a manner that does not create a conflict of interest with the accrediting government conformity assessment body. Such accreditation bodies are considered to be "registered legal entities" in this standard.
4.2 Structure
4.2.1 The structure and operation of the accreditation body should provide confidence in its accreditation. 4.2.2 The accreditation body shall make accreditation decisions including approval, maintenance, extension, reduction, suspension and withdrawal of accreditation.
4.2.3 The accreditation body shall have a statement of its legal status, including the name of the owner, where applicable. If the controller is different from the owner, it shall also be CB/T27011--2005/1S0/IEC 17011:2004 including the name of the controller.
4.2.4 The accreditation body shall document the responsibilities and authorities of the top management and other persons who may have contact with the accreditation body and may affect the quality of accreditation.
4.2.5 The accreditation body shall identify the top management who has overall responsibility for each of the following matters: a) formulation of the accreditation body's operating policy;
b) supervision of the implementation of policies and procedures;
c) supervision of the accreditation body's finances;
d) accreditation decisions;
e) contract arrangements
fWhen necessary, authorize committees or individuals to carry out specified activities on behalf of the top management. 4.2.6 The accreditation body should have a plan to obtain the necessary professional knowledge and skills. To obtain advice on matters directly related to accreditation. Note: The accreditation body can obtain the necessary professional knowledge and skills through one or more consulting committees (temporary or permanent) with clear terms of reference. 4.2.7 For the committees involved in the accreditation process, the accreditation body should have formal rules for their appointment, authority and operation, and should clearly define the participants of the committee.
4.2. 8 The accreditation body shall document its overall structure and indicate the hierarchy and relationships of authority and responsibility. 4.3 Impartiality
4.3.1 The organizational structure and operation of the accreditation body shall ensure the objectivity and impartiality of its activities. 4.3.2 In order to ensure impartiality and to develop and maintain the principles and key policies for the operation of the accreditation system, the accreditation body shall establish and operate a documented organizational structure that provides opportunities for effective participation of interested parties. The accreditation body shall ensure that the representation of interested parties is balanced and that no party is in a dominant position. 4.3.3 The policies and procedures of the accreditation body shall be non-discriminatory and shall be administered in a non-discriminatory manner. In the activities determined by the policies and rules of the accreditation body (see 4.6.1) The services of the accreditation body shall be open to all applicants for accreditation within a defined scope. The accreditation body shall not restrict the services it provides to applicants based on the size of the applicant or its membership of an association or group, nor shall it restrict accreditation based on the number of conformity assessment bodies it has accredited. 4.3.4 All accreditation body personnel and committees that may influence the accreditation process shall perform their duties objectively and shall not be subject to any improper commercial, financial or other influence that may impair impartiality. 4.3.5 The accreditation body shall ensure that each accreditation decision is made by competent personnel or committees who have not participated in the assessment. 4.3.6 The accreditation body shall not provide any services that may affect its impartiality, such as: a) conformity assessment services for conformity assessment bodies; b) consultancy.
The activities of the accreditation body shall not be linked to consultancy activities. The accreditation body shall not make any representation or suggestion that accreditation will be simpler, easier, faster or more economical if certain personnel or consultants are used. 4.3.7 The accreditation body shall ensure that the activities of its related bodies do not compromise the accountability, objectivity and impartiality of accreditation. However, a related body (as opposed to the accreditation body) may undertake consultancy or provide qualified services accredited by the accreditation body if it meets the following requirements: a) has different top management for the activities referred to in 4.2.5; b) has no personnel involved in the accreditation decision process; c) has no authority to influence the accreditation review results; and d) has a distinct name, logo and identity. In the case of stakeholder involvement referred to in 4.3.2, the accreditation body shall identify and analyse and document relationships with related bodies to determine potential conflicts of interest, whether these relationships arise within the accreditation body or from the activities of the related body. When conflicts of interest are identified, the accreditation body shall take appropriate measures. NOTE 1 Related bodies are different legal entities that are linked to the accreditation body referred to in 4.1 by common ownership or contractual arrangements. NOTE 21 Parts of government other than the government accreditation bodies referred to in 4.1 are considered related bodies. 4.4 Confidentiality
GB/T27011—2005/TSO/IFC17011:2004 The accreditation body shall make adequate arrangements to ensure that all levels of the accreditation body, including the committee and external organizations or individuals acting on behalf of the accreditation body, maintain confidentiality of information obtained from accreditation activities. The accreditation body shall not disclose confidential information about the accreditation body to any external parties without the written consent of the accreditation body, unless otherwise required by laws and regulations. 4.5 Responsibility and financial resources
4.5.1 The accreditation body shall make arrangements for the financial responsibility of its activities. 4.5.2 The accreditation body shall have the financial resources necessary to carry out its activities and shall confirm this through records and/or documents. The accreditation body shall have an explanation of its revenue sources.
4.6 Accreditation activities
4.6.1 The accreditation body shall clearly describe the accreditation activities it carries out in accordance with relevant standards, guidelines or other normative documents. 4.6.2 The accreditation body may adopt application documents or guidance documents and/or participate in their formulation: The accreditation body shall ensure that the above documents are formulated by a committee or personnel with the necessary competence and, where appropriate, shall facilitate the participation of relevant parties. If there are international government application documents or guidance documents, they shall be adopted.
4.6.3 The accreditation body shall establish procedures for expanding its activities and responding to stakeholder requests, which may include: a) analysis of existing capabilities, suitability for expansion, resources, etc. for new areas; 1) acquisition and use of external expertise and skills; 2) assessment of the need for applicable documents; 3) initial selection and training of assessors; 4) training of accreditation body staff in new areas. 5 Management
5. 1 General
5.1.1 The accreditation body shall establish, implement and maintain a management system in accordance with the requirements of this International Standard and continually improve the effectiveness of the system. The management system requirements specified in 5.2 to 5.9 take into account the characteristics of the accreditation body. 5.1.2 When this International Standard requires the accreditation body to have or establish procedures, it means that these procedures shall be documented, implemented and maintained and, whenever appropriate, shall be based on established policies.
5.2 Management system
5.2.1 The top management of the accreditation body shall establish and document the policies and objectives for its activities, including the quality policy, and shall provide evidence of its commitment to quality and conformity with this International Standard. The top management of the accreditation body shall ensure that the needs of interested parties are effectively communicated and that the accreditation body's policy is understood, implemented and maintained at all levels of the accreditation body. The objectives of the accreditation body shall be measurable and consistent with the accreditation body's policy. NOTE An accreditation body that has signed a mutual recognition agreement may refer to the obligations under the mutual recognition agreement in its policy. 5.2.2 The accreditation body shall operate a management system appropriate to the type, scope and volume of its work. The accreditation body shall implement all applicable requirements of this International Standard in its manual or associated documents. The accreditation body shall ensure that its personnel have access to the manual and associated documents and shall ensure the effective implementation of system procedures.
5.2.3 The top management of the accreditation body shall designate a member of management, regardless of his or her other responsibilities. He or she shall have the following responsibilities and limitations:
a) Ensure that procedures for the management system are established, 1) Report to top management on the operation of the management system and any need for improvement. 5.3 Document control
The accreditation body shall establish control procedures for all documents (internal and external) related to accreditation activities. These procedures shall specify the control requirements for the following aspects:
) Documents are approved before release to ensure the adequacy and suitability of the documents; GB/T27011--2005/IS0/1EC7011:2004b) Documents are reviewed, updated and re-approved when necessary; ensure that changes and current revision status of documents are identified: l) Ensure that the relevant versions of applicable documents are available to the personnel, subcontractors, assessors and experts of the accreditation body and the qualification assessment body when using them;
e) Ensure that documents remain clear and easy to identify: prevent the unintended use of obsolete documents, such as when obsolete documents are retained for any reason, these documents are appropriately marked g) Ensure that documents are kept confidential when relevant. 5.4 Records
5.4.1 The accreditation body shall establish procedures for the identification, collection, retrieval, archiving, storage, maintenance and disposal of records. 5.4.2 The accreditation body shall establish a record retention procedure, and the record retention period shall comply with the contractual legal obligations. Access to records shall be subject to confidentiality protection.
5.5 Nonconformities and corrective action
The accreditation body shall establish procedures for the identification and management of nonconformities in its operations. Where necessary, the accreditation body shall take action to eliminate the causes of nonconformities to prevent recurrence. Corrective actions shall be commensurate with the impact of the problem identified. The procedures shall include: a) identification of nonconformities (e.g. through complaints and internal audits); b) determination of the causes of nonconformities;
correction of nonconformities;
d) assessment of the need for action to ensure that nonconformities do not recur; e) timely determination and implementation of necessary actions; f) i) recording the results of actions taken; and
review of the effectiveness of corrective actions.
5.6 Preventive action
The accreditation body shall establish procedures for the identification of opportunities for improvement and for the implementation of preventive action to eliminate potential causes of nonconformities. The preventive measures taken shall be appropriate to the impact of the potential problems. The preventive measures procedures shall include the following requirements: a) Identify potential nonconformities and their causes; b) Determine the preventive measures needed for implementation; c) Record the results of the measures taken; d) Review the effectiveness of the preventive measures taken. 5.7 Internal Audit 5.7.1 The accreditation body shall establish an internal audit procedure to verify that the accreditation body complies with the requirements of this International Standard and that the management system is implemented and maintained. Note: GJ3/S: provides guidance on the implementation of internal audits. 5.7.2 Internal audits shall normally be conducted at least once a year. The frequency of internal audits may be reduced if the accreditation body can demonstrate that its management system has been effectively implemented in accordance with this International Standard and has proven stability. The accreditation body shall plan an internal audit programme, taking into account the importance of the processes and areas to be audited and the results of previous audits. 5.7.3 The accreditation body shall ensure that:
a) internal audits are carried out by qualified personnel who have knowledge of accreditation, auditing and standards requirements; b) personnel carrying out internal audits are not involved in the activities being audited; c) the results of the audit are communicated to the responsible personnel of the audited area; d) actions are taken in a timely and appropriate manner; e) any opportunities for improvement are identified.
5.8 Management review
5.8.1 The accreditation body shall establish procedures for reviewing its management system at regular intervals to ensure the continuing adequacy and effectiveness of the management system in meeting the relevant requirements of this standard, including established policies and procedures. Management reviews should normally be carried out at least once a year. GB/T27011--2005/1S0/IEC:17011:20045.8,2 When available, the inputs to the management review shall include the current status and improvement opportunities related to the following aspects: a) results of audits; b) results of interim reviews when relevant; participation in international activities when relevant; feedback from stakeholders: new areas of accreditation; trends in non-conformities; status of preventive and corrective actions; follow-up measures from previous interim reviews; achievement of objectives; changes that may affect the management system; k) Complaints: 1) Analysis of complaints.
5.8.3 The output of the management review shall include measures related to the following aspects: a) Improvement of the management system and its processes; b) Improvement of services and accreditation processes to meet the requirements of relevant standards and the expectations of stakeholders; c) Demand for resources; d) Determination or redefinition of policies and standards. 5.9 Complaints
The pre-accreditation body shall establish a complaint handling procedure. The accreditation body shall: Determine the validity of the complaint:
When applicable, ensure that complaints involving accredited conformity assessment bodies are first handled by the conformity assessment body; take appropriate measures and evaluate their effectiveness: l) Record all complaints and measures taken; Respond to the complainant.
6 Human Resources
6.1 Personnel of the Accreditation Body
6.1.1 The Accreditation Body shall have sufficient competent personnel (internal, external, temporary or permanent, full-time or part-time) who shall have education, training, technical knowledge, skills and experience appropriate to the type, scope and workload of the work they perform.
6.1.2 The Accreditation Body shall have a sufficient number of assessors (including the leader of the assessment team) and experts to carry out all its activities. 6.1.3 The Accreditation Body shall make the responsibilities and authority of all relevant personnel clear. 6.1.4 The Accreditation Body shall require all personnel to formally undertake to abide by the rules established by the Accreditation Body through signature or equivalent form. This commitment shall take into account the following aspects: confidentiality, freedom from commercial interests or other interests, and freedom from current or previous association with the conformity assessment organization to be assessed.
6.2 Personnel involved in the accreditation process
6.2.1 The accreditation body shall specify, for each activity involved in the accreditation process: a) the qualifications, experience and competence of the personnel required; b) the initial and continuing training required; 6.2.2 The accreditation body shall establish a formal procedure for the selection and approval of assessors and experts used in the assessment process. 6.2.3 The accreditation body shall determine the specific scope of competence demonstrated for each assessor and expert. GB/T 27011—2005/IS0/IEC 17011:20046.2.4 The accreditation body shall ensure that assessors (including experts, where applicable) a) are familiar with the accreditation process, accreditation tests and other relevant requirements; b) have received relevant accreditation assessor training; c) are proficient in relevant assessment methods; d) are able to communicate effectively in writing and verbally in the required language; and d) possess appropriate personal qualities.
Note: For information on individual records, please refer to documents such as GB/T 13011. 6.3 Standards
6.3.1 The accreditation body shall ensure that the assessment and accreditation decision process is satisfactory by establishing procedures to monitor the performance and competence of the relevant personnel. In particular, the accreditation body shall evaluate the performance and competence of its personnel in order to determine the need for training. 6.3.2 The accreditation body shall monitor the assessors (e.g. through on-site observation, or by other means, such as reviewing the assessment report, collecting feedback from the conformity assessment body and peer monitoring of the assessors) to evaluate their performance and propose appropriate follow-up improvement measures. The accreditation body shall conduct on-site observations of each assessor regularly, usually once every three years, unless there is sufficient evidence that he or she has continued to perform satisfactorily. 6.4 Personnel records
6.4.1 The accreditation body shall maintain records of the relevant qualifications, training, experience and competence of each person involved in the accreditation process. Training, experience and monitoring records shall be kept up to date.
6.4.2 The accreditation body shall maintain up-to-date records of assessors and experts, which shall contain at least the following: a) Name and address;
Position, as well as the position of external assessors and experts in their own organization; b)
Educational level and professional status;
Work experience;
Training in management systems, assessment and conformity assessment activities; f) Competence to undertake specific assessment tasks;
Results of assessment experience and regular monitoring.
7 Accreditation process
7.1 Accreditation criteria and information
7.1.1 The general principles used for the accreditation of conformity assessment bodies shall be those set out in relevant normative documents, such as standards and guidelines related to the operation of conformity assessment bodies.
7.1.2 The accreditation body shall make the following information publicly available and update it at appropriate intervals: Details of the accreditation review and accreditation process, including arrangements for granting, maintaining, extending, reducing, suspending and withdrawing accreditation a) Documents or references containing the requirements for accreditation, including, where applicable, specific technical requirements for each area of accreditation; Basic information on accreditation fees;
Description of the rights and obligations of the accreditation body; d) Information on accredited conformity assessment bodies as described in 8.2.1; e)
f) Information on the procedures for making and handling complaints and appeals; Information on the authorization for the implementation of the accreditation system;
Description of the rights and obligations of the accreditation body;
Basic information on the means by which the accreditation body obtains financial support; j) Information on the scope of the accreditation body's activities and operations; k) Where applicable, information on relevant bodies as described in 4.3.7. 7.2 Application for accreditation
7.2.1 The accreditation body shall require a formal application to be made by a fully authorized representative of the conformity assessment body seeking accreditation, including:2 The accreditation body shall establish a formal procedure for the selection and approval of assessors and experts used in the assessment process. 6.2.3 The accreditation body shall determine the specific scope of competence demonstrated by each assessor and expert. GB/T 27011—2005/IS0/IEC 17011:20046.2.4 The accreditation body shall ensure that assessors (including experts, where applicable) are: a) familiar with the accreditation procedures, accreditation tests and other relevant requirements; b) have received relevant accreditation assessor training; c) are proficient in relevant assessment methods; d) can communicate effectively in written and oral form in the required language; and possess appropriate personal qualities.
Note: For information on individual records, please refer to documents such as GB/T 13011. 6.3 Standards
6.3.1 The accreditation body shall ensure that the assessment and accreditation decision process is satisfactory by establishing procedures to monitor the performance and competence of the relevant personnel. In particular, the accreditation body shall evaluate the performance and competence of its personnel in order to determine the need for training. 6.3.2 The accreditation body shall monitor the assessors (e.g. through on-site observation, or by other means, such as reviewing the assessment report, collecting feedback from the conformity assessment body and peer monitoring of the assessors) to evaluate their performance and propose appropriate follow-up improvement measures. The accreditation body shall conduct on-site observations of each assessor regularly, usually once every three years, unless there is sufficient evidence that he or she has continued to perform satisfactorily. 6.4 Personnel records
6.4.1 The accreditation body shall maintain records of the relevant qualifications, training, experience and competence of each person involved in the accreditation process. Training, experience and monitoring records shall be kept up to date.
6.4.2 The accreditation body shall maintain up-to-date records of assessors and experts, which shall contain at least the following: a) Name and address;
Position, as well as the position of external assessors and experts in their own organization; b)
Educational level and professional status;
Work experience;
Training in management systems, assessment and conformity assessment activities; f) Competence to undertake specific assessment tasks;
Results of assessment experience and regular monitoring.
7 Accreditation process
7.1 Accreditation criteria and information
7.1.1 The general principles used for the accreditation of conformity assessment bodies shall be those set out in relevant normative documents, such as standards and guidelines related to the operation of conformity assessment bodies.
7.1.2 The accreditation body shall make the following information publicly available and update it at appropriate intervals: Details of the accreditation review and accreditation process, including arrangements for granting, maintaining, extending, reducing, suspending and withdrawing accreditation a) Documents or references containing the requirements for accreditation, including, where applicable, specific technical requirements for each area of accreditation; Basic information on accreditation fees;
Description of the rights and obligations of the accreditation body; d) Information on accredited conformity assessment bodies as described in 8.2.1; e)
f) Information on the procedures for making and handling complaints and appeals; Information on the authorization for the implementation of the accreditation system;
Description of the rights and obligations of the accreditation body;
Basic information on the means by which the accreditation body obtains financial support; j) Information on the scope of the accreditation body's activities and operations; k) Where applicable, information on relevant bodies as described in 4.3.7. 7.2 Application for accreditation
7.2.1 The accreditation body shall require a formal application to be made by a fully authorized representative of the conformity assessment body seeking accreditation, including:2 The accreditation body shall establish a formal procedure for the selection and approval of assessors and experts used in the assessment process. 6.2.3 The accreditation body shall determine the specific scope of competence demonstrated by each assessor and expert. GB/T 27011—2005/IS0/IEC 17011:20046.2.4 The accreditation body shall ensure that assessors (including experts, where applicable) are: a) familiar with the accreditation procedures, accreditation tests and other relevant requirements; b) have received relevant accreditation assessor training; c) are proficient in relevant assessment methods; d) can communicate effectively in written and oral form in the required language; and possess appropriate personal qualities. Www.bzxZ.net
Note: For information on individual records, please refer to documents such as GB/T 13011. 6.3 Standards
6.3.1 The accreditation body shall ensure that the assessment and accreditation decision process is satisfactory by establishing procedures to monitor the performance and competence of the relevant personnel. In particular, the accreditation body shall evaluate the performance and competence of its personnel in order to determine the need for training. 6.3.2 The accreditation body shall monitor the assessors (e.g. through on-site observation, or by other means, such as reviewing the assessment report, collecting feedback from the conformity assessment body and peer monitoring of the assessors) to evaluate their performance and propose appropriate follow-up improvement measures. The accreditation body shall conduct on-site observations of each assessor regularly, usually once every three years, unless there is sufficient evidence that he or she has continued to perform satisfactorily. 6.4 Personnel records
6.4.1 The accreditation body shall maintain records of the relevant qualifications, training, experience and competence of each person involved in the accreditation process. Training, experience and monitoring records shall be kept up to date.
6.4.2 The accreditation body shall maintain up-to-date records of assessors and experts, which shall contain at least the following: a) Name and address;
Position, as well as the position of external assessors and experts in their own organization; b)
Educational level and professional status;
Work experience;
Training in management systems, assessment and conformity assessment activities; f) Competence to undertake specific assessment tasks;
Results of assessment experience and regular monitoring.
7 Accreditation process
7.1 Accreditation criteria and information
7.1.1 The general principles used for the accreditation of conformity assessment bodies shall be those set out in relevant normative documents, such as standards and guidelines related to the operation of conformity assessment bodies.
7.1.2 The accreditation body shall make the following information publicly available and update it at appropriate intervals: Details of the accreditation review and accreditation process, including arrangements for granting, maintaining, extending, reducing, suspending and withdrawing accreditation a) Documents or references containing the requirements for accreditation, including, where applicable, specific technical requirements for each area of accreditation; Basic information on accreditation fees;
Description of the rights and obligations of the accreditation body; d) Information on accredited conformity assessment bodies as described in 8.2.1; e)
f) Information on the procedures for making and handling complaints and appeals; Information on the authorization for the implementation of the accreditation system;
Description of the rights and obligations of the accreditation body;
Basic information on the means by which the accreditation body obtains financial support; j) Information on the scope of the accreditation body's activities and operations; k) Where applicable, information on relevant bodies as described in 4.3.7. 7.2 Application for accreditation
7.2.1 The accreditation body shall require a formal application to be made by a fully authorized representative of the conformity assessment body seeking accreditation, including:
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