Appendix
Compulsory Product Certification Requirements
for Factory’s Quality Assurance Ability
Factory shall meet the requirements for factory’s quality assurance ability in this document, in order to ensure that all certified products are identical within accepted manufacturing tolerances to the sample or samples against which the type test was approved.
1. Responsibility, Authority and Resource
1.1 Responsiblity
Factory shall regulate the responsibilities and inter-relations of all the personnel involved in quality activities. And factory shall appoint a responsible person for quality from the organization who, irrespective of other responsibilities, shall have responsibility and authority that include
a) ensuring that quality system, which meets the requirements of this document, is established, implemented and maintained.
b) ensuring that the products with the certification label are produced in conformity with the standards to which they were certified.
c) establishing documented procedure to ensure that certification labels are kept and used appropriately.
d) establishing documented procedure to ensure that the certification label is not borne on any non-conforming product or changed product that was not notified by certification body.
The responsible person for quality shall be competent to perform the work.
1.2 Resources
Factory shall equip with necessary production facility and testing equipment in order to con
sistently manufacture the products in conformity with certification standards. In addition, factory shall provide relevant human resources, to ensure that personnel performing work affecting product quality is competent, and establish and maintain necessary environment suitable for manufacturing, test and inspection, storage etc.
2. Documents and Records
2.1 Factory shall establish and maintain documented quality plan or relevant documents for certified products, and needed documents in order to ensure that related processes to product quality are operated and controlled effectively. Quality plan shall define the objective of product design, realization process, test and related resource, as well as the requirements for changes (i.e. standard, workshop, critical components etc.) to certified products, use and management of labels.
Design standard or specification, as one essential part of quality plan, shall not be lower than the requirements of national standard for the product.
2.2 Factory shall establish and maintain documented procedure to control the documents required in this document, to ensure that
a) documents are approved by authorized personnel prior to issue and re-approved after changes.
b) changes and current revision status of documents are identified to prevent unintended use of obsolete documents.
c) relevant versions of applicable documents are available at points of use.
2.3 Factory shall establish and maintain documented procedure to define the controls for the identification, storage, protection and disposition of records. Records shall remain legible, integral to provide evidence of product conformity to requirements.documented evidence
Records shall be retained for an appropriate period.
3. Purchasing and Incoming Inspection
3.1 Control of Supplier
Factory shall establish the procedure that defines the criteria for selection, evaluation and routine supervision of supplier, which provide critical components and material, to ensure the supplier has ability to provide the critical components and material in accordance with requirements.
Records of the evaluations and routine supervision shall be maintained.
3.2 Inspection/Verification for Critical Components and Material
Factory shall establish and maintain procedure of inspection or verification for purchased critical components and material, and procedure of periodic verification inspection, to ensure that critical components and material meet specified certification requirements.
Inspection for purchased critical components and material may be carried out by factory or by supplier. Where inspection is performed at supplier’s premise, factory shall state the intended inspection requirements to supplier.
4. Monitoring and Measurement of Processes
4.1 Factory shall identify critical production processes and arrange operators with appropriate qualification at the processes. Where product quality can not be guaranteed when no operating document, appropriate operating instructions shall be prepared to make production processes under control.
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