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ANNEX 4 Requirements of Factory Quality Assurance
ANNEX 4 Requirements of Factory Quality Assurance
0. Introduction
This document is specially formulated to standardize and guide to establish
the quality management system for continuous compliance with CCC
certification requirements according to the requirements of Compulsory Product
Certification Management Regulation. This document is one of the basis for
enterprise to establish the quality management system and for SITIIAS to carry
out on-siteaudit.
The factory shall establish and maintain the quality management system
that meets the requirements of this document according to the type of protection,
Ex structure and characteristics of production on the target of ensuring
consistency between products and the approval documents. The site in this
document refers to the applicant, manfuacturer or factory that undertakes
corresponding duties.
1.1 Responsibilities
The site shall specify the responsiblities, authorities and relationships of
various personnel related to the certification requirements, and designate a
person to be responsible for Ex quality from the management of the
organization; regardless of the responsibilities of the member in other aspects,
the person shall have the following responsibilities and authorities:
(a) Ensure the requirements of this document are effectively established,
implemented and maintained;
(b) ensure product product compliies with standards;
(c) Correctly use CCC certificate and mark and ensure that the certificateis
continuously valid.
(d) Keep in touch with SITIIAS, track changes about certification and
communicate to relevant internal personnel or departments for implementation.
The personnel in charge of Ex quality shall be fully competent for the job,
and can also serve as the technical director of certification.
1.2 Resources
The site shall provide sufficient production equipment, inspection and
testing equipment to meet the needs of stably producing; provide appropriate
human resources to ensure that the personnel involved in the work that has an
impact on the quality of product; establish and maintain necessary environment
and facilities suitable for production, inspection and testing, storage, etc.
For externally rented resource, the site shall ensure continuous availability
and proper use of the external resources; the factory shall keep the records
related to the external resources, such as contract and agreement, use records,
etc.
when there are significant changes in the production and inspection
equipment, the site shall conduct corresponding applicability assessment,
calibration and testing to ensure that the changes do not affect the production
or are not below the level of the original equipment.records shall be retained
and submited to SITIIAS for filing.
4.1 The site shall identify the processes that affect the quality of certified
products (referred to as the “critical processes”), and the critical process shall
be identified and meet the specified requirements. The operators of critical
processes shall have corresponding competences; the critical processes shall
be controlled to guarantee the compliance of certified products with the
standards and product conformity; if the quality of certified products cannot be
guaranteed without regulations of document for the critical processes,
corresponding operation instructions shall be developed to make the production
process controlled.
4.2 If the production process has requirements for the environmental conditions,
the site shall ensure that the working environment meets the specified
requirements.
4.3 The site shall monitor and measure appropriate process parameters as
necessary.
4.4 The site shall establish and keep a maintenance system of the production
equipment to ensure that the capabilities of equipment continuously meet the
production requirements.
4.5 When necessary, the site shall check, monitor and measure the product and
its characteristics at appropriate stage of production as required to guarantee
the compliance of the product with the standards and product conformity.
7.3 The factory shall inform SITIIAS in a timely manner when it is informed
that there are major quality problems in its certified products (such as
nonconforming products of national and provincial supervision and spot
check, etc.).