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CNCA 00C-005-2014: Compulsory product certification and implementation rules - factory quality assurance capability requirements
CNCA 00C-005-2014
[Attachment 1]
Serial No.. CNCA-00C-005
CNCA-00C-005
China Compulsory Certification Implementation Rules -
Factory quality assurance capacity requirements
ISSUED ON. FEBRUARY 02, 2014
IMPLEMENTED ON. SEPTEMBER 01, 2014
Issued by. Certification and Accreditation Administration of the People's
Republic of China
Table of Contents
0 Introduction ... 4??
1 Application scope ... 4??
2 Terms and definitions ... 4??
2.1 Certification technical personnel in charge ... 4??
2.2 Certified product consistency (product consistency) ... 4??
2.3 Routine inspection ... 5??
2.4 Confirmation inspection ... 5??
2.5 Regular confirmation inspection of critical components ... 5??
2.6 Function check ... 5??
3 Factory quality assurance capacity requirements ... 5??
3.1 Responsibilities and resources... 5??
3.2 Documents and records ... 6??
3.3 Purchasing and critical component control ... 7??
3.4 Manufacture process control ... 8??
3.5 Routine inspection and/or confirmation inspection ... 8??
3.6 Inspection and test equipment ... 9??
3.7 Control of nonconforming products ... 9??
3.8 Internal quality audit ... 10??
3.9 Change and consistency control of certified products ... 10??
3.10 Product protection and delivery ... 10??
3.11 CCC certificate and mark ... 10??
0??Introduction??
According to the requirements of the ?€?China Compulsory Certification Management
Method?€?, the manufacturing enterprise shall control the consistency of the certified
products, and its quality assurance capacity shall sustain the compliance with the
certification requirements. This Implementation Rules is formulated for the purpose of
normatively guiding the manufacturing enterprise of the products in the China
Compulsory Certification (CCC certification) catalog to establish quality assurance
capacity to ensure that the products sustain the compliance with the CCC certification
requirements.
In the specific implementation of the certification work, the factory shall establish
quality assurance capacity that meet the requirements of this Implementation Rules,
aimed at ensuring the consistency of the certified products and the type test samples,
according to the implementation rules and the requirements of the corresponding
certification implementation rules/detailed-rules, and for product characteristics and
manufacture processing characteristics.
NOTE. The factory in this Implementation Rules involves certification client, manufacturer and
manufacturing enterprise.
1??Application??scope
This Implementation Rules specifies the basic requirements for the quality assurance
capacity of the factory and is also one of the bases for the certification body to
implement the factory inspection.
2??Terms??and??definitions??
2.1 Certification technical personnel in charge
An insider of the manufacturer and/or the manufacturing enterprise, who masters the
requirements of certification standards, and confirms the approval of the change of
certified products and assumes the corresponding responsibility according to the
scope of duties specified in the certification implementation rules/detailed-rules.
2.2 Certified product consistency (product consistency)
The certified products manufactured are consistent with the type test samples. The
specific requirements for product consistency are specified in the certification
implementation rules/detailed-rules.
2.3 Routine inspection
In order to eliminate nonconforming products caused by accidental factors in the
manufacturing process, 100 % inspection of certified products is usually carried out at
the final stage of manufacture. Routine inspection is allowed to be carried out by an
equivalent, fast method that is determined after verification.
NOTE. For special products, routine inspection may be sampling inspection according to the
requirements of the certification implementation rules/detailed-rules.
2.4 Confirmation inspection
A sampling inspection carried out to verify whether the certified products are capable
of sustaining the compliance with the certification standards.
2.5 Regular confirmation inspection of critical components
A regular sampling inspection carried out to verify whether the quality characteristics
of critical components are capable of sustaining the compliance with certification
standards and/or technical requirements.
NOTE. The critical component is a general term for components, parts, raw materials, etc. that
play a critical role in meeting the certification requirements.
2.6 Function check
A check carried out to determine whether the intended function of the test equipment
meets the specified requirements.
3??Factory??quality??assurance??capacity??requirements??
Factory is the responsible body of product quality, and its quality assurance capacity
shall be capable of sustaining the compliance with the certification requirements; the
products manufactured shall meet the requirements of the standard and it shall
ensure that the certified products are consistent with the type test samples. Factory
shall accept and cooperate with various factory on-site inspection, market inspection
and sampling test implemented by the certification body in accordance with this
Implementation Rules and relevant certification implementation rules/detailed-rules.
3.1 Responsibilities and resources
3.1.1 Responsibilities
The factory shall specify the duties, authorities and mutual relations of various
personnel related to the certification requirements, and designate the person in
charge of quality in the management of the organization. Regardless of other duties of
3.2.4 The factory shall identify and keep important documents and quality information
related to product certification, such as type test reports, factory inspection results,
CCC certificate status information (valid, suspension, withdrawal, cancellation, etc.),
certification change approval information, supervision sampling test report, product
quality complaints and processing results.
3.3 Purchasing and critical component control
3.3.1 Purchasing control
For the purchased critical components, the factory shall identify and clarify their
technical requirements in the purchasing documentation. The technical requirements
shall also ensure that the final product meets the certification requirements.
The factory shall establish and keep a catalogue of qualified manufacturers/
manufacturing enterprises of critical components and purchase critical components
from them. The factory shall keep records of the purchasing and use of critical
components, such as purchasing orders, inbound and outbound orders, and
accounts.
3.3.2 Quality control of critical components
3.2.2.1 The factory shall establish and maintain a documented procedure, and verify
and/or inspect the technical requirements for the purchasing of critical components
and keep relevant records upon receipt (incoming).
3.3.2.2 For the quality characteristics of the purchased critical components, the
factory shall select the appropriate control method to ensure that the critical
components sustain the compliance with the technical requirements, and that the final
products meet the certification requirements; keep the relevant records. Appropriate
control methods may include.
(a) Obtain a CCC certificate or a voluntary product certification result that can be
recognized for compulsory certification of the final product. The factory shall
ensure that the status of its certificate is valid.
(b) For the critical components of which the relevant certificate is not obtained, the
regular confirmation inspection shall meet the requirements of the certification
implementation rules/detailed-rules.
(c) The factory itself has a control plan with a control effect not lower than the
requirements of 3.3.2.2(a) or (b).
3.3.2.3 When purchasing critical components from distributors and traders, the factory
shall take appropriate measures to ensure the consistency of the purchased critical
components and their sustaining the compliance with the technical requirements.
3.6 Inspection and test equipment
3.6.1 Basic requirements
The factory shall be equipped with sufficient inspection and test equipment and
ensure that the capabilities of the equipment used in the purchasing, manufacturing,
and final inspection tests meet the inspection and test requirements for the mass
production of certified products.
The inspection and test personnel shall be able to use the equipment correctly, master
the inspection and test requirements and implement them effectively.
3.6.2 Calibration and verification
The test equipment used to determine whether the certified products manufactured
meet the specified requirements shall be calibrated or verified according to the
specified period. The calibration or verification period may be set according to the use
frequency and the previous calibration of the equipment. For internal calibration, the
factory shall specify calibration methods, acceptance criteria and calibration periods.
The calibration or verification shall be traceable to national or international standards.
The calibration or verification status of the equipment shall be used and easily
identified by the administrator. The factory shall keep the calibration or verification
records of the equipment.
For calibration or verification activities commissioned by external organizations, the
factory shall ensure that the capabilities of the external organization meet the
calibration or verification requirements and keep relevant capability evaluation results.
NOTE. For critical monitoring and measuring devices in manufacture process control, the
factory shall manage them in accordance with the requirements of the certification
implementation rules/detailed-rules.
3.6.3 Function check
When necessary, the factory shall perform function checks on the equipment for
routine inspection according to the specified requirements. When the function check
results are found to be unsatisfactory, it shall be able to trace to the products that have
been tested; when necessary, these products shall be re-tested. The factory shall
specify the measures that the operator shall take when discovering function failure of
the equipment.
The facility shall keep the record of the function check results and the actions taken
when the equipment function fails.
3.7 Control of nonconforming products
3.7.1 For nonconforming products found in purchasing, manufacturing, inspection,