CNCA 00C-005-2014 PDF English
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Compulsory product certification and implementation rules - factory quality assurance capability requirements
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CNCA 00C-005-2014: Compulsory product certification and implementation rules - factory quality assurance capability requirements
---This is an excerpt. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.), auto-downloaded/delivered in 9 seconds, can be purchased online: https://www.ChineseStandard.net/PDF.aspx/CNCA00C-005-2014
Announcement of Certification and Accreditation
Administration on Issuing China Compulsory Certification
Implementation Rules such as Factory Quality Assurance
Capability Requirements
No. 1, 2014
In order to further promote scientific, standardize and effective implementation of
China compulsory certification, according to the “Regulations of the People's Republic
of China on Certification and Accreditation”, “Regulation Concerning Management of
Compulsory Product Certification" and “Notice of Certification and Accreditation
Administration on Clarifying the Adjustment Plan and Requirements for China
Compulsory Certification Implementation Documents” (CNCA [2013] No. 39), CNCA
has formulated two general implementation rules for China compulsory certification.
“China Compulsory Certification Implementation Rules - Factory Quality Assurance
Capacity Requirements”, which is used to normatively guide the manufacturing
enterprise of the products in the compulsory certification catalogue to establish quality
assurance capacity to ensure that the products sustain the compliance with the CCC
certification requirements; “China Compulsory Certification Implementation Rules -
General Requirements for Factory Inspection”, which is used to normatively guide the
consistency of the implementation of the factory inspection work of the designated
certification body of compulsory certification, which are issued now.
The above two general implementation rules are used in conjunction with the specific
product certification implementation rules issued subsequently, and will be
implemented on September 1, 2014.
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
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.
2.3 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.
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.
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.
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
this person, he/she shall have the following duties and authority.
3.1.2 Resources
The factory shall be equipped with necessary manufacture equipment, inspection and
test equipment to meet the needs of stable manufacture of products that meet the
requirements of certification standards;
3.2 Documents and records
3.2.2 The factory shall ensure the adequacy, suitability and validity of the documents
used.
3.2.3 The factory shall ensure that the records are clear, complete and traceable, so
that they can be used as evidences that the product meets the specified requirements.
The retention period of quality-related records shall meet the requirements of laws
and regulations, to ensure that records from the previous inspection are available for
this inspection, and at least not less than 24 months.
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.
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).
3.3.2.3 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.
3.4 Manufacture process control
3.4.1 The factory shall identify the processes that affect the quality of the certified
products (referred to as the critical processes), and the identified critical processes
shall meet the specified requirements.
3.5 Routine inspection and/or confirmation inspection
The factory shall establish and maintain a documented procedure, and control the
routine inspection and/or confirmation inspection of the final products. The inspection
procedure shall meet the specified requirements, and the content of the procedure
shall include the frequency, items, content, methods, determination, etc. of inspection.
3.6 Inspection and test equipment
3.7 Control of nonconforming products
3.7.1 For nonconforming products found in purchasing, manufacturing, inspection,
etc., the factory shall take measures such as identification, isolation and disposal to
avoid unintended use or delivery of nonconforming products. Products that are
reworked or returned for repair shall be re-inspected.
3.8 Internal quality audit
The factory shall establish a documented internal quality audit process to ensure
sustained compliance of factory quality assurance capacity, product consistency and
compliance of products with standards.
3.9 Change and consistency control of certified products
The factory shall establish and maintain a documented procedure, control changes
(such as processes, production conditions, critical components and product structures)
that may affect product consistency and compliance of products with standards, and
the procedure shall meet the specified requirements.
3.10 Product protection and delivery
The product protection, such as labeling, handling, packaging, storage, protection,
etc., carried out by the factory in purchasing, manufacturing, inspection, etc. shall
meet the specified requirements. When necessary, the factory shall control the
delivery of products according to the specified requirements.
3.11 CCC certificate and mark
The management and use of CCC certificate and mark by the factory shall meet the
requirements of “China Compulsory Certification Management Method” and “China
Compulsory Certification Mark Management Method”. For the standard printed CCC
mark or the CCC mark applied by printing, molding, etc., the factory shall keep a
record of use. The following products may not be subject to the CCC mark or be
released.
Announcement of Certification and Accreditation
Administration on Issuing China Compulsory Certification
Implementation Rules such as Factory Quality Assurance
Capability Requirements
No. 1, 2014
In order to further promote scientific, standardize and effective implementation of
China compulsory certification, according to the “Regulations of the People's Republic
of China on Certification and Accreditation”, “Regulation Concerning Management of
Compulsory Product Certification" and “Notice of Certification and Accreditation
Administration on Clarifying the Adjustment Plan and Requirements for China
Compulsory Certification Implementation Documents” (CNCA [2013] No. 39), CNCA
has formulated two general implementation rules for China compulsory certification.
“China Compulsory Certification Implementation Rules - Factory Quality Assurance
Capacity Requirements”, which is used to normatively guide the manufacturing
enterprise of the products in the compulsory certification catalogue to establish quality
assurance capacity to ensure that the products sustain the compliance with the CCC
certification requirements; “China Compulsory Certification Implementation Rules -
General Requirements for Factory Inspection”, which is used to normatively guide the
consistency of the implementation of the factory inspection work of the designated
certification body of compulsory certification, which are issued now.
The above two general implementation rules are used in conjunction with the specific
product certification implementation rules issued subsequently, and will be
implemented on September 1, 2014.
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
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.
2.3 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.
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.
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.
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
this person, he/she shall have the following duties and authority.
3.1.2 Resources
The factory shall be equipped with necessary manufacture equipment, inspection and
test equipment to meet the needs of stable manufacture of products that meet the
requirements of certification standards;
3.2 Documents and records
3.2.2 The factory shall ensure the adequacy, suitability and validity of the documents
used.
3.2.3 The factory shall ensure that the records are clear, complete and traceable, so
that they can be used as evidences that the product meets the specified requirements.
The retention period of quality-related records shall meet the requirements of laws
and regulations, to ensure that records from the previous inspection are available for
this inspection, and at least not less than 24 months.
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.
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).
3.3.2.3 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.
3.4 Manufacture process control
3.4.1 The factory shall identify the processes that affect the quality of the certified
products (referred to as the critical processes), and the identified critical processes
shall meet the specified requirements.
3.5 Routine inspection and/or confirmation inspection
The factory shall establish and maintain a documented procedure, and control the
routine inspection and/or confirmation inspection of the final products. The inspection
procedure shall meet the specified requirements, and the content of the procedure
shall include the frequency, items, content, methods, determination, etc. of inspection.
3.6 Inspection and test equipment
3.7 Control of nonconforming products
3.7.1 For nonconforming products found in purchasing, manufacturing, inspection,
etc., the factory shall take measures such as identification, isolation and disposal to
avoid unintended use or delivery of nonconforming products. Products that are
reworked or returned for repair shall be re-inspected.
3.8 Internal quality audit
The factory shall establish a documented internal quality audit process to ensure
sustained compliance of factory quality assurance capacity, product consistency and
compliance of products with standards.
3.9 Change and consistency control of certified products
The factory shall establish and maintain a documented procedure, control changes
(such as processes, production conditions, critical components and product structures)
that may affect product consistency and compliance of products with standards, and
the procedure shall meet the specified requirements.
3.10 Product protection and delivery
The product protection, such as labeling, handling, packaging, storage, protection,
etc., carried out by the factory in purchasing, manufacturing, inspection, etc. shall
meet the specified requirements. When necessary, the factory shall control the
delivery of products according to the specified requirements.
3.11 CCC certificate and mark
The management and use of CCC certificate and mark by the factory shall meet the
requirements of “China Compulsory Certification Management Method” and “China
Compulsory Certification Mark Management Method”. For the standard printed CCC
mark or the CCC mark applied by printing, molding, etc., the factory shall keep a
record of use. The following products may not be subject to the CCC mark or be
released.
......
Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.
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