Ref . No.

CNCA-01C-016:2001

IMPLEMENTATION RULES FOR COMPULSORY

CERTIFICATION OF ELECTRICAL AND
ELECTRONIC PRODUCTS
Household and Similar Use Appliances

Announced on Dec.7, 2001

Implemented on May 1, 2002

Certification and Accreditation Administration

of
Peoples Republic of China

contents
1. Scope..........................................................................................................................3
2. Certification model.....................................................................................................3
3. Major processes for certification................................................................................4
3.1Application for certification...............................................................................4
3.2Type testing........................................................................................................4
3.3Initial inspection of the factory..........................................................................4
3.4Evaluation of certification results and approval of certification........................4
3.5Follow-up inspection..........................................................................................4
4. General requirements for certification.......................................................................4
4.1Application for certification...............................................................................4
4.2 Type testing.......................................................................................................5
4.3 Initial inspection of the factory.........................................................................6
4.4 Evaluation of certification results and approval of certification.......................7
4.5 Follow-up inspection.........................................................................................8
5. Certificate...................................................................................................................9
5.1 The validity of the certificate............................................................................9
5.2 Change of the certified product.......................................................................10
5.3 Extension of certified products.......................................................................10
5.4 Suspension, cancellation and withdrawal of the certificates...........................11
6. Use of compulsory product certification mark.........................................................11
6.1 Design of the mark allowed to use..................................................................11
6.2 Derivations of certification mark....................................................................11
6.3 Ways of use.....................................................................................................12
6.4 Location of the mark.......................................................................................12
7. Charge......................................................................................................................12
Appendix 1...................................................................................................................13
Appendix 2...................................................................................................................15
Appendix 3...................................................................................................................18
Appendix 4...................................................................................................................19
Appendix 5...................................................................................................................21
Appendix 6...................................................................................................................22

IMPLEMENTATION RULES FOR COMPULSOEY

CERTIFICATION OF ELECTRICIAL AND
ELECTRONIC PRODUCTS
Household and Similar Use Appliances
1. Scope
This document applies to household electric appliances and similar use.
It includes:

Household refrigerator
Food freezer
Electric fan
Air-conditioner
Washing machines
Storage water heaters
Room heaters
Vacuum cleaners
Appliances for skin and hair care
Instantaneous water heaters
Electric irons
Electromagnetic ovens
Roasters
Electric food processors
Microwave ovens
Cooking ranges, cooking table, ovens and similar appliances
Range hoods
Appliances for heating liquids
Electric rice cookers
Water dispensers
Motor-compressors

2. Certification model
Type testing + Initial inspection of the factory + Follow-up inspection

3. Major processes for certification

3.1Application for certification
3.2Type testing
3.3Initial inspection of the factory
3.4Evaluation of certification results and approval of certification
3.5Follow-up inspection

4. General requirements for certification

4.1Application for certification
4.1.1 Defining application unit for certification
4.1.1.1 In principle, application unit (see appendix 1) shall be defined according to
different product families, models /types, specifications, working principles,
constructions in terms of product safety, the components having significant influence
on EMC performance (see the components with * of appendix 5).

4.1.1.2 In principle, the application shall be made according to application unit.

The products, of same model/type, of same manufacturer, but from different
manufacturing premises, shall be in different application units, but only one type
testing is required.
4.1.2 Application documents
The formal application shall be submitted with the following documents:
1) Product assembly chart, circuit diagram;
2) List of critical components and/or materials
3) Description of the difference between the different model/type of products in the
same application unit.
4) Other necessary documents.

4.2 Type testing

4.2.1 Sample delivery for type testing
4.2.1.1 The principles of sample delivery for type testing
The representative samples from the units of application for certification shall be
selected and supplied for type testing. According to requirements, samples of other
products covered by the application unit should be supplied for additional testing on
differences.
4.2.1.2 Samples quantity/amount requirements
The applicants shall take responsibility of sample delivery for type testing in
accordance with the requirements of the certification body and be responsible for
them.
The quantities of samples shall be according to the requirements of appendix 3 and
those for components tested accompanying the appliances shall be according to the
requirements of appendix 4.
4.2.1.3 Handle of samples and relating documents after type testing
The samples tested and/or the relating documents should be handled in appropriate
ways after type testing.
4.2.2 Test standards, items and methods for type testing
4.2.2.1 Test standards
The test standards for certification are specified in appendix 2.
4.2.2.2

Test items

1) Test items for safety

The test items for safety shall include all appropriate items specified in standards.
Test items for EMC
a.

0.15MHz~30MHz radio continuous disturbance voltage

(GB4343-1995)

b.

30MHz~300MHz radio continuous disturbance power

(GB4343-1995)

c.

0.15MHz~30MHz radio discontinuous disturbance voltage (GB4343-1995)

d.

Limits for the harmonic current emissions

(GB17625.1-1998)

4.2.2.3 Test methods

The type testing shall be carried out according to the methods specified and/or
referred in the standards.
4.3 Initial inspection of the factory
4.3.1 Contents of the inspection
The contents of factory inspection shall include the factory quality assurance ability
assessment and the products consistency check.
4.3.1.1 Assessment of factory quality assurance ability.
The inspector assigned by the certification body shall carry out the factory quality
assurance capability assessment according to the Requirements for Factory Quality
Assurance Ability (see appendix 6) and the additional inspection requirements
stipulated by CNCA.

4.3.1.2 Check of consistency of the product

The consistency of the product applying for certification shall be checked on the site
of production. If more than one application unit are involved in the certification, at
least one type/model sample shall be taken from each unit for the product consistency
check. The following major points shall be checked:
1) The name of product, type/model and specification on the nameplates and packages
of products to be certified shall be identical with those indicated in the type testing
reports.
2) The constructions of products to be certified (mainly constructions in terms of
safety and EMC performance) shall be identical with those of the samples for type
testing.
3) The critical components in terms of safety and components having significant
influences on EMC shall be identical with those declared in type testing and
confirmed by certification body.

The witness tests on site, if necessary, should be carried out to confirm safety and
EMC performance of the products during the factory inspection.
4.3.1.3 Inspection scope
All the products to be certified and processing premises shall be covered for
inspection of factory quality assurance ability and of consistency of the products.
4.3.2 Timing of factory inspection
Normally, the initial inspection should be implemented after the sample has passed
the type testing. The type testing and factory inspection can be implemented at the
same time in special cases.
The duration of factory inspection shall be determined by the amounts of application
units of products to be certified and with the consideration of the scale of the factory.
It will normally take about 1 to 4 man-day for each processing premises.
4.4 Evaluation of certification results and approval of certification
4.4.1 Evaluation of certification results and approval of certification
The certification body shall be responsible for a general evaluation of the results of
type testing and factory inspection and for issuing the certificates to the applicants for
the conformed products. One certificate shall be issued for one application unit. The
application of the certificates shall comply with the requirements for Regulations for
Compulsory Product Certification.
4.4.2 Time frame
Time frame for certification means the working days from the acceptance of complete
application till the issuance of the certificates, which includes the time of type testing,
factory inspection, reports submission after inspection, evaluation of certification
results and approval of certificates, etc.
Normally, type testing takes 30 working days, not including the time for corrective
actions and retest of the non-conformity item(s). If the components are required to be
tested and the required time exceeds that of appliances, the time of type testing should
be calculated according to the longest test time of the component, counting upon the
receipt of the samples and testing fees.
The inspection reports should be submitted within 5 working days after the
inspection. It will be counted from the day when the inspectors complete the
7

inspection and receive from the factory the corrective action reports on nonconformities satisfying the requirements.
Evaluating certification results and approving the certificates shall normally be
completed within 5 working days.
4.5 Follow-up inspection
4.5.1 The frequency of follow-up inspection
The follow-up inspection shall normally be implemented at least once per year. The
first follow-up inspection shall normally be implemented 12 months after the
certificate being granted.
The frequency of inspection should be increased in any of the following cases:
1) The certified product has serious quality problem, or is complained by clients,
which has been verified to be the responsibility of the certificate holder.
2) The certification body doubts the conformity of the certified product against the
requirements of safety and EMC standards with sufficient reasons.
3) Sufficient information indicates that the conformity or the consistency of certified
products might be affected due to the changes in organization structure, production
condition and the quality system of the manufacturer and/or factories.
4.5.2

Contents of the follow-up inspection

The model of follow-up inspection: re-assessment of factory quality assurance ability

+ check of consistency of products certified, and if necessary, samples may be taken
and tested at the testing laboratories.
The certification body shall implement the factory re-assessment in accordance with
Requirements for Factory Quality Assurance Ability (see appendix 6). The items 3,
4, 5 and 9 specified in Requirements for Factory Quality Assurance Ability must be
assessed for follow-up inspection and the rest items may be selected. All the items of
the Requirements shall be covered at least every four years.
The duration for follow-up inspection shall be determined by the amounts of units of
certified products with appropriate consideration of the production scale of the
factory. It will normally take about 1 to 2 man-day.
4.5.3 Sampling & testing
8

If necessary, the certified products should be sampled and tested. The samples shall
be taken randomly from the qualified products of the factory (including those from
production line, stock and market). The designated testing bodies shall be responsible
for testing. The methods and requirements for sampling shall be carried out according
to the relevant specifications of the certification body.
The test items specified in the standards for certification can be applied to testing.
The certification body may carry out part or all of test items based on the degree of
effects on the safety and/or EMC performance of the products.
4.5.4 Evaluation of follow-up inspection results
The certificates can be retained and the certification marks can be continuously used
upon favorable inspection results. If there is any non-conformities found in the
follow-up inspection, the corrective actions shall be taken within three months.
Otherwise, the certificates will be withdrawn, the certification marks will be stopped
using, and the relevant results will be announced.

5. Certificate
5.1 The validity of the certificate
The certificate of the products covered by this Rules itself doesnt indicate specific
expiry date. The validity of the certificate depends on the follow-up inspection.
5.2 Change of the certified product
5.2.1 Applying for change of certified product
Should any change occur in the specification, type/model of the components listed in
appendix 3 of the certified products or the design, electric construction involved in
safety or EMC of the appliances, the application for approving/recording the change
shall be made to the certification body.
5.2.2 Evaluation and approval of change
The certification body shall evaluate the change according to the submitted
information and confirm whether it can be approved or samples should be submitted
for tests. If test is necessary, the change will be approved upon favorable test result.

5.3 Extension of certified products

5.3.1 Procedure for extension
For extension of the range of products covered by the unit of certified products, the
certificate holder shall first make application.
The certification body shall check the consistency of the extended products against
the certified products and confirm the applicability of the original certification results
to the extended products and carry out, if necessary, the additional test or inspection
based on the differences.
After approval, either a separate certificate can be issued or the original certificate can
be updated at the request of the certificate holder.
5.3.2 The requirements for sample
The certificate holder shall first submit the technical documents related to the
extended products. And, if necessary, one sample may be required by the certification
body according to the requirements of Clause 4.2 of this Rules, for which the testing
items shall be decided by the certification body.
5.4 Suspension, cancellation and withdrawal of the certificates
The suspension, cancellation and withdrawal of the certificates shall follow
Regulations for Compulsory Product Certification.

6. Use of compulsory product certification mark

The certificate holder shall follow the Regulations for Compulsory Product
Certification Mark
6.1 Design of the mark allowed to use
The certification mark with letter reference S(as below) shall be used for
certification involving safety only:

10

The certification mark with letter reference S&E (as below) shall be used for
certification involving both safety and EMC:

6.2 Derivations of certification mark

The products listed in this Rules shall not be allowed to use any derivation of
certification mark.
6.3 Ways of use
Any of the following three ways is required: affixing standard-size marks (labels)
printed only by CNCA, printing on the nameplate or moulding.
6.4 Location of the mark
The certification mark shall be applied on an exposed location on the outer body of
the product.
The certification marks shall be applied separately on the main part(s) and split part(s)
of split-type air-conditioners and similar appliances.

7. Charge

The certification shall be charged by the certification body according to the national
statutory structural fee chart.

11

Appendix 1
Principles of defining application unit
Products
Principles of defining application unit
Household refrigerators, food 1. The application unit should be defined according to
freezers
type (refrigeration mode), structure and the rated input
power of the compressor.
2. The critical components having effects on EMC of the
products should be the same.
Electric fans
1. The application unit should be defined according to
type, structure and specifications (dimensions, power).
2. The critical components having effects on EMC of the
products should be the same.
Air-conditioners
1. The application unit should be defined according to type
and specifications.
2. The critical components having effects on EMC of the
products should be the same.
Motor-compressors
1. The application unit should be defined according to
type structure and specifications.
2. The critical components having effects on EMC of the
products should be the same.
Household washing machines

1.The application unit should be defined according to type

structure and specifications.
2.The critical components having effects on EMC of the
products should be the same.

Storage water heaters

The application unit should be defined according to type,

structure and specifications (power range).
Room Heaters
The application unit should be defined according to type,
structure and specifications (power range).
Vacuum cleaners
1.The application unit should be defined according to type,
structure and specifications.
2. The critical components having effects on EMC of the
products should be the same
Appliances for skin and hair 1. The application unit should be defined according to
care
type, structure and motor.
2.The critical components having effects on EMC of the
products should be the same.
Instantaneous water heaters
The application unit should be defined according to type
structure and specifications (power range).
Electric irons
1. The application unit should be defined according to
type, structure and specifications (power range).
2. The critical components having effects on EMC of the
12

products should be the same.

Electromagnetic Ovens
The application unit should be defined according to type,
structure and specifications (power range).
Roasters
and
similar The application unit should be defined according to type,
appliances
structure and specifications (power range).
Electric food processors
(Kitchen Machines)

The application unit should be defined according to type,

structure and specifications.

Microwave ovens

The application unit should be defined according to type,

structure and specifications (power range).
Appliances for heating liquids The application unit should be defined according to type,
structure and specifications (power range).
Cooking ranges, hobs and The application unit should be defined according to type,
ovens
structures and specifications (power range). The cooking
ranges, hobs and ovens should be in different application
units.
Range hoods
The application unit should be defined according to type
and structure.
Electric rice cookers
1.The application unit should be defined according to type,
structure and specifications (power range).
2. The critical components having effects on EMC of the
products should be the same.
Water dispenser
The application unit should be defined according to type,
structure and specifications.

13

Appendix 2

Household and similar use appliances

Standards and Scope of Product Certification
Product Scope

Household refrigerators, food freezers

(with effective volume less than 500L); Applies to refrigerators for
household and similar use with/without frozen compartment, frozen
food storage cabinet, freezer and their combination
Electric fans and Regulators
Applies to Electric fans with single-phase a.c or d.c for household
and similar use e.g. ceiling fan, table fan, pedestal fan, ventilating
fans, partition fan, wall fan, and their regulators
Air-conditioners
(Cooling capacity shall not exceed 21000 cal/h )

Standards for
certification
GB4706.1-92
GB4706.13-1998
GB4343-1995
GB17625.1-1998
GB4706.1-92
GB4706.27-92
GB4343-1995
GB17625.1-1998
GB4706.1-92
GB4706.32-1996
GB4343-1995
GB17625.1-1998
GB4706.1-92
GB4706.17-1996

Motor-compressors (input power less than 5000W)

Applies to sealed (hermetic and semi-hermetic type) motorcompressors for household and similar use
Household washing machines
GB4706.1-1998
Applies to washing machines with/without water heating function, a GB4706.24-2000
spin extraction function and with a drying function
GB4706.20-2000
GB4706.26-2000
GB4343-1995
GB1765.1-1998
Storage water heater
GB4706.1-92
Applies to storage water heaters intended for heating water to a GB4706.12-1995
temperature below its boiling point
Room Heater

GB4706.1-92

Applies to electric rooms heaters for household and similar GB4706.23-1996

purposes, e.g. radiation heaters, panel heaters, liquid-filled radiators,
fan heaters, convector heaters, tubular heaters
Vacuum cleaner

GB4706.1-1998

Applies to vacuum cleaners and electric water suction cleaning GB4706.7-1999

appliances, driven by either series or D.C. motor

GB4343-1995
GB17625.1-1998

Appliances for skin and hair care

GB4706.1-92

Applies to appliances with electric heating components for skin and GB4706.15-1996

14

hair care of both human and animal

GB4343-1995
GB17625.1-1998

Instantaneous water heater

GB4706.1-92

Applies to instantaneous storage water heaters intended for heating GB4706.11-1997

water to a temperature below its boiling point
Electric iron

GB4706.1-92

Applies to electric dry irons and steam irons for household and
similar purpose

GB4343-1995
GB17625.1-1998
GB4706.2-1996

Electromagnetic Cookers

GB4706.1-92

Applies to electromagnetic heating kitchen appliance for household GB4706.29-92

or similar purpose, which may contain electromagnetic heating
components single hob or hobs
Roasters and similar appliances: (rated volume less than 10L)
Including roasters, toasters, waffle irons and similar appliances.

GB4706.1-1998
GB4706.14-1999

Electric food processor

GB4706.1-92
Applies to household food preparation machines and similar
multiple-use food preparation machines, e.g. food mixers, cream GB4706.30-92
whippers, egg beaters, blenders, sieving machines, churns, ice-cream
machines including those for use in refrigerators and freezers, citrus
fruit squeezers, centrifugal juicers, mincers, noodle makers, berry
juice extractors, slicing machines, bean slicers, potato peelers,
graters and shredders, knife sharpeners, can opens, knives, food
processors, coffee mills not exceeding 500g hopper capacity, grain
grinders not exceeding 3 liters hopper capacity.
Microwave ovens

GB4706.1-92

Applies to appliances for heating food and beverages using GB4706.21-1996

electromagnetic energy (microwaves) in one or more of the I.S.M.
frequency bands over 300 MHz and intended for household use.
These appliances may also incorporate a browning or steaming
function.
Cooking ranges and similar appliances

GB4706.1-92

Applies to stationary electric cooking ranges, hobs, ovens and GB4706.22-88

similar appliances for household use. Examples are stationary grills
and griddles, pyrolytic self-cleaning ovens, induction hobs and
steam ovens.
15

Range hoods

GB4706.1-1998

Applies to electric range hoods intended for installing above GB4706.28-1999

household cooking ranges, hobs and similar cooking appliances,
with fans, lights and controls.
Appliances for heating liquids
Applies to appliances for heating liquids no more than 30L for
household and similar purposes, e.g. kettles, electric boiled pot,
cooking pans, milk heaters, tea kettles, coffee-makers, steam
cookers, water boilers, etc.
Electric rice cooker
Applies to automatic heat-preservation electric rice cooker with
timer.

GB4706.1-1998
GB4706.19-1999

GB4706.1-92
GB4706.6-1995
GB4343-1995
GB17625.1-1998

Water dispenser
GB4706.1-1998
Applies to water dispenser and similar appliances for heating and
GB4706.42-1999
cooling beverage.

16

Appendix 3
Sample quantity required for type testing
Product category

Quantities of major type sample for test

Household refrigerators, food freezers

Electric fans

Air-conditioner and dehumidifier

Motor-compressor

3
(including one locked-rotor sample and one
open-lid sample)

Household washing machines

Storage water heater

Room Heater

Vacuum cleaner

Appliances for skin and hair care

Instantaneous water heater

Electric iron

Electromagnetic Cooker

Toasters and similar appliances

Electric food processor

Microwave ovens

Cooking ranges and similar appliances

Range hoods

Appliances for heating liquids

Electric rice cooker

2
Note: If the test cannot be continued after the abnormal test, the applicant shall add
the samples.

17

Appendix 4
List of Critical Components in terms of Safety
Type

Name

Power
supply Supply cord assemblies
connection
Plugs
Supply cord

Switches
Controls

Luminaries

Capacitors
Protectors

Couplers
(including connector)
Connectors
Flat quick-connecting
devices
Switches
Starting relays
Temperature controls
Time controls
Electric controls
Electric valves
Energy regulators
Starting relays for
motors
Screw lampholders
Ballasts

Applicable
standards
GB15934
GB2099.1
GB1002
GB5013
GB5023
GB17465

12 sets
12
10
12

GB13140
GB17196

10
24

GB15092
GB14536
GB14536
GB14536
GB14563
GB14563
GB14563
GB14563

10
10
10
10
10
10
10
10

GB17935
GB15143
(electronic)
GB2313(inductive)
Starters
QB2276
Bayonet lampholders
GB17936
Flasher
&
starter GB1312
holders
Ballast
for
high- GB14045
intention
discharge
lamp
Capacitors
GB13667
Miniature
GB9364

18

Quantity

12
10

30
12
10
17

20
48 (cartridge
fuselinks) 66(su
p-miniature
fuse-links)

Thermal fuse
GB9816
60
Compressor
thermal GB14536
10
protector
Motor
thermal GB14536
10
protector
Windings
Motor
GB12350
2
Transformers
GB13028
7
Note: Required non-metallic materials:
All non-metallic materials on appliance should be resistant to heat, fire and tracking.
Two/three non-metallic materials components or five material plates (125132mm)
are required together with appliance samples.

19

Appendix 5
List of Critical components in terms of EMC
Product Name

Components

Refrigerators

Compressor*
Micro-computer control board ( including inverter) or
mechanical thermostat*
Electro-magnetic valve, defrost timer, power filter
Air Conditioner
Compressor*
Micro-computer control board ( including inverter) or
mechanical thermostat*
Electro-magnetic valve, negative ion generator, power
filter
Washing Machines
Micro-computer controls or programme controller*
Timer, electric motor, power filter
Electric rice cooker
Thermostat or temperature limiter*
Electronic controls, silicon controlled rectifier
Electric iron
Thermostat or temperature limiter*
Electronic controls, silicon controlled rectifier
Electric
Electronic controls*
fans(Electronic control DC motor
fans and DC fans)
Electronic controls*
Appliance for Skin
Motor
Power filter
and hair care
Electronic controls*
Vacuum cleaner
Motor
Power filter
Note: * indicates the component having important effects on EMC performance

20

Appendix 6
Compulsory Product Certification Requirements
for Factorys Quality Assurance Ability
Factory shall meet the requirements for factorys 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 consistently 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
21

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.
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 suppliers 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.
4.2 Where environment condition is required, factory shall meet the requirements.
4.3 Factory shall monitor and control appropriate process parameters and product
characteristics, as applicable.
4.4 Factory shall establish and maintain maintenance procedure for manufacturing
facility.
4.5 Production shall be inspected at appropriate stages of manufacture to ensure that
components, sub-assemblies, wiring runs etc. are in accordance with the certification
approved sample.
5. Routine Tests and Verification Tests
Factory shall establish and maintain documented routine tests and verification tests
procedures to verify and demonstrate that products are in accordance with relevant
requirements. The procedures shall include test items, contents, method, acceptance
criteria etc. Test records shall be maintained. Routine tests and verification tests shall
22

meet the requirements specified in relevant product certification implementation rule.

Routine tests are line tests performed on 100% of production and are normally carried
out at the final stage of manufacture. Normally no further operations, except for
labeling and packing, may be carried out after these tests.
Verification tests are tests in addition to the routine tests on samples taken randomly
in order to verify and demonstrate that products consistently meet standard
requirements.
6. Inspection and Test Equipment
The equipment used for inspection and test must be regularly calibrated and checked
for correct operation, and meet inspection and test capacity requirements.
6.1 Calibration and verification
Inspection and test equipment used for determining the conformity of the products
being manufactured shall be calibrated or verified on a regular basis. All calibrations
and verification undertaken on such equipment must be traceable to national or
international standards. Where no measurement standards exist, calibration method,
acceptance criteria, calibration interval etc. shall be documented. Calibration and
verification status of equipment shall be easily identified by user and management
personnel.
Calibration and verification records shall be kept.
6.2 Functional Check
The equipment used for routine tests and verification tests shall undertake an
functional check in addition to daily check. When functional check is found to be not
satisfying specified requirements, arrangements shall allow previous production to be
traced and re-tested if necessary,. Operator shall be instructed on what action is to be
taken if a functional test is found to be unsatisfactory.
The results of functional check and all subsequent corrective action taken must be
recorded.
7. Control of Non-conforming Product
Factory shall establish procedure of control of non-conforming product, which shall
includes identification method, segregation, disposal, corrective action and preventive
action. Repaired and reworked product shall be re-inspected. Records of repairing for
critical components or sub-assemblies and disposal of non-conforming product shall
be maintained.
8. Internal Audit
Factory shall establish documented internal audit procedure to ensure that product
quality system is implemented effectively and certified products compliance. The
results of internal audit shall be kept.
Factory shall keep a record of all complaints known, especially to a products
compliance with requirements of relevant standard, and make these complaints as one
of input information of internal audit.
Corrective action and preventive action shall be taken to detected nonconformities
23

and records shall be maintained.

9. Compliance with Certified Product
Factory shall control production to comply with the type-test approved product, to
make certified products consistently be in conformity with relevant standard
requirements.
Factory shall establish procedure to monitor changes of the critical component,
material, construction and factors that may affect compliance with relevant standard.
The changes on certified products must be notified to the issuing certification body
for authorization, prior to their implementation.
10. Packing, Handling and Storage
Finished products shall be packaged, stored and handled in such a way as to ensure
that they will continue to comply with the applicable standards.

24