(CQC/PDC021-2005)
The 1st edition, edit the 0th times
The first factory is to make sure the product that obtain evidence accords with the person that product certification carries out regular the first responsibility.
The attestation product with the consistent sample that the 2nd factory should assure to ability asks production and classics attestation orgnaization affirm qualification according to product certification executive regulation and factory quality.
The 3rd factory should understand attestation orgnaization in time to make public the information in the file and requirement on the net.
The 4th factory should be built and carry the program that includes the following file to change at least or provision, content should manage with factory quality and product quality control suits:
(one) the program of custodial use control that attestation indicates;
(2) product change controls a process;
(3) file and data control program;
(4) quality record controls a process;
(5) supplier choice assess and day-to-day government program;
(6) crucial of parts of an apparatus and yuan of material examine or program of test and verify;
(7) crucial of parts of an apparatus and yuan of material affirm checking program regularly;
(8) system of manufacturing facilities care and maintenance;
(9) routine examines and affirm checking program;
(10) reject controls a process;
(11) program of in-house quality examine and verify;
(12) the duty of the of all kinds personnel that concerns with quality activity and correlation;
In addition, due still and necessary craft work instructor, examine system of operating rules of equipment of standard, instrument, management.
The 5th factory should be saved include the following quality record at least, in order to confirm the factory undertook full manufacturing inspection and production experiment really, quality records should true, effective:
(one) the record that has choice, assess and day-to-day government to the supplier;
(2) crucial the receiving inspection of parts of an apparatus and yuan of material / the eligible proof that record of test and verify and supplier offer;
(3) product routine examines and affirm examine record;
(4) the record that examines to undertake calibration or calibrating regularly with test equipment;
(5) routine examines and affirm examine the record that equipment runs an examination;
(6) of reject deal with record;
(7) the record of in-house examine and verify;
(8) the client is complained reach take the record that corrects measure;
(9) component affirms regularly examine record;
(10) the mark uses executive circumstance to record;
(11) move those who examine is unqualified correct a record;
The storage life of the record should not be less than the time-interval between the examination twice, namely at least 24 months, record with ensuring what after this second examination is over, arise is all, can check when be checked next time.
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