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PAKISTAN CONFORMITY ASSESSMENT RULES, 2011

[Gazette of Pakistan, Extraordinary, Part-I, 27th September, 2011]

S.R.O. 113(KE)/2011, dated 26.2.2011.–In exercise of the powers conferred by Section 26 of the Pakistan Standards and Quality Control Authority Act, 1996 (VI of 1996) the Federal Government is pleased to make the following rules, namely:–

1. Short Title and Commencement.–(1) These rules may be called the Pakistan Conformity Assessment Rules, 2011.

2.         They shall come into force at once.

2.  Definitions.–(1) In these rules, unless the context otherwise requires,–

(a)        "Act" means the Pakistan Standards and Quality Control Authority Act, 1996 (VI of 1996);

(b)        "applicant" means a person who has applied to the Authority for a licence;

(c)        "competent authority" means any officer of the Authority designated as competent authority by the Director General under sub-section (4) of Section 7 of the Act;

(d)       "form" means a form annexed to these rules;

(e)        "inspection" means examination of product, process or plant for determination of conformity with specific requirements of relevant Pakistan standard;

(f)        "licensee" means a person to whom a licence has been granted under the Act;

(g)        "manufacture" means to produce, make-or manufacture, including process and operations of assembling, mixing, blending, cutting, diluting, bottling, packaging, repacking or preparation of goods in any other manner;

(h)        "manufacturer" means the manufacturer of any article or process;

(i)         "Regulations" means regulations made under Section 27 of the Act; and

(j)         "verification" means confirmation through the provision of objective evidence that specified requirement have been fulfilled.

(2)        The words and expressions used but not defined herein shall have the same meanings as assigned to them under the Act.

(3)        The general terms for standardization or procedures for assessment of conformity not defined herein and the Act shall have the same meaning as assigned to them in the relevant standardization system.

3. Licensing.–(1) Every manufacturer of the articles notified by the Federal Government under Sections 13 and 14 shall apply to the Authority for grant of licence.

(2)  Any manufacturer of the articles other than covered under sub-rule (1) may apply to the Authority for licence for voluntary conformity assessment.

4. Application for a licence.–(1) Every application for a licence shall be made in Form I duly filled-in, signed and accompanied by,–

(a)        application fee as prescribed by the Authority;

(b)        self evaluation cum declaration as specified in Form II; and

(c)        test report of sample of article as specified in sub-rule (3).

(2)        For every manufacturing unit of the articles notified under Sections 13 and 14, separate licence shall be required.

(3)        An applicant shall get sample of the article tested from any laboratory in Pakistan recognized by the Authority or any laboratory abroad covered under a mutual recognition agreement with the Authority.

5. Initial scrutiny of licence application.–(1) On receipt of an application for a licence and its enclosures by the Authority, the same shall be numbered in order of its receipt and acknowledged to the applicant.

(2)        The Authority shall after scrutinizing the application in accordance with provisions of rule 4, process if further:

Provided that the Authority may reject the application for grant of licence if it is not in accordance with the provisions of Rule 4.

(3)        After initial scrutiny of the application for licence under sub-rule (2), the Authority may require, any further information or data from the applicant for substantiating the information contained in the application within the specified time not exceeding one month. In case of non-submission of the requisite information or data within specified time the application may be summarily rejected.

(4)        After scrutiny of information gathered under sub-rule (3), the Authority, may further process the application or reject the same after recording reasons in writing and communicating the same to the applicant.

6.         Inquiry.–After processing of the application for licence under sub-rule (4) of Rule 5, the Authority, keeping in view the relevant Pakistan standards specification requirements, shall,–

(a)        require evidence that the article or process in respect of which a licence has been applied for, conforms to the relevant Pakistan standard;

(b)        require evidence that the applicant has in operation a scheme or routine inspection and testing, which will adequately ensure that all marked products shall conform to the relevant Pakistan standard;

(c)        direct an inspector to inspect all the concerned premises of the applicant for verifying the statement and contents made in the application;

(d)       for the purpose of clause (a), may direct the applicant to submit samples, at his own cost, to such testing authority as the Authority may consider appropriate; and on the basis of any report received under clauses (c) or (d) or both, require the applicant to carry out such alterations or additions, in the scheme of inspection and testing or the process of manufacturing product with in the specified time, failing to which the application shall be rejected.

7.         Inspection.–The Authority after being satisfied on the inquiry under Rule 6 may proceed further conduct inspection rule 24 and thereafter issuing licence.

8.         Verification visit.–After submission of report of the inquiry and inspection by the Inspector under Rule 7, the Authority may authorize any senior officer to verify the report of the Inspector.

9.         Final scrutiny.–(1) After report of the inspection or verification visit, as the case may be, the application with all the documents shall be sent to the competent authority for further processing.

(2)        After examining the case if the competent authority is satisfied it may grant the licence to the applicant or may require further scrutiny and analysis of the case.

(3)        In case the competent authority requires further scrutiny and analysis, it may refer the case to the concerned officer who shall re-examine the case or conduct further verification in the light of the observation of the competent authority and submit his report to the competent authority:

Provided that the competent authority may call for any other information or record through a notice in writing giving not les than fourteen days for providing such information or record. In case the information or record is not provided the application may be rejected.

(4)        After the receipt of report under sub-rule (3) the competent authority considers that the case is not fit for the grant of licence, it may give the applicant a reasonable opportunity of being heard either in person or through a duly authorized representative and may either grant the licence or reject the application.

10. Grant of licence.–(1) Where the competent authority is satisfied, that the application is a fit case to use a Pakistan standard mark, he may approve grant of licence authorizing the use of Pakistan standard mark in respect of the article or process subject to such terms and conditions as the Authority may deem fit to specify:

Provided that where an application has been made for licence and commercial production of the article has not been commenced, the Authority may issue provisional licence for a period of three months.

(2)        A licence shall be granted in the Form annexed as Form III for a period not exceeding one year.

(3)        Where licence is granted, it shall be notified by the Authority in any manner as deemed appropriate, specifying particulars of the licence and such particulars shall be entered in a register maintained under Rule 29.

(4)        The Authority may during the period of validity of the licence, on thirty days notice to a licensee, and affording the licensee the opportunity of explaining his position alter any terms and conditions subject to which the licence has been granted.

(5)        The licence shall be non-transferable.

(6)        The Authority may refuse to grant a licence, if in its opinion the licence applied for is liable to be abused.

11.       Renewal of Licence.–(1) The Authority may renew the licence if an application in Form IV is made by the licensee at least one month before expiry of the licence.

(2)        The licence may be renewed for a further period of two years on every occasion if the licencee is eligible for the same.

(3)        Where any action under any provision of the Act or rules is pending against the licensee, renewal of his licence may be deferred for such period as deemed appropriate by the Authority.

(4)        In case the Authority decides not to renew any licence, it shall give the licensee a notice of not less than fourteen days of its intention to do so.

(5)        The licensee may submit his explanation, if any, within aforesaid notice period and the same shall be considered by the Authority and a hearing shall be given to him within fourteen days from the date of receipt of such explanation.

(6)        In case of failure of the licensee to submit his explanation within the prescribed time limit or the explanation submitted by him is not found satisfactory, the Authority may, on expiry of the notice period, allow the licence to lapse and an intimation together with the reasons thereof in writing shall be sent to the licensee under acknowledgement.

(7)        The licensee shall not use Authority's mark, in case his licence lapses or its renewal is deferred under sub-rule (3).

12. Conditions of licence to use Pakistan standard mark.–(1) The Pakistan standard mark of conformity shall only be used by the licensee having valid licence for such articles or process for which the licence has been granted.

Provided that no licensee shall use Pakistan standards mark unless the article conforms to the relevant Pakistan standard.

(2)        The licensee shall apply the Pakistan standard mark in a prominent manner that is easily visible and distinct on the article or the liable thereon or container or the lable thereof.

(3)        In case article or the process which cannot be packaged, the self-declaration of the licensee bearing the words "Declaration-Conforming to PS_________, Licence number _____________ “and the Pakistan standard mark shall be attached with every consignment dispatched from the premises of the licencess.

(4)        No person other than the person who is in possession of a valid licence shall make a publicity through advertisements, sales promotion leaflets, price-lists or the like that his article conforms to the Pakistan standard or make such a declaration on the article as under sub-rules (2) and (3).

(5)        In no case the Pakistan standard mark shall be used as logo in any form or manner by the licensee.

(6)  In any case of suspension, cancellation, withdrawal and expiry of licence and any pending process thereto, the licensee shall forthwith stop marking his articles or processes with the Pakistan standard mark:

Provided that in case of pending renewal and withdrawal of licence on the request of licensee under clause (b) of sub-rule (1) of Rule 15, he will continue to use Pakistan standard mark unless directed by the Authority not to do so.

13.  Suspension of a licence.–(1) The licence may be suspended for a limited period in any of the following cases, namely,–

(a)        non-conformity with the requirements of such a nature that immediate cancellation or withdrawal is not necessary ;

(b)        non-payment of any fees specified by the Authority;

(c)        improper use of the licence or the Pakistan standard mark;

(d)       contravention of the product certification scheme, the Act, the rules and regulations; and

(e)        non-compliance with any directives issued by the Authority in relation to conformity assessment.

(2)        A licence may be suspended by the Authority on written request from the licensee, if the operations in his premises can no longer be carried on due to any reason beyond his control that may include but not restricted to:–

(a)        natural calamities such as flood, fire, earthquake etc;

(b)        a lock-out; or

(c)        closure of operations directed by the Court or competent authority.

(3)        The suspension of licence shall be communicated to the licensee through any mode ensuring acknowledgement of receipt and the communication shall specifically mention:–

(a)        licence no;

(b)        description of article, its brand name and relevant Pakistan standard;

(c)        date of suspension ;

(d)       duration of suspension;

(e)        reasons of suspension;

(f)        remedial measure to undo suspension; and

(g)        time frame for taking remedial measures.

(4)  When the period of suspension is over or the conditions to be fulfilled by the licensee are met with, the Authority shall, prior to the re-instituting of the licence, satisfy itself by verification or otherwise that the conditions and requirements as stipulated in the suspension order have been complied with.

14.  Cancellation of a licence.—(1) The Authority may cancel the licence on any of the following grounds, namely :–

(a)        non-conformance of article or process established after in house or independent testing ;

(b)        expired licence;

(c)        non-availability of testing personnel or arrangements therefor;

(d)       significant modifications in the manufacturing process, plant, machinery etc. without prior evaluation and approval of the Authority;

(e)        relocation of plant and machinery;

(f)        non-payment of any fee specified by the Authority;

(g)        prolonged closure of factory;

(h)        marking non-conforming products; or

(i)         non-compliance to any of the terms and conditions of the licence.

(2)        Before the Authority cancels any licence it shall give the licensee a notice of not less than fourteen days of its intention to cancel the licence, alongwith a statement of the reasons for doing so:

Provided that in case of expired licence even if a notice under sub-rule (2) is not served or no renewal application is received, the licence shall be deemed to have been cancelled, by the Authority after sixty days of its expiry.

(3)        On receipt of notice under sub-rule (2), the licensee may submit an explanation to the Authority within notice period and where an explanation is submitted the Authority may consider it and give hearing to the licensee within fourteen days from the date of receipt of such explanation.

(4)        Where no explanation is submitted, the Authority may, on expiry of fourteen days of receipt of notice by the licensee, cancel the licence without any further notice.

(5)        In case the licensee submits an explanation and the Authority is satisified with contention of the licensee during the personal hearing under sub-rule (3) it shall withdraw the notice or cancel the licence.

(6)        Notwithstanding that an appeal is pending under Section 18 of the Act against cancellation of licence, the licensee shall forthwith stop use of Pakistan standard mark.

15. Withdrawal of licence.–(1) A licence may be withdrawn on the following grounds, namely :–

(a)        in case the licensee that obtained licence under sub-rule (2) of Rule 3 fails to comply with any of the provisions of the Act, rules and regulations or any of the Authority's directives; or

(b)        written request of the licensee expressing the reasons for which he does not wish to continue with the licence.

(2)  Where the Authority decides to withdraw a licence at its own initiative under clause (a) of sub-rule (1) the procedure prescribed in Rule 14 shall be followed.

16. Publication in official Gazette.–When a licence has been suspended or cancelled or withdrawn, the Authority shall publish, in the official Gazette, the particulars of the licence so suspended or cancelled or withdrawn.

17. Appeal.–An appeal under sub-section (1) of Section 8 shall, within thirty days and after payment of a fee of rupees five thousand, be preferred to the Court of sessions within whose jurisdiction the order has been passed.

18. Fees.—(1) All the fees payable under the Act shall be paid to the Authority with in the time and manner as specified, from time to time, by the authority.

(2) Where a-licensee fails to pay the marking fee or any part thereof within stipulated time as specified under sub-rule (1) shall in addition to the fee payable, pay late payment charges at the rate of three percentum over and above prevailing market rate of that year.

(3) No fee or part thereof paid to the Authority on account of application fee, licence fee or advance marking fee against cancelled and withdrawn licence in no circumstance shall be refunded.

(4) Notwithstanding cancellation or withdrawal of licence under Rules 14 and 15, the licensee shall be liable to clear all sums payable to the Authority at the time of cancellation or withdrawal of the licence.

19. Non-payment of marking fee.–(1) The Authority may through a notice of not less than fourteen days direct the licensee defaulting on account of payment of marking fee as prescribed under sub-rule (1) of Rule 16, or stop marking the articles or process with the Pakistan standard mark:

Provided that even after expiry of the notice period where the licensee continues to mark the articles with Pakistan standard mark, the Authority after serving another notice of seven days may stop manufacturing of such articles:

Provided further that the Authority after expiry of the notice period shall initiate action for recovery of outstanding dues in a manner as prescribed under sub-section (3) of Section 29.

(2)  The resumption of marking of article with Pakistan standard mark shall be permitted after the dues have been paid in full or in part as agreed by the Authority.

20.       Withdrawal of Pakistan standards.–(1) When Pakistan standard is withdrawn and not superseded by any other Pakistan standard, any licence issued in respect thereof shall be deemed to have been cancelled from the date of withdrawal of such Pakistan standard and any such licence shall be surrendered to the Authority by the licensee.

(2)  In case of cancellation of licence under sub-rule (1) the part of the marking fee, if paid in advance, proportionate to the un-expired period of the licence may be refunded to the licensee.

21.       Revision of Pakistan standard.–In case any Pakistan standard for which licence has been granted has been revised, the Authority shall notify such revision to respective licensee specifying therein the effective date from which the standard shall come into effect:

Provided that transition period for conformance of article or process to the revised Pakistan standard shall not be less than sixty days from the notification sent to the licensee.

Provided further that incase revision of Pakistan standard is done on account of human health, safety, and environmental concerns, the Authority may require immediate conformance with the revised Pakistan standard.

22.       Inspectors. —(1) The Authority may designate such officers of the Authority as Inspectors under sub-section (1) of Section 15, as it may consider necessary.

(2)        While appointing an Inspector the Authority shall consider the competence of the Inspector with relation to the assignment and the criteria specified by International Standardization Organizations.

(3)        Every Inspector shall be furnished by the Authority with a certificate of designation as an inspector in Form V. The certificate shall be carried by the Inspector at all times while he is on duty and shall, on demand, be produced by him.

23.       Powers of Inspectors. —(1) For the purpose of performing the duties imposed on him by or under Section 15 of the Act, an Inspector rnay,–

(a)        at any time during the usual business hours enter upon any premises in which any article or process in respect of which a licence has been granted under these rules with a view to ascertain that the Pakistan standard mark is being used in accordance with its terms and conditions and that the scheme of routine inspection and testing specified by the Authority is being correctly followed;

(b)        inspect and take samples at such premises of any such article or any material used or intended to be used in the manufacture of such article which is marked with a Pakistan standard mark;

(c)        inspect any process at such premises in respect of which the licensee has been given the authority to use the Pakistan standard mark.

(d)       examine the records kept by licensee relating to the use of the Pakistan standard mark;

(e)        enter into, and search any place, premises or conveyance for such article or process contravening provisions of Sections 10 or 11 or 14 of the Act as provided in Section 15; and

(f)        seize any article and any other thing as provided in Section 15 where as a result of search made under clause (e), such article or process has been found in relation to which contravention of Sections 10 or 11 or 14 of the Act has taken place.

(2)  For carrying out inspections for the purpose of the Act these rules every person shall afford to the inspector such reasonable facilities that inspector may require for discharge of his duties.

Provided that any person who impedes or hinders inspector in discharge of his duties under the Act these rules shall be liable to penal action as provided under the Act.

24. Procedure for inspection.–(1) The Authority shall depute an Inspector or Inspectors to conduct an inspection for grant, renewal or surveillance of a valid licence with regard to conformity of an article or process with the Pakistan standards and compliance with the terms and conditions of the licence.

(2)  The Authority may, on request of the Inspector or otherwise associate with him any person who has adequate technical qualification, experience and knowledge in that field or task assigned to the Inspector.

(3)        The Inspector or the Inspectors shall observe following procedure, namely:–

(a)        for inspection of the premises of the licensee or applicant, he shall whenever possible, give reasonable notice of visit to the licensee or applicant;

(b)        if during an inspection it is required to take one or more samples of any articles, material or substance, the same shall be done in presence of the licensee or the applicant or their agent;

(c)        the samples drawn under clause (b) for each article or item shall be three in number and shall be affixed with official seal and label containing complete information of the article, material or substance;

(d)       one sample out of samples as drawn under clause (b) shall be left with the licensee or the applicant and the rest shall be deposited with the Authority for further processing;

(e)        give a receipt for a sample taken and retain a duplicate copy of the receipt duly signed by the person in whose presence the sample is drawn; and

(f)        in case the licensee objects to the sampling by the Inspector or demands a joint sampling the three joint samples shall be drawn each affixed with official seal along with the identification of the person drawing samples with the Inspector and the process by which sample is drawn.

(4)        The Inspector may take samples of articles marked with the Pakistan standard mark from the godowns or any such premises of any agent of the licensee or from the articles put up for sale in the open market by the licensee or his agent.

(5)        The Inspector shall submit to the Authority a detailed report of every inspection made by him incorporating impression of the seal and details of identifications of the sample.

(6)        The Authority shall arrange at least two inspections a year in respect of each licensee.

25.       Procedure for inspection in case of unauthorized use of Pakistan standard mark.—Where there are reasons to believe that a Pakistan standard mark has been or is being used in violation of any provision of the act, rules and regulations, the Authority may direct its Inspector to make an inspection in accordance with Rule 24 and take necessary action as deemed appropriate.

26.       Report of seizure and detention.–(1) Where any Inspector makes any seizure or detention of the article or process, as the case may be he shall within forty-eight hours of seizure or detention make full report of all the particulars of such seizure and detention to the Authority.

(2)  The Authority on such report may confirm the seizure or detention or otherwise. If the same is not confirmed the Inspector shall forthwith comply with the direction of the Authority.

(3)  On the confirmation of seizure or detention the Authority shall give directions with regard to the custody of articles seized or detained.

27.       Inspection of the article or process when Pakistan standard mark or conformity to Pakistan standard is required by the Act or under any other law.–(1) The Authority may carry out inspection, though its Inspector or agent, of articles or processes for use of Pakistan standard mark and or for which conformance with Pakistan standard is required or claimed under the Act or any other law for the time being in force.

(2)        Inspection under sub-rule (1) may be carried out at place of manufacture, sale or use in Pakistan or at place of entry into Pakistan.

(3)        Such inspections may cover quality control system, verification of laboratory records or testing of samples or any other related matter.

(4)        The Authority shall be paid fees in advance for such inspection and expenses of travelling allowances, daily allowances and the like as may be mutually agreed.

28. Certificate.–(1) The Authority may issue a certificate on the receipt of an application alongwith prescribed fee and any relevant information as required by the Authority for the purpose of conformity assessment of article or process with relevant standard as requested for.

(2)        On receipt of the application, the Authority shall depute an Inspector for carrying out inspection of the article or process for which application is made. The inspector shall follow the procedure laid down in sub-rules (3) to (5) of Rule 24.

(3)        If the Authority is satisfied with the report of the inspector, it shall issue the non-transferable certificate as set out in Form-VI.

29. Registers.–The Authority shall maintain a register of licences which shall record in respect of each licence the following information, namely :–

(a)        name, address and business of each licensee;

(b)        licence No., date of its issue and validity;

(c)        the article or process covered by the licence;

(d)       the number and title of relevant Pakistan standard;

(e)        information regarding, renewal suspension, withdrawal of cancellation;

(f)        the number of licences held by each licensee; and

(g)        fees payable and paid by the licensee.

30.  Repeal.—The Pakistan Standards Conformity Assessment Rules, 2008 are hereby repealed.

See the Forms in Gazette of Pakistan at pages 557 to 570.