DEPARTMENT ADMINISTRATIVE ORDER NO. ____ Series of _____ SUBJECT: THE NEW RULES AND REGULATIONS CONCERNING THE PRODUCT

CERTIFICATION SCHEME OF THE BUREAU OF PHILIPPINE STANDARDS (BPS)

Pursuant to the provisions of R.A. No. 4109, R.A. No. 7394 and E.O. No. 913 Series of 1993, the following rules and regulations governing the BPS Product Certification Scheme are hereby prescribed and promulgated for the compliance, information and guidance of all concerned.

1. SCOPE 1.1 This Department Administrative Order prescribes the rules and regulations on

Product Certification Scheme for all products under BPS technical regulation, whether locally manufactured/assembled or imported. The objective of the Product Certification Scheme is to ensure that products designated under technical regulation meet the specified safety requirement/s consistent with a mechanism of safeguarding impartiality set forth in ISO 17065.

2. DEFINITION OF TERMS For purposes of this Order, the following definitions shall apply: 2.1 Audit - a systematic, independent and documented process for obtaining audit

evidence, and evaluating it objectively to determine the extent to which the audit criteria are fulfilled.1

2.2 Audit criteria – set of policies, procedures or requirements used as a reference against which audit evidence is compared.2

2.3 Attestation – issuance of a statement of conformity based on a decision following

review of an audit report, that fulfillment of specified requirements has been demonstrated.3

2.4 Accredited Conformity Assessment Body (CAB) – inspection body, testing

laboratory or certification body accredited under ISO/IEC 17020, ISO/IEC 17025 or ISO/IEC 17065, respectively, in its relevant updated version/edition by the Philippine Accreditation Bureau (PAB) or by an accreditation body that is a

1ISO 19011:2011 2Ibid. 3ISO/IEC 17000

BUREAU OF PHILIPPINE STANDARDS Membership 3F, Trade and Industry Building International Organization for Standardization(ISO) Sen. Gil J. Puyat Avenue, Makati City, Philippines Enquiry Point for WTO Technical Barriers to Trade (WTO-TBT) (632) 751-3123; 751-4736 Fax: (632) 751-4706 E-mail Address: bps@dti.gov.ph Website: www.bps.dti.gov.ph

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signatory to regional/international agreements entered into by the Government of the Republic of the Philippines through DTI (i.e. APLAC, ILAC, IAF)

2.5 Accredited Testing Laboratory and/or Inspection Body – a body accredited under

ISO/IEC 17025 and ISO/IEC 17020 or its future amendment/s by the PAB or by an accreditation body that is a signatory to regional/international agreements entered into by the Government of the Republic of the Philippines through DTI (i.e. APLAC, ILAC), and any other testing laboratory allowed by BPS (i.e. under Mutual Recognition Agreements with ASEAN, APEC).

2.6 BPS – Bureau of Philippine Standards of the Department of Trade and Industry 2.7 BOC – Bureau of Customs of the Department of Finance 2.8 Conformity Assessment Body (CAB) – a third party inspection body, testing

laboratory and certification body operating within its scope of competence.

2.9 Certification Body – third party conformity assessment body operating a certification scheme.

2.10 Commercial Quantity – presumed if the quantity of the shipment of the product is

greater in amount than the quantity required for sampling for testing.

2.11 Conformity – fulfillment of a requirement4. 2.12 DTI – Department of Trade and Industry 2.13 Determination – include assessment activities such as testing, measuring,

inspection, design appraisal, assessment of services, and auditing to provide information regarding the product requirements as input to the review and attestation functions.

2.14 Evaluation – systematic examination of the extent to which a product, process, or

service fulfills specified requirements.5

2.15 FTEB - Fair Trade Enforcement Bureau of the Department of Trade and Industry 2.16 International Standard – a standard developed under the WTO principles for

international standards development such as those developed by international bodies like the International Organization for Standardization (ISO), International Electrotechnical Commission (IEC), International Telecommunication Union (ITU) and those developed by foreign standards bodies under these principles.

2.17 Certificate of Conformity – a document issued by BPS or its recognized

certification body attesting that an imported/manufactured/assembled product conforms to the requirements of the applicable Philippine National Standard (PNS) or international/foreign standard identical to the applicable PNS.

4ISO/IEC 17000 5Ibid.

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2.18 Batch Certification – authority given by BPS to an importer/local applicant allowing the use of the certification mark by affixing the BPS issued sticker on its imported/manufactured products/commodities.

2.19 Inspection – examination of a product, process, service, or installation or

their design and determination of its conformity with specific requirements, or, on the basis of professional judgment, with general requirements.6

2.20 Inspection body – a body that performs inspection.7 2.21 ISO – International Organization for Standardization

2.22 ISO/IEC 17020 – Conformity assessment – Requirements for the operation of

various types of bodies performing inspection

2.23 ISO/IEC 17025 – General requirements for the competence of testing and calibration laboratories

2.24 ISO/IEC 17065 – Conformity assessment – Requirements for bodies certifying

products, processes and services. 2.25 ISO 19011 - Guidelines for Auditing 2.26 ISO 9000 - Quality Management System - Fundamentals and Vocabulary 2.27 ISO/IEC 9001 – Quality Management Systems – Requirements

2.28 License – a document issued by BPS authorizing a company to use the product

certification mark, as described herein.

2.29 Own Use/Personal Use – a declaration under oath by the applicant that the locally made or imported products, are not for sale, distribution, and supply in the Philippine market but is intended for private use and consumption only.

2.30 PS License – authority given by BPS to a local/foreign manufacturer/assembler,

authorizing the use of the Philippine Standard (PS) Certification Mark on its product.

2.31 PAB - Philippine Accreditation Bureau of the Department of Trade and Industry 2.32 Philippine National Standards (PNS) – Standards promulgated by the BPS. 2.33 Product certification – the provision of impartial third-party attestation that

fulfillment of specified requirements have been demonstrated.11 2.34 BPS Recognized Conformity Assessment Body (CAB) – the Accredited CAB

(inspection body, testing laboratory, or certification body) duly qualified by BPS to have the accredited scope and competence to conduct activities relevant to the requirements set forth by BPS, to include but not limited to, CABs recognized by BPS under the ASEAN MRA, APEC MRA and other regional and bilateral MRAs

6 ISO/IEC 17020 7 Ibid. 11ISO/IEC 17065

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entered into by the Government of the Philippines through the Department of Trade and Industry.

2.35 Review – verification of the suitability, adequacy and effectiveness of selection

and determination activities, and the results of these activities, with regard to fulfillment of specified requirements.12

2.36 Sampling – a method of getting a representative sample of a product shipment

according to a specified procedure.

2.37 Self-Declaration of Conformity – first-party attestations that fulfillment of specified requirements has been demonstrated.13

2.38 Surveillance – a systematic iteration of conformity assessment activities as a

basis for maintaining the validity of the statement of conformity.14 2.39 Scheme type 1b – this scheme type involves the certification of a whole batch of

products, following selection and determination as specified in the scheme. 15 If the outcome of the determination is positive, all items in the batch may be described as certified and may have a mark of conformity affixed. However, future batches of the product are not covered by the same certification.

2.40 Scheme type 5 – the surveillance part of this scheme allows for the choice between periodically taking samples of the product either from the point of production, or from the market, or from both, and subjecting them to determination activities to check that items produced subsequent to the initial attestation fulfill the specified requirements. The surveillance includes periodic assessment of the production process, or audit of the management system, or both. The extent to which the four surveillance activities are conducted may be varied for a given situation, as defined in the scheme. If the surveillance includes audit of the management system, an initial audit of the management system will be needed.16

2.41 Test Report – a document that presents test results and other information

relevant to a test. 2.42 Testing Laboratory – a laboratory which measures, examines, or determines the

characteristics of performance of material or products. It may also be a laboratory that calibrates inspection, measuring and test equipment.

2.43 Third Party – a body that is independent of the organization that provides the

product/service and is not the user of the product/service17 (testing, inspection, sampling).

3. CATEGORY OF PRODUCTS UNDER PRODUCT CERTIFICATION SCHEME

12ISO/IEC 17000 13 Ibid. 14 Ibid. 15ISO/IEC 17067 16Ibid. 17ISO/IEC 17000

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3.1 Mandatory Certification – products that pose a threat to health, life and safety and shall undergo mandatory certification from BPS as set forth in Annex A.

3.2 Mandatory Labeling with Self-Declaration of Conformity – products as set forth in

Annex B. All markings and labels shall be clear and legible and shall not be misleading and shall form an integral part thereof without danger of being erased or detached under ordinary handling of the products. The applicable PNS shall be used as reference in validating the information stated on the label under this scheme.

3.3 Voluntary Self-Declaration of Conformity – a company may, at its option, provide a statement relative to product conformity to a specific PNS for products not otherwise covered by clauses 3.1 and 3.2 herein using the format provided in Annex C.

4. APPLICATION FOR PRODUCT CERTIFICATION SCHEME

Application for Product Certification shall be made using forms obtainable from BPS or the nearest DTI Regional/Provincial Offices. The manufacturer or importer shall file the application together with the following documents:

4.1 Products Manufactured/Assembled in the Philippines or in other Countries under the PS Certification Scheme

4.1.1 Duly accomplished application form, subscribed and sworn to by

the applicant, or his duly authorized management representative (in case of an overseas applicant, the application form shall be duly authenticated by the Philippine Consul in the place where the manufacturing plant to be audited is located);

4.1.2 For a sole proprietorship: latest Tax Declaration and permit issued

by the local government unit having jurisdiction (submitted once a year valid until 31st of December regardless of date of submission unless an amendment has been made);

For a corporation or partnership: SEC Registration and Articles of Incorporation and By-Laws, (submitted once within the validity period of the License, unless an amendment has been made);

4.1.3 Quality Management System Manual covering the product being

applied for Batch Certification and PS License, including the product/s’ production process; and,

4.1.4 Oath of Undertaking to abide by the Terms and Conditions of the CoC and License, signed by the manufacturer/assembler prior to the approval and release of the Batch Certification and PS License.

4.2 Imported or Locally Manufactured Products Under the Batch Certification Scheme

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4.2.1 Duly accomplished application form, subscribed and sworn to by the applicant, or its duly authorized management representative;

4.2.2 Packing List; 4.2.3 Bill of Lading (if applicable); 4.2.4 Commercial Invoice; 4.2.5 DTI Business Registration Certificate for sole proprietorship

(submitted once a year valid until 31st of December regardless of date of submission unless there are changes);

4.2.6 SEC Registration Certificate and Articles of Incorporation

(submitted once a year valid until 31st of December regardless of date of submission, unless amended);

4.2.7 Summary of Batch Numbers/Serial Numbers of the product(s)

covered by the mandatory standard; 4.2.8 Special Power of Attorney (in cases where the ICC application is

filed by person with managerial/supervisory capacity connected with a sole proprietor or partnership authorizing him to process said application). Only one representative shall be designated. In case of a partnership, the representative shall be an organic employee of that company, with managerial/supervisory capacity (submitted once a year valid until 31st of December regardless of date of submission unless the authority is expressly revoked in writing);

4.2.9 For a corporation, a notarized Board Resolution or a notarized

Secretary’s Certificate clearly setting forth the authority of the person dealing with the Bureau of Philippine Standards shall be submitted (submitted once a year valid until 31st of December regardless of date of submission unless a new representative is designated);

4.2.10 The applicant may, at its option, designate in writing a licensed

Customs Broker duly accredited by the Bureau of Customs to process the application. Provided further that, the same Customs Broker merely acts as an agent of the applicant and the latter, as principal, remains to be the party primarily liable for all submissions. Provided finally that, all documents shall be in the name of the principal and the Customs Broker is designated as such. The application and all import documents shall be in the name of the principal;

4.2.11 List of distributors/retailers with their complete addresses and

contact details. 4.2.12 Proof of ownership or contract of lease of office and warehouse,

whichever is applicable.

5 PROCESSING OF APPLICATION

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5.1 Products Manufactured/Assembled in the Philippines or in other Countries

under the PS Certification Scheme

Processing of application under this scheme, known as Scheme type 5 per PNS ISO/IEC 17067, shall replace the PS Scheme under DAO 4:2008 subject to the requirements and transitory provision stated herein. 5.1.1 The application shall be standard-specific, site-specific, and brand-specific.

However, a separate application shall be filed for the same product but manufactured at different plant site/s.

5.1.2 Factory and Product Audit 5.1.2.1 Assessment on conformity of QMS to ISO/IEC 9001 or equivalent

QMS (e.g. TQM, QS9000, Six Sigma) and product specifications to specific PNS shall be conducted upon submission of complete documentary requirements and evaluation that an applicant has satisfactorily complied with requirements herein; and,

5.1.2.2 Audit work shall be undertaken by BPS or its duly recognized inspection bodies and/or certification bodies in accordance with the established procedure on the conduct of the audit (Annex D). Designated auditors shall be among the auditors listed by BPS.

5.1.2.3 During the audit, samples shall be drawn for independent testing

to be submitted to the BPS recognized testing laboratory samples to be drawn shall cover all types/models being applied for certification.

5.1.3 The PS License shall only be issued upon satisfactory results of evaluation

of the factory audit report and after determination of product compliance with specific PNS based on pertinent test report.

5.1.4 If the applicant has outsourced its production process to a plant site located overseas, the PS License’s terms and conditions shall remain solely with the holder thereof.

5.1.5 The PS License shall take effect from the date of its issue and shall be in full force and effect for a period of three (3) years, subject to a minimum annual surveillance audit either at the factory and/or at the market. At any time, the PS License can be suspended, withdrawn or cancelled for cause.

5.1.6 The PS License holder shall coordinate with BPS or the DTI Regional/Provincial Office in writing the schedule of the re-certification audit at least six (6) months before the expiration date to facilitate the renewal of the PS License. Otherwise, the PS License shall be considered as having expired immediately after end period of its validity.

5.2 Imported or Locally Manufactured Products Under the Batch Certification Scheme

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Processing of application under this scheme, known as Scheme type 1b per PNS ISO/IEC 17067, shall replace the ICC Scheme under DAO 5:2008. Batch Certification shall be issued in lieu of the Import Commodity Clearance (ICC).

5.2.1 Scheme type 1b shall be used as follows:

5.2.1.1 For imported products, the application for a Batch Certification

shall be on a per product, per Bill of Lading/Airway Bill basis. A separate application shall be filed for the same product under a different Bill of Lading or for same Bill of Lading/Airway Bill but different product.

5.2.1.2 For locally manufactured products, the application for a Batch Certification shall be on a per product per production batch/lot basis. A separate application shall be filed for the same product but different production batch/lot or the same production batch/lot but different product.

5.2.1.3 The application for Batch Certification may be filed under the following options:

Option 1: Application with valid test report/s Option 2: Application without valid test report/s Option 3: Application with reports of advanced testing Option 4: Application with Certificate of Conformity from other

BPS Recognized Certifying Bodies Option 5: Application prior to loading or shipment

5.2.1.2.1 Option 1: Application with valid test report/s

5.2.1.2.1.1 Application with a valid test report in accordance with the

validity requirements in Section 8 of this Order shall be accepted and processed and the Batch Certification with corresponding sticker/s shall be issued upon satisfactory compliance of all administrative provisions and documentary requirements and payment of the required fees.

5.2.1.2.2 Option 2: Application without valid test report/s

5.2.1.2.2.1 Application without a valid test report shall be accepted and

processed and a Provisional Batch Certificate shall be issued to facilitate the conduct of product inspection and sampling.

5.2.1.2.2.2 For imported products, the applicant shall have the option to request for product inspection and sampling at the country of origin, provided that the inspection and sampling shall be conducted by a BPS recognized third party inspection body.

5.2.1.2.2.3 For local inspection and sampling, the BPS, DTI Regional/Provincial offices, or the duly authorized inspection bodies shall conduct the product inspection and sampling.

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5.2.1.2.2.4 Inspection and Sampling shall be in accordance with

Section 6 hereof.

5.2.1.2.2.5 The samples drawn shall be submitted to the testing laboratory by the inspection body within three (3) days from the date of inspection.

5.2.1.2.2.6 The Batch Certification with stickers shall be issued upon

receipt of the test report showing compliance with the requirements of the particular PNS.

5.2.1.2.2.7 If the test result in the preceding clause shows non-

conformity, BPS shall communicate with the applicant in writing the non-conformity/ies as well as the available options that may be undertaken within five (5) working days from receipt of test results. If the applicant fails to communicate with BPS within two (2) working days, all pending applications shall not be processed until the non-compliance issue is resolved.

5.2.1.2.3 Option 3: Application with report/s of advanced testing

5.2.1.2.3.1 Application with reports of advanced testing shall be accepted and processed provided that the report of advanced testing meet the following requirements:

5.2.1.2.3.1.1 Issued by a BPS recognized testing

laboratory; 5.2.1.2.3.1.2 The scope of accreditation includes the

reference Philippine National Standard (PNS) or its identical standard;

5.2.1.2.3.1.3 Original copy is sent directly to the BPS by

the testing laboratory; 5.2.1.2.3.1.4 Product inspection and sampling are

compliant with the requirements of Section 6 hereof;

5.2.1.2.3.1.5 The reference standard used in product

testing is the PNS or its identical standard.

5.2.1.2.3.2 If the test report/s shows compliance with the requirements of the particular standard, Batch Certification shall be issued within three (3) working days, subject to inspection and verification at the declared warehouse. Inspection report shall be submitted within two (2) working days from the date of inspection.

5.2.1.2.3.3 If the test result in the preceding clause shows non-conformity, BPS shall communicate with the applicant in writing the non-conformity/ies as well as the available

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options that may be undertaken within five (5) working days from receipt of test results. If the applicant fails to communicate with BPS within two (2) working days, all applications shall not be processed until the non-compliance issue is resolved.

5.2.1.2.4 Option 4: Application with Certificate of Conformity from BPS Recognized Certifying Bodies

The application under this option shall be processed subject to the following: 5.2.1.2.4.1 Submission of copy of the CoC and Test Report duly

certified by the certifying body; 5.2.1.2.4.2 Batch Certification shall be issued by BPS and shall

be presented to BOC for the release of the shipment;

5.2.1.2.4.3 The importer shall notify BPS that the shipment has

been transferred to the importer’s declared warehouse within three (3) working days after release from BOC;

5.2.1.2.4.4 Product inspection and sampling shall be conducted

within three (3) days after the release of shipment from BOC;

5.2.1.2.4.5 Upon satisfactory compliance with the technical,

administrative and documentary requirements, stickers shall be issued in accordance with Section 6 hereof;

5.2.1.2.4.6 Product testing shall be conducted in accordance

with Section 7 hereof; 5.2.1.2.4.7 If the test report shows that the product complied

with the requirements of the relevant standards, the test report shall have a validity from the date of issuance as stated in Annex A;

5.2.1.2.4.8 If the test report shows non-compliance, product

inspection and inventory shall be conducted at the importer’s warehouse. The importer shall be required to issue a notice to its distributors/retailers, copy BPS, to refrain from further distribution or selling pending satisfactory compliance with the requirements of the standard;

5.2.1.2.4.9 If the re-testing shows compliance, the product

batch/lot shall be declared compliant. Otherwise, product recall shall be conducted in accordance with Section 17 hereof.

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5.2.1.2.5 Option 5: Application prior to loading or shipment

Application prior to loading or shipment shall be accepted and processed, subject to the following: 5.2.1.2.5.1 The application shall be filed prior to the product

loading or shipment;

5.2.1.2.5.2 Product inspection and sampling shall be conducted at the manufacturer’s/exporter’s warehouse by the recognized inspection body in accordance with Section 6 hereof;

5.2.1.2.5.3 Product testing shall be conducted by the

recognized testing laboratory in accordance with Section 7 hereof;

5.2.1.2.5.4 The original copy of the test report shall be sent

directly to the BPS by the recognized testing laboratory;

5.2.1.2.5.5 Batch Certification shall be issued if the test report

shows compliance with the requirements of the standard, otherwise, re-testing shall be conducted pursuant to Section 9 hereof;

5.2.1.2.5.6 Upon arrival of the shipment, the Batch Certification

shall be presented to BOC for the release of the products. The importer shall notify BPS that the shipment has been transferred to the importer’s declared warehouse within three (3) working days after release from BOC;

5.2.1.2.5.7 Upon receipt of notice, product inspection and

verification shall be conducted within three (3) working days by the BPS, DTI Regional/Provincial Office or the duly recognized inspection body at the importer’s declared warehouse. After confirmation that the actual shipment is the same with the lot/batch inspected at the country of origin, stickers shall be issued;

5.2.1.2.5.8 The BPS, DTI Regional/Provincial Office or the duly

recognized inspection body shall draw product samples and subject the same for confirmatory testing if BPS finds discrepancies between the product described in the test report and the actual product inspected;

5.2.2 The applicant shall inform BPS in writing if there are any revisions in the information provided in the application form and seek approval of such. Otherwise, appropriate action shall be undertaken by BPS;

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5.2.3 All applications shall not be processed in case the applicant has existing/pending issues on its prior application/s, such as, but not limited to, documented violation/s of this Scheme or any Trade and Industry Law, unclaimed application/s, pending product sampling or unpaid fees, until such time that all issues are settled or resolved.

6 INSPECTION and SAMPLING

6.1 Inspection and sampling shall be conducted by BPS, DTI Regional/Provincial

Office or the duly recognized Inspection Body within three (3) working days after the release of the Batch Certification.

6.2 Inspection and sampling shall be conducted in accordance with the Inspection

and Sampling Procedure stipulated in Annex E. 6.3 If inspection and sampling is not conducted within the prescribed period, the

concerned Inspection Body shall immediately inform the BPS in writing of the reason/s. Under justifiable reason, inspection and sampling may be re-scheduled, otherwise, appropriate action shall be undertaken.

6.4 The required number of samples per product is stated in Annexes A & B.

7 PRODUCT TESTING

7.1 The product samples shall be submitted to the BPS recognized testing laboratory; 7.2 Product testing shall be conducted in accordance with the requirements of the

relevant Philippine National Standard or its identical standard. 7.3 The test reports shall be sent directly to the BPS by the recognized testing

laboratory.

8 VALIDITY OF TEST REPORT

Test reports issued by the BPS recognized testing laboratory shall be valid for the period indicated in the List of Products Under the Mandatory Certification, herein attached as Annexes A & B. The BPS shall update Annexes A & B when there is/are additional product/s to be covered or whenever necessary.

9 PRODUCT COMPLIANCE AND NON-COMPLIANCE

9.1 Two (2) sets of samples per type/model must have been tested by the BPS recognized testing laboratory, both showing non-compliance before a declaration can be made that the product does not conform to the requirements of the PNS;

9.2 If in the determination of BPS, the first set of samples fail, the second set of

samples shall be tested. If the second set passes the retest, the third set of samples shall be tested;

9.3 If the third set passes, the product is declared as compliant with the requirements

of the PNS;

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9.4 If the third set fails, the product is declared non-compliant, BPS shall thereafter

advise the manufacturer/assembler or importer of the applicable actions :

9.4.1 For products under the PS Certification Scheme, to undertake the necessary remedial or corrective measures;

9.4.2 For products under the Batch Certification Scheme, denial of the application.

9.5 If the applicant fails to communicate with BPS within two (2) working days, all

applications shall not be processed until the non-compliance issue is resolved. 9.6 Only after reassessment and subsequent product compliance shall the

manufacturer/assembler be allowed by BPS to use the Product Certification Mark.

9.7 For imported non-compliant products, the same shall be destroyed or re-

exported to the country of origin in accordance with Annex F. The importer shall shoulder the cost of destruction or re-exportation.

10 GREEN LANE FOR QUALIFIED APPLICANTS

10.1 The application of importers with proven track record of consistent product compliance shall be processed, subject to the following:

10.1.1 The manufacturer’s products have been consistently compliant with the

requirements of the relevant product standards for a minimum of ten (10) shipments or, for at least one year prior to the date of application;

10.1.2 The manufacturer is certified under ISO 9001 or its equivalent Quality

Management System (i.e TQM, QS 9000, Six Sigma); 10.1.3 Submission of test report issued by BPS recognized testing laboratory

showing compliance with the requirements of the relevant PNS or Certificate of Conformity issued by a BPS recognized product certification body.

10.2 Upon satisfactory compliance with the technical, administrative and

documentary requirements, the batch certification and stickers shall be issued; 10.3 Product inspection and sampling shall be conducted within three (3) working

days after the release of the Batch Certification and stickers in accordance with Section 6 hereof;

10.4 Product testing shall be conducted in accordance with Section 7 hereof; 10.5 If the report shows compliance with the requirements of the relevant PNS, the

same shall be valid for the period as stated in Annex A; 10.6 If the test report shows non-compliance, product inspection and inventory shall

be conducted at the importer’s declared warehouse. The importer shall be required to issue a notice to its distributors/retailers, copy BPS, to desist from further distribution or selling pending satisfactory compliance with the requirements of the relevant PNS;

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10.7 If the re-testing shows compliance in accordance with Section 9 hereof, the product batch/lot shall be declared compliant;

10.8 If the re-testing shows non-compliance, product recall shall be conducted in

accordance with Section 17 of this Order, and the applicant’s privilege for green lane will no longer be provided by BPS;

10.9 During the course of certification process or market surveillance and the

applicant is found to be in violation of Section 23 hereof, the same privilege for green lane will no longer be provided by BPS;

10.10 If the applicant intends to reapply for green lane privilege, Section 10.1 hereof

shall apply. 11 IMPORTATION OF PRODUCTS UNDER MANDATORY CERTIFICATION WHICH ARE

INTENDED FOR OWN USE

11.1 If the shipment is intended for personal/own use, the same is exempted subject to the following:

11.1.1 Invoice value is less than the cost of certification; 11.1.2 The quantity is equal to or less than the required number of samples for

testing; 11.1.3 Submission of an affidavit of purpose including assumption of product

liability.

11.2 If the shipment is intended for own use by contractors, provided the contractor is also the importer, the shipment is subject to the Batch Certification process but stickers shall not be issued by BPS to the contractor.

11.3 The individual company shall be held liable under provisions of the Consumer Act of the Philippines (R.A. No.: 7394) and other applicable laws if the imported product causes damage to health, life and property.

12 TECHNICAL FILE

12.1 The importer/manufacturer/assembler and CABs shall maintain a technical file for each of its products under technical regulation, for no less than ten (10) years, including those products that have left the product line. It shall contain the following:

12.1.1 Certificate of Conformity and PS License or Batch Certification;

12.1.2 Copy of the test report/s;

12.1.3 Technical drawing and/or photographs of the product; and,

12.1.4 User’s manual, where applicable.

12.2 The importer or manufacturer/assembler shall furnish all distributors/retailers

with a certified true copy of the Batch Certification and PS License, which shall be made available for verification/validation by consumers and authorized DTI personnel.

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13 PRODUCT IDENTIFICATION AND TRACEABILITY

13.1 To establish identification and traceability of the products, importers/ manufacturers/assemblers are required to declare and submit to BPS the list of batch/serial numbers, production/batch code of each individual product of the lot/batch being imported/manufactured/assembled, duly certified by the manufacturers of the product overseas.

13.2 In addition, Importers/manufacturers/assemblers shall ensure that labeling and marking requirements of the applicable standard and of R.A 7394 (Consumer Act of the Philippines) are observed.

14 PRODUCT CERTIFICATION MARK

14.1 All products under technical regulation shall bear the Product Certification Mark before it can be supplied, distributed or sold in the Philippine market.

14.2 Holders of Batch Certification and PS License are responsible for ensuring that their products are affixed with the Certification Mark before they are supplied, distributed or sold in the market.

14.3 The Certification Mark shall be affixed on the product, or in the packaging if

affixing the Mark on the product is not possible due to size or if it will pose possible damage to the product. If the Certification Mark is affixed on the Product, it shall be affixed on the marking panel wherein the details on the importer/manufacturer/assembler are indicated.

14.4 For products where affixing the sticker is not feasible, other certification mark

shall be required. The certification mark shall be defined in the product’s standard implementing guidelines.

14.5 The design of the Product Certification Mark shall be in accordance with the

illustration in Annex J.

14.6 BPS reserves the right to change the format, text or any identifying marks of the certification instrument, at any given time, without prior notice to the public to protect the integrity of its product certification certificate from forgery and any other criminal acts.

15 TERMS AND CONDITIONS OF THE PS LICENSE AND BATCH CERTIFICATION

The following terms and conditions shall be binding on all Batch Certification and PS License applicants/holders. Any infraction one or more of the following thereof shall be a ground for the suspension, withdrawal or cancellation of the license.

15.1 The holder of PS License and Batch Certification shall abide by R.A. No.: 4109,

E.O. No.: 133: 1987, E.O. No.: 913: 1983 and R.A. No.: 7394 and their implementing rules and regulations, and orders which the BPS issues in pursuance with its authority under law.

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15.2 The holder of PS License and Batch Certification shall ensure that the certified product conforms at all times to a specific standard and shall be liable for any damage that might be caused by the said product to their consumers.

15.3 The Product Certification Mark shall be affixed only on the certified product. 15.4 The PS License and Batch Certification holder shall establish and maintain

systems of product recall and of addressing complaints filed by its clients or customers concerning its certified products and shall maintain records thereof.

15.5 The applicants or holders of PS License and Batch Certification shall give duly-

authorized representatives of the BPS or DTI Regional/Provincial Offices or, in the case of foreign companies, by BPS recognized CABs, access during working hours to the premises where the certified product is manufactured/assembled/stored; access to relevant equipment, records, personnel and subcontractors and access for purposes of investigating complaints; and access for the purpose of evaluating consistency of compliance to the requirements of the relevant standard; this Order, or other pertinent rules and regulations governing the conformity assessment procedures.

15.6 The PS License holders shall be subject to at least an annual factory or post

market audit to ensure consistent compliance with the BPS requirements of the Product Certification Scheme.

15.7 In case of subcontracts, it is understood that the PS License holders shall

assume full responsibility for the compliance of its sub-assemblies, semi-finished and finished products to the specific requirements.

15.8 The PS License and Batch Certification holder shall maintain a record of all

complaints made known to it, relating to compliance with certification requirements and make these records available to the certification body when requested, take appropriate action with respect to such complaints and any deficiencies found in the product that affect compliance with the requirements for certification; and, document the action taken, subject to verification by the certification body.

15.9 The PS License holder shall inform BPS in writing, one month prior to any

change/s that may affect its ability to conform with the certification requirements, such as, but not limited to change in management, business name, and/or transfer of plant site. Provided that where there is change or addition of brand name and modification in the product’s designs or specifications, BPS shall be notified three (3) months prior to the planned release of such product to the market.

15.10 Upon transfer of plant site, the PS License shall be deemed valid only after

satisfactory result of factory and product audit at the new site by BPS or its duly recognized inspection and/or certification bodies.

15.11 The PS License and Batch Certification holder shall pay the applicable fees and other charges as billed or stipulated by BPS, its duly recognized inspection and/or certification bodies or individual auditor.

15.12 The PS License and Batch Certification are non-transferable.

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15.13 Incorrect references to the certification scheme, or misleading use of Batch Certification, PS licenses, certificates, marks, or any other mechanism that indicate that a product is certified, found in documentation or publicity materials, shall be dealt with accordingly (i.e. corrective action, withdrawal of certificates, publication of the transgression and legal action).

15.14 No person shall trade, supply or advertise for the purpose of supplying any of

the products under technical regulation in the Philippines after the expiry, withdrawal or suspension of the Batch Certification and PS License.

15.15 Upon suspension, withdrawal or termination of the Batch Certification and PS

License, the holder shall discontinue its use of all advertising materials that contain any reference thereto and shall take action as required by the certification scheme including the return of the certification documents, inventory of remaining stocks and products in circulation, and take appropriate measures as may be necessary.

15.16 The BPS reserves the right to change the format, text or any identifying

marks of the certification instrument at any given time without prior notice to the public to protect the integrity of its product certification certificate from forgery and other criminal acts.

16 MARKET SURVEILLANCE

To ensure consistent compliance with the terms and conditions of the Batch Certification and PS License and of the applicable standards, random sampling and testing of products covered by the Batch Certification and PS License issued shall be conducted by BPS, FTEB, DTI Regional/Provincial Offices or Recognized Inspection Body at the market level in accordance with the surveillance guidelines (Annex G) as follows:

16.1 At least once a year per product, per factory for PS License under clause 5.1 herein, and

16.2 The cost of samples and testing shall be for the account of the Batch Certification and PS License holder, and;

16.3 Samples shall be disposed of in accordance with Clause 24 hereof

17 REQUIREMENTS IN CASE OF NON-COMPLIANCE WITH RELEVANT PNS

If any product under technical regulation does not conform to the requirements of this regulation and/or of the relevant PNS, the BPS may do any or all of the following:

17.1 Issue a public notice declaring such product to be unsafe;

17.2 Direct any person/entity who, in the course of trade or business, supplied such

product in the Philippine market, to take all steps as may be necessary to:

17.2.1 Control or cease the supply, distribution and selling of such product in the Philippine market; and

17.2.2 Issue a product recall in accordance with Section 18 hereof, to account for the products that are already in circulation. The product recall shall include information on the potential danger of such product. The

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manufacturer/importer/assembler/distributor shall keep BPS informed on the progress of the recall

18 PROCEDURES AND REQUIREMENTS FOR PRODUCT RECALL

After the product is declared by the BPS to be non-compliant, product recall shall be implemented by the importer/manufacturer/assembler. The following are the procedures and requirements for product recall:

18.1 Publication of the recall order in a newspaper of general circulation for at least two (2) consecutive Saturdays/Sundays;

18.2 The layout, content, font and size of the recall order shall be in accordance with Annex H;

18.3 The recall period shall have a duration of at least thirty (30) days from the date of the second publication;

18.4 Proof of the recall order shall be submitted to the BPS or the DTI Regional/Provincial Office within three (3) working days from the date of the last publication;

18.5 Submission to BPS or DTI Regional Regional/Provincial Office of the inventory of the recalled products within ten (10) days from the last day of the recall period;

18.6 If the importer fails to conduct the recall, appropriate action shall be undertaken by the DTI.

19 FILING OF PRODUCT CERTIFICATION APPLICATION

DTI RO/PO may accept product certification applications, but processing and approval shall be done by BPS.

20 DENIAL OF APPLICATION

20.1 Imported/manufactured/assembled products not complying with the requirements of the relevant PNS and/or other rules and regulations of the DTI shall not be issued a PS License or Batch Certification.

20.2 The BPS shall upload monthly in its website the list of applications denied and products recalled.

21 APPEAL PROCESS

Appeal against the decision of the BPS Bureau Director or, the designated bureau or head relative to an Application for PS License and Batch Certification may only be made for the following: 21.1 If the application for Batch Certification and PS License is denied, a motion for

reconsideration may be filed by the applicant to the official who rendered the decision within ten (10) working days from the date of denial of the application for Batch Certification and PS License.

21.2 If the BPS Bureau Director or his duly authorized representative sustains his

decision, an appeal may be filed with the DTI Secretary within fifteen (15)

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working days from the receipt of the letter of denial. An appeal may be filed when there is sufficient reason to believe that the official who rendered the decision acted with grave abuse of discretion amounting to lack or excess of jurisdiction.

21.3 The filing of a Motion for Reconsideration shall suspend the period within which

to appeal. 22 PROHIBITED ACTS

22.1 The Product Certification Mark shall not be used or attached to a product in any

misleading manner.

22.2 No person/entity shall, in the course of any trade or business, sell, offer for sale, or advertise any products not complying with safety standards and/or this technical regulation.

22.3 Failure or neglect to effect the product recall as directed by BPS.

22.4 The Batch Certification and PS License holder shall not make any misleading or

unauthorized statement and/or claim regarding its product certification. Claims regarding certification shall be consistent with the scope of certification and with the terms and conditions as stated in the Batch Certification and PS License. This includes unauthorized reproduction of product certification documents, or any part thereof, except that they may provide a copy to the retailers or distributors as listed as per Section 4.2.11 herein.

22.5 Any non-conformance of the above provisions shall be considered a violation of

this DAO and shall be subject to the following penalties:

22.5.1 BPS shall implement a system of watch-listing and blacklisting of importers/manufacturers/assemblers and of those extended the green lane privilege but which privilege was revoked for cause.

22.5.2 The maximum administrative fine as per E.O. 913 shall be imposed to any person found guilty of forging the signature of the Bureau Director or his designated representative in order to secure and/or use the Batch Certification and PS License. In case of a juridical entity, the president or general manager of such entity shall be held liable, without prejudice to the separate filing of civil and/or criminal case/s against the individuals.

22.5.3 The administrative fine as per Section 6, E.O. No.: 913, DAO 2:2007 or its future amendments and the ipso facto revocation or cancellation of the Batch Certification and PS License which may have been issued by the BPS shall be imposed as a penalty to any person or entity found guilty of using falsified document or record in obtaining the said Batch Certification and PS License, without prejudice to the separate filing of civil and/or criminal case/s.

23 FEES, CHARGES, BOND REQUIREMENT AND OTHER EXPENSES

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23.1 Fees and charges to be paid by the applicant in accordance with Annex I shall be as follows: 23.1.1 Application Fee;

23.1.2 Inspection/audit fees;

23.1.3 Transportation/travelling expenses, and board & lodging costs of

inspector/s during inspection/audit shall be subject to Third Party provision;

23.1.4 Processing Fee of Batch Certification on local and imported products

(non-refundable, payable upon filing of the application on per product, per Lot Number/Batch Number (local) and Bill of Lading/Airway Bill basis (imported), assessed by the BPS based on the amount declared in the Invoice);

23.1.5 PS License fee for manufactured/assembled products;

23.1.6 A Performance Bond in the amount of One Million pesos (PhP

1,000,000.00) shall be posted to cover all Batch Certification and PS Licenses issued to the importers/manufacturers/assemblers valid for one (1) year. Any violation of the terms and conditions of the Product Safety Certification Scheme shall result in the motu proprio forfeiture of the bond. The applicant shall immediately secure a performance bond to cover the remaining period of the calendar year. Processing of all application/s shall be held in abeyance pending submission of the replacement to the forfeited bond.

24 DISPOSAL OF SAMPLES

24.1 All remaining samples, which were drawn for testing purposes, and complied with the requirements of the standard, shall be claimed by the importer/manufacturer/assembler within five (5) days upon receipt of the PS License and Batch Certification. If the importer/manufacturer/assembler fails to claim the samples after receipt of PS License and Batch Certification or opted not to retrieve the sample at all, the laboratory shall dispose the samples as it may deem necessary.

24.2 Samples which fail to comply with the requirements of the relevant PNS shall be

stored for at least six (6) months in the laboratory to ensure their availability in the event the importer contests the result of the test including those subject of litigation.

25 PENALTIES

25.1 Any violation of this Order shall be subject to the administrative actions as

provided for by the applicable Rules and Regulations or Orders issued by the DTI, E.O. No. 913, Series of 1993 without prejudice to the criminal or civil actions under R.A. No. 4109 and R.A. No. 7394.

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26 TRANSITORY PROVISIONS

26.1 PS Licenses (local and foreign) issued under DAO 4:2008 shall remain valid

until the date of expiration unless sooner revoked, subject to the same terms and condition stated therein. After which, a new PS License will be issued to applicant under the terms and conditions of this DAO subject to the satisfactory result of the recertification process.

26.2 The BPS shall, within one (1) year upon effectivity of this DAO, develop an impartiality mechanism of the Product Certification Scheme.

27 SEPARABILITY CLAUSE

27.1 Should any provision of this Order or any part thereof be declared invalid, the

other provisions, so far as they are separable from the invalid ones, shall remain in force and effect.

28 REPEALING CLAUSE

28.1 This repeals Department Administrative Order Nos. 4 and 5 series of 2008 and all other Orders or parts thereof which are inconsistent with the provisions of this Administrative Order.

29 EFFECTIVITY

29.1 This Order shall take effect upon fifteen (15) days after its publication in a national newspaper of general circulation.

Done in the City of Makati this __ day of ___ in the year 2015.

RECOMMENDED BY : ATTY. ANN CLAIRE C. CABOCHAN ATTY. VICTORIO MARIO A. DIMAGIBA BPS Director-in-Charge Undersecretary

APPROVED BY :

GREGORY L. DOMINGO Secretary