IMPLEMENTING RULES AND REGULATIONS (IRR) of the Department Administrative Order (DAO) NO. 04 Series of 2008 ‘New Rules and Regulations Concerning the Philippine Standard (PS) Quality and or Safety Certification Mark Schemo ‘of the Bureau of Product Standards (BPS)” 4. SCOPE 41 This implementing Rules and Regulations (IRR) provides guidelines on the Implementation of the OAO 04 series of 2008, which prescnbes the rules and regulations on the licensing of companies to use the Philippine Standard (PS) Quality andlor Safety Certification Mark, 2. DEFINITION OF TERMS: For the purpose of this IRR, the definition of terms provided by DTI's DAO 04 series of 2008 ‘shall apply together with the following definition of terms: 2.1. ASEAN Association of Southeast Asian Nations 22 JPEPA- Japan Philippine Economic Partnership 23° Manufacturer or Assembler ~ an entity engaged in the manufacturing or assembly of products 3. AUTHORITIES AND RESPONSIBILITIES For the purpose of this IRR, the Authoiles and Responsbilties stated in DAO 04 series of 2008 causes 3.1 to 3.28 shall apply. 4, THE PHILIPPINE STANDARD (PS) QUALITY AND/OR SAFETY CERTIFICATION MARK ‘The provisions under clause 4 of DAO 04 series of 2008 including sub-clauses 4.1 to 43 shall apply, The PS Certification Mark License No, shall be indicated at the bottom of the PS M: See illustration at Annex C. 5. APPLICATION FOR PS CERTIFICATION MARK LICENSE 5.1. The provisions under clause 5.1 of DAO 04 series of 2008 shall apply. 5.2 The provisions under clause 5.2 of DAO 04 series of 2008 shell apply together with the following documentary requirements: 5.2.1 Articles of incorporation or Business Name and Sub-Contracting Agreement (it 1e brand owner subcontracts the manufacture ofits produc). 22 Quality Manual (Controlled Copy) 6.2.3 Brief description of manufacturing process. 624 Reference no. of the Product Identification File to Include process flow, ‘materials, process control and drawings among others. 525 List of test and measuring equipment with nominal capacties and serial frumbers at each Inspection point and final product testing together with the ‘evidence of ownership, such as oficial receipt. Implementing Rules and Regulations of DAO 4:2008, Page 1 0¢353 54 58 56 87 58 59 10 528 Brief description of equipment maintenance and calibration program for all testing and measuring equipment with their corresponding calibration cerbficates, 6.2.7 Copies of labels, markings and logos etc, as per requirements of specific standacd. 6.2.8 Vicinity map of the factory 6.2.9 Undertaking to abide by the terms and conditions of the PS License. ‘The provisions under clause 5.3 of DAO 04 series of 2008 shall apply together with the following provisions: 8.3.1 In cases of subcontracts, the owner ofthe product and brand shall apply forthe PS Quality andior Safety Certification Mark License. 5.32. An applicant company should submit all the required documents for BPS to process its application accordingly. Incomplete application forms and attachments shall not be processed. 5.3.3. Allapplications shall be processed by BPS. ‘The provisions under clause 6.4 of DAO 04 series of 2008 shal apply. 84.1 In case a certain specific standard applies to different products, separate application shall be fied for each product. The eventual license and certificates shall also be separately ssved for each product. ‘The provisions under clause §.5 of DAO 04 series of 2008 shall apply. “The provisions under clause 5.6 of DAO 04 series of 2008 shall apply. ‘The provisions under clause 5,7 of DAO 04 series of 2008 shall apply. Please rafer to ‘Annex A for the details of the procedures ‘The provisions under clause 5.8 of DAO 04 series of 2008 shall apply together with the following provisions: 5.8.1 The license js Issued to a company for a specific product and brand manufactured in a specific plant site, 5.82, The license shall not be used on any product in a misleading manner. “The provisions under clause 6.9 of DAO 04 series of 2008 shall apply, ‘The license shall be valé for three (3) years from the date of issuance and shall be ro- lesued every three (3) years and thereafier without any further requirement for an ‘application and processing, on the condition that all the terms and conditions of the License have been met and all the requirements of the DAO 04 series of 2008 have been complied with during its valicty. Otherwise, the license 's deemed expired and the ‘company may fie new application for PS License it warrants, 6, TERMS AND CONDITIONS OF THE LICENSE et ‘The provisions under clause 6 of DAO 04 series of 2008 including sub-clauses 6 1.1 to 6.1.11 shall appy. implementing RUes and Regulations of DAO 4:2008 Page 2 0t37. QUALITY MANAGEMENT SYSTEMS REQUIREMENTS 7.4. The provisions under clause 7 of DAO 04 series of 2008 shall apply. 7.44 All existing PS Licensees” qualty management systems (QMS) shall be In compliance with [SO 8001:2000 by the end of December 2008. Compliance shall be verified during the survaiance visis starting January 2009. 7.42 For new PS License appicants, the quality managernent system shall be aligned as per requirements of ISO 9001:2000. 8. PROHIBITED ACTS 8.1 The provisions under clause 8 of DAO 04 series of 2008 including sub-clauses 8.1, 8.2, 83,84 and 8 8 shall apply ‘98, SUSPENSION, WITHDRAWAL OR REVOCATION OF LICENSE, 8.1 The provislons under clause 9 of DAO 04 series of 2008 including sub-causes 8.1 to 9.3 shall apply. 40, PENALTIES 40.1 The provisions under clause 10 of DAO 0s series of 2008 shall apply. 11, FEES AND CHARGES 411.4. The provisions under clause 11 of DAO 04 series of 2008 including sub-clauses 11.1 to 115 shall apply. Please refer o Annex B forthe time frames of payment 12, SEPARABILITY CLAUSE 12.1. The provisions under clause 12 of DAO 04 series of 2008 shall apply 13, REPEALING CLAUSE 18.1 This IRR replaces the previously Issued Implementing Guidelines for DAO 1: 1907 ~ Rules and Regulations concerning the Philippine Standard (PS) Quality andior Safety Certification Mark Scheme dated 11 August 1997. 14, ERFECTIVITY 14,1. This IRR shall take effect immediately. Bureau Director fl JUL 25 2008 implementing RUes and Regulations of DAO 42008 Page Sof fir‘Annex A Procedure on the Conduct of Factory and Product Audit 1) Ropointment of Aust Team at 12 13 ‘The BPS Product Certification shall maintain an updated list of Product and QMS Auditors, Auditors with corresponding scope and quaifications will be appointed by the BPS Product Certification fram the pool of Product and QMS Ausitors to conduct factory and product audit Foreign auditors shall submit their qualification documents to BPS prior to the conduct of audit 2 Factory Audit a4 22 23 24 ‘The audit teanvauditor shall assess the quality management system of a company based on ISO $001:2000 and applicable Implementing guidelines. ‘The auditors shall check the company's perinent documents to determine whether actual quality activities are undertaken In accordance with the documented quality system. If there are non-contormities noted during the audit, the auditors shall infor the company and require them to undertake corrective actions. The auditors shall accomplish the non-conformity report for the non-conformities observed which shal be ‘acknowledged by the company’s authorized representative, In case of application for extension of the scope of existing certification, the BPS Product Certifcation may decide not to carry out the audit of production process or quality system but to require test samples of the additional types of products for independent testing to determine that they comply with the specie PNS. 3. Product Audit 3a 32 33 34 35 Annex A~| Evaluation of available test records (test record on initial production run, prototype, and routine test records) shall be made by the auditors 2s per requirements of specific standard and its implementing guidelines. Product sampling shall be made by the auditors as stated in the specific standard ‘and/or its implementing guidelines. Samples maybe drawn from the factory or in the ‘open market, a8 appropriate. ‘Samples should be representative of the entre line or group of production to be cerlfied and be manufactured from the same tools and assembly using the same methods established for the production run ‘When testing is based on intial production run or prototype sample, as in the case of new company, monitoring shall be made on commercial production run, Inplant and/or independent product testing is carried out in accordance with the specific standard and its implementing guidelines, Procedure on the Conduct of Factory & Product Audit Page tof4 Corrective Action and Follow-up Visit 4.1 The original copy of the non-conformity report duly signed by the company representative shall be given to the company wherein its proposed corrective action shall be indicated, The auditors shall keep photocopies of the non-conformity reports. 42 Corrective actions to be undertaken by the company maybe classified as follows: 4.2.1 Corrective actions that can be completed within the audit period. 4.22 Corrective action that requires changes in documentation. 4,23 Corrective action that needs a follow-up visit by the auditors such as in the ‘case of completion of faciities and testing of product 43 The company shall implement and complete the corrective actions within three (3) months for initial audit and one (1) month for surveilance audit If the company fails to implement the corrective actions within the specified period, it should be a cause for denial of PS application or suspension of the PS License. ‘Annex A ~ Procedure on the Conduct of Factory & Product Audit Page 2of2oem — 2 Gualy Hanus Review (Payal wun #8 ays afer bting US Datar Egan Toca ces BRST ——— 8 ys ai ica ol lg samen ‘ander a¢ cared by Dearand evant parton Roy al ePsore 18 ays ato eon of by stam Designated pectin Boy aes +5 pe soc ot lig wate ‘Desigrat mapecton Body BPSOTT Taps rw ing Hala Designo iepecian Body tr ar US Dots of ost Chogee se cexees i onimss | — Bret ——T 1 a snr apa __ [erst | ssp torre weoT Ta RTT RS RT US Dota ae ttt Cages erst ‘sistas oars same acmned by OPS Seen ‘Soyo aco ben) soent ta TTS | par anoene Tee bapccon 9 ‘apr agent | fiawesey, | H z acaba y ros eg Tat Tac a oa 2 son a aaa TGR ToTERT Tht nar aE Tr Same ‘eer Olea fecopitos | Aspe Oeil Reais ici | 1S stir” | art contut of mane sig ome ‘Annex 6 — Time Frames of Payment Paget oftAnnex PS Certification Marks (PS Certification Mark Logo with License No.) BPS BPS CERTIFIED CERTIFIED Product Safety Product Quality License No. Q-XXXX License No. Q-XXXX ‘Annex C— PS Mark Logo