FederationofMalysia EDICTOFGOVERNMENT±

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1 FederationMalysia EDICTOFGOVERNMENT± Inorderpromotepubliceducationpublicsafety,equal justiceforal,abeterinformedcitizenry,rulelaw, worldtradeworldpeace,thislegaldocumentishereby madeavailableonanoncommercialbasis,asitisright alhumansknowspeaklawsthatgovernm. MS 1900 (2005) (English): QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS FROM ISLAMIC PERSPECTIVES

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3 MALAYSIAN STANDARD MS 1900:2005 QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS FROM ISLAMIC PERSPECTIVES les: ICS: Descriprs: quality management systems, requirements, Islamic perspectives Copyright 2005 DEPARTMENT OF STANDARDS MALAYSIA

4 DEVELOPMENT OF MALAYSIAN STANDARDS The Department Stards Malaysia (STANDARDS MALAYSIA) is national stards accreditation body Malaysia. The main function STANDARDS MALAYSIA is foster promote stards, stardisation accreditation as a means advancing national economy, promoting industrial efficiency development, benefiting health safety public, protecting consumers, facilitating domestic international trade furring international cooperation in relation stards stardisation. Malaysian Stards (MS) are developed through consensus by committees which comprise balanced representation producers, users, consumers ors with relevant interests, as may be appropriate subject at h.. To greatest extent possible, Malaysian Stards are aligned or are adoption international stards. Approval a stard as a Malaysian Stard is governed by Stards Malaysia Act 1996 [Act 549]. Malaysian Stards are reviewed periodically. The use Malaysian Stards is voluntary except in so far as y are made mary by regulary authorities by means regulations, local by-laws or any or similar ways. STANDARDS MALAYSIA has appointed SIRIM Berhad as agent develop, distribute sell Malaysian Stards. For furr information on Malaysian Stards, please contact: Department Stards Malaysia OR Ministry Science, Technology Innovation Level 1 & 2, Block 2300, Century Square Jalan Usahawan Cyberjaya Selangor Darul Ehsan MALAYSIA Tel: Fax: central@stardsmalaysia.gov.my SIRIM Berhad (Company No V) 1, Persiaran ran Da' Menteri Section Shah Alam Selangor Darul Ehsan MALAYSIA Tel: Fax: msonline@sirim.my

5 CONTENTS Page Committee representation... Foreword... jii iii iv o Introduction Scope General Application Normative references Definitions Quality management system General requirements Documentation requirements Management responsibility Management commitment Cusmer focus Quality policy Planning..., '" Responsibility, authority communication Management review Resource management Provision resources HUman Human resources Infrastructure Work environment Product realisation Planning product realisation Cusmer-related processes Design development Purchasing Production service provision Control moniring measuring devices Measurement, analysis improvemenl improvement GeneraL General..., '", Moniring measurement Control nonconforming producl... product Analysis data Improvement... 31

6 CONTENTS (continued) Page Annexes A Shariah B Shariah implementation framework for quality management system from Islamic perspectives Bibliography ii

7 Committee representation The Industry Stards Committee on Ha/el Halal Stards (ISC I) under whose authority this Malaysian Stard was developed, comprises representatives from following organisations: Department Islamic Development Malaysia Department Stards Malaysia Department Veterinary Services Federation Malaysian Manufacturers Institute Islamic Understing Malaysia Institute Quality Malaysia Malaysian Agricultural Research Development Institute Malaysian Association Stards Users Ministry Domestic Trade Consumer Affairs Ministry Health Malaysia (Food Safety Quality Division) Ministry Health Malaysia (National Pharmaceutical Control Bureau) Ministry International Trade Industry Muslim Consumers' Association Malaysia The Technical Committee on Management Systems from Islamic Perspectives which developed this Malaysian Stard consists representatives from following organisations: Anti-Corruption Agency, Malaysia Department Islamic Development Malaysia Institut Tadbiran Awam Negara (INTAN) Malaysia Institute Islamic Understing Malaysia International Islamic University Malaysia Islamic Banking Finance Institute Malaysia Malaysian Administration Management Planning Unit Malaysian Institute Management Ministry Education (Department Islamic Moral Education) Ministry Health Malaysia (National Pharmaceutical Control Bureau) Muslim Consumers' Association Malaysia National Productivity Corporation Research Institute Stards In Islam SIRIM Berhad (Secretariat) SIRIM QAS International Sdn Bhd iii

8 FOREWORD This This Malaysian Malaysian Stard Stard was was developed developed by by Technical Technical Committee Committee on on Management Management Systems Systems from from Islamic Islamic Perspectives Perspectives under under authority authority Industry Industry Stards Stards Committee Committee on on Ha/al Halal Stards. Stards. The The requirements MS MS ISO ISO 9001: :2000 (identical (identical with with ISO ISO 9001:2000) 9001 :2000) are are given given in in boxed boxed text text in in this this stard, stard, followed followed by by relevant relevant requirements requirements from from lslamic Islamic perspectives. perspectives. For For purposes purposes this this Malaysian Stard, Stard, references references stated stated under under NOTE NOTE original text MS ISO 9001 :2000 for: for: a) a) read read as as 'See 'See ISO ISO for for guidance'; b) b) read as as 'See ISO ISO for for guidance'; c) c) references references International International Stards Stards stated stated in in boxed boxed text text under under NOTE NOTE for for should be be replaced by by equivalent Malaysian Stards as as follows: Referenced International International Stards Stards ISO ISO 10012:2003, Measurement management systems - ReqUirements Requirements for for measurement processes measuring equipment ISO :2002, Guidelines for for quality /or environmental management systems auditing Corresponding Malaysian Stards MS MS ISO ISO 10012:2003, Measurement management systems - Requirements for for measurement processes measuring equipment MS ISO :2003, Guidelines for for quality /or environmental management systems auditing Compliance with a Malaysian Stard does not itself confer immunity from legal obligations. iv

9 QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS FROM ISLAMIC PERSPECTIVES O. Introduction MS ISO 9001 :2000, Quality management systems - Requirements o Introduction 0.1 General The adoption a quality management system should be a strategic decision an organization. The design implementation an organization's quality management system is influenced by varying needs, particular objectives, products provided, processes employed size structure organization. It is not intent this International Stard imply uniformity in structure quality management systems or uniformity documentation. The quality management system requirements specified in this International Stard are complementary requirements for products. Information marked "NOTE" is for guidance in understing or clarifying associated requirement. This International Stard can be used by internal external parties, including certification bodies, assess organization's ability meet cusmer, regulary organization's own requirements. The quality management principles stated in ISO 9000 ISO 9004 have been taken in consideration during development this International Stard. 0.2 Process approach This International Stard promotes adoption a process approach when developing, implementing improving effectiveness a quality management system, enhance cusmer satisfaction by meeting cusmer requirements. For an organization function effectively, it has identify manage numerous linked activities. An activity using resources, managed in order enable transformation inputs in outputs, can be considered as a process. Often output from one process directly forms input next. The application a system processes within an organization, ger with identification interactions se processes, ir management, can be referred as "process approach". An advantage process approach is ongoing control that it provides over linkage between individual processes within system processes, as well as over ir combination interaction.

10 When used within a quality management system, such an approach emphasizes importance a) understing meeting requirements, b) need consider processes in terms added value, c) obtaining results process performance effectiveness, d) continual improvement processes based on objective measurement. The model a process-based quality management system shown in Figure 1 illustrates process linkages presented in clauses 4 8. This illustration shows that cusmers playa significant role in defining requirements as inputs. Moniring cusmer satisfaction requires evaluation information relating cusmer perception as wher organization has met cusmer requirements. The model shown in Figure 1 covers all requirements this International Stard, but does not show processes at a detailed level. NOTE In addition, methodology known as "Plan-Do Check-Act" "Plan-Do-Check-Act" (PDCA) can be applied all processes. PDCA can be briefly described as follows. Plan: Do: Check: Act: establish objectives processes necessary deliver results in accordance with cusmer requirements organization's policies. implement processes. monir measure processes product against policies, objectives requirements for product report results. take actions continually Improve improve process perfonnance. performance. 0.3 Relationship with ISO 9004 The present editions ISO 9001 ISO 9004 have been developed as a consistent pair quality management system stards which have been designed complement each or, but can also be used independently. Although two International Stards have different scopes, y have similar structures in order assist ir application as a consistent pair. ISO 9001 specifies requirements for a quality management system that can be used for internal application by organizations, or for certification, or for contractual purposes. It focuses on effectiveness quality management system in meeting cusmer requirements. ISO 9004 gives guidance on a wider range objectives a quality management system than does ISO 9001, particularly for continual improvement an organization's overall performance efficiency, as well as its effectiveness. ISO 9004 is recommended as a guide for organizations whose p management wishes move beyond requirements ISO 9001, in pursuit continual improvement performance. However, it is not Intended intended i for certification or for contractual purposes. 2

11 0.4 Compatibility with or management systems This International Stard has been aligned with ISO 14001: in order enhance compatibility two stards for benefit user community. This International Stard does not include requirements specific or management systems, such as those particular environmental management, occupational health safety management, financial management or risk management. However, this International Stard enables an organization align or integrate its own quality management system with related management system requirements. It is is possible for an organization adapt its its existing management system(s) in order establish a quality management system that complies with requirements this International Stard. Continual improvement quality management system Cusmers cusmers Cusmers,",-.. ~. ~ -. j I i. Satisfaction; SatiSfaction: : i 1.. l...._..j 1'---"-"------', l~--' ~ '-M ~-- -~1! i Input ~R!Requirements;I.-J.. quir"ments;..j: I--...:...---~--..-j r--'----~--..-j. Output Output Key --- Value-addlng Value-adding activities Information flow Figure 1. Model a process-based quality management system This Malaysian Stard is developed with aim ensure that organisations are managed in accordance principles practice quality management system from Islamic perspectives. ISO 9001 is internationally accepted stard on quality management systems. It however. however, does not address certain aspects Shariah requirements which is a concern Islamic practitioners consumers. Therefore, in addition existing ISO 9001 Shariah requirements are being incorporated, where applicable. 3

12 The user this stard should be able meet following expectations benefits: a) inculcate Shariah requirements in ir quality management practice with emphasis on value-based management. Islam promotes good universal values, which are readily acceptable all people in world; b) enhance level effectiveness efficiency. This stard requires practice universal good conducts at all levels organisation that could lead improvement in level quality production products; c) enhance level Shariah compliance confidence among Muslims stakeholders. To assist user, requirements MS ISO 9001 :2000 (identical with ISO 9001 :2000) are given in boxed text in this stard, followed by relevant requirements from Islamic perspectives. 1. Scope M5 MS ISO 9001 :2000, Quality management systems - Requirements 1 Scope 1.1 General This International Stard specifies requirements for a quality management system where an organization a) needs demonstrate its ability consistently provide product that meets cusmer applicable regulary requirements, b) aims enhance cusmer satisfaction through effective application system, including processes for continual improvement system assurance conformity cusmer applicable regulary requirements. NOTE In this International Stard. Stard, term "product" applies only product intended for, or required by. by, a cusmer. 1.2 Application All requirements this International Stard are generic are intended be applicable all organizations, regardless type, size product provided. Where any requirement(s) this International Stard cannot be applied due nature an organization its product, this can be considered for exclusion. Where exclusions are made, claims conformity this International Stard are not acceptable unless se exclusions are limited requirements within clause 7, such exclusions do not affect organization's ability, or responsibility, provide product that meets cusmer applicable regulary regulary requirements. requirements. 4

13 This Malaysian Stard, in conjunction with MS ISO 9001 :2000, defines quality management system requirements from Islamic perspectives. This stard does not in anyway replace but supplement Islamic law promulgated under Malaysian legal system. This stard emphasises implementation quality management system from Islamic perspectives, refore compliance this stard does not necessarily imply compliance Shariah-based product stards including MS Normative references The following normative references are indispensable for application this stard. For dated references, only edition cited applies. For undated references, latest edition normative references (including any amendments) applies. MS ISO 9000, Quality management systems - Fundamentals vocabulary MS 1500, Halal food - Production, preparation, hling srage - General guidelines 3. Definitions MS ISO 9001 :2000, Quality management systems - Requirements 3 Terms definitions For purposes this International Stard, terms definitions given in ISO 9000 apply. The following terms, used in this edition ISO 9001 describe supply chain, have been changed reflect vocabulary currently used: supplier organization cusmer The term "organization" replaces term "supplier" used in I ISO 9001: 1994, refers unit which this International Stard applies. Also, term "supplier" now replaces term "subcontracr". Throughout text this International Stard, wherever term "product" occurs, it can also mean "service". 5

14 For For purposes purposes this this stard, stard, terms terms definitions definitions given given in in MS MS ISO ISO following following apply. apply Shariah Shariah The The tality Allah's Allah's comms that that regulates life life every every Muslim Muslim in in all all aspects. aspects. NOTE. Detailed description Shariah is provided in Annex A. NOTE. Detailed description Shariah is provided in Annex A Shariah Shariah compliance compliance Conformity Shariah. 3.3 Fiqh Fiqh Council Council The The body body that that is is accountable issue issue decree decree (fatwa) on on Islamic Islamic matters. matters. 3.4 Shariah Advisory Committee The The body body that that is is accountable review, review, advice advice endorse endorse management management organisation on on Shariah matters. It It is is also also reference centre on on Islamic management issues issues an an organisation. organisation. 3.5 Shariah Compliance Unit Unit /or Officer Shariah Compliance Unit Unit A unit comprising two two or more Shariah qualified persons who who are are accountable monir ensure Shariah is is observed continuously practised practised in in management organisation according Shariah Advisory Committee's advice Officer A Shariah qualified person who is accountable monir ensure Shariah is is observed continuously practised in management organisation according Shariah Advisory Committee's advice HaJaJ Hala/ Things or actions which are permitted or lawful in in Islam, orwise it it will be be non-halal. non-ha/a/ AJ-Quran AI-Quran The very word Allah revealed un Prophet Muhammad (saw) in Arabic. It It contains knowledge imparted by Allah (swt) guidance for men which is righteously at at all times. 3.8 A/-Hadith AI-Hadith Prophetic tradition - A report about Prophet Muhammad's (saw) saying, doing or reaction (approving or disapproving it). The aunticity report (al Hadith) (a/-hadith) depends on reliability narrar(s}. narrar(s). 6

15 3.9 AI-Sunnah Practices by Prophet Muhammad (saw) AlwUma' AI-!jma' The consensus opinions companions Prophet Muhammad (saw) after his death agreement reached on decisions taken by learned jurists on various Islamic matters Fatwa A decree or legal opinion given by Fiqh CounciL Council. 4. Quality management system 4.1 General requirements MS M5 ISO 9001 :2000, Quality management systems - Requirements 4 Quality management system 4.1 General requirements The organization establish, document, implement maintain a quality management system continually improve its effectiveness in accordance with requirements this International Stard. The organization : a) identify processes needed for quality management system ir application throughout organization (see 1.2), b) determine sequence interaction se processes, c) determine criteria methods needed ensure that both operation control se processes are effective, d) ensure availability resources information necessary support operation moniring se processes, e} e) monir, measure analyze se processes, f) implement actions necessary achieve planned results continual improvement se processes. These processes be managed by organization in accordance with requirements this International Stard. 7

16 Where an organization chooses outsource any process that affects product conformity with requirements, organization ensure control over such processes. Control such outsourced processes be identified within quality management system. NOTE Processes needed for quality management system referred above should include processes for management activities, provision resources, product realization measurement. The organisation ensure that: a) processes identified in 4.1 a); b) criteria methods identified in 4.1 c); c) procurement financing resources information identified in 4.1 d) are Shariah compliant. In event outsourcing, organisation ensure that suppliers, sub-contracrs or interested parties involved comply with Shariah. 4.2 Documentation requirements General M5 ISO :2000, Quality management systems - Requirements 4.2 Documentation requirements General The quality management system documentation include a) documented statements a quality policy quality objectives, b) a quality manual, c) documented procedures required by this International Stard, d) documents needed by organization ensure effective planning, operation control its processes, e) records required by this International Stard (see 4.2.4). NOTE 1 Where term "documented procedure" appears within this International Stard, this means that procedure is established, documented, implemented maintained. NOTE 2 The extent quality management system documentation can differ from one organization anor due a) size organization type activities, b) complexity processes ir interactions, 8

17 c) competence personnel. NOTE 3 The documentation can be in any form or type medium, medium. The quality management system documentation include records documents as evidences Shariah compliance Quality manual M5 MS ISO 9001 :2000, Quality management systems - Requirements Quality manual The organization establish maintain a quality manual that includes a) scope quality management system, including details justification for any exclusions (see 1.2), b) documented procedures established for quality management system, or reference m, c) a description interaction between processes quality management system. In process developing quality manual, organisation identify areas document procedures that require Shariah compliance Control documents M5 MS ISO 9001:2000, Quality management systems -w Requirements Control documents Documents required by quality management system be controlled. Records are a special type document be controlled according requirements given in A documented procedure be established define controls needed a) approve documents for adequacy prior issue, b) review update as necessary re-approve documents, c) ensure that changes current revision status documents are identified, d) ensure that relevant versions applicable documents are available at points use, 9

18 i i MS 1900:2005 e) ensure that documents remain legible readily identifiable, f) ensure that documents external origin are identified ir distribution controlled, g} g) prevent unintended use obsolete documents, apply suitable identification m if y are retained for any purpose. With regard [4.2.3 a}], a)], organisation ensure that contents all documents are sufficient justify Shariah compliance. The organisation properly observe placement srage documents which contain Quranic elements Control records M ISO :2000, Quality management systems - Requirements Control records Records be established maintained provide evidence conformity requirements requirements effective operation quality management system. Records remain legible, readily identifiable retrievable. A documented procedure be established define controls needed for identification, srage, protection, retrieval, retention time disposition records. 5. Management responsibility 5.1 Management commitment I M5 ISO 9001:2000, Quality management systems - Requirements 5 Management responsibility 5.1 Management commitment Top management provide evidence its commitment development implementation quality management system continually improving its effectiveness by a) communicating organization importance meeting cusmer as well as statury regulary regulary requirements, requirements, b) establishing quality policy, c) ensuring that quality objectives are established, 10

19 d) conducting management reviews, e) ensuring availability resources. Top management establish Shariah Advisory Committee. The organisation ensure that quality objectives [5.1 c)] are Shariah compliant. The organisation be transparent its stakeholders all its activities. NOTE. See Annex B for Shar;ah Shariah implementation framework. 5.2 Cusmer focus MS ISO 9001 :2000, Quality management systems - Requirements 5.2. Cusmer focus Top management ensure that cusmer requirements are determined are met with aim enhancing cusmer satisfaction (see ). The organisation ensure that requirements cusmers are Shariah compliant. 5.3 Quality policy MS ISO :2000, Quality management systems - Requirements 5.3 Quality policy Top management ensure that quality policy a) is appropriate purpose organization, b) includes a commitment comply with requirements continually improve effectiveness quality management system, c) provides a framework for establishing reviewing quality objectives, d) is communicated undersod within organization, e) is reviewed for continuing suitability. The organisation ensure that quality policy is Shariah compliant. The review quality policy [5.3 e)] take in consideration new decree (fatwa) issued by Fiqh Council. 11

20 5.4 Planning Quality objectives MS ISO 9001 :2000. :2000, Quality management systems - Requirements 5.4 Planning Quality objectives Top management ensure that quality objectives, including those needed meet requirements for product [see 7.1 a)}, a)], are established at relevant functions levels within organization. The quality objectives be measurable consistent with quality policy. The organisation which is involved in both Ha/al non Halal activities establish a separate set quality objectives for its Ha/al operation Quality management system planning MS ISO 9001 :2000, Quality management systems - Requirements Quality management system planning Top management ensure that a) planning quality management system is carried out in order meet requirements given in 4.1, as well as quality objectives, b) integrity quality management system is maintained when changes quality management system are planned implemented. The organisation take in consideration Shariah requirements in planning its quality management system. This include Shariah requirements in financial management, human resource management, procurement procedures, production marketing. 12

21 5.5 Responsibility, authority communication Responsibility authority MS ISO 9001 :2000, Quality management systems - Requirements 5.5 Responsibility, authority communication Responsibility authority Top management ensure that responsibilities authorities are defined communicated within organization. Top management ensure that responsibilities authorities for Shariah compliance are defined communicated within organisation Management representative MS ISO 9001:2000, Quality management systems - Requirements Management representative Top management appoint a member management who, irrespective or responsibilities, have responsibility authority that includes a} a) ensuring that processes needed for quality management system are established, implemented maintained, b) reporting p management on performance quality management system any need for improvement, c} c) ensuring promotion awareness cusmer requirements throughout organization. NOTE The responsibility a management representative can include liaison with external parties on matters relating 10 quality management system. Top management appoint a Shariah Compliance Unit /or an Officer who have responsibility authority that includes: a) ensuring continuous conformity Shariah requirements in all activities organisation; b} b) reporting all Shariah noncompliances p management. 13

22 5.5.3 Internal communication MS ISO 9001 :2000, Quality management systems - Requirements Internal communication Top management ensure that appropriate communication processes are established within organization that communication takes place regarding effectiveness quality management system. The organisation ensure every personnel working for on behalf organisation is fully informed that quality management system is Shariah compliant. 5.6 Management review General MS ISO 9001 :2000, Quality management systems - Requirements 5.6 Management review General Top management review organization's quality management system, at planned intervals, ensure its continuing suitability, adequacy effectiveness. This review include assessing opportunities for improvement need for changes quality management system, including quality policy quality objectives. Records from management reviews be maintained (see 4.2.4). The organisation establish documented procedures identify address Shariah noncompliance from reviews. The review quality policy [5.3 e») e)] also take in consideration new decree (fatwa) issued by Fiqh Council. The policy review committee include representative(s) from Shariah Advisory Committee Review input MS ISO 9001 :2000, Quality management systems - Requirements ReqUirements Review input The input management review include information on a) results audits, b) cusmer feedback, 14

23 c) process performance product conformity, d) status preventive corrective actions, e) follow-up actions from previous management reviews, f) changes that could affect quality management system, g) recommendations for improvement Review output MS ISO 9001 :2000, Quality management systems - Requirements Review output The output from management review include any decisions actions related a) improvement effectiveness quality management system its processes, b) improvement product related cusmer requirements, c) resource needs. 6. Resource management 6.1 Provision resources MS ISO 9001 :2000, Quality management systems - Requirements 6 Resource management 6.1 Provision resources The organization determine provide resources needed a) implement maintain quality management system continually improve its effectiveness, b) enhance cusmer satisfaction by meeting cusmer requirements. The organisation ensure all resources are Shariah compliant in ir characteristics as well as procurement process. 15

24 With With respect respect financial financial resources, resources, organisation organisation determine determine its its commitment commitment Shariah Shariah compliant. compliant Human Human resources resources MS M5 150 ISO :2000, :2000, Quality Quality management management systems systems - Requirements Requirements Human Human resources resources General General Personnel Personnel performing performing work work affecting affecting product product quality quality be be competent competent on on basis basis appropriate appropriate education, education, training, training, skills skills experience. experience Competence, Competence, awareness awareness training training The The organization organization a) a) determine determine necessary necessary competence competence for for personnel personnel performing performing work work affecting affecting product product quality, quality, b) b) provide provide training training or or take take or or actions actions satisfy satisfy se se needs, needs, c) c) evaluate evaluate effectiveness effectiveness actions actions taken, taken, d) d) ensure ensure that that its its personnel personnel are are aware aware relevance relevance importance importance ir ir activities activities how how y y contribute contribute achievement achievement quality quality objectives, objectives, e) e) maintain maintain appropriate appropriate records records education, education, training, training, skills skills experience experience (see (see 4.2.4) ). The The organisation organisation ensure ensure that that all all personnel personnel working working for for on on behalf behalf organisation organisation be be given given sufficient sufficient training training on on Ha/al non non Ha/a/ Halal aspects aspects processes, processes, products products services. services. The The organisation organisation ensure ensure that that only only non non Muslim Muslim personnel personnel working working for for on on behalf behalf organisation organisation be be deployed deployed for for preparation, preparation, hling, hling, processing processing sring sring non non Halal Ha/al products within premises Infrastructure Infrastructure MS M5 ISO :2000, :2000, Quality Quality management management systems systems - Requirements Requirements 6.3 Infrastructure The The organization determine, provide provide maintain maintain infrastructure needed needed achieve achieve conformity product requirements. Infrastructure includes, as as applicable a) a) buildings, workspace associated utilities, utilities, 16 16

25 b) process equipment (both hardware stware), c) supporting services (such as transport or communication). The organisation provide maintain adequate proper infrastructure such as separate prayer room (Musolla) ablution facilities for Muslims fulfill ir compulsory religious obligations. Eateries within premise organisation provide Halal Ha/a/ foods beverages. Non Hala! Ha/a/ items be segregated accordingly avoid any cross-contamination. The organisation make necessary provision for any changes, modifications additions infrastructure so as cater any additional needs requirements Shariah for Muslims fulfil ir compulsory religious obligations. 6.4 Work environment MS ISO 9001 :2000, Quality management systems - Requirements 6.4 Work environment The organization determine manage work environment needed achieve conformity product requirements. The organisation provide a work environment which is non-discriminary. In performing ir work, employees not be made compromise on ir religious beliefs. 7. Product realisation 7.1 Planning product realisation MS ISO 9001 :2000, Quality management systems - Requirements 7 Product realization 7.1 Planning product realization The organization plan develop processes needed for product realization. Planning product realization be consistent with requirements or processes quality management system (see 4.1). In planning product realization, organization determine following, as appropriate: a) quality objectives requirements for product, 17

26 b} b) need establish processes, documents, provide resources specific product, c} c) required verification, validation, moniring, inspection test activities specific product criteria for product acceptance, d) records needed provide evidence that realization processes resulting product meet requirements (see 4.2.4). The output this planning be in a form suitable for organization's method operations. NOTE 1 A document specifying processes quality management system (including product realization processes) resources be applied a specific product, project or contract, can be referred as a quality plan. NOTE 2 The organization may also apply requirements given in 7.3 development product realization processes. The organisation ensure quality objectives requirements for products [7.1a}] [7.1a)] such as product characteristics production processes [7.1b}] b)] are Shariah compliant. The organisation ensure that required verification, validation, moniring, inspection test activities specific product criteria for product acceptance [7.1 c}] c)] are also Shariah compliant. 7.2 Cusmer-related processes Determination requirements related product MS ISO 9001 :2000, Quality management systems - Requirements 7.2 Cusmer-related processes Determination requirements related product The organization determine a) requirements specified by cusmer, including requirements for delivery post-delivery activities, b) requirements not stated by cusmer but necessary for specified or intended use, where known, c} c) statury regulary requirements related product, d) any additional requirements determined by organization. The organisation ensure all requirements related product as specified by cusmer [7.2.1 a)] not stated by cusmer [7.2.1 b)] are Shariah compliant. 18

27 MS MS 1900: : Review Review requirements requirements related related product product MS M5 ISO ISO :2000, :2000, Quality Quality management management systems systems - Requirements Requirements Review Review requirements requirements related related product product The The organization organization review review requirements requirements related related product. product. This This review review be be conducted conducted prior prior organization's organization's commitment commitment supply supply a product product cusmer cusmer (e.g. (e.g. submission submission tenders, tenders, acceptance acceptance contracts contracts or or orders, orders, acceptance acceptance changes changes contracts contracts or or orders) orders) ensure ensure that that a) a) product product requirements requirements are are defined, defined, b) b) contract contract or or order order requirements requirements differing differing from from those those previously previously expressed expressed are are resolved, resolved, c) c) organization organization has has ability ability meet meet defined defined requirements. requirements. Records Records results results review review actions actions arising arising from from review review be be maintained maintained (see (see 4.2.4) ). Where Where cusmer cusmer provides provides no no documented documented statement statement requirement, requirement, cusmer cusmer requirements requirements be be confirmed confirmed by by organization organization before before acceptance. acceptance. Where Where product product requirements requirements are are changed, changed, organization organization ensure ensure that that relevant relevant documents documents are are amended amended that that relevant relevant personnel personnel are are made made aware aware changed changed requirements. requirements. NOTE In some situations, such as internet sales, fonnal review is impractical for each order. Instead review NOTE In some situations, such as Internet sales, a formal review is impractical for each order. Instead review can cover relevant product information such as catalogues or advertising material. can cover relevant product information such as catalogues or advertising material. In In reviewing reviewing product product requirements, requirements, organisation organisation define, define, identify identify implement implement in in accordance accordance with with Shariah Shariah maintain maintain uphold uphold integrity integrity Ha/al Ha/al products. products. Ha/al Halal activities, activities, contracts contracts or or or or requirements requirements which which are are not not compatible compatible with with Shariah Shariah be be reviewed reviewed rectified rectified within within reasonable reasonable time time frame. frame Cusmer Cusmer communication communication MS M5 ISO ISO :2000, :2000, Quality Quality management management systems systems - Requirements Requirements Cusmer Cusmer communication communication The The organization organization determine determine implement implement effective effective arrangements arrangements for for communicating communicating with with cusmers cusmers in in relation relation a) a) product product information, information, 19

28 b) enquiries, contracts or order hling, including amendments, c) cusmer feedback, including cusmer complaints. The organisation ensure that information product be true valid should be undersod by cusmers. Inquiries, contracts amendments be made transparent. Feedback be hled with most appropriate, just effective manner in order satisfy cusmers. The organisation ensure correct true representation information not mislead cusmers. 7.3 Design development Design development planning M5 MS ISO 9001 :2000, Quality management systems - Requirements 7.3 Design development Design development planning The organization plan control design development product. During design development planning, organization determine a) design development stages, b) review, verification validation that are appropriate each design development stage, c) responsibilities authorities for design development. The organization manage interfaces between different groups involved in design development ensure effective communication clear assignment responsibility. Planning output be updated, as appropriate, as design development progresses. The organisation establish documented guidelines procedures ensure that design development planning processes are Shariah compliant. 20

29 7.3.2 Design development inputs MS SO 9001 :2000, Quality management systems - Requirements Design development inputs Inputs relating product requirements be determined records maintained (see 4.2.4). These inputs include a) functional performance requirements, b) applicable statury regulary requirements, c) where applicable, information derived from previous similar designs, d) or requirements essential for design development. These inputs be reviewed for adequacy. Requirements be complete, unambiguous not in conflict with each or. The organisation ensure that all inputs relating product development are Shariah compliant. The applicable statury regulary requirements [7.3.2 b)] not contradict with Shariah Design development outputs MS ISO 9001 :2000, Quality management systems - Requirements Design development outputs The outputs design development be provided in a form that enables verification against design development input be approved prior release. Design development outputs a) meet input requirements for design development, b) provide appropriate information for purchasing, production for service provision, c) contain or reference product acceptance criteria, d) specify characteristics product that are essential for its safe proper use. The organisation ensure design development outputs are Shariah compliant. 21

30 7.3.4 Design development review MS SO 9001 :2000, Quality management systems - Requirements Design development review At suitable stages, systematic reviews design development be performed in accordance with planned arrangements (see 7.3.1) a) evaluate ability results design development meet requirements, b) identify any problems propose necessary actions. Participants in such reviews include representatives functions concerned with design development stage(s) being reviewed. Records results reviews any necessary actions be maintained (see 4.2.4). The organisation ensure that requirements for are Shariah compliant Design development verification MS M5 ISO 9001 :2000, Quality management systems - Requirements Design development verification Verification be performed in accordance with planned arrangements (see 7.3.1) ensure that design development outputs have met design design development input requirements. Records results verification any necessary actions be maintained (see 4.2.4). The organisation ensure product design development input output are Shariah compliant Design development validation MS ISO :200, Quality management systems - Requirements Design development validation Design development validation be performed in accordance with planned arrangements (see 7.3.1) ensure that resulting product is capable meeting requirements for specified application or intended use, where known. Wherever practicable, validation be completed prior delivery or implementation product. Records results validation any necessary actions be maintained (see 4.2.4). The final validation design development be Shariah compliant. 22

31 Control Control design development changes changes M :2000, Quality management systems - Requirements Control design development changes Design development changes be be identified records maintained. The The changes be be reviewed, verified verified validated, validated, as as appropriate, appropriate, approved approved before before implementation. The review design development changes include evaluation effect changes on on constituent parts parts product already delivered. Records Records results results review review changes changes any any necessary necessary actions actions be be maintained (see 4.2.4), 4.2.4). 7.4 Purchasing Purchasing process M :2000, Quality management systems - Requirements 7.4 Purchasing Purchasing process The organization ensure that purchased product conforms specified purchase requirements. The type extent control applied supplier purchased product be dependent upon effect purchased product on on subsequent product realization or final product. The organization evaluate select suppliers based on ir ability supply product in accordance with organization's requirements. Criteria for selection, evaluation reevaluation be established. Records results evaluations any necessary actions arising from evaluation be maintained (see 4.2.4). The organisation ensure that suppliers all purchased products conform Shariah compliance. The type extent control applied supplier purchased product be dependent on ability supply Shariah compliant product. The organisation evaluate select suppliers based on ir ability comply with Shariah. Criteria for selection, evaluation re-evaluation be be established ensure purchased products conform Shariah. 23

32 7.4.2 Purchasing information MS ISO 9001 :2000, Quality management systems - Requirements Purchasing information Purchasing information describe product be purchased, including where appropriate a) requirements for approval product, procedures, processes equipment, b) requirements for qualification personnel, c) quality management system requirements. The organization ensure adequacy specified purchase requirements prior ir communication supplier Verification purchased product MS ISO 9001 :2000, Quality management systems - Requirements Verification purchased product The organization establish implement inspection or or activities necessary for ensuring that purchased product meets specified purchase requirements. Where organization or its cusmer intends perform verification at supplier's premises, organization state intended verification arrangements method product release in purchasing information. The organisation ensure verification purchased product is Shariah compliant. 7.5 Production service provision Control production service provision MS ISO 9001 :2000, Quality management systems - Requirements 7.5 Production service provision Control production service provision The organization plan carry out production service provision under controlled conditions. Controlled conditions include, as applicable a) availability information that describes characteristics product, 24

33 b) availability work instructions, as necessary. necessary, c) use suitable equipment, d) availability use moniring measuring devices, e) implementation moniring measurement, f) implementation release, delivery post-delivery activities. The organisation shalf ensure that au all work instructions on production preparation Halal products are well-documented made available relevant employees. The organisation ensure that dedicated equipment assembly lines used [7.5.1 c)] in production, preparation, hling srage non Halal products not be reused for provision Halal products as prescribed in MS Validation processes for production service provision M5 MS ISO :2000, Quality management systems - Requirements Validation processes for production service provision The organization validate any processes for production service provision where resulting output cannot be verified by subsequent moniring or measurement. This includes any processes where deficiencies become apparent only after product is in use or service has been delivered. Validation demonstrate ability se processes achieve planned results. The organization establish arrangements for se processes including, as applicable a) defined criteria for review approval processes, b) approval equipment qualification personnel, c) use specific methods procedures. procedures, d) requirements for records (see 4.2.4), e) revalidation. The organisation ensure that validation processes for production service provision provision is carried out by its Shariah Compliance Unit/Officer. UniUOfficer. 25

34 7.5.3 Identification traceability M5 MS ISO 9001 :2000, Quality management systems - Requirements Identification traceability Where appropriate, organization identify product by suitable means throughout product realization. The organization identify product status with respect moniring measurement requirements. Where traceability is a requirement, organization control record unique identification product (see 4.2.4). NOTE In some industry secrs, configuration management is a means by which identification traceability are maintained. The organisation identify, control remove any doubtful elements or non Hala! Halal contents in production process or service provision. If non Hala! Halal contents cannot be removed from processes, whole products be eliminated from production system. The organisation validate processes for production service provision ensure Shariah compliance. The organisation establish a procedure for identification traceability remedy problem Shariah noncompliance Cusmer property M5 MS ISO 9001 :2000, Quality management systems - Requirements Cusmer property The organization exercise care with cusmer property while it is under organization's control or being used by organization. The organization identify, verify, protect safeguard cusmer property provided for use or incorporation in product. If any cusmer property is lost, damaged or orwise found be unsuitable for use, this be reported cusmer records maintained (see 4.2.4). NOTE Cusmer property can include intellectual property. The organisation ensure that all cusmer properties under its care all usage related properties are Shariah compliant. The organisation develop appropriate sufficient policies with regard voluntary compensation in events damages losses. 26

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