zilongwang/ReadingBank huggingface dataset:
Guidelines for quality plans [11] , Quality management systems — Guidelines for quality management in projects [12] , Quality management systems — Guidelines for configuration management [13] , Quality management — Customer satisfaction — Guidelines for electronic commerce transactions [14] , Measurement management systems — Requirements for measurement processes and measuring equipment [15] , Guidelines for quality management
management systems [27] , Information technology — Security techniques — Information security management systems — Requirements [28] , Risk management — Principles and guidelines [29] , Energy management systems — Requirements with guidance for use [30] IEC International electrotechnical vocabulary — Part 192: Dependability [31] , Standardization and related activities — General vocabulary [32] , Risk management — Vocabulary
ISO 9000:2015(E) Figure A.10 — 3.7 Concepts of the class “result” and related concepts 40 © ISO 2015 – All rights reserved BS EN ISO 9000:2015 ISO 9000:2015(E) Figure A.11 — 3.8 Concepts of the class “data, information and document” and related concepts © ISO 2015 – All rights reserved 41 BS EN ISO 9000:2015 ISO 9000:2015(E) Figure A.12 — 3.9 Concepts of the class “customer” and related concepts 42 © ISO 2015 – All rights reserved BS EN ISO 9000:2015 ISO 9000:2015(E) Figure A.13 — 3.10 Concepts of the class “characteristic” and related concepts © ISO 2015 – All rights reserved 43 BS EN ISO 9000:2015 ISO 9000:2015(E) Figure A.14 — 3.11 Concepts of the “determination” and related concepts 44 © ISO 2015 – All rights reserved BS EN ISO 9000:2015 ISO 9000:2015(E) Figure A.15 — 3.12 Concepts of the class “action” and related concepts © ISO 2015 – All rights reserved 45 BS EN ISO 9000:2015 ISO 9000:2015(E) Figure A.16 — 3.13 Concepts of the class “audit” and related concepts 46 © ISO 2015 – All rights reserved BS EN ISO 9000:2015 ISO 9000:2015(E) Bibliography [1] ISO 704:2009, Terminology work — Principles and methods [2] ISO 1087-1:2000, Terminology work — Vocabulary — Part 1: Theory and application
6 Have the criteria for managing these processes and their interaction been established? 7 Have all responsibilities, methods, measurements and related performance indicators, needed to ensure the effective operation and control, been established? Leadership Finding Implementation Plan (if No) Yes No ISO Clause Process Owner Action Needed Date Planned Date Actual 8 Has top management taken accountability for the effectiveness of the QMS? 9 Have the policy and objectives for the QMS, which are compatible with the strategic direction of the organisation, been established and communicated?
10 Have the objectives been established at relevant departmental and individual levels with the business? 11 Have the requirements for the QMS been integrated into the business processes and have management promoted awareness of the process approach? 12 Have customer requirements and applicable statutory and regulatory requirements been determined, met and communicated throughout the organisation? 13 Have the risks and opportunities that are relevant to the QMS been established? 14 Has the organisation established and communicated the responsibilities and authorities for the effective operation of the QMS?
PAC Training Programme Introduction to ISO/IEC 17065 with emphasis on related standards ISO/IEC 17025, ISO/IEC 17020, ISO/IEC 17021 21 June & 22 June 2014 Guadalajara Mexico PROGRAMME DAY ONE Saturday, 21 June 2014 Time Content Trainer 08:30 – 08:45 Registration of participants 08.45 – 09:15 Course overview & organization Introduction of participants Reinaldo Figueiredo 09:15 – 10:20 Terms & Definitions related to Product Certification Functional Approach ISO/IEC 17000 Marlene Reinaldo Figueiredo 10:20 – 10:40 Tea break 10:40 – 11:00 Introduction to ISO/IEC 17065 & Related Standards Marlene Moore/Reinaldo Figueiredo 11:00 – 11:30 General Requirements Section 4 Marlene Moore 11:30 – 12:30 Contractual and Structural requirements Impartiality Requirements Exercise 1: Impartiality Marlene Moore 12:30 – 13:30 Lunch break
13:30 – 15:00 Resource Requirements Section 6 Exercise 2: Competence of certification body personnel Marlene Moore 15.00 – 15.30 Pre-certification, application & evaluation process Marlene Moore 15:30 – 15:45 Tea break 15.45 – 16.30 Evaluation, Review, Decision Section 7 Exercise 3: Process review Marlene Moore/ Reinaldo Figueiredo 16:30 – 17:00 Management System Section 8 Marlene Moore DAY TWO Sunday, 22 June 2014 Time Content Trainer 08.30 – 09.15 Application of ISO/IEC 17025, ISO/IEC 17020 and ISO/IEC 17021 in certification process Marlene Moore 09:15 – 10:15 Exercise 4 ISO/IEC 17025 in certification process Marlene Moore 10:15 – 10:35 Tea break 10:35 – 12:30 Application of ISO/IEC 17067 Scheme contradicts ISO/IEC 17065 AB reviews and accepts scheme(s) Reinaldo Figueiredo 12:30 – 13:30 Lunch break 13:30 – 14:45 Presentation on status of participants & discussion All participants 14:45 – 15:15 IAF, CASCO Interpretations Explanations by ABs posted to websites Reinaldo Figueiredo 15:15 – 15:35 Tea break 15:35 – 16:30 Assessing a certification body against ISO/IEC Non-conformances – most common Reinaldo Figueiredo 16:30 – 17:00 Questions & Wrap-up All participants Trainers
system. Such issues shall include environmental conditions being affected by or capable of affecting the organization. 4.2 Understanding the needs and expectations of interested parties The organization shall determine: a) the interested parties that are relevant to the environmental management system; b) the relevant and expectations (i.e. requirements) of these interested parties; c) which of these needs and expectations become its compliance obligations. Planning-Actions to address risks and opportunities (includes consequences) 6.1.1 Planning, Actions to address risk & opportunities …and determine the risks and opportunities, related to its environmental aspects (see 6.1.2), compliance obligations (see 6.1.3) and other issues and requirements, identified in 4.1 and 4.2, that need to be addressed to: — give assurance that the environmental management system can achieve its intended outcomes; — prevent or reduce undesired effects, including the potential for external environmental conditions to affect the organization; — achieve continual improvement. … The organization shall maintain documented information of its: — risks and opportunities that need to be addressed;
b) changes in: 4) risks and opportunities; 10.2 Nonconformity and corrective action When a nonconformity occurs, the organization shall: react to the nonconformity and, as applicable: 2) deal with the consequences, including mitigating adverse environmental impacts ISO 14001:2015 Requirements Accomplished During Audit (Audit ID): 5.1 Leadership and commitment Top management shall demonstrate leadership and commitment with respect to the environmental management system by: a) taking accountability for the effectiveness of the environmental management system; b) ensuring that the environmental policy and environmental objectives are established and are compatible with the strategic direction and the context of the organization; c) ensuring the integration of the environmental management system requirements into the organization’s business processes; d) ensuring that the resources needed for the environmental management system are available; e) communicating the importance of effective environmental management and of conforming to the environmental management system requirements; f) ensuring that the environmental management system achieves its intended outcomes; g) directing and supporting persons to contribute to the effectiveness of the environmental management system; h) promoting continual improvement; i) supporting other relevant management roles to demonstrate their leadership as it applies to their areas of responsibility. Life Cycle
to manage environmental risks and hence assure compliance with their permits. This is due to the more complex and high risk activities carried out by EPR permit holders. In doing so, it encourages the uptake of standards such as ISO 14001 and ISO 14031 to demonstrate a robust approach. Recognition of good performance management through the use of ISO and ISO 14031 standards will help organisations to improve their risk rating and reduce annual subsistence charges. An organisation operating an independently verified ISO 14001 EMS (or EMAS) is given a higher performance rating than those operating a non-certified or ‘in-house’ EMS under the Operator Risk Appraisal (OPRA) scheme. One of the benefits of using the ISO 14031 standard is that organisations within each sector can become more consistent and streamlined in applying performance measures. This will potentially simplify and reduce the costs of regulation for sectors. Standard Compliance Best Practice EMS Structured management of compliance with environmental legal and other obligations. Staff are aware of compliance obligations for their role and are competent to meet them. Non-compliances are detected and addressed to prevent re-occurrence. EMS is integrated with and part of normal business practice. The EMS is independently assessed. The EMS is continuously reviewed and improved. EPE All compliance obligations are identified. Performance measures are established to monitor and report on compliance status. Top management receive and act on environmental compliance data. EPE is integrated within the business, is industry relevant, complete, consistent, accurate and transparent and part of normal business practice. All business environmental risks are identified. Performance measures are established to monitor and report on environmental risks. Part 4 – The next steps for industry and organisations – David Smith The revision and republication of ISO 14031 provides a new opportunity for industry, trade associations, environmentalists, regulators and standards writers to work together to provide more coherent guidance and tools to help organizations get the best out of their environmental and performance management. Improved environmental performance management would provide greater assurance to stakeholders, potential cost savings and help enhance credibility and reputation in the world marketplace.
The imamate It means ‘leadership’ and refers in Shi’a Islam to the twelve imams who succeeded Muhammad as the leaders of Islam. Immanence The belief that Allah is close to humanity ad involved in the world. The name of the religion followed by Muslims. To surrender to the will of God.Peace. Jibril The most important of the angels and spoke with many of the prophets of Allah. Jibril dictated the Qur’an to Muhammad. On Judgement Day he will assist with the weighing of a person’s deeds. Jihad 'To struggle’. It refers to the effort made to obey Allah. Jummah Weekly communal salah performed after midday on a Friday. Justice Bringing about what is right, fair, according to the law or making up for a wrong that has been committed. The Ka'aba The black covered cube-shaped building in the centre of the grand mosque in Makkah. All Muslims face towards it when they pray. Khums This is a practice in Shi’a Islam. It is a 20% tax on annual surplus income and is given to the poor and to religious leaders. Lesser jihad This refers to the military struggle to defend Islam. It is carried out according to strict and clear cut rules. Life after death Akhirah. Muslims believe that death is not the end. Makkah The city where Muhammad was born. The spiritual centre of Islam, it is in Saudi Arabia. Mercy One of Allah’s 99 Beautiful Names. It refers to Allah’s willingness to forgive the sins of those who repent. Mika’il One of the most important angels. He gives spiritual and material help to humans. On Judgement Day he will assist with the weighing of a person’s deeds. Mina Place to be visited on hajj – stoning of pillars.
469 5.3 Organizational roles, responsibilities and authorities 470 Top management shall ensure that the responsibilities and authorities for relevant roles are assigned and 471 communicated within the organization. 472 Top management shall be accountable for the effectiveness of the quality management system and shall assign the responsibility and authority for: a) ensuring that the quality management system conforms to the requirements of this International Standard and, b) ensuring that the processes interact and are delivering their intended outputs, c) reporting on the performance of the quality management system to top management and any need for improvement, and d) ensuring the promotion of awareness of customer requirements throughout the organization. 6 Planning 6.1 Actions to address risks and opportunities When planning for the quality management system, the organization shall consider the issues referred to in 4.1 and the requirements referred to in 4.2 and determine the and opportunities that need to be addressed to a) assure the quality management system can achieve its intended outcome(s), b) assure that the organization can consistently achieve conformity of goods and services and customer satisfaction, c) prevent, or reduce, undesired effects, and d) achieve continual improvement. 491 492 The organization shall plan: 493 a) actions to address these risks and opportunities, and 494 b) how to 495 1) integrate and implement the actions into its quality management system processes (see 4.4), and 496 2) evaluate the effectiveness of these actions. 497 498 Any actions taken to address risks and opportunities shall be proportionate to the potential effects on 499 conformity of goods and services and customer satisfaction. 500 501 Note Options to address risks can include for example risk avoidance, risk mitigation or risk acceptance 502 6.2 Quality objectives and planning to achieve them 503 The organization shall establish quality objectives at relevant functions, levels and processes. 504 The quality objectives shall 505 a) be consistent with the quality policy,
If requesting a Scope Extension 1: List any products or processes not included in the previous certification audit which should be included in a scope extension audit: Yes or No Products: ______________________________ If your facility has been previously certified by someone other than FSNS, please provide your ISO 22000/22003 report and certificate number. Yes or No Site Code: ______ Certificate Number: ______ If known, please circle the product categories requested- Refer to ISO 22003 Annex A. C I – Processing of Animal Perishable Products C II – Processing of Perishable Plant Products CIII – Processing of Perishable Animal and Plant Products (Mixed Products) CIV – Processing of Ambient Stable Products If this is an application for a surveillance audit, please describe any substantial changes made to your operations since the last certification or surveillance audit. Scope extension may be necessary if products the client desires to be certified were not included in the scope of the certifying audit or additional process technology or processes were added. Contact FSNS C&A for more information regarding the scope extension requirements. Please list products produced. Please describe processes utilized. Describe intended use (raw consumption, further processing, retail, food service, etc): Please describe packaging systems used at your facility. (Examples: vacuum packaging, bulk or Modified Atmosphere Packaging)
extremely likely that the programmer did not intend to put the semi-colon there. C.26.2 Guidance to language users Simplify statements with interspersed comments to aid in accurately programming functionality and help future maintainers understand the intent and nuances of the code. The flexibility of C permits a programmer to create extremely complex expressions.  Assignments embedded within other statements can be potentially problematic. Each of the following would be clearer and have less potential for problems if the embedded assignments were conducted outside of the expressions: int a,b,c,d; /* … */ if ((a == b) || (c = (d-1))) /* the assignment to c may not occur */ /* if a is to b */ or: int a,b,c; /* … */ foo (a=b, c); Each is a valid C statement, but each may have unintended results.  Null statements should have a source line of their own. This, combined with enforcement by static analysis, would make clearer the intention that the statement was meant to be a null statement. C.27 Dead and Deactivated Code [XYQ] C.27.1 Applicability to language As with any programming language that contains branching statements, C programs can potentially contain dead code. It is of concern primarily since dead code may reveal a logic flaw or an unintentional mistake on the part of the programmer. Sometimes statements can be inserted in C programs as defensive programming such as adding a default case to a switch statement even though the expectation is that the default can never be reached – until through some twist of logic or through modifications to the code the notifying error message reveals the surprising event. These types of defensive statements may be able to be shown to be computationally impossible and thus are dead code. Those are not the focus. The focus is on those statements which are not defensive and which are unreachable. It is impossible to identify all such cases and therefore only those which are blatant and that indicate deeper issues of flawed logic may be able to be identified and removed. C uses some operators that can be confused with other operators. For instance, the common mistake of using an assignment operator in a Boolean test as in: int a,b; /* … */ if (a = b) … can portions of code to become dead code since unless b can contain the value 0, the else portion of the if
this is undefined behaviour so this macro expansion is difficult to predict. Another mechanism of failure can occur when the arguments within the body of a function-like macro are not fully parenthesized. The following example shows the CUBE macro without parenthesized arguments [2]: #define CUBE(X) (X * X * X) /* ... */ int a = CUBE(2 + 1); This example expands to: int a = (2 + 1 * 2 + 1 * 2 + 1) evaluates to 7 instead of the intended 27. 6.52.2 Guidance to language Replace macro-like functions with inline functions where possible. Although making a function inline only suggests to the compiler that the calls to the function be as fast as possible, the extent to which this is done is implementation-defined. Inline functions do offer consistent semantics and allow for better analysis by static analysis tools. Ensure that if a function-like macro must be used, that its arguments and body are parenthesized. Do not embed pre-processor directives or side-effects such as an assignment, increment/decrement, volatile access, or function call in a function-like macro. 6.53 Suppression of language-defined run-time checking [MXB] Does not apply to C since there are no language-defined runtime checks. 6.54 Provision of inherently unsafe operations [SKL] 6.54.1 Applicability to language C was designed for implementing system software some unsafe operations are inherent and common. 6.54.2 Guidance to language Follow the guidelines of TR 24772-1 clause 6.54.5.
National Central Bank (NCB) The principal monetary authority of a nation, a central bank performs several key functions, including issuing currency and regulating the supply of credit in the economy. Corporate The most common form of business organization, and one is chartered by a state and given many legal rights as an entity separate from its owners. This form of business is characterized by the limited liability of its owners, the issuance of shares of easily transferable stock, and its existence as a going concern. Bank A business establishment in money is kept for saving or commercial purposes or is invested, supplied for loans, or exchanged. A bank is licensed by a government. Its primary activity is to lend money. A bank does most or all of the following: receives demand deposits and time deposits, honors instruments drawn on them, and pays interest on them; discounts notes, makes loans, and invests in securities; collects checks, drafts, and notes; certifies depositor's checks; and issues drafts and cashier's checks. Market Infrastructure The party that provides, through common membership, services to create a fair and open process for the execution of transactions between trading parties and the creation of settlement obligations. Market Data Provider An organization that provides data on financial instruments to parties. Such as services provided by Thomson, Reuters, Bloomberg … BusinessRoles/Participants Matrix Table Participants BusinessRoles Instructing Party Executing/Servicing Bank X Corporate X CSD X X Market Data Provider X X Market Infrastructure X
Query/Query Response process Description of the BusinessActivities Initiator Instruction: Instructing Party instructs Executing/Servicing Party to run a query or Audit Trail Query. Instructing Party Process Query: Executing/Servicing Party processes the request. In case the processing of the query takes too much time or cannot give any positive response, the Executing/Servicing Party sends an error message back to the Instructing Party with the error code and the related explanation. Executing/Servicing Party Response: Executing/Services Party sends the response to the Instructing Party according to query results. Executing/Servicing Monitor process: Instructing Party monitors the status of the instruction. Instructing Party
Rejection If the Account Switch Service cannot successfully validate the Information Request message it will send a Technical Rejection message to the new account servicer, containing the switch status and response code appropriate for the validation failure. If the old account servicer cannot successfully validate the Information Request message it will send an Information Response message to the Account Switch. The old account servicer will always include within the Information Response message all warning messages applicable to the validation performed to facilitate rectification with the goal of successful validation/verification at the next attempt. . If the Account Switch Service cannot successfully validate the Information Response message it will send a Technical Rejection message to the old account servicer. Payment and collection transaction redirection The new account servicer will send a Request Redirection message to the Account Switch Service. Rejection If the Account Switch Service cannot successfully validate the Request Redirection message it will send a Technical Rejection message containing the appropriate response codes back to the new account servicer.
Introduction Terms and definitions The following terms are reserved words defined in ISO 20022 – Part1. When used in this document, they will follow the UpperCamelCase notation. Term Definition BusinessRole functional role played by a business actor in a particular BusinessProcess or BusinessTransaction Participant involvement of a BusinessRole in a BusinessTransaction BusinessProcess unrealized definition of the business activities undertaken by BusinessRoles within a BusinessArea whereby each BusinessProcess fulfils one type of business activity and whereby a BusinessProcess may include and extend other BusinessProcesses BusinessTransaction particular solution that the communication requirements and the interaction requirements of a particular BusinessProcess and BusinessArea MessageDefinition formal description of the structure of a MessageInstance Glossary Acronyms Acronym Definition CCP Central Counterparty BOE Bank of England SA Supervisory Agency CB Central Bank NCA National Competent Authority EMIR Regulation (EU) No 648/2012 of the European Parliament and of the Council of 4 July 2012 on OTC derivatives, central counterparties and repositories Text with EEA relevance Abbreviations Abbreviation Definition
investigation workflow must be kept informed of the status of the investigation at all times. The rule is explained below. Each workflow specifies the parties to which a case can be assigned. For example, a request for cancellation case assignment follows the route of the payment instruction (from instructing party to instructed party), while the unable to apply case assignment travels in the opposite direction (from the instructed party to the instructing party). The following table summarises the direction of the various investigation activities: Activity Case Assignment Message Case Assigner Case Assignee Request for cancellation (C2B space), FIToFICancellationRequestV02 (B2B Instructing party Instructed Request for modification RequestToModifyPaymentV04 Instructing party Instructed party/creditor Unable to apply UnableToApplyV04 Instructed party/creditor, Instructing party for statement queries Instructing party Claim non receipt ClaimNonReceiptV04 Instructing party Instructed party
Description of BusinessActivities This section presents the different BusinessActivities within each BusinessProcess. The BusinessActivities of a process are described with activity diagrams. Legend Symbol Name Definition Start Point Shows where the lifecycle of the business process commences. End Point Shows where the lifecycle of the business process may ends. Lozenge (or diamond) Indicates that a choice between several actions can be made. Bar Indicates that several actions are initiated in parallel.
<AnyBIC>BBBBUS39</AnyBIC> </OrgId> </Id> <Rsn> <Cd>AG01</Cd> </Rsn> </RtrRsnInf> <OrgnlTxRef> <IntrBkSttlmAmt Ccy="USD">1025</IntrBkSttlmAmt> <IntrBkSttlmDt>2015-06-28</IntrBkSttlmDt> <ReqdColltnDt>2015-07-13</ReqdColltnDt> <MndtRltdInf> <MndtId>VIRGAY123</MndtId> </MndtRltdInf> <Dbtr> <Pty> <Nm>Jones</Nm> <PstlAdr> <StrtNm>Hudson Street</StrtNm> <BldgNb>19</BldgNb> <PstCd>NJ 07302</PstCd> <TwnNm>Jersey City</TwnNm> <Ctry>US</Ctry> </PstlAdr> </Pty> </Dbtr> <Cdtr> <Pty> <Nm>Virgay</Nm> <PstlAdr> <StrtNm>Virginia Lane</StrtNm> <BldgNb>36</BldgNb> <PstCd>NJ 07311</PstCd> <TwnNm>Jersey City</TwnNm> <Ctry>US</Ctry> </PstlAdr> </Pty>
<BICFI>BBBBIE2D</BICFI> </FinInstnId> </InstdAgt> </GrpHdr> <CdtTrfTxInf> <PmtId> <InstrId>AAAA/151109-CCT/EUR/443/1</InstrId> <EndToEndId>CROPS/SX-25T/2015-10-13</EndToEndId> <TxId>AAAA/151109-CCT/EUR/443/1</TxId> <IntrBkSttlmAmt Ccy="EUR">750000</IntrBkSttlmAmt> <IntrBkSttlmDt>2015-11-09</IntrBkSttlmDt> <InstdAmt Ccy="EUR">75000</InstdAmt> <ChrgBr>SHAR</ChrgBr> <UltmtDbtr> <Nm>Biogenetics - <PstlAdr> <StrtNm>Growth Street</StrtNm> <BldgNb>17</BldgNb> <PstCd>G5 OTW</PstCd> <Ctry>GB</Ctry> </PstlAdr> </UltmtDbtr> <Dbtr> <Nm>Biogenetics - HQ</Nm> <PstlAdr> <StrtNm>Corn Street</StrtNm> <BldgNb>13</BldgNb> <PstCd>W6 8DR</PstCd> <TwnNm>London</TwnNm> <Ctry>GB</Ctry> </PstlAdr> </Dbtr> <DbtrAcct> <Id> <Othr> <Id>46373892034012</Id> </Othr>
15.□ Asset and media preparation 16.□ Location preparation 17.□ Users notification 18.□ Ongoing user operations protection 19.□ Return to last correct state – preparation 20.□ Performing and supervision 21.□ Verification 22.□ Evidence and notification 23.□ Other parties required: 25.Other: request - security – admittance: 26.Record - observation - review: 27.Correction – improvements – enhancements: 28.□ as planned 33.□ nonconformity / incident / weakness: ……………………………………………….. 29.□ user complaint ……………………………………………..………………………………………………….. 30.□ HW-SW error 34.□ other / comment:……………………………….……………………………………….. 31.□ complaint to request ……………………………………………………………………………………………….. 32.□ complaint to support h) Reviewed: i) Date: .
Proposed by: Date: Proposed implementation date: 7. VERIFICATION OF VALIDITY OF CORRECTIVE “or” PREVENTIVE ACTION: Addresses the root cause? Prevents recurrence? Valid Invalid. Issue new NCPAR Remarks: Addresses the root cause? Prevents occurrence? Valid Invalid. Issue new NCPAR Remarks: Signature: (Lead Auditor) Date: Signature: (Lead Auditor) Date: 8. FOLLOW-UP OF IMLEMENTATION CORRECTIVE/PREVENTIVE ACTION TAKEN: Implementation of corrective action is: Implemented Not implemented. Issue new NCPAR Remarks: Implementation of preventive action is: Implemented Not implemented. new NCPAR Remarks: Signature: (Lead Auditor) Date: Signature: (Lead Auditor) Date: 9. VERIFICATION OF EFFECTIVENESS OF IMPLEMENTED CORRECTIVE/PREVENTIVE ACTION: Corrective action is: Effective Not effective. Issue new NCPAR Remarks: Preventive Action: Effective Not effective. Issue new NCPAR Remarks: Signature: (Lead Auditor) Date: Signature: (Lead Auditor) Date:
Determine the monitoring and measurement requirements Determine where and how monitoring and measuring should be applied. This should be both for control and improvement of the processes and the intended process outputs. Determine the need for recording results. Identify the validation necessary to assure effectiveness and efficiency of the processes and system. Take into account such factors as: Monitoring and measuring criteria Reviews of performance Interested parties’ satisfaction Supplier performance On time delivery and lead times Failure rates and waste Process costs Incident frequency measures of conformity with requirements DO Implement Implement actions necessary to achieve planned activities and results. The organization should perform activities, monitoring, measures and controls of defined processes and procedures (which may be automated), outsourcing and other methods necessary to achieve planned results. Determine the resources needed Determine the resources needed for the effective operation of each process. Examples of resources include: Human resources Infrastructure Environment Information and knowledge Natural resources Materials. Financial resources CHECK Verify the process against its planned objectives Confirm that the process is effective and that the characteristics of the processes are consistent with the purpose of the organization. The organization should compare outputs against objectives to verify that all the requirements are satisfied. Processes are needed to gather data. Examples include measurement, monitoring, reviews, audits and performance analysis.
1. INTRODUCTION This Implementation Guidance has been developed to assist users in understanding the issues that need to be considered during the co-existence period of ISO 9001:2008 and ISO 9001:2015. A wide diffusion of this implementation guidance is recommended, in particular the comparison table between ISO 9001:2008 and ISO 9001:2015 matrix showing the correlation between the clauses of these international standards can be found on the website. The revision of ISO 9001:2015 introduces a new 10 clause structure, many new requirements and many terms. Users will need to take into consideration that changes may be necessary to their Quality Management System (QMS). 2. BACKGROUND TO THE ISO 9001:2015 REVISION PROCESS In order to assist organizations to have a full understanding of the new ISO 9001:2015, it may be useful to have an insight on the revision process, how this revision reflects the inputs received from users of the standard, and the consideration given to benefits and impacts during its development. Prior to the commencement of a revision to a management system standard, a “Justification Study” is prepared to present a case for the proposed project which outlines details of the data and inputs used to support its arguments. In relation to the development of ISO 9001:2015 user needs were identified from the following: ISO Annex SL provides a common structure, text, terms and definitions for management system standards The results of a formal “Systematic Review” on ISO 9001:2008 was performed by the members of ISO/TC 176/SC2 Feedback from the ISO/TC 176/SC2 Working Group on Interpretations An extensive worldwide “User Feedback Survey” on ISO 9001 was performed by ISO/TC 176/SC 2 The Justification Study identified the need for a revision to: adapt to a changing world enhance an organization's ability to satisfy its customers provide a consistent foundation for the future reflect the increasingly complex environments in which organizations operate ensure the new standard reflects the needs of all relevant interested parties with other management systems The key focus of the ISO 9001:2015 revision was to enhance clarity and compatibility with other management system standards. The benefits identified for the ISO 9001:2015 edition: Provides clarity Enhanced leadership involvement in the management system Risk-based thinking Simplified language, common structure and terms Aligning QMS policy and objectives with the strategy of the organization
ability to provide welfare, but also because civil society organisations contribute enthusiasm, engagement and closeness. The third sector is the indispensable glue that connects people in a joint cause. Best regards ISOBRO Robert Hinnerskov General Secretary The board of ISOBRO Tina Donnerborg, Red Cross Nis Peter Nissen, Alzheimer's Society Trine Sisbo, The Cancer Society Torben Schack, DaneAge Association David Vincent Nielsen, Caritas Denmark Johnny Lindgreen, The Lutheran Mission Society's Lene Smith, The Danish Society for Nature Conservation
List any Outsourced processes: An outsourced process is performed by an organization outside the scope of the management system although the outsourced function or process is within the scope. (e.g., process performed by a supplier or by a sister organization that is not included in your internal audit program.) Are you currently certified by another certification body? yes no If yes, please attach copy of certificate If yes above, reason for transfer Are you using a consultant? yes no If yes, what company? If applicable, what other regulatory / industry standards are relevant to your company? For ISO 14001 only: What types of Hazardous Materials are used: Solvents Acids Bases Metals Other: ____________ For ISO 14001 only: List applicable environmental regulatory agencies: Federal: State / Province: Local: For R2 only: Do you have any potentially hazardous processing technologies yes no If yes, please provide details (number and description) For R2 only: Please describe the nature and complexity of the downstream recycling For R2 only: Do you currently export any recycled or processed materials. yes no If yes, please provide details For AS9100 / AS9120 audits only; Are International Traffic in Arms Regulations (ITAR) applicable to your organization? yes no If yes, please provide details For CMDCAS only: Does the site to be certified currently hold a Medical Device License issued by Health Canada? Yes Will apply within next 12 months For CMDCAS only: If you have or plan to apply for a medical device license in Canada, what products are included? Class I Class II Class III Class IV Describe below including product type and intended use: For MDSAP only: countries are you currently or planning to ship medical devices into? USA Canada Brazil Australia
Which of my mother’s attributes is in me as a trainer? When we say “A2J” in my country: One thing that makes me proud: When we say “A2J” in my country: One thing that makes me sorry: What should happen here? What should not happen here? -Punctuality of my mother- getting up early (on time performance) - Organization - Leadership - Selflessness - Helpfulness - Every mother understand her children- I take that from her - communication - Patience - Attention to all - Hard working - Having interests of the students at the forefront - Enthusiasm for education - Proactive assessment and evaluation - Justness and fairness - Kindness - Responsibility - Passion - Calmness in the face of hopelessness - Good listening skills - Open to questions - Problem solving -Lawyers’ collective movement - General knowledge of the law - Robust law and constitutional structure - Justice system - Laws for protection of women, etc. - Pro-women laws - Increasing public awareness (Afghanistan) - Network of legal aid offices - Increase in legal empowerment initiatives - Pro-activeness for formalizing laws for communities -Non adherence to SDGs - Lack of access to justice for women and children - Lack of awareness in the society - Lack of implementation of law - Inequality of access to justice - Security as an impediment (Afg) - Patriarchal and feudal system - Lack of commitment towards nation and national issues (Afg) - Lack Government’s interest in A2J - Slow, time consuming and delays -- Cost of litigation - New Learning - Punctuality - Open sharing without fear - Sharing of knowledge about access to justice in other countries - Interactive learning - Role - Group work - Positive attitude towards learning - Practice of adult learning methodology - Getting inspired by experiences from everywhere - Build bridges - Insights about how to train most effectively - Learning about making law accessible - Sitting arrangements should be proper - Intensive session - Unnecessary criticism - Political discussions - Criticism of countries - Ranking - Formal advices - Lengthy lectures - Groupism - Late coming - Taking the training for granted - Falling asleep - Differences becoming conflicts - Spoiling environment - on theories
CLINICAL CLI Participation in client and services that are an integral part of an academic program. Clinical / practical instruction occurs in an appropriate setting and involves work with clients who receive professional services from students serving under the direct supervision of a faculty member and/or approved professional member of the agency staff. There is regular consultation with the faculty member. 30 contact hours = 1 credit 2:1 INDEPENDENT STUDY IND Faculty and student negotiate an individualized plan of study including student projects and other activities with minimal faculty associated direction. 15 contact hours = 1 credit 1:1 INTERNSHIP INT Applied and supervised learning experiences in business and industry environments that offer experience and responsibility following a negotiated and/or directed plan of study. 45 contact hours = 1 credit 3:1 LAB LAB Instructional activities conducted by faculty which require student participation, experimentation, observation, or practice. This portion of the course has no lecture component. 30 contact hours = 1 credit 2:1* LECTURE LEC Formal presentation /communication by faculty. Faculty responsible for delivery and discussion of learning material and related instructional activities. 15 contact hours = 1 credit 1:1 CTE LEC/LAB LLB Instructional activities involving training for employment with an active faculty teaching role. Lecture and lab activities occur during the same meeting times. 22.5 contact = 1 credit 1.5:1 PHYSICAL EDUCATION PED Participation in or the performance of some form of physical activity. Knowledge associated with the proper performance of the activity is presented. 30 contact hours = 1 credit 2:1 PRIVATE INSTRUCTION PRI Formal presentation in a one-to-one relationship between student and instructor. 7.5 contact hours = 1 credit 0.5:1 STUDIO MUSIC SMU Bands, ensembles, music labs, and the like conducted by faculty. 37.5 contact 2.5:1 level
OBJECTIVE Isolation of hydrocarbon degrading bacteria from the soil of automobile workshop. Identification of bacteria by their morphological and colony characteristics and biochemical tests. To check ability of bacteria to utilize different hydrocarbon sources like Benzene, Petrol, Engine oil, Diesel, Toluene as sole carbon source. MATERIALS AND METHODS MATERIALS
HISTORICAL CONTEXT Prior to 1941, the was reluctant to enter World War II. Many Americans, called Isolationists, considered the cost of World War I too great and wanted the country to focus on recovering from the Great Depression and implementing President Roosevelt’s New Deal programs. Isolationists did not want to fight another long and costly war. As a result, Congress passed the Neutrality Act of 1935 which outlawed providing funds or supplies to warring countries. In 1939, invaded . Then, invaded and and attacked , while the Nazis built concentration camps throughout northern . Germany’s aggression towards other European nations made the United States more inclined to action, called intervention. President Roosevelt was an interventionist. He created a military draft and sought money from Congress to build new naval vessels. He also asked Congress to allow the to provide supplies, arms, and ammunition to in the Neutrality Act of 1939. Roosevelt called on the to be an “arsenal of democracy.” However, Isolationists still opposed intervention. Charles Lindbergh and the First Committee were the leading critics of the entering World War II and argued that the German military was too strong to defeat. In 1940, , , and joined together in the Tripartite Pact to form the Axis Powers; they pledged to go to war if any of them were attacked by the . In 1941, Roosevelt and Churchill met secretly and drafted the Atlantic Charter in which each country pledged to aid the other. Throughout 1940 and 1941, the strengthened its defenses and sent more and more supplies to and the . U-boat attacks on supply ships increased. sought to control more and more of the western Pacific Ocean and . Interventionists felt that the economy would suffer if it were left as the only democratic country because it would not trade freely with totalitarian regimes; trade was already being affected by the Japanese control of the Pacific. Finally, on December 7, 1941, Japanese forces attacked . The and the Isolationists could no longer resist involvement in World War II. Answer the question from the positions of the Isolationists and Interventionists using the following criteria. Criteria Isolationist Interventionist Effects of World War I Domestic Economy Wartime Preparation National Security . PRACTICE DOCUMENT – Examine and discuss this as a group.
Reporting At the time of routine culture result reporting, report “B. pseudomallei culture pending”. When all B. pseudomallei culture work is complete, make an additional report stating ether “B. pseudomallei isolated” or “B. pseudomallei NOT isolated”. Quality assurance and identification tests should be quality controlled according to the relevant SOP. Limitations Prior antimicrobial use may result in negative cultures. References MORU SOP MBL3.8M. Isolation of Burkholderia pseudomallei from clinical samples (Version 1.3; August 2012).
7. Create an isometric sketch of one of the following objects. You do not need to measure the object, but try to represent the object at an appropriate scale to fill a quarter of a sheet of graph paper using correct proportions. Highlighter, pen, or pencil Toothbrush Clothes pin Flash drive Coffee cup Flashlight Beverage can or bottle Monitor Surge protector Cell phone Remote control device Chair Other instructor approved object
Substances that dissociate into 3 ions: 2.6 Substances that dissociate into 4 ions: 3.4 Substances that dissociate into 5 ions: 4.2 Adjusting the Isotonicity of Hypotonic Solutions: Example: How much sodium chloride is required to render 100 ml of a 1% solution of apomorphine hydrochloride isotonic with serum? Solution: From the previous table, it is found that a 1% solution of the drug has a freezing point lowering of 0.08⁰C. To make this solution isotonic with blood, sufficient sodium chloride must be added to reduce the freezing point by an additional 0.44⁰C (0.52 - 0.08). In the freezing point table, it is also observed that a 1% solution of sodium chloride has a freezing point lowering of 0.58. By the method of proportion, Thus 0.76% sodium chloride will lower the freezing point the required 0.44o and will render the solution isotonic. The solution prepared by dissolving 1.0 g of apomorphine hydrochloride and 0.76 g of sodium chloride in sufficient water to make 100 ml of solution. Sodium Chloride Equivalent Method: The sodium chloride equivalent, of a drug is the amount of sodium chloride that has the same Osmotic effect as 1 gram of the drug. The sodium chloride equivalents E for a number of drugs are listed in the previous table. Calculations for determining the amount of sodium chloride or other inert substance to render a solution isotonic simply involve: Multiplying the quantity of each drug in the prescription by its sodium chloride equivalent. Calculating the amount of sodium chloride that renders the whole prescription volume isotonic. Subtract the value in step (a) from that in step b give the amount of sodium chloride must be added. If the isotonicity is to be adjusted with some other inert substance the calculated NaCl amount in the previous step is converted to the inert substance using its NaCl equivalent value. Example:
Quality Subcommittee of the Association for Clinical Genetic Science Genetics ISO 15189 Accreditation workshop To be held on Friday 16th May 2014 Seminar Room 1a, Centre for Genomic Medicine, St Mary’s Hospital, Manchester, M13 9WL 9.30 – 10.00am Tea / Coffee and registration 10.00am Introduction Sandi Deans – Chair of the ACGS Quality Subcommittee 10.00 – 10.45am Overview and mapping of ISO 15189 to CPA standards UKAS Representative 10.45 – 11.00am Tea / Coffee 11.00 – 11.30am First-hand experience of the ISO 15189 accreditation process Lara Cresswell (Leicester Genetics Service) 11.30 – 12.00pm The changing assessment process Graham Fews (West Midlands Regional Genetics Laboratory) 12.00 – 12.15pm Questions and Discussion 12.15 – 1.00pm LUNCH (included) 1.00 – 1.30pm Gap analysis in anticipation of the move to ISO15189 Nigel Coles (West Midlands Regional Genetics Laboratory) 1.30 – 2.00pm Root Cause Analysis Clinical Risk Department, Manchester 2.00 – 2.15pm Tea / Coffee 2.15 – 2.45 The IT implications of ISO15189 Paul Westwood (West of Scotland Genetics Service) 2.45 – 3.15pm Validation, Verification and Uncertainty of Results Graham Fews (West Midlands Regional Genetics Laboratory) 3.15 – 4.00 Questions and Discussion 4pm Close The workshop will be suited to laboratory Quality Managers (or deputy) and Genetic Technologists to support Genetics laboratories in the transition from CPA assessment and accreditation to ISO 15189 accreditation. For further information please contact: Louise Monkman or Natasha Leo Directions to the venue are shown at
SAFETY DATA SHEET 12.3 BIOACCUMULATIVE POTENTIAL Bioaccumulation: Does not bioaccumulate 12.4 MOBILITY Mobility: Mobility in soil: Mobility in non-soil: 12.5 OTHER ADVERSE EFFECTS Ozone layer: No data available. No data available. No data available. No data available. SECTION 13: DISPOSAL CONSIDERATIONS 13.1 WASTE TREATMENT METHODS Disposal method: This material must be disposed of in accordance with all local, state, provincial, and federal regulations. Contaminated packaging: Since emptied containers may retain product residue, follow label warnings even after container is emptied. Dispose of contents and container in accordance with all local, regional, national and international regulations. EU codes: The Waste code should be assigned in discussion between the user, the producer and the waste disposal company. Residual Dispose of in accordance with local regulations. Empty containers or liners may retain some product residues. This material and its container must be disposed of in a safe manner (see: Disposal instructions). Disposal instructions: Collect and reclaim or dispose in sealed containers at licensed waste disposal site. Dispose of contents and container in accordance with all local, regional, national and international regulations. Waste codes: D001: Waste Flammable material with a flash point <140°F (<60°C) The Waste code should be assigned in discussion between the user, the producer and the waste disposal company. Other disposal recommendations: None SECTION 14: TRANSPORT INFORMATION DOT Non-Bulk UN: UN1263 Proper shipping name: Paint Hazard class: 3 Environmental hazards: No DOT Bulk UN: UN1263 Proper shipping name: Paint Hazard class: 3 Environmental hazards: No IMDG UN: UN1263 Proper shipping name: Paint Hazard class: 3 Environmental hazards: No ICAO/IATA UN: UN1263 Packing group: PG II Packing group: PG II Packing group: PG II Page 14 of 17