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welcome page 1 of 1 home welcome http is-wok-intranet/quality/online/welcome_1.htm 12/06/2012

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contents quality and environmental manual qm page 1 of 3 home quality and environmental manual contents quality and environmental manual revision history iso 9001 2008 or contents iso 13485 2003 section index distribution introduction 1.0 activities scope and permissible exclusions 1.01 quality statement 2.0 normative reference 3.0 terms and definitions 4.0 quality management system general requirements 4.1 4.2 documentation requirements 4.2.1 general documentation requirements quality and environmental manual 4.2.2 4.2.3 control of documents 4.2.4 control of records 5.0 management responsibility management commitment 5.1 5.2 customer focus procedure iqp process ipm iso 14001 section environmental iqp contents ipm contents 4 4.1 ipm 4.1 4.4.4 iqp 501 iqp 1601 4.4.5 4.5.4 4.2 4.4.1 4.3.1 4.3.2 4.6 4.2 4.3 4.3.3 4.3.3 4.3.1 4.3.2 4.3.3 5.3 5.4 5.4.1 5.4.2 5.4.3 5.4.4 5.4.5 5.5 5.5.1 5.5.2 5.5.3 5.5.4 quality policy environmental policy planning planning quality objectives quality management system planning environmental aspects legal and other environmental requirements environmental objectives targets and programmes responsibility authority and communication responsibility and authority management representative internal communication environmental communication iqp 5005 5006 iqp 5002 iqp 5007 iqp 5010 4.4.1 4.4.1 4.4.3 4.4.3 http is-wok-intranet/quality/online/mergedprojects/man1/contents_quality_and_e 12/06/2012

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contents quality and environmental manual qm page 2 of 3 5.6 5.6.1 5.6.2 5.6.3 6.0 6.1 6.2 6.2.1 6.2.2 6.3 management review general review input review output resource management provision of resources human resources general competence awareness and training infrastructure iqp 101 ipm 4.1.13 4.6 4.6 4.6 4.4.1 ipm 4.4 4.4.2 4.4.2 4.4.1 iqp 1801 iqp 902 903 904 905 906 ipm 2.2 manufacture 4.3 finance 6.4 7.0 7.1 7.2 7.2.1 work environment product realisation planning of product realisation customer-related processes determination of requirements related to the product review of requirements related to the product customer communication design and development design and development planning design and development inputs design and developments outputs design and development review design and development verification design and development validation control of design and development changes purchasing purchasing process purchasing information verification of purchased product production and service provision control of production and service provision validation of processes for production and service provision general requirements validation of processes for production and service provision particular requirements for sterile medical devices identification and traceability customer property preservation of product control of monitoring and measuring devices measurement analysis and improvement general monitoring and measurement iqp 901 ipm 2 manufacture 4.4 4.4.6 ipm 3 sell 4.3.1 4.3.2 4.4.6 4.3.1 4.4.6 4.4.3 ipm 1 design 4.4.6 4.4.6 4.4.6 4.4.6 4.4.6 4.4.6 4.4.6 ipm 4.8 4.4.6 4.4.6 4.4.6 ipm 2 manufacture 4.4.6 iqp 908 iqp909 4.4.6 4.4.6 7.2.2 7.2.3 7.3 7.3.1 7.3.2 7.3.3 7.3.4 7.3.5 7.3.6 7.3.7 7.4 7.4.1 7.4.2 7.4.3 7.5 7.5.1 7.5.2.1 7.5.2.2 iqp 301 iqp 401 402 iqp 907 iqp 601 iqp 603 7.5.3 7.5.4 7.5.5 7.6 8.0 8.1 8.2 iqp 801 1201 iqp 1501 1502 1503 iqp 1101 ipm 4.1 4.4.6 4.5.1 4.5 4.5.1 ipm 4.1 http is-wok-intranet/quality/online/mergedprojects/man1/contents_quality_and_e 12/06/2012

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contents quality and environmental manual qm page 3 of 3 8.2.1 8.2.2 8.2.3 8.2.4 8.2.5 8.3 8.3.1 8.4 8.5 8.5.1 customer satisfaction internal audit monitoring and measurement of processes monitoring and measurement of product evaluation of environmental compliance control of nonconforming product emergency preparedness and response analysis of data improvement continual improvement iqp 1701 iqp 2001 iqp 602 1001 1002 1003 iqp 5000 5001 5002 5003 5008 iqp 1301 iqp 5004 5009 ipm 4.1 4.5.5 4.5.1 4.5.2 4.5.1 4.5.2 4.5.2 4.4.7 4.5.3 4.4.7 4.5.1 4.2 4.3.3 4.6 4.5.3 4.5.3 8.5.2 8.5.3 9.0 ap 1 ap 2 ap 3 ap 4 ap 5 ap 6 corrective action preventive action information technology intersurgical quality and environmental procedures list quality plan for production design and development plan design activity chart intersurgical sites worldwide intersurgical manufacturing and inspection process chart iqp 1401 1402 1403 1404 iqp 1405 iqp 2100 2101 ipm 4.2 2102 2103 http is-wok-intranet/quality/online/mergedprojects/man1/contents_quality_and_e 12/06/2012

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activities scope and permissible exclusions qm page 1 of 1 home quality and environmental manual contents activities scope and permissible exclusions qm iqm 1.0 activities scope and permissible exclusions § 820.5 quality system activities intersurgical designs and manufactures a range of sterile and non-sterile respiratory systems and accessories used in conjunction with life support and anaesthetic equipment the range of products in this category is wide and the company offers to its customers most of their needs either in complete systems or components we also provide a full technical advisory facility offering advice and support to users in this range of medical devices intersurgical s european manufacturing sites supply products to intersurgical incorporated for distribution in the us market correspondance and liason with the us food and drug administration takes place through intersurgical inc scope this manual and its associated procedures and documentation describe a intersurgical s quality system requirements for the design manufacture and distribution of their products b intersurgical s environmental management system s requirements for legal compliance conformity with the environmental policy and objectives targets and information about significant environmental aspects the numbering of the section headers in the manual reflects those in iso 9001:2008 and fda cfr 21 part 820 as the iso 14001 requirements are all under clause 4 of the standard the sub-clauses are quoted in the manual where applicable permissible exclusions there are no permissible exclusions http is-wok-intranet/quality/online/mergedprojects/man1/1.0_activities_scope_and 12/06/2012

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analysis of data qm page 1 of 1 home quality and environmental manual contents analysis of data qm iqm 8.4 analysis of data data is collected and analysed to determine the suitability and effectiveness of the quality and environmental management system and to evaluate where continual improvement of the effectiveness of the quality and environmental management system can be made this includes data generated as a result of monitoring and measurement and from other relevant sources data is analysed to provide information on z z z customer satisfaction conformance to product requirements characteristics and trends of processes products and services including opportunities for preventive action suppliers the primary sources of data analysis are stored in the following locations zzzzzzzz management review minutes iqp101 capa meeting minutes sites 1 2 3 iqp1402 supplier review minutes sites 1 2 3 iqp 603 directors meeting minutes access to minutes restricted sales meeting minutes various site and group meeting minutes 1 2 3 group company aims http is-wok-intranet/quality/online/mergedprojects/man1/8.4_analysis_of_data.htm 12/06/2012

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assembly and packing area activities qm page 1 of 1 home quality and environmental manual contents assembly and packing area activities qm iqm ap 2 assembly and packing area activities approved products go to stores and despatch rejected products are scrapped http is-wok-intranet/quality/online/mergedprojects/man1/ap_2_assembly_and_pa 12/06/2012

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assembly and packing area procedures qm page 1 of 1 home quality and environmental manual contents assembly and packing area procedures qm iqm ap 2 assembly and packing area procedures iqp 801 901 903 1002 1003 1201 1402 1502 product identification traceability cleaning assembly in-process inspection final inspection inspection and test status corrective and preventive action packing http is-wok-intranet/quality/online/mergedprojects/man1/ap_2_assembly_and_pa 12/06/2012

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company aims and critical factors for success qm page 1 of 1 home quality and environmental manual contents company aims and critical factors for success qm iqm 5.3 company aims and critical factors for success these are based on our company goal and add the concept of continuous improvement company goal to provide the most comprehensive range of respiratory products offering quality innovation and choice we are totally focused on the area of respiratory care a key factor that makes intersurgical unique aims aim to be distinctive we aim to be the most knowledgeable reliable and cost effective supplier in this market knowledgeable what will make us to be a leading innovator with a continuous programme of product and service distinctive improvement which addresses customer requirements and anticipates future needs providing a choice of solutions critical factors for to constantly review market requirements and respond to change in a creative and timely success manner aim what will make us distinctive critical factors for success reliable to ensure that our speed of response to customer requirements is superior to any other supplier by providing products and services right first time to have management controls that ensure all customer requirements are satisfied within the shortest possible time and that standard products are always in stock aim cost effective what will make us to ensure the company uses the most appropriate technologies to achieve the lowest distinctive possible costs in all areas whilst maintaining the highest possible quality critical factors for to ensure all staff are trained to fulfil their responsibilities in the most efficient manner success so that products and services are right first time every time and continuous to improve all aspects of the company and monitor this by the use of surveys audits improvement evaluations of clinical data and other techniques see also quality policy and environmental policy http is-wok-intranet/quality/online/mergedprojects/man1/5.3_company_aims_and 12/06/2012

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company focus qm page 1 of 1 iqm 5.3 company focus we are totally focused on the area of respiratory care a key factor that makes intersurgical unique http is-wok-intranet/quality/online/mergedprojects/man1/5.3_company_focus.htm 12/06/2012

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company goal qm page 1 of 1 iqm 5.3 company goal to provide the most comprehensive range of respiratory products offering quality innovation and choice http is-wok-intranet/quality/online/mergedprojects/man1/5.3_company_goal.htm 12/06/2012

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organisation quality and regulatory affairs qm page 1 of 1 organisation quality and regulatory affairs organisation main page click on link http is-wok-intranet/quality/online/mergedprojects/man1/5.5.1_organisation_quali 12/06/2012

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competence awareness and training qm page 1 of 2 iqm 6.2.2 competence awareness and training § 820.25 personnel it is the company policy to identify and determine competency needs for personnel performing activities affecting conformity to product requirements provide training to satisfy those needs and evaluate the effectiveness of the training provided as required by the clause 4.4.2 of the iso14001 standard the company is also obliged to ensure that staff whose work is related to significant environmental aspects are given training to understand how their job could impact on the environment if not carried out properly records are maintained of education experience and training the company provides all new employees with an induction training package which includes details of the company s management structure and describes the company s products also included is a copy of the intersurgical quality policy and environmental policy which all employees are required to follow employees are made aware of the relevance and importance of their activities and how they contribute to the achievement of quality objectives and environmental objectives depending on the employees work in the organisation it is the responsibility of the departmental director manager or supervisor to identify the training needs of their staff employees whose work is related to significant environmental aspects or who are involved with new products and processes which might influence or generate new environmental aspects shall be given training to ensure they understand how their job could impact on the environment if not carried out properly the competency of persons working on behalf of the company such as contractors or suppliers on-site may be checked by reviewing appropriate documentation or receiving confirmation of their competency membership of an appropriate association or other documentation proving their competency for those employed in production this will generally be by shop floor training and demonstration until the manager or supervisor is satisfied that they are competent to carry out the particular task.temporary staff will also be adequately trained quality assurance staff and those delegated in production to perform inspection or test activities will receive training organised by quality assurance management staff full records shall be kept of all training given to employees and such records will detail the training given the date and the name of the trainer master records of training are held at each manufacturing site uncontrolled copies of production staff training records can be held by managers and supervisors staff who have not received appropriate training or do not have the required skills shall not be allowed to perform functions or activities which may result in unacceptable product a review of the training programme shall be carried out by senior staff at management review meetings who will report the level of expertise available to perform the functions within the organisation and to note any shortcomings for further action it is the departmental director s manager s or supervisor s responsibility to identify the training needs of their staff these needs are reviewed during annual appraisals http is-wok-intranet/quality/online/mergedprojects/man1/6.2.2_competence_aware 12/06/2012

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competence awareness and training qm page 2 of 2 as the company s products are under constant development and improvement it is essential that training needs are identified at the pre-production stage of design external training courses and attendance at seminars are required of staff occasionally and these details shall be entered on the training record persons who are required to work or enter into environmentally controlled areas including cleanrooms or who perform special processes and internal quality and environmental audits are appropriately trained or are supervised by qualified personnel http is-wok-intranet/quality/online/mergedprojects/man1/6.2.2_competence_aware 12/06/2012

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computer software used in process control qm page 1 of 1 iqm 7.5.2 computer software used in process control § 820.70 i automated processes any software for in-house designed to run equipment which is used for the manufacture of medical devices should be validated and the results of the validation documented this will usually be done by examination and tesing of the output of the process http is-wok-intranet/quality/online/mergedprojects/man1/7.5.2_computer_softwar 12/06/2012

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