1、ISO9001质量手册英文版样本ISO 9001:QUALITY MANUAL WOLSTENHOLME INTERNATIONAL LIMITED CONTENTS1.0 Scope of the Quality Management System at Wolstenholme International Limited1.1 Statement of Quality Policy2.0 Quality Management System Documented Procedures 2.1 Document Control 2.2 Control of Quality Records 2.
2、3 Internal Quality Audits 2.4 Control of Nonconforming Product 2.5 Corrective Action 2.6 Preventative Action3.0 Quality Management System Processes and Interrelations 3.1 Organisation Charts 3.2 Responsibilities 3.3 Interrelation of Processes 3.4 Processes1.0 Scope of the Quality Management System a
3、t Wolstenholme International LimitedWolstenholme International Limited is a Company with a long-standing successful history of supplying metal powders, pastes,pellets,varnish,offset ink,flexography ink and other related products for use in a large range of applications,on a worldwide basis. The scop
4、e of the Quality Management System encompasses all activities on the Darwen Site.The Metallic Powders Operation at Darwen is responsible for the manufacture and supply of metal powders and pigments mainly in aluminium,copper and brass (bronze) based alloys,for use in printing,inks,plastics and other
5、 industrial and engineering applications.The Ink Operation at Darwen is responsible for the manufacture of a wide range and type of printing ink,one-pack gold ink, varnish and related printing products.All production processes at Darwen are validated before leaving the site and as such sub-clause 7.
6、5.2 is excluded. The overall operation at Darwen is controlled by the Ink & Print business unit and the Industrial business unit.Technical Service and Research and Development are vital to the future development of the Company,together with understanding and developing new products and applications
7、for our customers.The manufacturing,technical and administration functions of the Company are based in Darwen,Lancashire,England and employ some 210 staff at that location. Through the application of Quality Management Systems and Company wide training programmes,Wolstenholme International Ltd. is c
8、ommitted to ensuring continuous improvements to both its processes and product technology.WOLSTENHOLME INTERNATIONAL LTD.QUALITY POLICYWolstenholme International Limited is committed to the provision of customer satisfaction. Quality in everything we do is the central ingredient in the above commitm
9、ent. Our commitment goes beyond maintaining a quality system which fully complies with the requirements of BS-EN-ISO 9001. We are committed to achieving,maintaining and improving overall organisational performance and capabilities by the application of the principles outlined in BS-EN-ISO 9004:We wi
10、ll maintain and continuously improve our quality management system by the setting of measurable quality objectives throughout the organisation and vigorous internal audits. We will review our performance at regular management reviews. Additional inputs to these reviews will also include customer fee
11、dback,process performance and product conformance. The prime output of the review will be to ensure continuing customer satisfaction and improvement of products.As part of this commitment we will identify and meet the training needs of our employees,so ensuring that the needs of our customers are me
12、t. This Policy will be made available throughout our organisation to ensure that the commitment to our customers is clear and widely understood.Chris RavenscroftManaging Director2.0 Quality Management System Documented Procedures2.1. Document ControlAll quality system documentation will be made avai
13、lable via supervision in the Triangle ISO Achiever Plus databases. All documents relating to the quality system will be controlled. Changes to quality system documentation may be proposed by any member of the Company. Such proposed changes will be reviewed by the Management Representative who will l
14、iaise with other quality system documentation users as necessary. Dead Triangle ISO Achiever Plus documents will be archived within the databases.REF:Control of Quality/ Environmental Documents- WIQSP.1 Control of Quality RecordsAll quality records will be maintained and controlled. The records will
15、 be legible and stored in such a manner as to protect them from damage,loss and deterioration. Quality records will also be stored and clearly located in such a manner as to facilitate easy retrieval of information.REF:Control of Quality/ Environmental Records - WIQSP.22.3 Internal Quality AuditsInt
16、ernal audits will be carried out in accordance with Company procedures and will be conducted for any of the following reasons:-(i) On a scheduled basis.(ii) As a result of a customer complaint (part or full audit)(iii) As a result of the need for new procedures to accommodate new business situations
17、.(iv) Un-scheduled Audits as requested by the Operations Director or Management Representative.(v) Follow-up audits (part or full audits) will take place in order to establish the effectiveness of relevant audit related Corrective Action Requests previously raised.The management of internal audits w
18、ill be the responsibility of the Management Representative,who will also be responsible for ensuring that any necessary corrective actions are satisfactorily implemented and closed out in the relevant department by the declared deadline date.Internal audits will be carried out as laid down in the in
19、ternal audit schedule by trained personnel having no direct involvement with the department,section or function being internally audited. If for any reason an audit cannot be completed as scheduled,the Management Representative will re-schedule as required.REF:Internal Audits - WIQSP.32.4 Control of
20、 Non-Conforming ProductsAll non-conforming products will be clearly identified with the relevant identification label,or held in clearly identified areas and removed from normal production or storage areas to await a disposal decision.Where products are thought to be marginally suspect,and re-inspec
21、tion or re-testing required,they will be clearly identified as such and only released for use subject to passing the re-testing stage and a suitable end use identified. Where products are found to be outside specification,they may be re-worked in accordance with relevant procedures,or concession sou
22、ght from the customer. Corrective and Peventitive actions will be implemented where necessary to determine the root cause of the non-conformance.Non-conforming products detected at the goods inward stage will be rejected,and the question of disposal discussed with the supplier. The supplier will be
23、advised of the rejection by the Purchasing Department.REF:Control of Non-Conforming Products - WIQSP.4a,4b and 4c2.5 Corrective ActionCorrective action will be raised as a result of non-conformances identified during internal audits,when suppliers provide defective materials or services,when custome
24、rs have cause to complain or following in-progress/ final inspection. Corrective action requests may also be raised in an effort to improve current working practises. Corrective actions and customer complaints will be reviewed at Management Review Meetings.When non-conforming products or services ar
25、e identified,the root cause of the problem will be investigated,corrective action taken and preventative measures initiated to preclude a recurrence.REF:Corrective Action - WIQSP.52.6 Preventative ActionCorrective action is taken as a result of Product or process nonconformity. It is hence a reactiv
26、e measure and does not necessarily prevent further non conformance. Preventive action aims to identify product or process conformity before such an event happens and. is thus a proactive measure. The requirement for preventive action is established by the analysis and review of measurement data with
27、in the Company. All such data within the Company will be subject to evaluation as to the requirement for preventative actions to be taken in order that potential processes or product non conformities are identified.REF:Preventative Action - WIQSP.63.0 Quality Management Systems Processes and Interre
28、lations1.2.2 ResponsibitiesManaging DirectorThe Managing Director is responsible to the Wolstenholme International Ltd Board of Directors and has overall responsibility for all Company operations such as sales,quality,design and development of the products/ services supplied to the customer.Operatio
29、ns DirectorThe Operations Director is responsible to the Managing Director for all production and engineering operations. The Operations Director also reports to the Board of Management on the operation of the ISO 9001 Quality System.SARA (Management Representative)The SARA Manager is responsible to
30、 the Operations Director for the upkeep and maintenance of the quality system to the requirements of BS-EN-ISO 9001 :The SARA Manager (MR) represents the Company on all quality assurance matters,pertinent to the quality system as established by the contract requirements,regulatory requirements and q
31、uality policies and procedures.The SARA Manager (MR) has the primary responsibility to structure the quality system which will involve all sections and also to ensure compliance with all quality system requirements.Specifically,the Management Representative is involved in areas such as:- Drafting th
32、e policy on quality assurance of the Company along with the Operations Director.- Setting the quality management objectives of the Company.- Reporting on the performance of the Quality System at Management Review Meetings.- Determining and reporting the principle causes of quality system non-conformances.- Monitoring the quality system to determine where improvements are needed and monitoring the necessary corrective action.- Maintain contact with the exter
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