Quality Manual ISO 9000:2015. FMB Oxford Limited Units 1-4 Ferry Mills, Osney Mead, Oxford, OX2 0ES, United Kingdom. ISO Quality Manual

Transcription

1 ISO 9000:2015 FMB Oxford Limited Units 1-4 Ferry Mills, Osney Mead, Oxford, OX2 0ES, United Kingdom. ISO Quality Manual

2 Contents 1 Scope 3 2 Applicable Standard 3 3 Terms and Definitions 3 4 Context of the Organisation Establishing Organisational Context Needs and Expectations of Interested Parties Scope of the QMS System and Processes 4 5 Leadership Management Commitment Customer Focus Policy Responsibilities 6 6 Planning Risks and Opportunities Quality Objectives Planning 6 7 Support Resources Competence Awareness Communication Information 7 8 Operation Planning and Control Requirements for Products and Services Design and Development of Products and Services Externally Provided Processes, Products and Resources Production and Service Provision Release of Products and Services 9 9 Performance Evaluation Monitoring, Measurement, Analysis and Evaluation Internal Audit Management Review Improvement Opportunities for Improvement Nonconformity and Corrective Action Continual Improvement 11 ISO Quality Manual Page 2 of 11

3 1 Scope In support of its business activities FMB Oxford has implemented a quality management system (QMS). The QMS takes account of the needs of interested parties, aims to minimise business risk and provides processes and procedures that promote consistency of operation. All FMB Oxford employees have access to the QMS and its associated documents via the FMB Intranet. This manual provides an overview of the QMS. It is specifically aimed at customers and other stakeholders who do not have access to the full QMS. 2 Applicable Standard The FMB Oxford QMS meets the requirements of ISO 9000:2015 and is independently validated and accredited by BSI. 3 Terms and Definitions The structure of this manual and the terminology used is consistent with that used in ISO 9000:2015. ISO Quality Manual Page 3 of 11

4 4 Context of the Organisation 4.1 Establishing Organisational Context FMB Oxford has established its organisational context by: 1. Publishing a business strategy and making this available to all employees via the QMS 2. Identifying all interested parties and understanding the business relationship with each, including the needs and expectations of those parties 3. Determining the scope of the products and services offered to customers 4.2 Needs and Expectations of Interested Parties FMB Oxford has identified and mapped all interested parties relevant to its business operations. For each interested party the company has defined the relationship in terms of the benefits, services and information received by the interested party and also the benefits, services and information provided to FMB Oxford. 4.3 Scope of the QMS The scope of the QMS includes the design, development, delivery and deployment of products and services relevant to our chosen market and associated customers. The scope includes the supply of information and expertise as well as the delivery, commissioning and support of equipment. 4.4 System and Processes The FMB Oxford QMS comprises of 7 key processes: Sales Design & Development Procurement Manufacture Shipping & Installation Customer Support Performance evaluation The scope of each process is defined by the context of the organisation and is in turn supported by appropriate operating procedures, work instructions, people systems and infrastructure. ISO Quality Manual Page 4 of 11

5 5 Leadership 5.1 Management Commitment The QMS is driven top down with active participation of top management. The management team hold regular management reviews in line with the requirements of ISO 9000:2015. Managers also have functional responsibility for the key processes detailed in this manual. 5.2 Customer Focus Customer focus is embedded into all of the 7 key processes listed in section 4.4 of this Quality Manual. Customer satisfaction is monitored and reported on using a variety of measures including: Customer compliments and complaints Performance KPIs o On time delivery o In-field failures o Customer service response times Risks and opportunities are evaluated at various stages in the overall customer delivery process. Any identified risks are communicated to customers via formal reviews, monthly reports and other project specific documents. 5.3 Policy The Managing Director has issued the following Quality Policy. The policy is reviewed annually and establishes a basis for the organisation s Quality Objectives. ISO Quality Manual Page 5 of 11

6 5.4 Responsibilities In support of the QMS the Managing Director has appointed a Quality Manager who is also a member of the senior management team. The day to day operation of the QMS is under the control of the Quality Coordinator who reports directly to the Quality Manager. 6 Planning 6.1 Risks and Opportunities FMB Oxford has compiled a risks and opportunities register. The register is reviewed and updated by the Quality Manager, with input from other departments. This activity is monitored during the quality management meetings, see section Quality Objectives FMB Oxford sets and reviews annual Quality Objectives. These include: Customer focus Quality system performance Non-conformance Key supplier performance Improvement projects covering specific areas such as: o Communications o People o Products & Services o Suppliers o Processes 6.3 Planning Management, project and departmental reviews monitor resource needs and determine priorities and actions. Supporting information is derived from market and business intelligence as well as data provided by business systems including MRP. 7 Support 7.1 Resources The 7 key business processes listed in section 4.4 are underpinned by the support process shown above. This process focusses on resources, including people, infrastructure and knowledge. 7.2 Competence To ensure the business has trained and competent people performing key roles FMB Oxford takes care that: All jobs have an associated role profile Managers and team leaders carry out regular development reviews with staff Staff have access to continuing professional development (CPD) Candidate qualifications, experience and behaviours are matched with recruitment needs ISO Quality Manual Page 6 of 11

7 7.3 Awareness Awareness of the QMS forms part of the standard FMB Oxford induction for new staff. 7.4 Communication Key issues relating to quality and customer satisfaction are routinely communicated at regular monthly staff meetings. All staff are encouraged to raise quality issues and propose improvement projects. 7.5 Information FMB Oxford provides access to the QMS via the company Intranet. Work instruction and records are also displayed at the place of work where appropriate. Critical documents, data and records are protected by a system of user permissions that prevent unauthorised alteration. 8 Operation 8.1 Planning and Control Sales fulfilment is satisfied by the Sales (Customer Requirements) process shown in section 8.2. Responsibilities for the planning and control of each stage are detailed in supporting procedures and role profiles. 8.2 Requirements for Products and Services The above process and supporting procedures ensure that customer requirements are documented, authorised and communicated across the organisation. Functional Specifications and Project Plans are generally agreed with the customer and are two of the key documents that define the requirements of each major contract. ISO Quality Manual Page 7 of 11

8 8.3 Design and Development of Products and Services The design and development process uses a series of stage gates to control progress from one stage to the next. At key stages in the process there are document approvals and review meetings which validate customer requirements and identify and mitigate product or schedule risk. 8.4 Externally Provided Processes, Products and Resources FMB Oxford uses subcontractors and specialist to supply a variety of goods and services. Wherever possible these are ISO 9000:2015 approved organisations. New suppliers are subject to an assessment and approval process and supplier performance data is routinely collected and evaluated. General supplier information is held in the Sage 200 system. A recommended supplier list is also maintained for critical categories of supply and includes supplier risk assessments. ISO Quality Manual Page 8 of 11

9 8.5 Production and Service Provision Product and service provision information is provided in various forms: System generated information, mainly provided by the Sage 200 MRP system Design information, mainly provided by the Solid Edge CAD system and DDM document management system Standard documentation and information forming part of the QMS Project specific documentation and information provided by the project manager Records relating to parts and labour usage are held within the Sage 200 system. Information relating to test and inspection information is stored in the project and manufacturing folders within the IT network. 8.6 Release of Products and Services Authority for the release of products and services lies with the relevant project manager. For project and service delivery there are usually agreed criteria for acceptance by the customer. 8.7 Control of Nonconforming Outputs The manufacturing process, see section 8.5 above, controls the identification, segregation and determination of nonconforming outputs. Documented procedures and instructions support this process. The performance evaluation process, see section 9 of this manual, provides further oversight on the effectiveness of the control of nonconforming outputs. ISO Quality Manual Page 9 of 11

10 9 Performance Evaluation 9.1 Monitoring, Measurement, Analysis and Evaluation FMB Oxford monitors: The performance of its processes via internal review meetings, change requests, corrective actions, internal audits (first party audits) and external audits (third party audits) The performance of its suppliers via key performance indicators (KPIs) and supplier audits (second party audits) Conformance to product specifications via internal testing and customer feedback Customer satisfaction through a combination of direct feedback (compliments and complaints) and internal KPIs 9.2 Internal Audit FMB Oxford operates an internal audit programme. The programme of audits is carried out in line with an annual schedule set by the Quality Manager and Quality Coordinator. This also takes account of the schedule of BSI surveillance audits. Internal auditors are trained in line with ISO 19011:2011; Guidelines for Auditing Management Systems. 9.3 Management Review The senior management team hold regular quality management meetings to discuss the effectiveness of the QMS. The structure of the meetings are in line with ISO 2000:2015 and agenda items include: Set and review quality policy and objectives Agree changes to the QMS, where appropriate Assess new risks and opportunities Monitor customer satisfaction and put in place corrective actions where appropriate Review the outcomes of internal and external audits and associated corrective actions Review key supplier performance and put in place corrective actions where appropriate Identify and track improvement projects 10 Improvement 10.1 Opportunities for Improvement In additional to identifying a number of strategic opportunities FMB Oxford also engages with staff and other stakeholders to identify opportunities for improvement in products, services and internal processes. Where opportunities are identified top management assign responsibility and resources. Progress on improvement projects is monitored and reviewed at management meetings and communicated to staff via departmental or company meetings. ISO Quality Manual Page 10 of 11

11 10.2 Nonconformity and Corrective Action FMB Oxford monitors all business processes for nonconformity. Examples include: Monitoring the quality of supplied parts and services Monitoring products and services against the requirements of test and functional specifications Monitoring the QMS to check adequacy of controls and conformity to procedures and work instruction Where a nonconformity is identified it is documented and reviewed and a corrective action put in place. Corrective actions are monitored as part of the QMS management review and only closed out on the authority of the Quality Manager 10.3 Continual Improvement FMB Oxford continually strives to improve and develop its products, services, partnerships, processes infrastructure and people. It achieves this goal by: Identifying and responding to risks and opportunities Measuring satisfaction levels both internally and externally Evaluating the performance of supplied products and services Acting on feedback from other interested parties Monitoring the efficiency and effectiveness of business processes and looking for improvement opportunities ISO Quality Manual Page 11 of 11