Certificate of Registration

Transcription

1 Certificate of Registration QUALITY MANAGEMENT SYSTEM - ISO 9001:2015 This is to certify that: Connects2 Ltd Qualtronyc Business Park High Street Princes End Tipton DY4 9HG United Kingdom Holds Certificate Number: FM and operates a Quality Management System which complies with the requirements of ISO 9001:2015 for the following scope: The design, development, programming and assembly of electronic and software interfaces for both original equipment (OEM) and aftermarket in car entertainment (ICE) manufacturer's product specifically for the motor manufacturing industry. The storage, sale and distribution of in-car entertainment products and accessories. For and on behalf of BSI: Andrew Launn, EMEA Systems Certification Director Original Registration Date: Effective Date: Latest Revision Date: Expiry Date: Page: 1 of 1 This certificate was issued electronically and remains the property of BSI and is bound by the conditions of contract. An electronic certificate can be authenticated online. Printed copies can be validated at Information and Contact: BSI, Kitemark Court, Davy Avenue, Knowlhill, Milton Keynes MK5 8PP. Tel: BSI Assurance UK Limited, registered in England under number at 389 Chiswick High Road, London W4 4AL, UK. A Member of the BSI Group of Companies.

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4 Connects2 Ltd High Street Princes End Tipton DY4 9HG I hereby approve the Quality Management System (QMS) described in this Quality Manual (QM), in support of our Quality Policy and Quality Objectives. I am committed to the ongoing development, implementation, and continual improvement of our Quality Management System.

5 Table of Contents Section Title Quality management Systems - Requirements i) Revision History and Approvals 1 Scope 2 Normative References 3 Terms and definitions 4 Context of the Organisation 4.1 Understanding the organisation and its context 4.2 Understanding the needs and expectations of interested parties 4.3 Determining the scope of the quality management system 4.4 Quality management system (QMS) and its processes 5 Leadership 5.1 Leadership and commitment 5.2 Policy 5.3 Organisational Roles, Responsibilities and Authorities 6 Quality managements system Monitoring, Measurement, Analysis and Improvement 6.1 Actions to address Risks and Opportunities 6.2 Quality Objectives and Planning to achieve them 6.3 Planning of changes 6.4 Improvement 6.5 Management Review 7 Support 7.1 Resources 7.2 Competence 7.3 Awareness 7.4 Communication 7.5 Documented Information 8 Operation 8.1 Operation planning and control 8.2 Requirements for products and services 8.3 Design and Development of products and services 8.4 Control of externally provided processes, products and services 8.5 Production and service provision 8.6 Release of products and services 8.7 Control of nonconforming outputs

6 Table of Contents (continue Section Title 9 Performance Evaluation 9.1 Monitoring, Measurement, Analysis and Evaluation 9.2 Internal Audit 9.3 Management review 10 Improvement 10.1 General 10.2 Nonconformity and Corrective action 10.3 Continual improvement Appendix 1 C2QM001 - Quality Policy C1QM002 - Organisation Chart C2QM003 - QMS Objectives C2QM004 - Distribution list Appendix 2 C2QM007 - QMS system management model C2QM008 - QMS Leadership model C2QM009 - QMS Document control C2QM010 - Risk management Process and responsibilities C2QM011 - PDCA Cycle C2QM012 - Quality Product Flow

7 i) Revision History and Approval Date of Revision Section Revised Nature Of Revision Approved By

8 1.0. Scope About Connects2 Connects2 Ltd was established in 1999, formerly part of Qualtronyc Group Ltd. Today we are firmly proved as the market leader in Europe for the supply of car audio interfaces, providing electronic boxes that allow aftermarket radios and other audio devices to be fitted seamlessly into most vehicles. We are unique in the aspect that our extensive product range spans some ten years and covers the majority of European vehicles that were sold globally during this period. No other business can claim to have such complete coverage as part of its intellectual property. 1.3 Our Mission Connects2 integrate aftermarket products seamlessly into a vast range of vehicles. Product innovation and industry firsts allow Connects2 to lead the way in the integration market. 1.4 Our Vision We continue to strive to offer our customers the optimum integration solutions. The future at Connects2 is always exciting and we look forward to continuing to support our global customers for many years to come. 1.5 The design, development, programming and assembly of electronic and software interfaces for both Original Equipment (OEM) and aftermarket in car entertainment (ICE) manufacturer s product specifically for the motor manufacturing industry. The storage, sale and distribution of in car entertainment products and accessories. Connets2 has established a Quality Management System (QMS) (Appendix 2 C2QM007 ) based on ISO 9001:2015, with the aim to support consistent quality management performance outcome, and to provide a sound basis for sustainable processes within our company. The potential benefits to our company from implementing a QMS based on ISO9001:2015 are: 1.6 The ability to consistently provide products and services that meet or exceed our current and future customer needs and applicable statutory and regulatory facilitating opportunities to enhance customer satisfaction; addressing risks and opportunities associated with our organisational context and objectives; the ability to demonstrate conformity to all relevant QMS requirements. 1.7 The policies established in this Quality manual and its scope and purpose are written to conform to the international ISO 9001:2015 standard as a working document that describes, as a minimum, the QMS to be deployed and at all times maintained by Connects2.

9 Connects2 promotes the adoption of a process approach when developing, implementing and improving the effectiveness of the quality management system, in order to ensure to enhance customer satisfaction by meeting customer requirements. Management of QMS processes (Appendix 2 C2QM007 ) as a whole will be achieved by using the PDCA cycle with overall focus on risk-based thinking, aiming to take advantage of opportunities and preventing undesirable results. PDCA Cycle (Appendix 2 C2QM011) can be briefly described as follows: Plan: Establish the quality objectives of the QMS and its processes, and plan the resources needed to deliver results in accordance with customers' requirements and company's polices, and also identify and address all business risks and opportunities Do: Implement what was planned. Check: Monitor and (where applicabl measure the QMS processes and the resulting products and services against QMS polices, objectives, requirements and planned activities, and report the results. Act: Take actions to improve the QMS performance, as necessary. This PDCA application of the process approach in our QMS enables us to: understand and stay consistent in meeting customer requirements; Consider QMS processes in terms of added value; Achieve effective process performance; Improve QMS processes based on evaluation of data and information Risk based thinking Connects2 applies the concept of risk-based thinking, as extension of the task known as carrying out preventative action to eliminate potential nonconformities by analysing any nonconformities that do occur, and taking action to prevent recurrence. Riskbased thinking is essential for achieving effective QMS application, as the planning and implementation of actions to address risks and opportunities increases the effectiveness of the QMS, supporting the prevention of negative effects, while using opportunities that can arise as a result of risk mitigation situations favourable to achieving intended result within the context of the QMS.

10 2.0 Normative References The following documents are normatively referenced in the document. Only edited in its latest edition applies including any amendments. ISO 9001:2015 Quality Management Systems - Fundamentals and vocabulary. 3.0 Terms and Definitions For the purpose of this quality manual, the terms and definitions given in 9001:2015 apply to this document 4.0 Context of the Organisation 4.1 Connects2 has reviewed and analysed key aspects of itself and its stakeholders to determine the strategic direction of the company. 4.2 The organizational context involves: Understanding our core products and services and scope of management system. Identifying "Interested Parties" who receive our products, or whom may be impacted by them, or those parties who may otherwise have a significant interest in our company. Interested Parties Customers Owners/stakeholders Employees Suppliers Regulatory & Statutory Needs & Expectations Price, reliability & value Profitability & growth Shared values & security Beneficial relationships Compliance & reporting Understanding internal and external issues that are of concern to Connects2 and its interested parties; also identified in C2QF097 - Risk Assessment register. Many such issues are identified through an analysis of risks facing Connects2 or interested parties. Such issues are monitored and updated as appropriate, and discussed as part of Management Reviews f) Scope of the Quality Management System Scope determination: Our senior management determines the boundaries and applicability of our QMS to establish its scope considering: The external and internal issues referred to in clause 4.1 of the ISO 9001:2015 standard the requirements of the relevant interested parties referred to in clause 4.2 of the ISO9001:2015 Standard to establish consistency in the quality of the applicable products and services of our company to enhance customer satisfaction through effective application of the QMS all statutory, regulatory and/or legal requirements establishment of suitable processes for improvement of the QMS

11 Based on an analysis of the above issues of concern, interests of stakeholders, and in consideration of its products and services, Connects2 has determined the scope of the Management System as follows: The design, development, programming and assembly of electronic and software interfaces for both Original Equipment (OEM) and aftermarket in car entertainment (ICE) manufacturer s product specifically for the motor manufacturing industry. The storage, sale and distribution of in car entertainment products and accessories. The scope of the quality management system and the understanding of our core products and services must be also at all time based on our strategic business planning concept outlined within the document Facilities within the scope The quality system applies to all processes, activities and employees within the company. The facility is located at: High Street Princes End Tipton DY4 9HG Permissible Exclusions Connects2 does not have any permissible exclusions, all clauses within the standard are applicable QMS process management: Connects2 has established, implemented, is maintaining and continually improving the QMS, including the processes needed and their interactions, in accordance with the requirements of the ISO 9001:2015 standard. The processes needed for the quality management System have been determined and include the business activities and their application throughout the company. Process Identification Connects2 has adopted a process approach for its management system. By identifying the top-level processes within the company, and then managing each of these discreetly, this reduces the potential for nonconforming products during initial processes through to final processes or after delivery. Nonconformities are identified by actions taken within each of the top-level processes.

12 The following top level processes have been identified for Connects2 - Development - Sales - Purchasing - Goods in - Warehouse - Production - Accessories - Despatch - Returns Each process may be supported by other activities, such as tasks or sub-processes. Monitoring and control of each process ensures effective implementation and control of all associated tasks and sub-processes. Each top-level process has a process map which defines: - applicable inputs - applicable outputs - applicable responsibilities and authorities - applicable risks and opportunities - critical and supporting resources - criteria and methods employed to ensure the effectiveness of the process - quality objectives related to that process - Control & risk prevention - process owner Process controls and objectives Each process has at least one objective established for it: this is a statement of the intent of the process. Each objective is then supported by at least one Key Performance Indicator (KPI) which is then measured to determine the process' ability to meet the quality objective. KPI data is measured and gathered by process owners or other assigned managers, in order to present the data to the management team. The data is analysed by the management team in order that the management may set goals and make adjustments for the purpose of long term continual improvement. The specific Quality objectives for each process are defined in the Process Matrix. When a process does not meet a goal, or an unexpected problem is encountered with a process, the corrective and preventative action process is implemented to research and resolve the issue. In addition, Opportunities for improvement are sought and implemented, for the identified processes.

13 4.3.3 QMS Process Implementation To establish QMS processes, Connects2 has created and maintains the process flow charts that provide the following: determine the inputs required and the outputs expected from each process determine the sequence and interaction of our QMS determine and apply the criteria and methods (including monitoring, measurements and related performance indicators) needed to ensure the effective operation and control of each process determine the resources needed for each process and ensure their availability assign the responsibilities and authorities for each process f) address the risks and opportunities for each process as determined in accordance with the requirements of clause 6.1 of the standard g) evaluate each process on effectivity on a regular basis and implement any changes needed to ensure that these processes achieve their intended result h) try to constantly improve all processes and the quality management system Connects2 will maintain documented information to support the operation of all QMS processes to ensure that all QMS processes including its business activities are being carried out as planned. 5 Leadership Responsibility (C2QM008 - QMS Leadership Appendix 2) Quality commitments: Connects2's management must be committed at all times to developing and maintaining an efficient and effective Quality Management System with focus on the following quality management principles. Customer Focus: Our customers determine the expectations, standards and requirements. Our senior management must strive at all times to understand, meet & exceed all of our existing customer requirements, inclusive focus on predicted future customer expectations. Our customers determine the expectations, standards and requirements of our QMS. Connects2 strives to understand, meet and exceed these requirements. this requires us to apply continuous customer satisfaction research and measurement. This approach between satisfying current and future customer needs and managing needs of all interest parties must also include tracking of internal customers satisfaction. (Regular internal audits, employee training, feedback etc.) Customers are defined as: External customers as product and service end users. Internal customers which are all people in our organisation. The public that can be affected by our product and services.

14 Expectations include: Product safety & product liability Availability of products Packaging, Delivery and shipping Conformity Standards shall include: Customer established written requirements (if provide Government or industry specifications (if provided and/or relevant) Regulatory specifications (if provide Requirements shall include: Key product and service characteristics Internal product and process specifications Internal Process procedures Purchase material and service specifications Key supplier selection Leadership: Senior management establishes the quality management vision, goals, measurable objectives and quality related direction for the QMS. At all times the needs of all the applicable interested parties are considered. Management must apply "risk-based thinking" when planning QMS activities. Management provides freedom to act with responsibility and accountability. Company leaders encourage and recognise people contributions. People engagement: Quality is seen as the responsibility of all employees and must be intrinsic in the products and services provided, as we can only achieve our vision, goals and measurable QMS objectives by including all employees. Employees must be competent and experience a blend of job satisfaction, organisational commitment, job involvement and responsibility in order to deliver quality and value. This shall include a well communicated perception of job importance, clarity of job expectation and regular feedback. Process Approach: Senior management must at all times recognise, identify, understand, document and manage processes that determine final outcome of the quality management related activities. Senior management must ensure that at all times, customer requirements and other requirements (Statutory/regulatory/industry requirements) are built within the QMS processes. We identify these as Input - Process - Output and connect these as a series of interrelated processes. All employees must be trained and understand the QMS process map, which must be defined within the continuous PDCA process cycle.

15 Continuous Improvement: Continuous improvement is the core of the quality policy. All employees must be trained in the Quality Policy, and in the methods and tools of improvement management. Management must make the commitment to improve efficiency and effectiveness of the products and processes as QMS performance objective, with the aim to improve the entire company. Evidence based approach to decision-making: Management must make effective and efficient decisions based on evidence data and information and is at all times responsible for collecting evidence by performing observations, measurements, tests, or by using any other suitable methods of producing data or information that is sufficiently accurate and reliable. QMS related data and information should include determination, measurement and monitoring of key indicators to manage performance of all processes. Relationship Management: Management must see all external and internal interested parties as suppliers to the Company as integral important part of meeting our customer needs and expectations. Improving the internal and external supplier performance benefits our customers and the Company. Management must at all time establish relationships that balance short-term considerations with long term focus; including identification and selection of key suppliers and creating open dialog with all our stakeholders for improvement purposes and to communicate shared achievements. Connects2 has established a Quality Policy that provides an overall framework for establishing specific Quality Objectives, and provides direction for the goal of continual improvement and is determined by the following factors: Senior Management shall ensure that the quality policy is appropriate to Connects2. The quality policy shall provide a commitment for product and services to meet the highest quality standards. Continuous Improvement is the core of Connects2 Quality policy. Review of the quality policy will form part of the Quality Management Reviews. The Quality policy must be communicated to all employees of Connects Connects2 Quality Policy: Is outlined in the Document C2QM001 - Quality Policy (Appendix 1) Quality Policy Implementation: The quality policy is implemented by senior management establishing and maintaining well connected quality plans, standard operating procedures and training plans to execute on quality improvement.

16 The management team is jointly responsible for: Identification and recording of product, service or systematic quality problems. Initiation, recommendation and development of risk mitigating preventative measures and solutions f) Verification of such preventative measures and solutions. g) Control of further processing and delivery of non-conforming product until appropriate corrective action of the deficiency Roles & Responsibilities: Senior Management is overall responsible for effective deployment, communication and improvement of all matters regarding our QMS, which is managed by the Quality Director and quality department. The Chairman, Managing Director, Operations Director and the Quality Director form the senior management team. They are the key personnel jointly responsible for achieving product and service quality, compliant to the quality system processes and operating guidelines within this manual. Supporting the Quality Policy of Continuous Improvement. Creation, implementation and review of quality plans and Quality Objectives. Initiation of corrective action to prevent product, service or any other operational nonconformance within our QMS Personnel who are in charge of inspection, review and testing of products and service are responsible for: Identifying and segregating any non-conforming products, Monitoring the production and service process on a scheduled basis, and Maintaining manufacturing and inspection plans for all significant process characteristics and parameters (where appropriat QMS Management representative The Quality Director is designated by the company as the management representative for the Quality System. Although senior management is responsible for ensuring that the necessary processes needed for the QMS are established, implemented and maintained, the Quality Director has the authority and responsibility to ensure that the daily operation of the quality system is maintained in compliance with ISO 9001 requirements. The Quality Director is responsible on a daily basis for reporting to senior management on any deviation to this compliance and the performance of the QMS and any needed necessary improvements. Senior Management is responsible for ensuring the promotion of awareness of customer requirements throughout Connects2, while the Quality Director is supporting this task on a daily basis.

17 6 Planning 6.1 Risks and Opportunities Quality planning must focus on effectively meeting Quality Objectives and customer and legal requirements, as well as try to mitigate all potential operational risks, which includes product risk, service risk, but also all other operational risk, based on the context of the organisation. Connects2 considers risks and opportunities when taking actions within the Quality Management System, as well as when implementing or improving the Quality Management System; likewise, these risk considerations have to be updated within the regular management reviews Operational risks and opportunities are managed in accordance with the Risk management procedure C2QF082 and risk management responsibilities C2QM010 (Appendix 2) and are based on results from the C2QF081 - R i sk Assessment Report and C2QF068 - Internal Audit risk report and evaluated in C2QF097 - Risk Assessment Register. An Action Plan C2QF098 provides mitigation or back-up plans based upon the risk assessments and is contained in the risk assessment register. 6.2 Quality Objectives and Planning Senior Management is responsible for the quality planning throughout our company. f) g) h) Inputs of the quality planning include: Organisation strategies Organisation QMS objectives Customer and regulatory requirements Product and service performance data Risk and opportunity strategies Process performance data Lessons learned, knowledge and change management Quality Management review i) j) k) l) Output needs of Quality Planning include: Process improvement plans Necessary skills, resources and knowledge capture Performance indicators Documentation

18 6.2.2 Quality Objectives, Key Performance Indicators Senior Management determines the Quality Objectives. These objectives must meet the Quality Policy. The Quality Objectives must be at all time established, implemented and maintained as goals to be achieved at relevant functions and levels within the Company/organization. Senior Management ensures that also QMS objectives are established: Quality Objectives must at all time be defined and documented. Quality Objectives will be periodically reviewed on a schedule basis during management review meetings f) g) QMS objectives will be specific, measurable, applicable, reliable and defined within a scheduled achievement time/date. QMS objectives will be tracked. Improvement actions to achieve the Quality Objectives will be implemented based on results of measurements f) The quality Objectives can include but are not limited to: Customer Satisfaction Process Performance Product Performance On time delivery Supplier Performance Overall QMS Performance Quality Objectives are identified within C2QM003 - Process Quality Objectives (Appendix 1). The Quality Objectives are reviewed by senior management and approved by the CEO. The specific Quality Objectives for each process are defined in the applicable process activities of each core process, and further described in the Process Flow Charts. KPI's, along with current standings and goals for each quality objective, are recorded in records of management reviews. When a process does not meet a goal, or an unexpected problem is encountered within a QMS core process, the corrective action process is implemented to research and resolve the issue. In addition, opportunities for improvement are sought and implemented, for the identified processes. 6.3 QMS Change management When the Company determines the need for changes to the Quality Management System and its processes, these changes must be at all times planned and then implemented.

19 7 Support 7.1 Resource Management Senior management determines and provides the resources necessary to implement, maintain and improve the quality management system, including both internal requirements and resources required from external sources Senior management determines and provides resources needed to implement and maintain the Quality Management System. Resource allocation is done with consideration of the capability and constraints on existing internal resources, as well as needs related to supplier expectations Resources include: f) Operational Knowledge g) h) People Facilities Suppliers and Supplies Infrastructure Work environment Natural resources Equipment Senior Management shall at all time ensure the availability of resources. This includes but are not limited to: Adequate staffing Adequate equipment Adequate facilities Adequate supplies Note: The management system does not include other aspects of human resources management, such as payroll, benefits, insurance or disciplinary actions. Infrastructure: Connects2 determines, analyses, provides and maintains the infrastructure to maintain and continuously improve this quality system and ensure that customer requirements are met. This includes the following: targeted plans for new equipment or services Product specific requirements Scheduled Preventative Maintenance of equipment Initial and continual supplier evaluations

20 7.1.4 Work Environment: Connects2 determines, analyses, provides and maintains the work environment to maintain and continuously improve this quality system and ensure that customer requirements are met. This includes the following: Safety training Statutory and regulatory environment training (as neede Feedback from employees Environmental controls needed, such as lighting, heat, noise etc Note: Human factors are considered to the extent that they directly impact on the quality of the products. Only work environment aspects which can directly affect process efficiency or product and service quality are managed by the management system Monitoring and Measuring of resources Connects2 determines and provides the resources needed to ensure valid and reliable results when monitoring or measuring is used to verify the conformity of products and services to requirements. Connects2 ensures that the resources provided: are suitable for the specific type of monitoring and measurement activities undertaken; are maintained to ensure their continuing fitness for their purpose Connects2 retains appropriate documented information as evidence of fit for purpose of the monitoring and measurement resources Measurement traceability When measurement traceability is a requirement, or is considered by the organization to be an essential part of providing confidence in the validity of measurement results, measuring equipment shall be: Calibrated or verified, or both, at specified intervals, or prior to use, against measurement standards traceable to international or national measurement standards; when no such standards exist, the basis used for calibration or verification shall be retained as documented information. A master list of calibrated equipment is maintained on form C2QF067 - Scale Calibration Register. Identified in order to determine their status; Safe guarded from adjustments, damage or deterioration that would invalidate the calibration status and subsequent measurement results. Connects2 determines if the validity of previous measurement results has been adversely affected when measuring equipment is found to be unfit for its intended purpose, and shall take appropriate action as necessary.

21 7.1.6 Organisational Knowledge Connects2 determines the knowledge necessary for the operation of its processes and to achieve conformity of products and services. This may include knowledge and information obtained from: 7.2 internal sources, such as lessons learned, staff feedback, and/or intellectual property; external sources such as standards, and/or information gathered from customers or suppliers. Competency and Training Senior management ensures that it provides sufficient staffing for the effective operation of the management system, as well its identified processes. Staff members performing work affecting product quality are competent on the basis of appropriate education, training, skills and experience, as defined on Job Descriptions. The Skills Matrices define these activities in detail. Connects2 shall determine the required competence for personnel performing work affecting product and service quality. Consideration will be given to: Future demands Cross training Audit results Statutory and regulatory requirements Importance for awareness of non-conformity and failure within the QMS process Connects2 shall provide training or take other action to satisfy these needs. The objective is to provide people with skills, knowledge and experience that will improve their competence Connects2 shall evaluate the effectiveness of the actions/training given Connects2 shall ensure its personnel are aware of the relevance and importance of their activities and how they contribute to the quality objectives Records of education, training, skills and experience shall be maintained Personnel Awareness Connects2 shall select personnel based on appropriate education, training, skills and experience to perform work that affects product quality.

22 7.3.2 Connects2 encourages the involvement and development of it's people by: Ongoing Training (training records) Establishing responsibilities and authorities Involving them in objective setting and decision making Operator Certification (training records and certificates) Establishing training needs (job descriptions, Skills Matrices) 7.4 Management of communication Senior Management ensures that appropriate communication systems are established within the organization. Senior Management must define and implement an effective and efficient communication of our quality management system matters f) g) Communication parameters of the QMS include: Quality policy and promotion of risk-based thinking QMS objectives and request for detailed support Results of objective measurements Ongoing improvement All QMS requirements Convey the importance of our applicable standards All employee accountability for the QMS f) Senior management must also be at all times committed to communicating and meeting all internal and external customer requirements as well as statutory and regulatory requirements by: Continuous training of employees on QMS compliance Detailed documentation on legal and customer requirements Understanding external customer needs and expectations and transferring this information to employees through pertinent disclosure Encouraging all employees to contribute to Risk Based Thinking on all operational processes during regular meetings Understanding and communicating internal customer needs and expectations and transferring this information into documented activities to satisfy these needs Encouraging employees to strive for continuous improvement of customer satisfaction

23 7.4.5 Methods of communication include: Schedule quality reviews Meetings (periodic scheduled and/or unschedule to discuss the QMS Performance Notice Boards (KPI's, attendance et Use of corrective and preventive action processes to report nonconformities or suggestions for improvement f) g) h) i) Use of the results of analysis data Use of the results of the internal audit Regular company meetings with all employees Internal s Memos to employees 7.5 Management of documented information ( C2QM009 - Document Control chartappendix 2 ) Documented and controlled information comprising the QMS includes: Documented statements of the quality policy and quality objectives The documented scope of the QMS The quality manual Documented procedures relevant to the QMS All documented information needed to ensure the effective planning, operation and control of the internal and external QMS processes. f) Records required by ISO 9001 as being documented information needed to be retained by Connects2 for the purpose of providing evidence of result achieved Controlled document information of Quality planning can include: f) g) Product, equipment and process control documentation Procedures Quality system documentation Quality records in hardcopy and/or any kind of electronic format Documents containing QMS relevant internal communications Any other kind of test and inspection plan, quality plan, risk plan, quality manual, strategic plan, records or forms Work instructions

24 7.5.3 Control of documented information Approve documents for Adequacy prior to use (authorisation) Review and update as necessary and re-approve documents Ensure that the changes and the current revision of documents are identified Ensure that relevant versions of the documents are available at point of use Ensure that controlled documents remain legible and identifiable and are un-editable by unauthorised personnel Ensure that documents of external origin and their internal distribution are identifiable f) and controlled by our QMS within documented filing. Prevent unintended use of obsolete documents and apply suitable identification to g) them if they are retained for any purpose. (Obsolete Records) Operation Connects2 ensures that all QMS controlled documents are under change and revision control and are maintained on C2QM005 QMS document control list. All other documented information necessary to manage the QMS must be kept accessible and preserved at all time during day to day work. Records are controlled per section Connects2 has established a documented procedure C2QF073 - Document Control process which defines the controls in place to: Control of Records Connects2 establishes and maintains records to provide evidence of conformity to all our legal and customer requirements and establish measurable evidence for effective operations of our quality management system. These records will at all time remain legible, easily identifiable and retrievable either in hardcopy or electronic format. The documented procedure C2FC008 - Control of records defines the controls needed for identification, storage, protection, retrieval, retention time and disposition of our QMS related records, which shall be (P) planned in forms, (Do) taken regularly, (C) measured and (A) acted on the evidence based results of the records. Record control is maintained in the Document folder on the Connects2 quality server. 8.1 Operational planning and control Connects2 plans and develops the processes needed for product realisation. Planning of product realisation is consistent with the requirements of the other processes of the management system. Such planning considers the information related to the context of the organisation (see section 4.0 abov, current resources and capabilities, as well as product and service requirements. Note: All changes to operational processes are strictly prohibited and can only be authorised by the Quality department and/or the Quality Director.

25 8.2 Requirements for Products and Services Customer communication Connects2 has implemented effective communication with customers in relation to: providing information relating to products and services handling enquiries, contacts or orders including changes; obtaining customer feedback relating to products and services, including customer complaints handling or controlling customer property establishing specific requirements for contingency actions, when relevant Determining the requirements for products and services Once requirements are identified, Connects2 reviews the requirements prior to its commitment to supply the product. This review ensures that: product requirement is defined contract or order requirements differing from those previously expressed are resolved the organisation has the ability to meet the defined requirements, and/or the claims for the products and services it offers, and risks have been identified and considered Review of the requirements for products and services statutory and regulatory requirements related to the product; any additional requirements determined by Connects2 During the review of new customer requirements, Connects2 ensures they have the ability to meet the customer requirements and shall review the requirements prior to committing to take the order and also review: requirements specified by the customer, including the requirements for delivery and post delivery activities; requirements not stated by the customer but necessary for specified or intended use, where known; order requirements that differ from those supplied by the customer previously identified Changes to requirements for products and services Design and Development Connects2 shall establish, implement and maintain a design and development process that is appropriate to ensure the subsequent provision of products and services.

26 8.3.2 Design and development planning f) g) h) i) j) In determining the stages and controls for design and development, Connects2 considers; the nature, duration and complexity of the design and development activities; the required process stages, including applicable design and development reviews; the required design and development verification and validation activities; the responsibilities and authorities involved in the design and development process; the internal and external resources needed for the design and development process; the need to control interfaces between persons involved in the development process; the need for involvement of customers and users in the design and development process; the requirements for subsequent provision of products and services; the level of control expected for the design and development process by customers and other relevant interested parties; the documented information needed to demonstrate that design and development requirements have been met. Design and Development inputs Connects2 determines the requirements essential for the specific types of products to be designed and developed (C2FC003 - Development Process ) Connects2 considers: Functional and performance requirements; information derived from previous similar design and development activities; Statutory and regulatory requirements Standards or codes of practice that Connects2 has committed to implement; potential consequences for design and development purposes. Connects2 retains documented information on design and development inputs Design and Development controls Connects2 apply controls to the design and development process to ensure that: the results to be achieved are defined reviews are conducted to evaluate the ability of the results to meet requirements verification activities are conducted to ensure that the design and development outputs meet the input requirements Validation activities are conducted to ensure that the resulting products meet the requirements for the specified application or intended use any necessary actions are taken on problems determined during the reviews, or verification and validation activities f) documentation information of these activities is retained

27 8.3.5 Design and development outputs Connects2 shall ensure that design and development outputs: meet the input requirements are adequate for the subsequent processes for the provision of the product include or reference monitoring and measuring requirements, as appropriate specify the characteristics of the products that are essential for their intended purpose and their safe proper provision Connects2 shall retain documented information on design and development outputs Design and development changes Connects2 shall identify, review and control changes made during, or subsequent to, the design and development of the product, to the extent necessary to ensure that there is no adverse impact on conformity to requirements. 8.4 Connects2 shall retain documented information on: design and development changes; the results of reviews; the authorisation of changes; the actions taken to prevent adverse impacts. Control of externally provided processes, products and services Outsourcing: If Connects2 decides to outsource any process that affects product and service conformance with related requirements, Connects2 shall ensure control over such processes. These processes must be clearly identified within the QMS, to ensure that the QMS is not adversely affected. Processes, products, and services Products and services from external sources that are intended for use into Connects2's own products and services Products and services provided directly to the customer by an external source on behalf of Connects2 A process or part of a process is provided by an external source as a result of a decision by Connects2 Connects2 determines the criteria for the evaluation, selection, monitoring of performance, and re-evaluation of external providers based on the criticality of the product/service and their ability to provide processes, products, or service that meet requirements.

28 8.4.2 Type and extent of control Ensure that externally provided processes remain within the control of the QMS Take into consideration: 1 - The potential impact of the externally provided processes, products and services on the ability to consistently meet customer and any statutory and regulatory requirements 2 - The effectiveness of the controls applied by the external provider Connects2 ensures that externally provided processes, products and services are controlled to the aspect that they do not adversely affect the ability to consistently deliver conforming products and services to customer requirements. Connects2 will: Define the controls that it will apply to an external provider and those it intends to apply to the resulting product or service Determine the verification or other activities necessary to ensure that the externally provided processes, products and services meet requirements Information for External Providers The purchasing person shall ensure that all supplies and services procured from suppliers conform to specified requirements. The company shall select suppliers on the basis of their ability to meet and exceed requirements within initial documented supplier evaluation analysis, following annual supplier performance evaluation. A controlled list of approved critical material suppliers is maintained on the company's Approved Vendors List, which is maintained in Navision. Critical is defined as material that has been deemed to affect product quality. Records of the results of the evaluations and any necessary actions arising from the evaluation are maintained on the Vendor Evaluation Worksheet f) g) Purchasing information All company purchase orders shall contain data clearly describing the product ordered and where appropriate, the following information: The type, class, style, grade, quality code or other precise identification. The title, document number, and revision level of all relevant technical data or standards. The number and issue of any quality system standard to be applied. All requirements for approval of the purchased item. All requirements for qualification of personnel. Quality Management System requirements. Connects2 shall ensure the purchase requirements are adequate and correct prior to placing the order with the supplier.

29 8.4.5 Verification of Purchase products Inspection of products at delivery point 8.5 Production and service Provision Control of Production and service f) g) h) i) Connects2 has established and implemented inspection procedures with acceptance criteria for purchase products and services to assure product and services meets purchase requirements. This includes the following: Acquisition of objective evidence of the quality of the product or service from subcontractors (e.g., accompanying documentation, certificate of conformity, test reports, statistical records, process control) Inspection and audit at the source. If inspection is required at source, the verification arrangements and product and service release information will form part of the purchase order. Review the required document Connects2 management plans and carries out production and service under controlled conditions within planned control points. This includes but is not limited to: Availability of specifications and information that describe the characteristics of the product and process requirements, including Work Orders and customer drawings Availability of procedures and work instructions for manufacturing processes and inspections covering all operational relevant risks The use of suitable equipment including its maintenance and repairs. The availability of monitoring and measuring devices. The implementation of measurement and monitoring at control points The implementation of release, delivery and post-delivery activities Product or critical materials liable to deterioration shall be identified and assessed or tested at defined intervals. Critical materials with limited shelf life shall be identified on receipt to stock or stores at the time it is produced. Final stocked product subject to deterioration shall be identified, and inspected in accordance with the Work Order. Connects2 will validate any process change where the resulting output cannot be verified by subsequent monitoring or measurement. This includes any process where deficiencies become known only after the product has been delivered. Validation will demonstrate the ability of these processes to achieved planned results. Connects2 has established validation processes for appropriate applications using the following: 1 - Defined criteria for review and approval of the process 2 - Approval of equipment, process and qualification of personnel 3 - Use of specific methods and procedures 4 - Requirements for records 5 - Revalidation

30 8.5.2 Identification and Traceability All products, including raw material shall be identified with a part number, lot number, or works order number. All final product shall be traceable to all raw material sources for the purposes of investigation. This traceability is documented from receiving to final product and defined in appropriate procedures. According to the level of traceability required by contract, regulatory, or other established requirement, the quality system shall provide for the following: Identification to be maintained throughout the product life All the products manufactured from the same batch of raw material or from the same manufacturing batch to be traced, as well as the destination (delivery, scrap) of all products of the same batch For a given product, a sequential record of its production is to be retained (works order) f) Identification of the product or service status with regards to monitoring and measurement requirement Maintaining the identification of the configuration - via the lot number/id number of the product - in order to identify any differences between the actual configuration and the agreed configuration Incoming defect products or services must be at all time placed in quarantine areas, to avoid inclusion into our conforming products and must be processed under formulised quality control. (C2FC021 - Customer returns ) g) Adequate bins, containers, pallets, trays, or bags shall be used to move production inhouse under safety and operational risk considerations. h) Cleaning, Prevention, detection and removal of foreign objects Property Belonging to customers or external providers Connects2 shall exercise care with customer or external provider s property while it is under Connects2s control or being used by Connects2. Connects2 shall identify, verify, protect and safeguard customer or external provider s property provided for use or incorporation into the product. If any customer or external provider s property is lost, damaged or otherwise found unsuitable for use, it shall be reported to the customer or external provider and records maintained. The full process can be defined in greater detail in document C2QF071 Control of external property. Note: A customer's or external provider's property can include materials/packaging, components, tools and equipment and intellectual property.

31 8.5.4 Preservation All product, at whatever stage of production or delivery shall be handled in a manner such as to prevent damage or deterioration to the product. The proper handling method will be documented in the appropriate Work Order. The use and configuration of packaging and labelling material shall be defined in the Work Order (BOM) and/or in accordance with customer requirements. The Work Order covers the specific requirements for: f) g) h) Special handling for sensitive products. Marking and labelling, including safety warnings. Shelf-life control and stock rotation. Hazardous materials. Where applicable, product specifications must always be under regulations. Shipping documentation shall exist to identify product, customer and destination. Product shipped from stock shall be processed to "first in-first out" (FIFO) policy The company shall ensure that the accompanying documents for the product are present at delivery as specified in the contract/order and are protected against loss and deterioration. Post-Delivery activities Connects2 shall meet the requirements for post-delivery activities associated with our products and services In determining the extent of post-delivery activities, Connects2 considers: Nature, use and intended lifetime of products Statutory and regulatory requirements Any potential undesired consequences associated with products and services Customer requirements Customer Feedback Note: Post-delivery activities can include installation, warranty activities, maintenance services and customer returns (including services such as recycling and product disposal Control of changes Connects2 reviews and controls both planned and unplanned changes to processes to the extent necessary to ensure continuing conformity with all requirements. Process change management is controlled and each document has an authorised by, revision number and date.

32 8.6 Release of Products and services Connects2 ensures release of product to the customer shall not proceed until the planned arrangements have been satisfactory completed, unless otherwise approved by a relevant authority and, where applicable, by the customer. Product and service activities are verified at various stages to ensure all requirements have been met. Records are maintained to enable identification of the individual releasing the product. 8.7 Control of non-conforming output Connects2 ensures that product and services that does not meet requirements are identified and controlled to prevent use or delivery of the product or service. Nonconforming product is documented on form C2QF012 Corrective action report and control of the nonconforming product/service process is identified in procedure C2FC016 Non-conforming Product & C2FC018 Corrective Action. All nonconforming material is reviewed by the Quality Director. Review and disposition guidelines are defined in procedure C2FC016 Non-conforming Product. The nonconforming material review is established to provide a means for evaluating discrepant material and initiating corrective action. The review can be performed by the Quality Director, or the Managing Director. The disposition decision authority performed on final manufactured product rests solely with the Quality Director or designated representative within the Quality department. Only the Chairman can override this decision. Nonconforming product reviews are conducted to determine the status of nonconforming material which may include: Rework, Use-As-Is, Regraded, Scrapped, or Return to Vendor. A description of nonconforming product or lots and its condition shall be recorded on the corrective action register. C2QF015 - Corrective action register The Nonconforming product decision shall be recorded on the Corrective Action register and the material processed accordingly Established procedures shall take into account process nonconformity that may result in product or service nonconformity. Parties requiring notification of nonconforming product may include subcontractors, internal organizations, customers, distributors and regulatory authorities.

33 the company shall not use-as-is or repair, unless specifically authorised by the customer, if: 1 - the product is provided to customer design, or 2- The non-conformity results in a departure from the contract requirements Unless otherwise restricted in the contract, company-designed product or service which is controlled via a customer specification may be dispositioned by the company as use-as-is or repair, provided the nonconformity does not result in departure from customer-specified requirement. Product dispositioned for regrade requires a change in product identification to preclude the product s original use. Adequate test reports and certifications shall reflect the regrading. The same process must be applied for servicing programs. Product and services that have been reworked shall be subject to re-verification to demonstrate conformity to requirements. When nonconforming product, services or processes are detected after delivery or use has started, the organization shall take action appropriate to the effects or potential effects of the nonconformity. The nonconformity is documented on the Corrective Action register and the customer may need to be notified. 9 QMS Performance Evaluation Monitoring, Measurement, Analysis and Evaluation, Connects2 determines: What information or processes need to be monitored or measured What methods will be used to ensure valid results When monitoring and measuring will be performed and when the results will be analysed and evaluated The performance of the quality management system will be evaluated and records maintained as part of the management review and QMS audit Monitoring and measurement of customer satisfaction Connects2 shall monitor information relating to customer perception as to whether the organisation has met customer satisfaction. Our Customer Satisfaction System includes methods for obtaining and using this information. Methods include: Internal and External Customer complaints Delivery data Customer feedback through analysis of customer feedback and concerns Warranty Claims Customer returns data Note: The above results are reviewed and discussed during management review meeti

34 9.1.3 f) g) Connects2 realizes that measurement data is important for making evidence-based decisions. To ensure Connects2 performance and customer satisfaction, effective and efficient measurement, collection and validation of data is necessary. Examples of process performance measurables include: Conformity of products, services and processes Customer satisfaction Performance and effectiveness of the QMS Planning effectiveness Effectiveness of actions taken to address risks and opportunities Performance of external providers Need for continual improvement to the QMS The above results and data are reviewed and discussed during management review meetings. Data for the above is collected on the corrective action report, customer complaints and concerns log, approved suppliers register and internal audit Reports. 9.2 Internal Audits Internal Audits, performed as identified in procedure C2FC015 Process Audit are conducted at planned intervals to determine whether the quality management system conforms and is effectively implemented and maintained to: Planned arrangements (C2QF037 - Audit timetabl Requirements of the ISO 9001:2015 standard Requirements established by this The audit program is planned under the focus and purpose of finding opportunities for improvement in all QMS areas, based on process improvement, not People improvement, and shall take into consideration the status, importance, and previous audits of processes and areas by creating appropriate sampling plans for targeted process audit areas The audit program defines the following: Criteria Scope frequency Methods Responsibilities f) Planning g) Reporting results h) Maintaining records The Management responsible for the audited area shall ensure actions are taken to eliminate deficiencies with undue delay. Follow up activities shall include verification of the actions and reporting of verification results.

35 9.3 Management Review Senior Management reviews the quality management system every year to ensure its suitability, adequacy, effectiveness and alignment with Connects2's strategic direction. The review will include review of the quality objectives, quality policy, and necessary changes and improvement to the quality management system. Guidelines for this review are detailed in document C2FC009 Management Review The Management Review shall be planned and documented on form C2QF069 - Management Review Agenda. These reviews must include these inputs but not limited to: Results from previous QMS management review meetings and follow up actions Changes in external and internal issues that are relevant to the QMS Information on the performance and effectiveness of the QMS, including: f) Customer satisfaction 2 - Extent to which Quality Objectives have been met 3 - Process performance and conformity of products and services 4 - Nonconformities and Corrective Action 5 - Monitoring and Measurement Results 6 - Audit Results 7 - Performance of external providers Adequacy of resources Effectiveness of actions taken to address risks and opportunities Opportunities for improvement Management Review Outputs: The output from the quality management review shall include any decisions and actions made by our senior management related to: Opportunities for improvement Any need to change the QMS Resource needs Records from the management reviews are maintained on Connects2 management review minutes, these files are kept on the system in the Connects2 Quality folder. Other related documents for the Management review include Board Meeting Minutes and Reports.

36 10 QMS Improvement 10.1 QMS improvement Plan f) g) h) Connects2 management continually seeks to improve the effectiveness and efficiency of the processes. Connects2 has a process in place to identify and manage improvement activities. This process is partially based of results from the following: Quality Policy implementation Quality objectives Audit results Analysis of data Corrective Actions Risk and Opportunities Preventative actions Management review 10.2 Nonconformity and Corrective Action f) When a nonconformity occurs, including that from customer complaints, Connects2: Reacts to nonconformity and performs the following actions: 1 - Takes action to control and correct the nonconformity 2 - Deals with the consequences arising from the nonconformity Evaluates the need for action to eliminate the cause of the nonconformity to prevent reoccurrence by: 1 - Reviewing and analysing the nonconformity 2 - Determining the root cause of the nonconformity 3 - Determining if similar nonconformities exist or could occur Implement any action needed Review the effectiveness of any corrective action taken Update risks and opportunities determined during planning if necessary Make changes to the QMS, if needed Determination of the need for corrective action is determined by management, based on the effect of the nonconformity The Corrective Action process is identified and controlled in accordance with procedure C2FC018 Corrective Action and Non-conformances and Corrective Actions are documented on form C2QF015 Corrective action and complaint register Continual Improvement Connects2 continually improves the suitability, adequacy and effectiveness of the QMS by reviewing the results of data analysis, process evaluations, internal audit results, corrective and preventive action, and management review meetings.

37 APPENDIX 1 C2QM001 - Quality Policy C2QM002 - Organisation Chart C2QM003 - QMS Objectives C2QM004 - Distribution list

38 Quality Policy Commitment to Quality through our Quality Management System Quality of products supplied will conform to all contractual requirements and meet the needs of and, in fact, exceed the expectations of our customers. Improve all aspects of our business via active participation and involvement Review and measure the companies Quality Objectives regularly to ensure compliance and relevance This and supporting procedures are approved by the CEO and must be adhered to for all orders unless specific written instructions are given to the contrary. Any deviation from this Quality System requires the approval and authorisation of the CEO or the Quality Director. M.D Fereday CEO and Chairman

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40 TARGET MEASURE CONTROL SALES DEVELOPMENT Meet or exceed sales budget Invoice all Product designed received orders to agreed that have been deadlines and shipped daily. requirements High level of customer service Monthly Accounts Individual targets Daily Sales Customer complaints Development Plan Board Meeting Sales Meeting Sales Spreadsheet Customer Concerns Log Line Plan Development Review PURCHASING PRODUCTION DESPATCH GOODS IN RETURNS Enough parts to achieve at least 85% availability Produce product right first time and have over 85% availability All UK orders received before 5.30 pm are Shipped correctly. All Export orders are picked and packed correctly. On time Deliveries All standard deliveries received before 1 pm are booked on to system same day. Accurate checking and booking in of all stock received All returns processed within 3 days. Returns system up to date> High level of customer service Output KPI & MRP Returns Timed delivery process output Date stamp on notes used, KPI>30 returns paperwork, Clear customer by part number area, no booking complaints and investigated in errors concerns further All approved credits processed, Clear area. Returns to vendor completed Purchasing Ops Meeting warehouse Manager reports any issues or complaints to Ops Director Visual check by Goods-In staff, Issues reported to Ops Director RA system check, Quality Department and Ops meeting WAREHOUSE 100% Accuracy. Weekly/monthl y PIF's completed Stock rotation. No losses or damages PIF accuracy, stock take, monthly accounts, stock adjustments Ops meeting C2QM003 PROCESS QUALITY OBJECTIVES

41 Distribution List NUMBER HOLDER 1 Quality (Printed Copy) 2 Connects2 Gatehouse (Printed Copy) NUMBER WHERE DISPLAYED 3 Connects2 Website A shortcut to the manual on the connects2 website is available on all PC desktops

42 APPENDIX 2 C2QM007 - QMS system management model C2QM008 - QMS Leadership model C2QM009 - QMS Document control C2QM010 - Risk management Process and responsibilities C2QM011 - PDCA Cycle C2QM012 - Quality Product Flow

43 Customer REQUIREMENTS, QUOTES & ORDERS Customer Enquiries/ Quotations Product Development Sales Order Processing Purchasing and Supplier evaluation Production Process Control of Warehouse activities & Logistics Customer QUALITY MANAGEMENT SYSTEM AND PROCESS RESOURCE MANAGEMENT PRODUCT PROCESS Resources Control of internal communication Control of workplace Health & Safety HR & Training Control of maintenance Verification Testing & Calibration POLICIES & DIRECTIVES CONTINUAL IMPROVEMENT Marketing MEASUREMENT, ANALYSIS & IMPROVEMENT Forecasting & Planning Internal Audits Performance management (KPI) Final Testing & Quality check Process data Preventative and corrective Action Control of Nonconformances Handling Customer complaints Measurement of Customer satisfaction FEEDBACK Management System Resource needs MANAGEMENT RESPONSIBILITY PROCESS Management System Requirements Documentation & record control System Review Planning for Quality Performance Data C2QM007 01/01/2018

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45 Q M S H E I R A R C H Y Level 1 Documents Level 2 Documents Level 3 Documents Level 4 Documents QMS DOCUMENT CONTROL Quality Policy Security Policy ISO 9001 Certification Quality Department Notice Boards Company PC s Company Website Operating procedures Process flow charts Visual Aids Quality Department Notice Boards Department Files Quality Folder (server) Work Instructions Job Descriptions Training records Quality Department Notice Boards Quality Folder (server) Department Files Audit reports Corrective action Customer complaints Calibration records Quality Department Quality Folder (Server) Defines the requirements and responsibility according to the ISO standard What is required to be done How the requirements are done Recording and monitoring the information C2QM009 15/01/2018

46 QUALITY DIRECTOR Build a risk aware culture within the company Agree risk management targets Ensure implementation of risk management Identify and report changed circumstances/risks Understand, accept and implement RM processes QUALITY DEPARTMENT Develop the risk management policy and keep it up to date Document internal risk polices and structures Co-ordinate the risk management (and internal control) activities Compile risk information and prepare reports for management review meetings SENIOR MANAGEMENT Determine strategic approach to risk Establish the structure for risk management Understand and the significant risks Manage the organisation in a crisis RISK MANAGEMENT PROCESS & RESPONSIBILITIES INTERNAL AUDITORS Develop a risk-based internal audit programme Audit the risk process across the organisation Receive and provide assurance on the management of risk Report on the efficiency and effectiveness of internal controls MANAGEMENT TEAM SWOT Analysis Quality Reviews Customer concern and complaint reviews Interested parties analysis Risk Matrix and Review EMPLOYEES Understand, accept and implement the RM processes Report inefficient, unnecessary or unworkable controls Report loss and near miss incidents Co-operate with management on incident investigations C2QM010 Issue 1 01/01/2018

47 C2QM011 - PDCA CYCLE

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