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ISO 9001 2015 QMS Manual - Integrated with SOP

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ISO 9001 2015 QMS Manual - Integrated with SOP

  1. 1. Company Name QMS Manual ISO 9001:2015 Quality Management System Document number : QA-M1 Rev 0 Effective date : Document owner : Date : Signature : Approved by : Date : Signature :
  2. 2. Document title : Quality Manual Document no : QA-M1 Rev 0 Effective date : Pages : 2 of 22 Company Name Table of contents & Correlations with ISO 9001:2015 ISO 9001:2015 Clause QMS Manual Clause Clause title Page - - Cover page 1 - - Table of contents & Correlation with ISO 9001:2015 2 - - Revision history 4 - - About the Company, vision and mission 1 1 Purpose of the QMS 2 2 Normative references 3 3 Terms and definitions 4 4 Context of the Company 4.1 4.1 Understanding the external and internal environments 4.2 4.2 Needs and expectations of interested parties 4.3 4.3 Scope of the QMS 4.4 4.4 General requirements of the QMS and its documentation 5 5 Leadership 5.1 5.1 Leadership and commitment towards the QMS and customer focus 5.2 5.2 Quality Policy 5.3 5.3 Roles, responsibilities and authorities 6 6 Planning 6.1 6.1 Actions to address risks and opportunities 6.2 6.2 Quality objectives 6.3 6.3 Management of change 7 7 Support
  3. 3. Document title : Quality Manual Document no : QA-M1 Rev 0 Effective date : Pages : 3 of 22 Company Name ISO 9001:2015 Clause QMS Manual Clause Clause title Page 7.1 7.1 Provision and maintenance of resources 7.2 7.2 Competency 7.3 7.3 QMS Awareness 7.4 7.4 External and internal communication 7.5 7.5 Control of documented information 8 8 Operation 8.1 8.1 Operational planning and control 8.2 8.2 Determination of customer requirements 8.3 8.3 Design and development of products and services 8.4 8.4 Procurement of products, services and processes 8.5 8.5 Production and service provision 9 9 Performance evaluation 9.1.2 9.1 Monitoring and measurement of customer satisfaction 9.1.1 9.2 Process monitoring and measurement 9.1.3 9.3 Data analysis and evaluation 9.2 9.4 Internal audit 9.3 9.5 Management review 10 10 Improvement 10.1 10.1 Improvement of products and services 10.3 10.2 Improvement of the QMS 10.2 10.3 Nonconformity and corrective action
  4. 4. Document title : Quality Manual Document no : QA-M1 Rev 0 Effective date : Pages : 4 of 22 Company Name Revision history Revision number Effective date Description of amendments 0 First issue
  5. 5. Document title : Quality Manual Document no : QA-M1 Rev 0 Effective date : Pages : 5 of 22 Company Name About the Company Company description Vision Statement Mission Statement
  6. 6. Document title : Quality Manual Document no : QA-M1 Rev 0 Effective date : Pages : 6 of 22 Company Name 1 Purpose of the QMS This document describes the Company’s QMS which has been established to achieve the following goals: a) Demonstrate the Company’s ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements, b) Enhance customer satisfaction through the effective application of the system, including processes for improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements. The QMS shall be subjected to internal and external audits on an annual basis. The QMS Coordinator shall be responsible for managing and communicating such audits to the CEO and relevant Managers. This document shall be distributed to all Managers who in turn shall promptly make it accessible to their respective personnel. 2 Normative references The following documents are normatively referenced by the QMS and are indispensable for its application: a) ISO 9001:2015 Quality management systems - Requirements b) ISO 9000:2015 Quality management systems - Fundamentals and vocabulary 3 Terms and definitions For the purposes of this document, the terms and definitions given in ISO 9000:2015 shall apply, including the following abbreviations: a) QMS Quality Management System b) CAR Corrective Action Request 4 Context of the Company 4.1 Understanding the external and internal environments In line with the Company’s mission and strategic direction, the QMS Coordinator and Managers shall determine, monitor and review both positive and negative issues arising out of the external and internal environments of the QMS. External issues can be political, legal, economic, technological, cultural, social or economic while internal issues may relate to organizational values, culture, knowledge or performance. 4.2 Needs and expectations of interested parties Due to their potential effects on the Company’s ability to consistently provide products and services that meet customer, legal and other requirements, the QMS Coordinator and Managers shall determine, monitor and review both positive and negative issues arising out of the requirements of interested parties.
  7. 7. Document title : Quality Manual Document no : QA-M1 Rev 0 Effective date : Pages : 7 of 22 Company Name Interested parties and their requirements have been generally defined as follows: Interested parties Requirements Customers Products and services that meet or exceed their requirements Regulatory bodies Compliance to applicable statutes and regulations ISO Certification Body Conformance to ISO 9001:2015 requirements Suppliers Accurate purchase orders and prompt payment Staff Adequate provision of resources and training 4.3Scope of the QMS The boundaries and applicability of the QMS shall cover all significant issues related to the Company’s external and internal environments, including the needs and expectations of interested parties, and all of the Company’s products and services. 4.4 General requirements of the QMS and its documentation The Company shall implement, maintain and continually improve a QMS, including the processes needed and their interactions, in accordance with the requirements of the ISO 9001:2015 International Standard without any exclusions. The QMS processes shall be managed in terms of the following: a) Inputs, sequence and interaction and outputs b) Criteria and methods needed to ensure effective operation and control c) Resource requirements d) Responsibilities and authorities of personnel e) Risks and opportunities arising from issues related to the external and internal environments, and requirements of interested parties f) Performance evaluation and customer satisfaction g) Improvement. The QMS shall be guided and controlled by the following documented information: a) Quality Policy b) Documented quality objectives c) QMS Manual d) Organization Charts e) Job Descriptions f) Procedures, work instruction and forms g) Work records. 5 Leadership 5.1 Leadership and commitment towards the QMS and customer focus The CEO shall demonstrate leadership and commitment with respect to the QMS by: a) Taking accountability for the effectiveness of the QMS b) Ensuring that the quality policy and objectives are established for the QMS and are
  8. 8. Document title : Quality Manual Document no : QA-M1 Rev 0 Effective date : Pages : 8 of 22 Company Name compatible with the context and strategic direction of the Company c) Ensuring the integration of the QMS requirements into the Company's business processes d) Promoting the use of the process approach and risk-based thinking e) Ensuring that the resources needed for the QMS are available f) Communicating the importance of effective quality management and of conforming to the QMS requirements g) Ensuring that the QMS achieves its intended results h) Engaging, directing and supporting persons to contribute to the effectiveness of the QMS i) Promoting improvement j) Supporting other relevant management roles to demonstrate their leadership as it applies to their areas of responsibility. The CEO shall demonstrate leadership and commitment with respect to customer focus by: a) Determining, understanding and meeting customer and applicable statutory and regulatory requirements b) Determining and addressing risks and opportunities that can affect conformity of products and services and the ability to enhance customer satisfaction c) Maintaining the focus on enhancing customer satisfaction. 5.2 Quality policy The CEO has authorized a quality policy that documents the Company’s commitment to satisfy applicable requirements related to customers and other interested parties, and continually improve the QMS. The QMS Coordinator shall ensure that the Quality Policy is communicated, understood and applied within the Company and made available to relevant interested parties, as appropriate. 5.3 Roles, responsibilities and authorities Roles, responsibilities and authorities within the QMS have been defined in the Organization Chart, Job Descriptions, QMS Manual, procedures and work instructions. All personnel shall be required to execute their duties accordingly. The QMS Coordinator and Managers shall be responsible for ensuring that the QMS is being implemented and maintained effectively as per the requirements of the QMS Manual, including analyzing, evaluating and reporting its performance to the CEO during the management review meetings. 6 Planning 6.1 Actions to address risks and opportunities The QMS Coordinator and Managers shall address significant risks and opportunities arising out of the issues related to the Company’s external and internal environments including the needs and expectations of interested parties as referred to in Clauses 4.1
  9. 9. Document title : Quality Manual Document no : QA-M1 Rev 0 Effective date : Pages : 9 of 22 Company Name and 4.2 as per the following procedure: 6.2 Quality objectives The CEO shall assign quality objectives at relevant functions, levels and processes needed for the QMS. The quality objectives shall be consistent with the quality policy, measurable, take into account applicable requirements, relevant to conformity of products and services and to enhancement of customer satisfaction, monitored, communicated to relevant personnel and updated as appropriate. For each quality objective, an action plan shall be drawn up in consultation with the respective Managers. 6.3 Management of change The CEO shall ensure that all changes to the QMS are carried out in a planned manner and take into account the following: a) Purpose of the changes and their potential consequences b) Integrity of the QMS Process owner determines relevant positive or negative issue Process owner logs issue in the Risk Register Analyze its cause and potential impact to the QMS Determine existing control measures or capabilities Evaluate the likelihood of occurrence Evaluate the magnitude of potential impact Decide if action is necessary to address the risk or opportunity Draw up an action plan if action is necessary Update the Risk Register Implement the action plan Monitor, analyse, evaluate and record the results in the Risk Register Report the results during management review meeting
  10. 10. Document title : Quality Manual Document no : QA-M1 Rev 0 Effective date : Pages : 10 of 22 Company Name c) Availability of resources d) Allocation or reallocation of responsibilities and authorities. Action plans shall be drawn up in consultation with relevant Managers and other interested parties as appropriate. 7 Support 7.1 Provision and maintenance of resources The CEO shall ensure that the QMS is supported by the following resources: a) Adequate human resources via an effective personnel recruitment process b) Well-maintained infrastructure such as buildings and associated utilities, equipment, including hardware and software, transportation resources, information and communication technology c) Conducive work environment in terms of its physical, social and psychological aspects d) Suitable monitoring and measuring resources that are calibrated or verified to national or international standards, identified in terms of their status and safeguarded from undue adjustments, damage or deterioration e) Necessary knowledge in terms of its acquisition, capture, sharing and prevention from loss. 7.2 Competency Managers shall carry out annual appraisals and analyses in order to ensure that personnel are competent on the basis of appropriate education, training or experience. Where gaps exist, suitable actions shall be taken to acquire the necessary competence and the effectiveness of actions taken shall be evaluated the following year. 7.3 QMS awareness Managers shall induct all of their respective personnel into the QMS via the QMS Induction Form by briefing them on the quality policy and objectives, roles and responsibilities within the QMS, benefits of improved performance and implications of not conforming to the requirements of the QMS. 7.4 Internal and external communication The QMS Coordinator and Managers shall conform to the communication requirements as defined in the QMS Manual and ensure that their respective external and internal communication requirements are adequately defined within their respective processes in terms of what is to be communicated and to whom, who will communicate it and when. The QMS Coordinator shall maintain a QMS Bulletin Board by posting relevant information in order to keep personnel abreast of any QMS activity, promotion, status, etc. Any personnel can provide feedbacks or suggestions on the QMS via email to the QMS Coordinator whom shall then review the feedbacks and bring them to the CEO’s attention for follow-up actions, where appropriate.
  11. 11. Document title : Quality Manual Document no : QA-M1 Rev 0 Effective date : Pages : 11 of 22 Company Name 7.5 Control of documented information 7.5.1 Control of documents Managers shall control their respective documents as follows: Procedures shall contain the following elements: a) Title a) Unique document code* b) Revision number (Rev 0 for first issues and so forth sequentially) c) Effective date d) Page numbers e) Table of contents f) Revision history g) Document owner’s name and signature on the front cover h) Approver’s name and signature on the front cover b) Purpose c) Scope d) Distribution list e) References f) Terms and definitions g) Responsibilities and authorities h) Main content Work instructions and forms shall contain the following elements: a) Title b) Unique document code* c) Revision number (Rev 0 for first issues and so forth sequentially) d) Effective date e) Page numbers f) Approver’s signature and date on the back cover (for master copies only) g) Main content * To ensure uniqueness, document codes shall be assigned as follows: a) Department’s acronym or code b) Hyphen c) Document type code** d) Document number (starts with 1 and so forth sequentially) e) Space f) Revision number For an example, refer to the QMS Manual’s document code. ** Document type codes shall be assigned as follows: a) M for manuals b) P for procedures c) WI for work instructions d) F for forms.
  12. 12. Document title : Quality Manual Document no : QA-M1 Rev 0 Effective date : Pages : 12 of 22 Company Name The procedure for the control of documents shall be as follows: The procedure for the control of external documents shall be as follows: Manager determines requirements and generates document Manager gets document approval from superior Manager registers document in Documents Register Manager distributes document to all users Manager reviews and amends document whenever necessary Manager gets document re- approval from superior Manager re- distribute document to all users Users dispose or mark as OBSOLETE if previous version is retained Manager determines external documentation requirements Manager acquires external document Manager registers document in Documents Register Manager uses and distributes document to all users Manager re-acquires document with every update Manager udates Documents Register with the new version Manager re- distributse document to all users Users dispose or mark as OBSOLETE if previsous version is retained
  13. 13. Document title : Quality Manual Document no : QA-M1 Rev 0 Effective date : Pages : 13 of 22 Company Name 7.5.2 Control of records Managers shall maintain their respective work records in order to provide evidence of conformity to QMS requirements and of the effective operation of their processes. The procedure for the control of records shall be as follows: 8 Operation 8.1 Operational planning and control Managers shall plan, implement and control the Company’s operational processes by: a) Determining the requirements for the products and services b) Establishing criteria for the processes and the acceptance of products and services c) Determining the resources needed to achieve conformity to the product and service requirements d) Implementing control of the processes in accordance with the criteria e) Controlling planned changes and reviewing the consequences of unintended changes, including taking action to mitigate any adverse effects f) Controlling outsourced processes g) Determining and keeping documented information to have confidence that the processes have been carried out as planned and demonstrate the conformity of products and services to their requirements 8.2 Determination of customer requirements The Manager shall ensure effective control of the following activities in order to ensure that customer needs and requirements are respectively met and defined: a) Provision of information relating to products and services to existing and potential Manager determines records to be maintained Manager registers records in Records Register and fill up all columns Manager organizes and labels record folders / racks / storage areas accordingly Manager preserves and protects records until retention period lapses Manager requests record disposal from superior via Records Register Manager disposes records via suitable method Manager updates Records Register
  14. 14. Document title : Quality Manual Document no : QA-M1 Rev 0 Effective date : Pages : 14 of 22 Company Name customers and handling of enquiries and sales contracts or orders, including changes b) Obtaining customer feedback relating to products and services c) Handling of customer property d) Establishing specific requirements for contingency actions, where appropriate. Customer requirements shall be adequately defined and reviewed prior to committing the Company to the customer. The review shall consider the following: a) Requirements specified by the customer, including the requirements for delivery and post-delivery activities b) Requirements not stated by the customer, but necessary for the specified or intended use, when known c) Requirements specified by the Company d) Statutory and regulatory requirements applicable to the products and services e) Contract or order requirements differing from those previously expressed. Sales contracts or order requirements differing from those previously defined shall be resolved and where the customer does not provide a documented statement of their requirements, confirmation shall be required before acceptance. Whenever requirements for products and services are changed, relevant documented information shall be amended and affected personnel be made aware of the changes. In determining the requirements for post-delivery activities associated with the Company’s products and services, the following shall be considered: a) Statutory and regulatory requirements b) Potential undesirable consequences associated with its products and services c) Nature, use and intended lifetime of its products and services d) Customer requirements and customer feedback. All customer complaints shall be directed to the QMS Coordinator whom shall then manage them according to the following procedure: QMS Coordinator records details of complaint in the Complaints Form QMS Coordinator investigates to verify the complaint If complaint is verified, QMS Coordinator implements suitable corrections QMS Coordinator communicates the actions taken to the customer QMS Coordinator initiates the corrective action procedure after complaint has been resolved
  15. 15. Document title : Quality Manual Document no : QA-M1 Rev 0 Effective date : Pages : 15 of 22 Company Name 8.3 Design and development of products and services The Manager shall ensure that products and services are designed and developed to meet the needs and expectations of customers. In determining the stages and controls for the design and development of a product or service, the following shall be considered: a) Nature, duration and complexity of the design and development activities b) Required process stages, including applicable design and development reviews c) Required design and development verification and validation activities d) Responsibilities and authorities involved in the design and development process e) Internal and external resource needs f) The need to control interfaces between relevant parties g) The need for customer and end-user involvement h) Requirements for subsequent provision of products and services i) Expectations of customers and other relevant interested parties j) Documented information needed to demonstrate that design and development requirements have been met. Inputs shall be adequate for design and development purposes, complete and unambiguous and conflicting design and development inputs shall be resolved. The following inputs shall be considered: a) Functional and performance requirements b) Information derived from previous similar design and development activities c) Statutory and regulatory requirements d) Standards or codes of practice that the Company has committed to implement e) Potential consequences of failure due to the nature of the products and services. The design and development process shall be controlled as follows: a) Results to be achieved shall be defined b) Reviews shall be conducted to evaluate the ability of the results of design and development to meet requirements c) Verification activities shall be conducted to ensure that the design and development outputs meet the input requirements d) Validation activities shall be conducted to ensure that the resulting products and services meet the requirements for the specified application or intended use e) Necessary actions shall be taken on problems determined during the reviews, or verification and validation activities f) Documented information of these activities shall be retained. Design and development outputs shall: a) Meet the input requirements b) Be adequate for the subsequent processes for the provision of products and services c) Include or reference monitoring and measuring requirements and acceptance criteria d) Specify the characteristics of the products and services that are essential for their intended purpose and their safe and proper use.
  16. 16. Document title : Quality Manual Document no : QA-M1 Rev 0 Effective date : Pages : 16 of 22 Company Name Design and development changes shall be identified, reviewed and authorized, and appropriate actions shall be taken to prevent adverse impacts caused by the changes. 8.4 Procurement of products, services and processes The Manager shall ensure that the scope of the purchasing process shall cover products and services from external providers that are intended for incorporation into the Company's own products and services, or that are provided directly to the customers on behalf of the Company, and outsourced processes. The criteria for the evaluation, selection, monitoring of performance, and re-evaluation of external providers shall be based on their abilities to meet purchase order requirements, including any applicable statutory requirements. Approved suppliers shall be registered in the Approved Suppliers Register. All instances of nonconforming supply shall be recorded and evaluated in this document, including subsequent decisions. Externally provided processes, products and services shall not adversely affect the Company's ability to consistently deliver conforming products and services to its customers. As such, the Manager shall: a) Ensure that externally provided processes remain within the control of the QMS b) Define both the controls that it intends to apply to an external provider and those it intends to apply to the resulting output c) Take into consideration the potential impact of the externally provided processes, products and services on the Company's ability to consistently meet customer and applicable statutory and regulatory requirements and the effectiveness of the controls applied by the external provider d) Determine the verification, or other activities, necessary to ensure that the externally provided processes, products and services meet requirements. Where appropriate, purchase orders shall include the following information: a) The processes, products and services to be provided b) The approval of products and services, methods, processes and equipment and the release of products and services c) Competence, including any required qualification of persons d) Communication requirements, if necessary e) Control and monitoring of the external providers' performance to be applied by the Company f) Verification or validation activities that the Company, or its customer, intends to perform at the external providers' premises. An effective inventory system shall be maintained for all purchased products in terms of traceability of storage and movement, and re-order levels.
  17. 17. Document title : Quality Manual Document no : QA-M1 Rev 0 Effective date : Pages : 17 of 22 Company Name The procedure for the supplier registration and evaluation and the procurement process shall be as follows: 8.5 Production and service provision The Manager shall ensure that the production and service provision are carried out under controlled conditions by: a) Making available documented information that defines the characteristics of the products to be produced, the services to be provided, or the activities to be performed, and the results to be achieved b) Making available and using suitable monitoring and measuring resources Prospective supplier fills out the Supplier Registration Form Manager reviews the form and decides if supplier is capable of meeting purchase requirements Manager registers supplier into the Approved Suppliers Register Manager receives Purchase Plan or Purchase Requisition from Managers / staff Manager refers to suppliers' price lists and issue purchase order or ... Manager defines RFQ requirements including intended controls Manager issues RFQ to 3 or more eligible suppliers in the Approved Suppliers Register Manager reviews supplier quotations Manager selects supplier and issues purchase contract or order Manager monitors supplier's activities as required by purchase contract or order Manager inspects and verifies Delivery / Service Order Manager records supplier nonconformity in the Approved Suppliers Register, if any Manager consults with QMS Coordinator whether to issue CAR or take other actions Manager updates the Approved Suppliers Register with the evaluation and decision Manager analyzes overall suppliers' performance and reports the results during management review
  18. 18. Document title : Quality Manual Document no : QA-M1 Rev 0 Effective date : Pages : 18 of 22 Company Name c) Implementing monitoring and measurement activities at appropriate stages to verify that criteria for control of processes or outputs, and acceptance criteria for products and services, have been met d) Using suitable infrastructure and environment for the operation of processes e) Appointing competent persons, including any required qualification f) Validating, and periodically revalidating the ability to achieve planned results of the processes for production and service provision, where the resulting output cannot be verified by subsequent monitoring or measurement g) Implementing actions to prevent human error h) Implementing release, delivery and post-delivery activities. Outputs shall be identified and traceable in order to ensure the conformity of products and services with respect to monitoring and measurement requirements. Property belonging to customers or external providers such as materials, components, tools and equipment, premises, intellectual property and personal data shall be identified, verified, protected and safeguarded while it is under the Company’s control or use. Should any loss or damage occur, owners of these properties shall be informed and the matter be resolved fairly. Outputs generated during production and service provision shall be preserved to the extent necessary to ensure conformity to requirements. Preservation activities can include identification, handling, contamination control, packaging, storage, transmission or transportation, and protection. Products and services shall be inspected to verify that requirements have been met. The release of products and services to the customer shall not proceed until all planned arrangements have been satisfactorily completed, unless otherwise approved by a relevant authority and, as applicable, by the customer. Post-delivery activities associated with products and services shall be implemented as per contractual and legal requirements. Changes to the production or service provision shall be reviewed and authorized by the authorized personnel in order to ensure continuing conformity with requirements. Nonconforming outputs that do not conform to their requirements shall be identified and controlled to prevent their unintended use or delivery. Nonconforming outputs shall be dealt in one or more of the following ways: a) Correction, including verification of corrections b) Segregation, containment, return or suspension of products and services c) Informing the customer and obtaining authorization for acceptance under concession. 9 Performance evaluation 9.1 Monitoring and measurement of customer satisfaction The QMS Coordinator shall carry out routine customer satisfaction surveys in order to monitor and measure the degree to which customer needs and expectations have been fulfilled by the Company.
  19. 19. Document title : Quality Manual Document no : QA-M1 Rev 0 Effective date : Pages : 19 of 22 Company Name 9.2 Process monitoring and measurement The QMS Coordinator and Managers shall respectively monitor and measure relevant key QMS indicators in order to enable subsequent data analysis and evaluation, as follows: Process area KPI Customer requirements Number and types of sales inquiries Sales conversion rates Market share Design and development Design cycle time of products and services Procurement Number and types of supplier nonconformities Products / Services Number and types of nonconforming output incidents Number of late or erroneous supplier deliveries Productivity and wastage rates Customer satisfaction survey Percentage of satisfied customers Customer satisfaction Number and types of formal customer complaints Infrastructure Number and types of machinery / equipment breakdowns Legal compliance Number and types of non-compliance notices from statutory or regulatory bodies Risk management Number of risks and opportunities identified Measurable outcomes from actions taken to address risks and opportunities Competency Percentage of training programs completed against planned Improvement Number of product or service or process improvement initiatives QMS conformity Number and types of nonconformities 9.3 Data analysis and evaluation The QMS Coordinator and Managers shall analyze statistical data in order to evaluate the effectiveness of planning and determine any need for further improvements. Such data shall relate to the following: a) Degree of customer satisfaction b) Degree of legal compliance c) Process performance and effectiveness d) Performance of external providers e) Nonconforming outputs and nonconformities f) Effectiveness of actions taken to address risks and opportunities g) Achievement or non-achievement of assigned quality objectives. The QMS Coordinator and Managers shall present the results of these analyses to the CEO during the management review meetings. 9.4 Internal audit The QMS Coordinator shall plan for annual internal audits in order to provide information on whether the QMS conforms to its own requirements and the requirements of the ISO 9001:2015 Standard, and whether the QMS has been effectively implemented and maintained.
  20. 20. Document title : Quality Manual Document no : QA-M1 Rev 0 Effective date : Pages : 20 of 22 Company Name The audit program shall be defined in terms of its frequency, methods, responsibilities, planning requirements and reporting, which shall take into consideration the importance of the processes concerned, changes affecting the Company, and the results of previous audits. The procedure shall be as follows: * QMS Coordinator shall qualify Internal Auditors via a two-day Internal Auditor Training Program and ensure that Internal Auditors do not audit their own work. ** OFI stands for “Opportunity For Improvement”. It represents an inherent risk that needs to be addressed and therefore, Mnagers shall undertake improvement initiatives to address the OFI findings. QMS Coordinator generates Audit Plan in consultation with Managers QMS Coordinator obtains CEO's approval for Audit Plan QMS Coordinator distributes Audit Plan to all Managers and assigned Auditors* CEO chairs Opening Meeting and kicks off the audits Auditors conduct audit as per Audit Plan via interviews, observations and inspections Auditors record findings in Audit Notes forms Auditors review the findings and record their audit decisions as conformance, nonconformity or OFI** Auditors prepare Audit Reports Auditors present audit findings to Managers in Closing Meeting Auditors hand over Audit Reports and Audit Notes to QMS Coordinator QMS Coordinator reviews Audit Reports for adequacy and accuracy QMS Coordinator distributes Audit Reports to CEO and Managers QMS Coordinator initiates corrective action process
  21. 21. Document title : Quality Manual Document no : QA-M1 Rev 0 Effective date : Pages : 21 of 22 Company Name 9.5 Management review The CEO shall review the performance of the QMS with the QMS Coordinator and Managers at regular intervals in order to ensure its continuing suitability, adequacy, effectiveness and alignment with the Company’s strategic direction. Inputs to the reviews shall include the following: a) Status of actions from previous management reviews b) Changes in external and internal issues that are relevant to the QMS c) Customer satisfaction and feedback from relevant interested parties d) Extent to which quality objectives have been met e) Process performance, including conformity of products and services f) Nonconformities and corrective actions g) Audit results h) Performance of external providers i) Adequacy of resources j) Effectiveness of actions taken to address risks and opportunities k) Opportunities for improvement. Outputs of the management reviews shall include decisions and actions related to opportunities for improvement, any need for changes to the QMS and resource needs. 10 Improvement 10.1 Improvement of products and services The CEO shall determine and select opportunities for improving the Company’s products and services in order to meet requirements and enhance customer satisfaction as well as address future needs and expectations of customers 10.2 Improvement of the QMS The CEO shall ensure that the QMS is continually improved in terms of its suitability, adequacy and effectiveness by considering the results of analysis and evaluation, and the outputs from management reviews. 10.3 Nonconformity and corrective action The QMS Coordinator and Managers shall monitor and detect incidents of nonconformities within the respective QMS processes. All nonconformities shall be reported to the QMS Coordinator for corrective action purposes. When a nonconformity occurs, including any arising from complaints, Managers shall: a) react to the nonconformity and take action to control and correct it and deal with the consequences b) evaluate the need for action to eliminate the causes of the nonconformity, in order that it does not recur or occur elsewhere, by reviewing and analysing the nonconformity, determining the causes of the nonconformity and determining if similar nonconformities exist, or could potentially occur c) implement any action needed
  22. 22. Document title : Quality Manual Document no : QA-M1 Rev 0 Effective date : Pages : 22 of 22 Company Name d) review the effectiveness of any corrective action taken e) update risks and opportunities determined during planning and make changes to the quality management system, if necessary The procedure for the control of nonconformity shall be as follows: Manager detects nonconformity and implements immediate corrections and other necessary actions Manager reports nonconformity to QMS Coordinator QMS Coordinator reviews nonconformity against QMS requirements QMS Coordinator logs nonconformity in CAR Register if nonconformity is verified QMS Coordinator issues CAR to Manager Manager performs root cause analysis on the nonconformity Manager plans corrective action Manager responds to QMS Coordinator with completed CAR within 3 days of issuance Manager implements corrective action plan Manager updates the Risk Register as necessary QMS Coordinator reviews CAR response and corrective actions taken QMS Coordinator closes out the CAR or returns it to the Manager for improvement QMS Coordinator updates the CAR Register if actions taken are deemed to be effective QMS Coordinator reports on the statuses of all CAR during management review

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