ISO 9001 Page: 1 of 29 Quality Assurance Manual ISO 9001:2008 Atlantic Technical Systems, Inc. 415 Headquarters Drive # 2 Millersville, MD 21108 USA Office: (410) 507-2779 Fax: (410) 451-9609 APPROVALS Prepared By: Date: President Approval: Date: Evan Parnell 11/20/14 Brian Flynn 11/20/14 Technical Mgr. Approval: Date: QA/Doc. Control Approval: Date: Evan Parnell 11/20/14 Kristal Jewell 11/20/14
ISO 9001 Page: 2 of 29 TABLE OF CONTENTS Item No. DESCRIPTION Page 1.0 PURPOSE AND SCOPE 5 1.1 Purpose 5 1.2 Scope 5 2.0 APPLICABLE DOCUMENTS 6 2.1 General 6 3.0 DEFINITIONS 7 3.1 General 7 4.0 QUALITY MANAGEMENT SYSTEM 8 4.1 General Requirements 8 4.2 Documentation Requirements 8 4.2.1 General 8 4.2.2 Quality Manual 9 4.2.3 Control of Documents 9 4.2.4 Control of Records 9 5.0 MANAGEMENT RESPONSIBILITY 10 5.1 Management Commitment 10 5.2 Customer Focus 11 5.2.1 General 11 5.3 Quality Policy 11 5.3.1 General 11 5.4 Planning 13 5.4.1 Quality Objectives 13 5.4.2 Quality Management System Planning 13 5.5 Responsibility, Authority and Communication 13 5.5.1 Responsibility and Authority 13 5.5.2 Management Representative 13 5.5.3 Internal Communication 15 5.6 Management Review 15 5.6.1 General 15 5.6.2 Review Input 15 5.6.3 Review Output 16
ISO 9001 Page: 3 of 29 TABLE OF CONTENTS Item No. DESCRIPTION Page 6.0 RESOURCE MANAGEMENT 16 6.1 Provision of Resources 16 6.1.1 General 16 6.2 Human Resources 17 6.2.1 General 17 6.2.2 Competence, Training and Awareness 17 6.3 Infrastructure 17 6.3.1 General 17 6.4 Work Environment 18 6.4.1 General 18 7.0 PRODUCT REALIZATION 18 7.1 Planning of Product Realization 18 7.1.1 General 18 7.2 Customer-Related Processes 19 7.2.1 Determination of Requirements Related to the Product 19 7.2.2 Review of Requirements Related to the Product 19 7.2.3 Customer Communication 20 7.3 Design and Development 20 7.4 Purchasing 20 7.4.1 Purchasing Process 20 7.4.2 Purchasing Information 20 7.4.3 Verification of Purchased Product 21 7.5 Production and Service Provision 21 7.5.1 Control of Production and Service Provision 21 7.5.2 Validation of Processes for Production and Service Provision 21 7.5.3 Identification and Traceability 22 7.5.4 Customer Property 22 7.5.5 Preservation of Product 23 7.6 Control of Monitoring and Measuring Equipment 23 7.6.1 General 23
ISO 9001 Page: 4 of 29 TABLE OF CONTENTS Item No. DESCRIPTION Page 8.0 MEASUREMENT, ANALYSIS AND IMPROVEMENT 24 8.1 General 24 8.2 Monitoring and Measurement 25 8.2.1 Customer Satisfaction 25 8.2.2 Internal Audit 25 8.2.3 Monitoring and Measurement of Processes 25 8.2.4 Monitoring and Measurement of Product 26 8.3 Control of Nonconforming Product 26 8.3.1 General 26 8.4 Analysis of Data 27 8.4.1 General 27 8.5 Improvement 28 8.5.1 Continual Improvement 28 8.5.2 Corrective Action 28 8.5.3 Preventive Action 29 TABLE OF FIGURES Figure 1 Quality Policy Statement 12 Figure 2 Quality System Organizational Chart 14
ISO 9001 Page: 5 of 29 1.0 PURPOSE AND SCOPE 1.1 Purpose 1.1.1 The purpose of this Quality Assurance Manual (QAM) is to document and communicate the Quality Management System (QMS) implemented at Atlantic Technical Systems, Inc. (ATS). 1.1.2 The ATS QMS encompasses customer order entry through delivery as defined in the Contracts, Program Management, Human Resources, Purchasing, Production Operations and Quality Assurance processes. The ATS QMS meets or exceeds the requirements of ISO 9001:2008, Quality Management Systems - Requirements. 1.1.3 The ATS QMS is designed to ensure product provided by our company is subject to adequate control of quality to ensure customer satisfaction. This system is designed to prevent discrepancies from occurring and is enforced with positive corrective action when necessary. This system is directed by ATS s Quality Policy Statement shown in Figure 1 ATS Quality Policy Statement (see 5.3). 1.2 Scope 1.2.1 The scope of this Quality Assurance Manual is applicable to all Customer orders received by ATS as defined in this document. 1.2.2 ATS is in the business of providing the follow Microbial Testing for Enumeration & Speciation, Calibration Services, Warehouse and Distribution Services and Value- Added Assembly, Test & Inspection Services: Warehouse & Distribution Services(ATS-SOP-2101) Value-Added Assembly, Test & Inspection Services (ATS-SOP-3101) Calibration Services (ATS-SOP-4101) Microbial Lab Test Services; Enumeration & Identification (ATS-SOP-5101) 1.2.3 The scope of this work is performed at our offices in Millersville, MD and/or customer office locations. The scope of the QMS registration is as follows: "Microbial Testing for Enumeration & Speciation, Calibration Services, Warehouse and Distribution Services and Value-Added Assembly, Test & Inspection Services" Exclusion(s): Design & Development (7.3)
ISO 9001 Page: 6 of 29 2.0 APPLICABLE DOCUMENTS 2.1 General 2.1.1 The following documents are applicable to the extent specified herein: Commercial/Industrial/Government Documents ISO 9001:2008 Quality Management Systems - Requirements ATS Documents ATS-CGP-1001 ATS-CGP-1002 ATS-CGP-1003 ATS-DCP-1001 ATS-HRP-1001 ATS-PGP-1001 ATS-PGP-2001 ATS-PGP-3001 ATS-QAP-1001 ATS-QAP-1002 ATS-QAP-1003 ATS-QAP-1004 ATS-QAP-1005 ATS-QAP-1006 ATS-QAP-1007 ATS-QAP-1008 ATS-QAP-1009 ATS-QAP-1010 ATS-QAP-1011 ATS-QAP-1013 ATS-SOP-1003 ATS-SOP-1004 ATS-SOP-1006 ATS-SOP-1007 ATS-SOP-1008 ATS-SOP-1010 ATS-QAP-1010 ATS-QAP-1011 ATS-QAP-1016 ATS-QAP-1017 ATS-QAP-1403 ATS-QAP-1406 Contracts Documentation System Proposals/Quotes/Bids Customer Satisfaction Document Control Training and Certification Purchasing System Supplier Evaluation and Approval/Disapproval Receiving Inspection Quality Policy Quality Objectives and Planning Continuous Improvement Quality Records Nonconforming Material System Corrective Action(s) System Customer Concerns/Complaints Internal Audits Management Review Validation of Processes Analysis of Data Customer Property Service Work Orders ESD Materials Handling & Storage Materials Handling and Storage Limited Shelf Life Material Control ESD Workstation Certification Stockroom Material Control Validation of Processes Analysis of Data Calibration System Customer Property Customer Return Material Authorization (RMA) and Material Processing Shipping Inspection
ISO 9001 Page: 7 of 29 ATS-SOP-1017 ATS-SOP-1020 ATS-SOP-2101 ATS-SOP-3101 ATS-SOP-4101 ATS-SOP-5101 Product Identification and Traceability Packaging and Shipping Warehouse & Distribution Services Value-Added Assembly, Test & Inspection Services Calibration Services Microbial Lab Test Services; Enumeration & Identification Legend DCP Document Control Procedure HRP Human Resources Procedure PGP Purchasing General Procedure QAP Quality Assurance Procedure CGP Contracts General Procedure SOP Service Operations Procedure 3.0 DEFINITIONS 3.1 General 3.1.1 Product Implies both products and services. 3.1.2 Tender Offer made by a supplier in response to an invitation to satisfy a contract award to provide product. 3.1.3 Contract, Accepted Order Agreed requirements between a supplier and customer transmitted by any means.
ISO 9001 Page: 8 of 29 4.0 QUALITY MANAGEMENT SYSTEM 4.1 General Requirements 4.1.1 ATS has established, documented, implemented and maintains a QMS and continually improves its effectiveness in accordance with the requirements of ISO 9001, Quality Management System Requirements. See ATS-QAP-1009, Management Review procedure and this document for implementation information. Our President and Quality Assurance management are responsible for the QMS implemented at ATS. 4.1.2 The ATS QMS: a) determines the processes needed for the quality management system and their application throughout the ATS organization b) determines the sequence and interaction of these processes, c) determines criteria and methods needed to ensure that both the operation and control of these processes are effective, d) ensures the availability of resources and information necessary to support the operation and monitoring of these processes, e) monitors, measures where applicable and analyses these processes, and f) implements actions necessary to achieve planned results and continual improvement of these processes. 4.1.3 The QMS process is in accordance with ISO 9001:2008 Requirements and is managed by the ATS Quality Assurance Department. In addition, see ATS-QAP-1003, Continuous Improvement procedure, ATS-QAP-1002, Quality Objectives and Planning procedure, and ATS-QAP-1006, Corrective Action(s) System procedure for information related to this activity. 4.1.4 Where our Purchasing Department chooses to outsource any process that affects product conformity with requirements, Purchasing ensures control over such processes. The type and extent of control to be applied to these processes is defined within the QMS. See ATS-PGP-1001, Purchasing System procedure for information related to this activity. 4.2 Documentation Requirements 4.2.1 General 4.2.1.1 The Document Control/Configuration Management Department is responsible for ensuring that the ATS QMS documentation includes: a) documented statements of a quality policy and quality objectives, b) a quality manual, c) documented procedures and records required by ISO 9001:2008, d) documents, including records, needed by ATS to be necessary to ensure the effective planning, operation and control of its processes
ISO 9001 Page: 9 of 29 4.2.1.2 See ATS-DCP-1001, Document Control, ATS-QAP-1001, Quality Policy and ATS- QAP-1004, Quality Records procedure for information related to this activity. 4.2.2 Quality Manual 4.2.2.1 Our Quality Assurance management has established and maintains this quality manual which includes: a) the scope of the quality management system, including details of and justification for any exclusions, b) the documented procedures established for the quality management system, or reference to them, and c) a description of the interaction between the processes of the quality management system 4.2.3 Control of Documents 4.2.3.1 Documents required by the QMS are controlled per ATS-DCP-1001, Document Control. Records are a special type of document and are controlled according to the requirements given in paragraph 4.2.4 and ATS-QAP-1004, Quality Records procedure. Our Document Control/Configuration Management Department is responsible for Document Control activities. 4.2.3.2 ATS-DCP-1001, Document Control is established to define the controls needed: a) to approve documents for adequacy prior to issue, b) to review and update as necessary and re-approve documents, c) to ensure that changes and the current revision status of documents are identified, d) to ensure that relevant versions of applicable documents are available at points of use, e) to ensure that documents remain legible and readily identifiable, f) to ensure that documents of external origin determined by the organization to be necessary for the planning and operation of the QMS are identified and their distribution controlled, and g) to prevent the unintended use of obsolete documents, and to apply suitable identification to them if they are retained for any purpose. 4.2.4 Control of Records 4.2.4.1 Our Quality Assurance/Document Control/Configuration Management Department ensures that records are established to provide evidence of conformity to requirements and of the effective operation of the quality management system shall be controlled. A documented procedure is established to define the controls needed for the identification, storage, protection, retrieval, retention time and disposition of records. Records remain legible, readily identifiable and retrievable. See ATS-QAP-1004, Quality Records procedure for information related to this activity.
ISO 9001 Page: 10 of 29 5.0 MANAGEMENT RESPONSIBILITY 5.1 Management Commitment 5.1.1 Our President has provided evidence of its commitment to the development and implementation of the quality management system and continually improving its effectiveness by: a) communicating to the ATS organization the importance of meeting customer as well as statutory and regulatory requirements, b) establishing the quality policy, c) ensuring that quality objectives are established, d) conducting management reviews, and e) ensuring the availability of resources 5.1.2 The President is responsible for ensuring that the ATS QMS is reviewed twice per year (typically every six months) minimum, and meets the requirements of ISO 9001:2008, and Customer orders. See ATS-QAP-1009, Management Review procedure for information related to this activity. 5.1.3 See ATS-QAP-1001, Quality Policy and ATS-QAP-1002, Quality Objectives and Planning procedure for information related to this activity. 5.1.4 The President ensures the need to meet customer as well as statutory and regulatory requirements is communicated to all personnel during staff and personnel meetings as a normal way of doing business. 5.1.5 In addition, the President ensures the availability of resources needed to maintain an organization that is effective and continually improves its quality management system. This is accomplished through annual resource planning and budget and management review meetings, and other input deemed necessary to make a proper decision.
ISO 9001 Page: 11 of 29 5.2 Customer Focus 5.2.1 General 5.2.1.1 Our Contracts/Technical Manager/General Administrative and Operations personnel ensure that customer requirements are determined and are met with the aim of enhancing customer satisfaction (see 7.2.1 and 8.2.1). Our President has top management responsibility for ensuring Customer satisfaction. See ATS-CGP-1001, Contracts Documentation System procedure and ATS-CGP-1003, Customer Satisfaction procedure for information related to this activity. 5.3 Quality Policy 5.3.1 General 5.3.1.1 The President has ensured that the quality policy: a) is appropriate to the purpose of the ATS, b) includes a commitment to comply with requirements and continually improve the effectiveness of the quality management system, c) provides a framework for establishing and reviewing quality objectives, d) is communicated and understood within the ATS, and e) is reviewed for continuing suitability. 5.3.1.1.1 See ATS-QAP-1001, Quality Policy, ATS-QAP-1002, Quality Objectives and Planning procedure and Figure 1 ATS Quality Policy Statement for information related to this activity.
ISO 9001 Page: 12 of 29 Figure 1 ATS Quality Policy Statement Quality Policy Statement Atlantic Technical Systems, Inc.and Employees are committed to Customer Satisfaction and continual improvement of products and services. Quality Policy Customer Satisfaction is our primary focus, All products/services and support documentation will meet or exceed contractual requirements for product and service quality, All products/services will be delivered on time in accordance with the agreed upon delivery date, We will strive continuously to improve our products/services, processes and systems and All employees are responsible for the quality of their work Approved By: Brian Flynn President
ISO 9001 Page: 13 of 29 5.4 Planning 5.4.1 Quality Objectives 5.4.1.1 The President ensures that quality objectives, including those needed to meet requirements for product (see 7.1 a), are established at relevant functions and levels within the ATS organization. The quality objectives are measurable and consistent with the quality policy. See ATS-QAP-1002, Quality Objectives and Planning procedure for information related to this activity. 5.4.2 Quality Management System Planning 5.4.2.1 The President and Quality Assurance management ensure that: a) The planning of the quality management system is carried out in order to meet the requirements given in 4.1, as well as the quality objectives, and b) The integrity of the quality management system is maintained when changes to the quality management system are planned and implemented. 5.4.2.2 When it is necessary to update the quality management system, the Quality Assurance/Document Control Department prepares the necessary change documentation and obtains the appropriate approvals per ATS-DCP-1001, Document Control. The Quality Assurance management ensures changes/updates to the quality management system are in compliance with applicable ISO 9001:2008 QMS statutory and regulatory requirements. 5.5 Responsibility, Authority and Communication 5.5.1 Responsibility and Authority 5.5.1.1 The ATS President ensures that responsibilities and authorities are defined and communicated within ATS via the quality manual and written procedures. In addition, an ISO 9001 Functional Responsibility memo is prepared, approved, distributed and maintained by the President detailing primary and backup responsibilities to all elements of the quality management system. See Figure 2 ATS QMS Organizational Chart for information related to this activity. 5.5.2 Management Representative 5.5.2.1 The President appointed a member of ATS s management, our Technical Manager, as the Management Representative. See ATS-QAP-1009, Management Review procedure for information related to this activity. The Quality Assurance management, a member of management who, irrespective of other responsibilities, has the responsibility and authority that includes: a) ensuring that processes needed for the quality management system are established, implemented and maintained, b) reporting to top management on the performance of the quality management system and any need for improvement, and c) ensuring the promotion of awareness of customer requirements throughout the ATS organization.
ISO 9001 Page: 14 of 29 Figure 2 ATS QMS Organizational Chart QMS Organizational Chart President (*) Quality Council (*) Contracts a. Contracts b. Business Development c. Marketing Purchasing a. Purchasing Quality Assurance (*) a. QA Support: Internal Auditing Calibration Quality Records Training Analysis of Data Customer Complaints & Concerns Preventive & Corrective Action b. Final Inspect/ QA Close-Out c. Document Control d. Customer Property Production Operations (*) Warehouse a. Receiving b. Receiving Inspection c. Stock Room d. Packaging & Shipping e. Shipping Inspection f. Maintenance Value-Added Assembly Technical Management (*)/ General Administration a. Technical Manager b. Program Manager c. Human Resources d. Administrator e. Receptionist f. Finance Accounts Receivable Accounts Payable Payroll Controller Micro Lab Test Services a. Micro Biologist; Tech. b. Final Inspect/QA Close-Out a. Tech., Field Service b. Final Inspect/QA Close-Out Calibration Services a. Tech., Calibration b. Final Inspect/QA Close-Out Note(s): (*) Indicates a member of the Quality Council led by our President.
ISO 9001 Page: 15 of 29 5.5.3 Internal Communication 5.5.3.1 The President ensures that appropriate communication processes are established within ATS and that communication takes place regarding the effectiveness of the quality management system. 5.5.3.2 Our Quality Assurance Manual and functional procedures define the information to be communicated, systems/tools or other means for proper communication, and the frequency of communication. In addition, the internal intranet web, emails, talking, company meetings, management reviews and etc. ensure internal communication is enhanced. 5.6 Management Review 5.6.1 General 5.6.1.1 The President reviews the ISO 9001 QMS, at planned intervals, to ensure its continuing suitability, adequacy and effectiveness. This review includes assessing opportunities for improvement and the need for changes to the quality management system, including the quality policy and quality objectives. See ATS-QAP-1009, Management Review procedure for information related to this activity. 5.6.1.1.1 The Management Review is conducted twice per year (typically every six months) minimum. Our President is the central figure at the Management Review session. 5.6.1.2 Records from Management Reviews are maintained (see 4.2.4) per ATS-QAP-1004, Quality Records procedure. 5.6.2.1 Review Input 5.6.2.1 The input to the management review includes information on: a) results of audits, b) customer feedback, c) process performance and product conformity, d) status of preventive and corrective actions, e) follow-up actions from previous management reviews, f) changes that could affect the quality management system, and g) recommendations for improvement 5.6.2.1.1 During the Management Review, input data from the Quality Assurance management, Production Operations management, Technical Manager and other functional Departments, when necessary, is reviewed and used for decision-making as required.
ISO 9001 Page: 16 of 29 5.6.3 Review Output 5.6.3.1 The output to the management review includes any decisions and actions related to: a) improvement of the effectiveness of the quality management system and its processes, b) improvement of product related to customer requirements, and c) resource needs 5.6.3.1.1 The Management Review input data is documented by responsible personnel for President and Quality Council review during the Management Review meeting. All Management Review meeting decisions and comments are recorded, and action items are tracked by the Quality Assurance management. The duties of the President and Quality Council members are defined in ATS-QAP-1009, Management Review procedure. 5.6.3.1.2 All Management Review meeting reports are retained by Quality Assurance Department. See ATS-QAP-1004, Quality Records procedure for information related to this activity. 5.6.3.1.3 The ATS Quality Council is led by the President and includes the Technical Manager, Quality Assurance and Production Operations management and other management personnel as deemed necessary by the President. 6.0 RESOURCE MANAGEMENT 6.1 Provision of Resources 6.1.1 General 6.1.1.1 The ATS President determines and provides the resources needed: a) to implement and maintain the quality management system and continually improve its effectiveness, and b) to enhance customer satisfaction by meeting customer requirements 6.1.1.2 The application and need of resources is evaluated annually during management planning and budget meetings. The President and Functional Department management participates to ensure proper resources are allocated. The need for additional resources is also discussed during the management review, department meetings or upon the receipt of a new customer order, as deemed necessary, to ensure ongoing improvement and to meet anticipated requirements. 6.1.1.2.1 A record of this review is documented as part of the Management Review (5.6) at least once per year in the Resources Needs section, and/or the Resource memo approved by Quality Assurance/Technical Manager.
ISO 9001 Page: 17 of 29 6.2 Human Resources 6.2.1 General 6.2.1.1 Our Technical Manager/Quality Assurance Department is responsible for ensuring that personnel performing work affecting conformity to product requirements are competent on the basis of appropriate education, training, skills and experience. See ATS-HRP-1001, Training and Certification for information related to this activity. 6.2.2 Competence, Training and Awareness 6.2.2.1 Technical Manager/Quality Assurance, along with the appropriate functional department: a) determine the necessary competence for personnel performing work affecting product requirements, b) where applicable, provide training or take other actions to achieve the necessary competence, c) evaluate the effectiveness of the actions taken, d) ensure that its personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objectives, and e) maintain appropriate records of education, training, skills and experience (see 4.2.4). 6.2.2.2 The employee training record types, retention frequency and storage is defined in ATS-HRP-1001, Training and Certification procedure and ATS-QAP-1004, Quality Records procedure. 6.3 Infrastructure 6.3.1 General 6.3.1.1 The President and functional department management personnel determine, provide and maintain the infrastructure needed to achieve conformity to product requirements. Infrastructure includes, as applicable: a) buildings, workspace and associated utilities, b) process equipment (both hardware and software), and c) supporting services (such as transport, communication or information systems). 6.3.1.1.1 The infrastructure is evaluated annually during management planning and budget meetings. The President and functional department management participates to ensure proper infrastructure is allocated. The need for additional infrastructure is also discussed during the management review, department meetings or upon the receipt of a new customer order, as deemed necessary, to ensure ongoing improvement and to meet anticipated requirements.
ISO 9001 Page: 18 of 29 6.3.1.1.2 A record of this review is documented as part of the Management Review (5.6) at least once per year in the Resources Needs section, and/or the Resource memo approved by Quality Assurance/Technical Manager. 6.4 Work Environment 6.4.1 General 6.4.1.1 The President and functional department management determine and manage the work environment needed to achieve conformity to product requirements. 6.4.1.1.1 The work environment is evaluated annually during management planning and budget meetings. The President and functional department management participates to ensure proper work environment is allocated. The need for additional work environment is also discussed during the management review, department meetings or upon the receipt of a new customer order, as deemed necessary, to ensure ongoing improvement and to meet anticipated requirements. 6.4.1.1.2 A record of this review is documented as part of the Management Review (5.6) at least once per year in the Resources Needs section, and/or the Resource memo approved by Quality Assurance/Technical Manager. 7.0 PRODUCT REALIZATION 7.1 Planning of Product Realization 7.1.1 General 7.1.1.1 Warehouse & Distribution Services, Value-Added Assembly, Test & Inspection Services, Calibration Services, Microbial Lab Test Services; Enumeration & Identification and business processes are documented, reviewed, approved and maintained to allow products to be delivered to meet customer expectations. Production Operations plan and develop the design and development processes needed for product realization. The Production Operations and Quality Assurance Departments plan and develop the Production and Service Provision processes needed for product realization. See ATS-SOP-2101, Warehouse & Distribution Services, ATS-SOP-3101, Value-Added Assembly, Test & Inspection Services, ATS-SOP- 4101, Calibration Services and ATS-SOP-5101, Microbial Lab Test Services; Enumeration & Identification procedures for information related to this activity. Planning of product realization is consistent with the requirements of the other processes of the QMS (see 4.1). 7.1.1.2 In planning product realization, Production Operations and Quality Assurance determines the following, as appropriate: a) quality objectives and requirements for the product;
ISO 9001 Page: 19 of 29 b) the need to establish processes and documents, and provide resources specific to the product; c) required verification, validation, monitoring, measurement, inspection and test activities specific to the product and the criteria for product acceptance; d) records needed to provide evidence that the realization processes and resulting product meet requirements (see 4.2.4). 7.1.1.3 The output of this planning is in a form suitable for ATS method of operations. The ATS planning method is documented in ATS-SOP-2101, Warehouse & Distribution Services, ATS-SOP-3101, Value-Added Assembly, Test & Inspection Services, ATS- SOP-4101, Calibration Services and ATS-SOP-5101, Microbial Lab Test Services; Enumeration & Identification procedures. 7.2 Customer-Related Processes 7.2.1 Determination of Requirements Related to the Product 7.2.1.1 The Contracts/Technical Manager/General Administrative Department shall determine: 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 specified or intended use, where known, c) statutory and regulatory requirements applicable to the product, and d) any additional requirements considered necessary by ATS. 7.2.1.2 See ATS-CGP-1001, Contracts Documentation System, ATS-CGP-1004, Program Management and ATS-CGP-1002, Proposals/Quotes/Bids procedures for information related to this activity. 7.2.2 Review of Requirements Related to the Product 7.2.2.1 The Contracts/Technical Manager/General Administrative person reviews the requirements related to the product. This review is conducted prior ATS commitment to supply a product to the customer (e.g. submission of tenders, acceptance of contracts or orders, acceptance of charges to contracts or orders) and ensure that: a) product requirements are defined, b) contract or order requirements differing from those previously expressed are resolved, and c) ATS organization has the ability to meet the defined requirements. 7.2.2.2 See ATS-CGP-1001, Contracts Documentation System procedure for information related to this activity.
ISO 9001 Page: 20 of 29 7.2.3 Customer Communication 7.2.3.1 The Contracts/Technical Manager/General Administrative/Operations Department is responsible for implementing effective arrangements for communicating with customers in relation to: a) product information, b) enquiries, contracts or order handling, including amendments, and c) customer feedback, including customer complaints. 7.2.3.2 See ATS-CGP-1003, Customer Satisfaction, ATS-SOP-2101, Warehouse & Distribution Services, ATS-SOP-3101, Value-Added Assembly, Test & Inspection Services, ATS-SOP-4101, Calibration Services and ATS-SOP-5101, Microbial Lab Test Services; Enumeration & Identification procedures for information related to this activity. 7.3 Design and Development 7.3.1 Design and Development Planning 7.3.1.1 Design and Development is not included in the scope of registration. 7.4 Purchasing 7.4.1 Purchasing Process 7.4.1.1 The Purchasing Department is responsible for ensuring that purchased product conforms to specified purchase requirements. The type and extent of control applied to the supplier and the purchased product is dependent upon the effect of the purchased product on subsequent product realization or the final product. See ATS- PGP-1001, Purchasing System procedure for information related to this activity. 7.4.1.2 The Purchasing Department evaluates and selects suppliers based on their ability to supply product in accordance with the ATS Purchase Order requirements. The criteria used for supplier selection, evaluation and re-evaluation is defined in ATS- PGP-2001, Supplier Evaluation and Approval/Disapproval procedure. Records of the results of evaluations and any necessary actions arising from the evaluation are maintained (see 4.2.4) as specified in per ATS-PGP-2001, Supplier Evaluation and Approval/Disapproval procedure. 7.4.2 Purchasing Information 7.4.2.1 ATS Purchasing information describes the product to be purchased, including where appropriate: a) requirements for approval of product, procedures, processes and equipment, b) requirements for qualification of personnel, and c) quality management system requirements.
ISO 9001 Page: 21 of 29 7.4.2.2 Purchasing ensures the adequacy of specified purchase requirements prior to their communication to the supplier. See ATS-PGP-1001, Purchasing System procedure for information related to this activity. 7.4.3 Verification of Purchased Product 7.4.3.1 Our Production Operations/Purchasing Department has documented the Receiving Inspection or other activities necessary for ensuring that purchase product meets specified purchase requirements. Our Production Operations/Purchasing Department is responsible for conducting Receiving Inspection activities. See ATS-PGP-3001, Receiving Inspection procedure for information related to this activity. 7.4.3.2 Where ATS or its customer intends to perform verification at the supplier s premises, ATS Production Operations/Purchasing states the intended verification arrangements and method of product release in the purchasing information. See ATS-PGP-1001, Purchasing System procedure for information related to this activity. 7.5 Production and Service Provision 7.5.1 Control of Production and Service Provision 7.5.1.1 The Production and Service Provision is the responsibility of Production Operations and Quality Assurance Departments. 7.5.1.1.1 The Products and Services are defined as the Warehouse & Distribution Services, Value-Added Assembly, Test & Inspection Services, Calibration Services, Microbial Lab Test Services; Enumeration & Identification activities. 7.5.1.2 The Production Operations and Quality Assurance Departments plan and carry out business processes under controlled conditions per ATS-SOP-2101, Warehouse & Distribution Services, ATS-SOP-3101, Value-Added Assembly, Test & Inspection Services, ATS-SOP-4101, Calibration Services and ATS-SOP-5101, Microbial Lab Test Services; Enumeration & Identification procedures. Controlled conditions include, as applicable: a) the availability of information that describes the characteristics of the product, b) the availability of work instructions, as necessary, c) the use of suitable equipment, d) the availability and use of monitoring and measuring equipment, e) the implementation of monitoring and measurement, and f) the implementation of product release, delivery and post-delivery activities. 7.5.2 Validation of Processes for Production and Service Provision 7.5.2.1 The Quality Assurance/Production Operations Department validates any processes for production provision where the resulting output cannot be verified by subsequent monitoring or measurement (i.e. visual inspection) and, as a consequence, deficiencies become apparent only after the product is in use or the service has been delivered. See
ISO 9001 Page: 22 of 29 ATS-QAP-1010, Validation of Processes procedure for information related to this activity. 7.5.2.2 Validation demonstrates the ability of these processes to achieve planned results. 7.5.2.3 Quality Assurance has established arrangements in ATS-QAP-1010, Validation of Processes procedure for these processes including, as applicable: a) defined criteria for review and approval of the processes, b) approval of equipment and qualification of personnel, c) use of specific methods and procedures, d) requirements for records (see 4.2.4), and e) revalidation 7.5.3 Identification and Traceability 7.5.3.1 Where appropriate, Production Operations and Quality Assurance personnel shall identify the product by suitable means throughout product realization per ATS-SOP- 1017, Product Identification and Traceability procedure. 7.5.3.1.1 Production Operations and Quality Assurance personnel ensure product status with respect to monitoring and measurement requirements throughout product realization. Products requiring identification and traceability include documentation for Warehouse & Distribution Services, Value-Added Assembly, Test & Inspection Services, Calibration Services, Microbial Lab Test Services; Enumeration & Identification. Each of these activities or records is traceable to the Service Work Order and/or job number where required, and personnel approving the documentation and date. 7.5.3.2 Production Operations and Quality Assurance personnel identify the product status with respect to monitoring and measurement requirements. 7.5.3.3 Where traceability is a requirement per the customer order, Production Operations and Quality Assurance personnel control and record the unique product identification and traceability information.
ISO 9001 Page: 23 of 29 7.5.4 Customer Property 7.5.4.1 The ATS personnel exercise care with customer property while it is under the ATS control or being used by ATS personnel. Quality Assurance, Production Operations and Receiving Inspection identifies, verifies, protects and safeguards customer property provided for use or incorporation into the product. If any customer property is lost, damaged or otherwise found to be unsuitable for use, Quality Assurance or Production Operations reports this information to the customer and maintains records (see 4.2.4). See ATS-QAP-1017, Customer Property procedure for information related to this activity. 7.5.5 Preservation of Product 7.5.5.1 Production Operations and Quality Assurance personnel preserve the product (i.e. Warehouse & Distribution Services, Value-Added Assembly, Test & Inspection Services, Calibration Services, Microbial Lab Test Services; Enumeration & Identification) and related documentation during internal processing and delivery to the intended destination in order to maintain conformity to requirements. As applicable, this preservation includes identification, handling, packaging, storage and protection. Preservation shall also apply to the constituent parts of a product. See ATS-SOP-1004, ESD Materials Handling & Storage, ATS-SOP-1006, Materials Handling and Storage, ATS-SOP-1007, Limited Shelf Life Material Control and ATS-SOP-1008, ESD Workstation Certification procedures for information related to this activity. 7.6 Control of Monitoring and Measuring Equipment 7.6.1 General 7.6.1.1 The Quality Assurance Department determines the monitoring and measurement to be undertaken and the monitoring and measuring devices needed to provide evidence of conformity of product to determined requirements. See ATS-QAP-1016, Calibration System for information related to this activity. 7.6.1.2 Quality Assurance has established processes to ensure that monitoring and measurement (test/inspection equipment, etc.) can be carried out and are carried out in a manner that is consistent with the monitoring and measurement (test/inspection equipment, etc.) requirements. 7.6.1.3 Where necessary to ensure valid results, measuring equipment is: a) Calibrated or verified, or both, at specified intervals, or prior to use, against measurement standards traceable to international or national measurement standards; where no such standards exist, the basis used for calibration or verification shall be recorded (see 4.2.4); b) Adjusted or re-adjusted as necessary; c) Have identified in order to determine calibration status; d) Safeguarded from adjustments that would invalidate the measurement result;
ISO 9001 Page: 24 of 29 e) Protected from damage and deterioration during handling, maintenance and storage 7.6.1.3.1 Records of the results of calibration and verification are maintained (see 4.2.4). 7.6.1.4 In addition, Quality Assurance assesses and records the validity of the previous measuring results when the equipment is found not to conform to requirements. Quality Assurance takes appropriate action on the equipment and any product affected per ATS-QAP-1016, Calibration System and ATS-QAP-1006, Corrective Action(s) System. Records of these results of calibration and verification are maintained (see 4.2.4) as defined in ATS-QAP-1016, Calibration System. 7.6.1.5 When used in the monitoring and measurement (test/inspection) of specified requirements, the ability of computer software to satisfy the intended application is confirmed by Quality Assurance. This is undertaken prior to initial use and reconfirmed as necessary. See ATS-DCP-1001, Document Control and ATS-QAP- 1016, Calibration System for information related to this activity. 8.0 MEASUREMENT, ANALYSIS AND IMPROVEMENT 8.1 General 8.1.1 Contracts, Technical Manager, Production Operations and Quality Assurance Departments plan and implement the monitoring, measurement, analysis and improvement processes needed: a) To demonstrate conformity to product requirement, b) To ensure conformity of the quality management system, and c) To continually improve the effectiveness of the quality management system. 8.1.2 This includes determination of applicable methods, including statistical techniques, and the extent of their use.
ISO 9001 Page: 25 of 29 8.2 Monitoring and Measurement 8.2.1 Customer Satisfaction 8.2.1.1 As one of the measurements of the performance of the quality management system, the Technical Manager/General Administrative and Contracts monitors information relating to customer perception as to whether ATS has met customer requirements. The methods for obtaining and using this information are defined in ATS-CGP-1003, Customer Satisfaction procedure. 8.2.2 Internal Audit 8.2.2.1 Quality Assurance ensures internal audits are conducted in accordance with ATS- QAP-1008, Internal Audits procedure at planned intervals to determine whether the quality management system: a) conforms to the planned arrangements (see 7.1), to the requirements of this International Standard and to the quality management system requirements established by ATS, and b) is effectively implemented and maintained. 8.2.2.2 The audit program is planned, taking into consideration the status and importance of the processes and areas to be audited, as well as the results of previous audits. The audit criteria, scope, frequency and methods are also defined. The selection of auditors and conduct of audits is defined and ensures objectivity and impartiality of the audit process. Auditors do not audit their own work. See ATS-QAP-1008, Internal Audits procedure for information related to this activity. 8.2.2.3 ATS QA has defined the responsibilities and requirements for planning and conducting audits, establishing records and reporting results (see 4.2.4) are defined in ATS-QAP-1008, Internal Audits procedure. 8.2.2.4 The management responsible for the area being audited ensures that any necessary corrections and corrective actions are taken without undue delay to eliminate detected nonconformities and their causes. Follow-up activities include the verification of the actions taken and the reporting of verification results (see 8.5.2). 8.2.3 Monitoring and Measurement of Processes 8.2.3.1 Production Operations and Quality Assurance apply suitable methods for monitoring and, where applicable, measurement of the quality management system processes. Monitoring and measurement of processes types are defined by the Operations Department for each product offering as defined in ATS-SOP-2101, Warehouse & Distribution Services, ATS-QAP-1406, Shipping Inspection, ATS-SOP-3101, Value- Added Assembly, Test & Inspection Services, ATS-SOP-4101, Calibration Services and ATS-SOP-5101, Microbial Lab Test Services; Enumeration & Identification procedures. These methods demonstrate the ability of the processes to achieve planned results. When planned results are not achieved, correction and corrective
ISO 9001 Page: 26 of 29 action is taken, as appropriate. See ATS-QAP-1006, Corrective Action(s) System procedure for information related to this activity. 8.2.4 Monitoring and Measurement of Product 8.2.4.1 Production Operations and Quality Assurance monitor and measure the characteristics of the product to verify that product requirements have been met. This is carried out at appropriate stages of the product realization process in accordance with the planned arrangements (see 7.1). The planned arrangements are as defined in ATS-SOP-2101, Warehouse & Distribution Services, ATS-QAP-1406, Shipping Inspection, ATS- SOP-3101, Value-Added Assembly, Test & Inspection Services, ATS-SOP-4101, Calibration Services and ATS-SOP-5101, Microbial Lab Test Services; Enumeration & Identification procedures. Operations and Quality Assurance ensures evidence of conformity with acceptance criteria is maintained. 8.2.4.2 Records indicate the person(s) authorizing release of product for delivery to the customer (see 4.2.4). See offering as defined in ATS-SOP-2101, Warehouse & Distribution Services, ATS-QAP-1406, Shipping Inspection, ATS-SOP-3101, Value- Added Assembly, Test & Inspection Services, ATS-SOP-4101, Calibration Services and ATS-SOP-5101, Microbial Lab Test Services; Enumeration & Identification procedures for information related to this activity. 8.2.4.3 The release of Product (i.e. Warehouse & Distribution Services, Value-Added Assembly, Test & Inspection Services, Calibration Services, Microbial Lab Test Services; Enumeration & Identification and required records, etc.) to the customer do not proceed until the planned arrangements (see 7.1) have been satisfactorily completed, unless otherwise approved by Production Operations management or Quality Assurance and, where applicable, by the customer. See ATS-SOP-2101, Warehouse & Distribution Services, ATS-QAP-1406, Shipping Inspection, ATS- SOP-3101, Value-Added Assembly, Test & Inspection Services, ATS-SOP-4101, Calibration Services and ATS-SOP-5101, Microbial Lab Test Services; Enumeration & Identification procedures for information related to this activity. 8.3 Control of Nonconforming Product 8.3.1 General 8.3.1.1 Quality Assurance and Production Operations Departments ensure that product (i.e. Warehouse & Distribution Services, Value-Added Assembly, Test & Inspection Services, Calibration Services, Microbial Lab Test Services; Enumeration & Identification) which does not conform to product requirements is identified and controlled to prevent its unintended use or delivery. The controls and related responsibilities and authorities for dealing with See ATS-QAP-1005, Nonconforming Material System procedure for applicable information.
ISO 9001 Page: 27 of 29 8.3.1.2 Where applicable, Quality Assurance deals with nonconforming product by one or more of the following ways: a) by taking action to eliminate the detected nonconformity; b) by authorizing its use, release or acceptance under concession by a relevant authority and, where applicable, by the customer; c) by taking action appropriate to the effects, or potential effects, of the nonconformity when nonconforming product is detected after delivery to preclude its original intended use or application. d) by taking action appropriate to the effects, or potential effects, of the nonconformity when nonconforming product is detected after delivery or use has started. 8.3.1.3 When nonconforming product is corrected it is subject to re-verification to demonstrate conformity to the requirements. Records of the nature of nonconformances and any subsequent actions taken, including concessions obtained, are maintained (see 4.2.4) by Quality Assurance/Production Operations. 8.4 Analysis of Data 8.4.1 General 8.4.1.1 Quality Assurance determines, collects and analyses appropriate data to demonstrate the suitability and test effectiveness of the quality management system and to evaluate where continual improvement of the effectiveness of the quality management system can be made. See ATS-QAP-1011, Analysis of Data procedure for information related to this activity. This includes data generated as a result of monitoring and measurement (test/inspection) and from other relevant sources. 8.4.1.2 The analysis of data provides information relating to: a) customer satisfaction (see 8.2.1), b) conformity to product requirements (see 8.2.4), c) characteristics and trends of processes and products including opportunities for preventive action (see 8.2.3 and 8.2.4), and d) suppliers (see 7.4) 8.4.1.3 Quality Assurance Department prepares and approves an Analysis of Data Report memo with originators name and date issued, covering each of the above a) through d) data items a minimum of twice per year (typical every 6 months). The Analysis of Data Report information is reviewed at the Management Review meeting per ATS- QAP-1009, Management Review.
ISO 9001 Page: 28 of 29 8.5 Improvement 8.5.1 Continual Improvement 8.5.1.1 The President, Technical Manager, Production Operations, Program Management, Quality Assurance and other functional personnel continually improve the effectiveness of the quality management system through the use of the quality policy, quality objectives, audit results, analysis of data, corrective and preventive actions and management review. See ATS-QAP-1003, Continuous Improvement procedure for information related to this activity. 8.5.1.2 Quality Assurance/Technical Manager documents and approves a Continual Improvement (8.5) memo twice per year (typical every six months) providing evidence of Continual Improvement review. 8.5.2 Corrective Action 8.5.2.1 Quality Assurance takes action to eliminate the causes of non-conformities in order to prevent recurrence. Corrective actions taken are appropriate to the effects of the nonconformities encountered. 8.5.2.2 ATS-QAP-1006, Corrective Action(s) System procedure, and ATS-QAP-1005, Nonconforming Material System procedure define the requirements for: a) reviewing nonconformities (including customer complaints), b) determining the causes of nonconformities, c) evaluating the need for action to ensure that nonconformities do not recur, d) determining and implementing action needed, e) records of the results of action taken (see 4.2.4), and, f) reviewing corrective action taken. 8.5.2.3 Quality Assurance/Technical Manager documents and approves a Continual Improvement (8.5) memo twice per year (typical every six months) providing evidence of Continual Improvement review.
ISO 9001 Page: 29 of 29 8.5.3 Preventive Action 8.5.3.1 Production Operations, Technical Manager and Quality Assurance Departments determine action to eliminate the causes of potential nonconformities in order to prevent their occurrence. Preventive actions taken are appropriate to the effects of the potential problems. See ATS-QAP-1006, Corrective Action(s) System procedure for information related to this activity. 8.5.3.2 Our documented procedure has established the requirements for: a) determining potential non-conformities and their causes b) evaluation the need for action to prevent occurrence of non-conformities, c) determining and implementing action needed, d) records of results of action taken (see 4.2.4), and e) reviewing the effectiveness of the preventive action taken. 8.5.3.3 Quality Assurance/Technical Manager documents and approves a Continual Improvement (8.5) memo twice per year (typical every six months) providing evidence of Preventive Action review.