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Quality Management Systems (QMS) Manual

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DCS #: 05-006-0001 Issue Date:07/18/15 Revision Date: 03/14/16 Classification: C-IS-MGOD Page | i All printed documents are uncontrolled copies. Please go to the link below for the most updated version. https://sp.cog-ps.com/iso27k1/Shared%20Documents/A.%20Finalized%20Documents Quality Management Systems (QMS) Manual (ISO 9001:2008)
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Page 1: Quality Management Systems (QMS) Manual

DCS #: 05-006-0001 Issue Date:07/18/15 Revision Date: 03/14/16 Classification: C-IS-MGOD P a g e | i

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Quality Management Systems (QMS)

Manual (ISO 9001:2008)

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Table of Contents 1. Purpose and Scope ......................................................................................................................4

1.1 Purpose ..............................................................................................................................4

1.2 Scope and Exclusions ........................................................................................................4 2. Company Profile .........................................................................................................................4 3. Terms and Definitions.................................................................................................................5 4. Quality Management System (QMS)..........................................................................................5

4.1 General Requirements .......................................................................................................5

4.1.1 Sequence and Interaction of Business Processes .......................................................6

4.1.2 Outsourcing ................................................................................................................6

4.2 Documentation Requirements ...........................................................................................7 4.2.1 General Requirements ................................................................................................7

4.2.2 Quality Manual ..........................................................................................................8 4.2.3 Control of Documents ................................................................................................8

4.2.4 Control of Records .....................................................................................................8 5. Management Responsibility........................................................................................................8

5.1 Management commitment .................................................................................................8

5.2 Customer Focus .................................................................................................................9 5.3 Quality Policy ....................................................................................................................9 5.4 Planning .............................................................................................................................9

5.4.1 Quality Objectives .....................................................................................................9

5.4.2 QMS Planning ............................................................................................................9 5.5 Responsibility, Authority, and Communication ................................................................9

5.5.1 Responsibility and Authority .....................................................................................9

5.5.2 Management Representative ......................................................................................9 5.5.3 Internal Communication ..........................................................................................10

5.6 Management Review .......................................................................................................10 5.6.1 General .....................................................................................................................10

5.6.2 Review Input ............................................................................................................10 5.6.3 Review Output .........................................................................................................10

6. Resource Management ..............................................................................................................10 6.1 Provision of Resources ....................................................................................................10 6.2 Human Resources ............................................................................................................10

6.2.1 Assignment of Personnel .........................................................................................10

6.2.2 Competence, Awareness, and Training ...................................................................10

6.3 Infrastructure ...................................................................................................................10 6.4 Work Environment ..........................................................................................................11

7. Product Realization ...................................................................................................................11 7.1 Planning of Product Realization Processes .....................................................................11 7.2 Customer Related Processes............................................................................................11

7.2.1 Determination of Requirements Related to Service .................................................11 7.2.2 Review of Requirements Related to Service ...........................................................11

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7.2.3 Customer Communication .......................................................................................11

7.3 Design and Development ................................................................................................11 7.3.1 Design and Development Planning ..........................................................................11 7.3.2 Design and Development Inputs ..............................................................................11 7.3.3 Design and Development Outputs ...........................................................................12 7.3.4 Design and Development Review ............................................................................12

7.3.5 Design and Development Verification .....................................................................12 7.3.6 Design and Development Validation .......................................................................12 7.3.7 Control of Design and Development Changes.........................................................12

7.4 Purchasing .......................................................................................................................12

7.4.1 Purchasing Process...................................................................................................12 7.4.2 Purchasing Information ............................................................................................12

7.4.3 Verification of Purchased Product ...........................................................................12 7.5 Production and Service Provision ...................................................................................12

7.5.1 Control of Production and Service Provision ..........................................................12

7.5.2 Validation of Processes ............................................................................................13 7.5.3 Identification and Traceability .................................................................................13

7.5.4 Customer Property ...................................................................................................13 7.5.5 Preservation of Product ............................................................................................13

7.6 Control of Monitoring and Measuring Devices ..............................................................13

8. Measurement, Analysis and Improvement ...............................................................................13 8.1 Planning ...........................................................................................................................13

8.2 Monitoring and Measurement .........................................................................................13

8.2.1 Customer Satisfaction ..............................................................................................13

8.2.2 Internal Quality Audits ............................................................................................13 8.2.3 Monitoring and Measurement of Processes .............................................................14

8.2.4 Monitoring and Measurement of Product ................................................................14 8.3 Control of Non-Conforming Products ............................................................................14 8.4 Analysis of Data ..............................................................................................................14

8.5 Improvement ...................................................................................................................14 8.5.1 Planning for Continual Improvement ......................................................................14

8.6 Corrective Action ............................................................................................................14 8.7 Preventative Action .........................................................................................................14

Table of Figures

Figure 1 - Cognitive Organizational Chart Overview ........................................................................... 5 Figure 2 - Cognitive Process Sequence and Interrelationships ............................................................ 6 Figure 3 - Cognitive Documentation Hierarchy ..................................................................................... 8

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1. Purpose and Scope

1.1 Purpose Cognitive Professional Services Inc (Cognitive) has issued this Quality Management Systems (QMS) Manual to provide guidance for maintaining a consistent approach to the delivery of services in an environment that fosters customer satisfaction and continual improvement. The Cognitive’s QMS defines its commitment through the Quality Policy located in Section 5.3 of this manual.

1.2 Scope and Exclusions This QMS Manual addresses the ISO 9001:2008 requirements and makes reference to the relevant procedures that are applicable to Cognitive. Cognitive conforms to all ISO 9001:2008 International Standard requirements except as noted below. The scope for the QMS registration for BS EN ISO 9001:2008 is “The provision and management of professional services to Federal, State and Local municipal customers as well as industry clients from Cognitive’s Headquarters located in Round Rock, TX.” Exclusions: ISO 9001:2008 – Clauses 7.3.1 – 7.3.7 (inclusive) Design and Development – Cognitive neither designs nor develops product for delivery to customers. Clause 7.5.2 – Validation of Processes for Production and Service Provision – Cognitive does not have processes that can be verified until after the product is in use or the service is delivered. Clause 7.6 - Control of Monitoring and Measuring Equipment – Cognitive does not use any equipment for monitoring or measuring that requires calibration, testing or adjustment. 2. Company Profile

Cognitive has existed since 1987 and provides diverse, cost-effective workforce and IT solutions to government and industry clients. We are passionate about providing people-focused solutions that deliver best value, and are committed to the following:

Collaborating with clients to achieve higher productivity and lower costs

Building relationships, not transactions

Helping clients manage the change triggered by innovative solutions

Making a difference in the communities in which we live and work The top-level Organizational Chart is shown in Figure 1.

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Figure 1 - Cognitive Organizational Chart Overview

3. Terms and Definitions

Cognitive utilizes the terms and definitions from ISO 9001 in the version, currently 2008. Cognitive does plan to transition to the 2015 version in the 2017 year.

4. Quality Management System (QMS)

4.1 General Requirements Cognitive’s policy is to establish, document, implement, and maintain a QMS based on the ISO 9001:2008 standard as a means of ensuring that products and contracted services conform to specified requirements, as well as fostering an environment of continual improvement. Operation and Control

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The criteria and methods requiring the effective operation and control of Cognitive business processes are documented in the Document Control System (DCS), which is a database in the Cognitive SharePoint ISO site. DCS# 05-004-0001 Procedure: Document Control oulines this particular process and is available to all Cognitive employees. Each of the business process documents within the DCS specifies the controls by which Cognitive ensures conformance to its QMS. 4.1.1 Sequence and Interaction of Business Processes Cognitive has defined the processes that are utilized in the fulfillment of obligations to customers, within Figure 2 below. The processes are defined and included in the DCS and are organized as follows:

Customer Oriented Processes – Processes that directly interact with the customer and are used to ensure the delivery of high quality products and services.

Support Processes – Processes that are used by Cognitive in the delivery of products and services but are transparent to the customer.

Quality Management Processes – Processes that are used to manage, monitor and control the QMS.

Customer Oriented Processes

Support Processes

Marketing and Sales

Service Delivery InvoicingContract Review

Management ProcessesDocument Control / Record Control

CAPA / Internal Audits / Management Review / Customer Satisfaction / Control of Nonconforming Product

Quality Management System

Quality PolicyQuality

Objectives

Human Resources

Accounting

Quality Planning

Purchasing / Supplier

Evaluation

Figure 2 - Cognitive Process Sequence and Interrelationships

4.1.2 Outsourcing Cognitive will on occasion use approved suppliers or vendors, along with subcontractors and/or teaming partners, in the fulfillment of requirements to customers. All suppliers or vendors are managed using DCS # 05-007-0001:

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Procedure – Supplier Management Process, and subcontractors and/or teaming partners are managed by DCS # 05-007-0002: Procedure Supplier Management-Subcontractor and Teaming Partner. In order for a supplier or vendor to be utilized, the DCS # 05-007-0004: Procedure – Supplier Selection Evaluation Checklist has to be completed and approved. To apply a subcontractor or a teaming partner’s products or services DCS # 06-002-0002: Procedure – Subcontractor-Teaming Partner Selection Evaluation Checklist would have to be concluded and accepted. Performance of these additional resources are periodically evaluated using DCS # 05-007-0005 Supplier Performance Evaluation Checklist for supplies or vendors, and DCS # 06-002-0003 Subcontractor-Teaming Partner Performance Evaluation Checklist regarding subcontractors and/or teaming partners. In order to ensure legal, regulatory and contractual requirements are met, Cognitive retains approval authority of all items developed for customers by subcontractors.

4.2 Documentation Requirements 4.2.1 General Requirements Cognitive has documented its QMS consistent with the requirements of ISO 9001:2008. These documents describe criteria, methods, detail activities, responsibilities, and the quality assurance measures that are required to ensure the effective operation and control of the Cognitive business processes. It also includes other documentation required by Cognitive to ensure the effective operation and control of its business processes. Consideration has been given to:

Size of the organization

Type of activities

Nature, complexity and interaction of processes

Competence and stability of personnel The QMS is maintained, updated, and improved as Cognitive seeks better business practices. The structure and outline of the documentation system is as follows:

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Quality Manual

QualityProcedures

WorkInstr

uctions

Formsand Records

Figure 3 - Cognitive Documentation Hierarchy

4.2.2 Quality Manual Cognitive has established, documented, and implemented this QMS Manual as a means to ensure that products and services conform to specified quality requirements, and well as to foster an environment of continual improvement within the QMS. This QMS Manual is a controlled document subject to the requirements of DCS # 05-004-0001 Procedure: Document Control. 4.2.3 Control of Documents Documents are controlled by Cognitive in accordance with DCS # 05-004-0001: Procedure – Document Control and the location for all documents are managed and recorded in the DCS Master Listing, which is located inside the SharePoint ISO database. 4.2.4 Control of Records Records are controlled by Cognitive in accordance with DCS # 05-005-0001: Procedure – Record Control and the location of all records for the QMS is recorded in the Record Control System (RCS) Master Listing, which is located inside the Cognitive SharePoint ISO site.

5. Management Responsibility

5.1 Management commitment Cognitive is committed to the development and improvement of a total QMS. This commitment is demonstrated by:

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Training provided to employees related to the QMS requirements.

Establishing Quality Objectives defined in Section 5.4 of this manual.

Committing to the performance of management reviews in accordance with DCS # 05-001-0003: Procedure – Management Review.

Providing or acquiring resources based on the performance of processes as demonstrated in DCS # 05-001-0003: Procedure – Management Review.

5.2 Customer Focus Cognitive has established DCS # 02-001-0001: Procedure – Business Development (BD) Process to define customer requirements, and actively collect or evaluate results of customer oriented processes. In DCS # 05-001-0003: Procedure – Management Review customer requirements are evaluated to determine if minimum requirements are being met. If necessary, management may provide recommendations for improvement of performance, which are then implemented to ensure those customer requirements are fully met.

5.3 Quality Policy Cognitive management has defined and documented a corporate Quality Policy as follows:

Cognitive employees and contractors are committed to providing our customers with high value products and services that meet both customer requirements and our expectations for excellence. The Cognitive‘s commitment to continually improve the effectiveness of our QMS by monitoring the results of our activities against the quality objectives and taking action to improve performance.

5.4 Planning 5.4.1 Quality Objectives The Cognitive Quality objectives are grouped into core areas with unique measurements aligned to the QMS processes. The quality objectives and measurement timeframes are defined in DCS # 05-001-0010: Metrics Repository Record Template. Measurement data is periodically reviewed by the Management Review Board (MRB) to ensure that goals are being achieved and to initiate corrective action when measurement data indicates that performance is below the established goal. 5.4.2 QMS Planning Cognitive has identified and planned for the resources and processes needed to achieve its quality objectives. The Cognitive QMS Manual identifies the business processes in Figure 2, and the QMS is assessed for ongoing suitability, adequacy, and effectiveness through the Management Review process. Planning for changes to the QMS is documented and controlled by the MRB, and updates to system documentation are made in accordance with DCS # 05-004-0001: Procedure – Document Control.

5.5 Responsibility, Authority, and Communication 5.5.1 Responsibility and Authority The responsibility and authority for each process is defined within each process document; each employee is provided an introduction to the processes and department owners through training provided by Cognitive. 5.5.2 Management Representative Cognitive has identified the Operations Manager as the Management Representative for the company.

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5.5.3 Internal Communication Cognitive ensures communication is transmitted between its various departments regarding the processes of the QMS and their effectiveness. This is accomplished through various business meetings, e-mails, and the provision of training when the process results do not meet expectations.

5.6 Management Review 5.6.1 General Management performs periodic management reviews of the QMS in accordance with DCS # 05-001-0003: Procedure – Management Review.

5.6.2 Review Input Performance metric inputs are collected and recorded in DCS # 05-001-0010: Metrics Repository Record Template, and presented during management review in accordance with DCS # 05-001-0003: Procedure – Management Review. Other Inputs are defined in specific MRB meeting agendas and meeting minutes.

5.6.3 Review Output Management’s review of performance metric outputs are gathered and entered into the Cognitive RCS (located inside the MRB Meeting Agenda-Minutes) in the SharePoint ISO site.

6. Resource Management

6.1 Provision of Resources Cognitive management evaluates the needs for resources by a combination of the following factors: evaluating customer requirements and managing the effectiveness of all processes using DCS # 05-001-0003: Procedure – Management Review. Additional resources are procured by using DCS # 05-007-0001: Procedure – Supplier Management Process, DCS # 05-007-0002: Procedure Supplier Management-Subcontractor and Teaming Partner, DCS # 05-007-0012: Purchasing Procedure, and DCS # 03-004-0001: Human Resources (HR) Procedures.

6.2 Human Resources 6.2.1 Assignment of Personnel Cognitive utilizes DCS # 03-004-0001: HR Procedures to identify the skills and background necessary for each position within the company, along with collecting and monitoring training provided to Cognitive staff to ensure competency. When subcontractors and/or teaming partners are utilized the specific requirements that are essential for completing the required tasks are defined in DCS # 05-007-0002: Procedure Supplier Management-Subcontractor and Teaming Partner. 6.2.2 Competence, Awareness, and Training Cognitive utilizes DCS # 03-004-001: HR Procedures as well as DCS # 06-005-0001: Facility Sercurity Officer (FSO) Procedures to define the requirements for competence, awareness, and training, as well as utilizing the performance of processes to provide input on training needs and the evaluation of competence.

6.3 Infrastructure Cognitive provides the necessary infrastructure to achieve corporate objectives and meet customer requirements at all times. Corporate employees are provided with a location for the performance of work, access to the

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internet, computer equipment, software applications appropriate to the work, and a phone, at a minimum. The MRB monitors infrastructure needs with input from upper (or senior or Executive) management and plans for upcoming business needs.

6.4 Work Environment Cognitive provides management of service delivery at the Cognitive corporate headquarters. The primary requirements for the work environment are the availability of power, internet connection, space to set up computer equipment, access to a phone, internet and company networks, and ideally an environment free from excessive noise.

7. Product Realization

7.1 Planning of Product Realization Processes Cognitive provides services specific to contractually defined customer requirements. Each customer contract requires specific deliverables and requirements for delivery. Cognitive utilizes DCS # 02-001-0001: Procedure –BD Process and DCS # 06-002-0001: Procedure – Contracts Management to ensure customer requirements are understood and met. New documents and records resulting from the performance of this process are handled in accordance with DCS # 05-004-001: Procedure – Document Control and DCS # 05-005-001: Procedure – Record Control.

7.2 Customer Related Processes 7.2.1 Determination of Requirements Related to Service Cognitive utilizes DCS # 02-001-0001: Procedure – BD Process to collect the necessary information related to the opportunity and the specific needs of the customer. 7.2.2 Review of Requirements Related to Service Cognitive utilizes DCS # 02-001-0001: Procedure – BD Process to evaluate if the customer’s requirements can be met prior to the issuance of a proposal and the proposal is reviewed for accuracy prior to executing a final signed copy of the proposal. When contract or order requirements are changed, Cognitive ensures that a contract modification is performed and relevant contract personnel are made aware of the changed requirements, per DCS # 06-002-0001: Procedure – Contracts Management and the amendment is maintained in accordance with DCS # 05-005-001: Procedure – Record Control. 7.2.3 Customer Communication Identification of required customer communication methodology is part of the BD Process. Each contract or order is considered a project with activities that are customized for each client. Clients are made aware of the ability to submit a customer complaint at any time, or during the course of the performance as stated in DCS # 05-007-0010: Procedure – Customer Satisfaction Evaluations. All changes to contracts or orders are performed as a modification to the contract or order.

7.3 Design and Development 7.3.1 Design and Development Planning Exclusion. Cognitive does not design or develop product for delivery to customer. 7.3.2 Design and Development Inputs Exclusion. Cognitive does not design or develop product for delivery to customer.

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7.3.3 Design and Development Outputs Exclusion. Cognitive does not design or develop product for delivery to customer. 7.3.4 Design and Development Review Exclusion. Cognitive does not design or develop product for delivery to customer. 7.3.5 Design and Development Verification Exclusion. Cognitive does not design or develop product for delivery to customer. 7.3.6 Design and Development Validation Exclusion. Cognitive does not design or develop product for delivery to customer. 7.3.7 Control of Design and Development Changes Exclusion. Cognitive does not design or develop product for delivery to customer.

7.4 Purchasing 7.4.1 Purchasing Process Cognitive primarily purchases contracted services, skilled labor to support the service delivery process and commodity products for office consumption. Purchases may be made via contract, online ordering system, or in from of check, credit card, or as appropriate for the transaction. Service contracts are managed using subcontractor and teaming partner processes in accordance with DCS # 05-007-0002 Procedure – Supplier Management Process – Subcontractor and Teaming Partner. Purchases are made in accordance with DCS # 05-007-0012: Purchasing Procedure, along with the associated evaluation of suppliers as needed which is referred to in DCS # 05-007-0001 Procedure – Supplier Management Process. Additional commodities (computers, printers, paper, etc.) are also purchased for company use, but do not directly impact the fulfillment of customer obligations, and thus are subject to a lower level of scrutiny. 7.4.2 Purchasing Information Cognitive creates purchasing information in accordance with DCS # 05-007-0012: Purchasing Procedure. Any special requirements for products or personnel are identified in the order to the supplier. Information is reviewed for accuracy prior to transmission to supplier. 7.4.3 Verification of Purchased Product Cognitive reviews and monitors deliverables in accordance with DCS # 05-007-0012: Purchasing Procedure in the performance of the schedule and work. Product orders are tracked through delivery and acceptance to ensure purchased product meets requirements.

7.5 Production and Service Provision 7.5.1 Control of Production and Service Provision Cognitive manages the control of production and service provision through DCS# 05-007-0007: Procedure – Professional Services Delivery in accordance with the plan per customer contract. No special equipment is utilized in the development of proposals or provision of services. The release of all products is controlled through the above processes.

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7.5.2 Validation of Processes Excluded - Cognitive does not operate any special processes; all information and outputs can be verified against stated requirements prior to delivery to the customer. 7.5.3 Identification and Traceability Cognitive identifies customer products or services by order or contract and each order/contract is tracked through completion via DCS# 05-007-0007: Procedure – Professional Services Delivery to ensure products or service are delivered in accordance with customer requirements. Process and records throughout the lifecycle are updated as changes occur to reflect current applicable process step descriptions and workflows. 7.5.4 Customer Property Cognitive collects customer information related to pricing, organizational overviews, marketing information, technical information, supplier information and any other appropriate information required to deliver a response to an order/solicitation, RFO, RFI, or RFP. When requested, all customer property is returned at the end of an engagement, otherwise it is kept in accordance with the retention periods defined in DCS # 05-005-0001: Procedure – Record Control. Any lost information will be communicated to a customer and, if appropriate, managed as a corrective action using DCS # 05-003-0001: Procedure – CAPA. 7.5.5 Preservation of Product Cognitive does not typically handle products directly. Product preservation is ensured as needed by tracking of product in shipment from the vendor to customer, and the use of capable suppliers and shipping mechanisms. Copies of electronic deliverables and records are retained in accordance with DCS # 05-005-0001: Procedure – Record Control.

7.6 Control of Monitoring and Measuring Devices Excluded - Cognitive does not use monitoring and measuring devices in provision of services.

8. Measurement, Analysis and Improvement

8.1 Planning Cognitive has defined quality objectives and the associated targets for performance in DCS # 05-001-0010: Metrics Repository Record Template. The achievement against targets is reviewed during quarterly management reviews in line with DCS # 05-001-0003: Procedure– Management Review. When performance does not meet expectations, corrective actions are taken in line with DCS # 05-003-0001: Procedure – CAPA. The objectives and established targets are reviewed at least annually (if not quarterly) for continued suitability during management review.

8.2 Monitoring and Measurement 8.2.1 Customer Satisfaction Cognitive ensures that customer perception is collected, measured and evaluated in accordance with DCS # 05-007-0010: Procedure – Customer Satisfaction Evaluations using a customer satisfaction survey. 8.2.2 Internal Quality Audits Cognitive performs internal audits at least annually in accordance with DCS # 05-001-0004: Procedure – Internal Audit Process. The results of these internal audits demonstrate the importance of processes. Each audit duration

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and depth is criticality tied to the delivery services for the customer and can be modified to better suit the customer’s requirements. 8.2.3 Monitoring and Measurement of Processes Cognitive monitors and measures processes against the objectives defined within each process document and is captured and collected in accordance with DCS # 05-001-0003: Procedure – Management Review, while the quality objectives are defined in DCS # 05-001-0010: Metrics Repository Record Template. 8.2.4 Monitoring and Measurement of Product Cognitive monitors and measures the services provided as part of DCS# 05-007-0007: Procedure – Professional Services Delivery as well as DCS # 05-001-0009: Procedure – Measurement Analysis and Improvement.

8.3 Control of Non-Conforming Products Cognitive’s non-conforming products/services are considered in DCS# 05-007-0007: Procedure – Professional Services Delivery as well as the DCS # 05-007-0017: Procedure – Non-Conforming Product. Any non-conforming product or service identified will be subsequent to rework, updated to customer requirements, and a corrective action will be logged in accordance with DCS # 05-003-0001: Procedure – CAPA.

8.4 Analysis of Data Cognitive uses DCS # 05-001-0010: Metrics Repository Record Template to capture the results of information and provide input to management on the suitability of the QMS. The results are characterized in a stoplight format with green being acceptable performance to the organization with no actions required, yellow meaning that the results should be monitored for improvement, or red that action is required to correct an issue, which results in the development of an action plan using DCS # 05-003-0001: Procedure – CAPA.

8.5 Improvement 8.5.1 Planning for Continual Improvement Cognitive primarily manages the planning for continual improvement through the use of DCS # 05-001-0003: Procedure – Management Review; however, all employees are encouraged to submit information to leadership for consideration of future improvements.

8.6 Corrective Action Cognitive utilizes DCS # 05-003-0001: Procedure – CAPA to manage corrective actions.

8.7 Preventative Action Cognitive utilizes DCS # 05-003-0001: Procedure – CAPA to manage preventive actions.


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