QUALITY SYSTEM MANUAL - GEX Corp Quality Manual.pdf · 2018. 3. 13. · between the groups and...

MAN-01-01, Rev. K

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GEX Corporation

QUALITY SYSTEM MANUAL

Index

SECTION 1 – SCOPE - Page 2

SECTION 2 – REFERENCE DOCUMENTS - Page 3

SECTION 3 – TERMS AND DEFINITIONS - Page 3

SECTION 4 – CONTEXT OF THE ORGANIZATION - Page 3

SECTION 5 – LEADERSHIP - Page 6

SECTION 6 – PLANNING - Page 9

SECTION 7 – SUPPORT - 0

SECTION 8 – OPERATION - Page 15

SECTION 9 – PERFORMANCE EVALUATION - Page 22

SECTION 10 – IMPROVEMENT - Page 25

APPENDIX A – QUALITY SYSTEM PROCESSES DIAGRAM - Page 27

APPENDIX B – QUALITY AREAS - Page 28

APPENDIX C – ISO CORRELATION MATRIX - Page 29

SECTION 11 - REVISION HISTORY - Page 31

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SCOPE - SECTION 1 1.1 QUALITY POLICY

GEX staff and management are committed to the continual improvement of all quality processes to provide products and services designed to fulfill customer requirements.

President: Date:

1.2 INTRODUCTION GEX is the world leader in providing total DOSIMETRY SOLUTIONS for industrial users. We continuously work with radiation equipment systems manufacturers, in-house users, and contract irradiation facilities around the world to develop complete dosimetry systems designed to meet end user requirements.

GEX has one facility located in Centennial, Colorado:

GEX Corporation 7330 S. Alton Way, Suite 12-I Centennial, CO 80112 USA

With the implementation of the Quality System, GEX has embraced continuous improvement through defect prevention and detection.

The purpose of this manual is to define and describe the quality system, to define authorities and responsibilities of the management personnel affected by the system, and to provide general procedures for all activities comprising the quality system. This manual specifies the quality system policies used by GEX to provide the highest degree of quality throughout all phases of the product life cycle; from design through servicing. The GEX Quality Management System (QMS) satisfies applicable requirements defined in ISO 9001:2015 and ISO 17025:2005.

Management representatives review the Quality Manual on an annual frequency to ensure overall adequacy, and are responsible for ensuring changes are accurate, approved, instituted, and implemented. The Quality Assurance Manager and/or regulatory representative shall ensure proper execution of changes to the Quality System.

President: ______________ Date: _____________

QA Mgmt. Representative: Date: _____________

Lab Mgmt. Representative: Date: _____________

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1.3 APPLICATION

The quality management system (defined in this manual) applies to the design, manufacture, and distribution of all dosimetry products and services offered by GEX Corporation.

1.4 SCOPE

GEX Corporation provides products and services for radiation processing dosimetry in any industry.

REFERENCE DOCUMENTS - SECTION 2

2.1 STANDARDS AND GUIDELINES

• ISO 9000:2005 QMS – Fundamentals and vocabulary

• ISO 9001:2015 QMS – Requirements

• ISO 9004:2000 QMS – Guidelines for performance improvements

• ISO 17025:2005 QMS – General requirements for the competence of testing and calibration laboratories

• NIST Handbook 150:2016 – NVLAP Procedures and General Requirements

TERMS AND DEFINITIONS - SECTION 3

3.1 GENERAL 3.1.1 Descriptions for the terms and definitions used in this manual are specified within

ISO 9001, or otherwise explained in this document. In addition, the Laboratory Department embraces and has policies and procedures with information and instructions to provide specific conformance with ISO 17025 and NIST Handbook 150 requirements.

3.1.2 For administrating the quality management system, top management includes the President, Quality Assurance Manager, Laboratory Manager, Engineering Manager and Production Manager.

3.1.3 The CEO and President comprise Executive Management.

CONTEXT OF THE ORGANIZATION - SECTION 4

4.1 UNDERSTANDING THE ORGANIZATION AND ITS CONTEXT

4.1.1 External and internal issues that are relevant to the purpose and strategic direction of GEX, and affect the ability to achieve the intended result(s) of the QMS are determined, monitored, and reviewed during annual performance of management review and internal audit.

4.1.2 External or internal issues that are relevant to the QMS: product/equipment

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updates, infrastructure, personnel changes, updates on services provided, new methods (i.e. automation, collection, categories of information, etc.), testing facilities, contractors/sub-contractors/vendors, technological/software updates, competitive analysis, and company personnel.

4.2 UNDERSTANDING THE NEEDS AND EXPECTATIONS OF INTERESTED PARTIES 4.2.1 Requirements and review of relevant interested parties

Interested parties are determined due to their effect or potential effect on the ability for GEX to consistently, provide products and services that meet customer and applicable statutory and regulatory requirements. The information and relevant requirements of interested parties are monitored and reviewed.

• Company personnel: performance evaluations via employee review, company quarterly updates.

• Critical suppliers/sub-contractors: GEX to provide product/service requirements, and mutual agreements/contracts (i.e. change notification agreement, quality agreement, supplier self-assessment) in order to manufacture or provide products and services to meet GEX requirements and expectations. Information and requirements are reviewed on an annual frequency by top management via management review. The Approved Supplier’s List (ASL) is monitored on a quarterly frequency by QA, which includes related supplier information.

• Customers: on-time delivery, maintaining regulatory accreditation, providing products and services to meet their requirements, maintaining mutual agreements/contracts.

• Regulatory agencies (ISO and NVLAP): meet regulatory requirements of ISO 9001, ISO 17025, and NIST Handbook 150 (NVLAP). Monitored and reviewed on an annual frequency.

• Shareholders: meet established annual budget. Monitored and reviewed on a scheduled frequency by Executive Management.

4.3 QUALITY MANAGEMENT SYSTEM AND ITS PROCESSES

4.3.1 Process approach

The QMS is composed of interrelated processes and interactions to achieve the intended results in accordance with the quality policy and strategic direction of the company. Quality system processes are the main activities in the company, listed below:

• Context of the organization • Leadership • Planning • Support

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• Operation • Performance evaluation • Improvement

4.3.1.1 The Quality System Processes Diagram (see Appendix A) defines the quality system processes, and illustrates the sequence and interrelation between the groups and individual processes.

4.3.1.2 Appendix B lists areas where quality is applied, and segregates areas of the company along functional lines. Used as the basis for job descriptions.

4.3.1.3 Appendix C provides correlation matrices from ISO 9001:2008 to ISO 9001:2015.

4.3.1.4 The Document Control Master List provides a list of the company’s quality system documents maintained by the QA Manager. Quality system documents define the criteria and methods required to ensure effective operation and control of all quality system processes; see Section 7.3 Documented Information. Documentation includes assignment of responsibilities and allocation of resources for the process, instructions on how to carry out (or operate) the process, and definition of methods for monitoring and/or measuring the effectiveness of the process.

4.3.1.5 NIST Handbook 150:2016 (Annex A) is used as the policy and procedure for controlling the use of the term “NVLAP”, the NVLAP logo, and NVLAP symbol.

4.3.2 Resources and organizational knowledge

4.3.2.1 Quality Assurance is responsible for determining resources and informational requirements necessary to support the operation and monitoring of quality system processes, and for communicating these requirements to top management.

4.3.2.2 Top Management is responsible for ensuring the availability of necessary resources and information. Section 7.1 Provision of Resources elaborates on resource requirement details.

4.3.3 Monitoring and measurement

4.3.3.1 Monitoring and measurement of quality systems process performance is to ensure effectiveness, and identify opportunities for improvement.

4.3.3.2 Internal and external quality audits monitor the performance of quality system processes.

4.3.3.3 Measuring customer satisfaction monitors overall performance of the quality system.

4.3.3.4 Quality system processes are assessed and analyzed during management review; see Section 9.3 Management Review.

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4.3.4 Continual improvement

4.3.4.1 Management reviews quality system processes to identify any possible failures or breakdowns. Quality objectives, risk assessment, and implementation of corrective actions address actual or potential problems, and maintain the effectiveness of these processes.

4.3.4.2 This Quality Manual and QSP-56-01, Management Review, define how

the quality management system ensures its own compliance and effectiveness.

4.3.5 External providers

4.3.5.1 When processes that affect product conformity are outsourced, implemented controls ensure that these processes meet specified requirements. Such controls may include, as appropriate:

• Evaluation and pre-qualification of external providers

• Assessment of external provider’s manufacturing processes and their quality system

• Flow-down of the requirements of interested parties (i.e. customer and contract requirements)

• Monitoring of supplier quality performance

• Requirements for process control, inspection, testing or other records demonstrating product/ service conformity

• Verification of the provided product or service

4.3.5.2 Ensuring control over outsourced processes does not absolve GEX Corporation of the responsibility to conform to all customer requirements.

LEADERSHIP - SECTION 5

5.1 LEADERSHIP AND COMMITMENT

5.1.1 General

5.1.1.1 Top management demonstrates leadership and their commitment with respect to the QMS by:

a. taking accountability for the effectiveness of the QMS;

b. ensuring that the quality policy and quality objectives are established for the QMS, and are compatible with the content and strategic direction of the organization;

c. ensuring the integration of the QMS requirements into the organization’s business processes;

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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 (e.g. requirements of interested parties such as customer and statutory and regulatory requirements);

g. ensuring that the QMS achieves its intended results with performance of a periodic review to ensure its continuing suitability, adequacy, and effectiveness;

h. engaging, directing, and supporting persons to contribute to the effectiveness of the QMS;

i. promoting improvement;

j. encouraging and supporting other relevant management roles to demonstrate their leadership as it applies to their areas of responsibility.

5.1.2 Customer Focus

5.1.2.1 The principal objective of the quality management system is to focus the organization on the customer, and in particular, on customer satisfaction. The key to achieving high customer satisfaction is an accurate determination of customer requirements and effective verification of meeting them.

5.1.2.2 Top management demonstrates leadership and commitment with respect to customer focus by ensuring that:

a. customer and applicable statutory and regulatory requirements are determined, understood, and consistently met;

b. risks and opportunities that can affect conformity of products and services and the ability to enhance customer satisfaction are determined and addressed.

5.1.3 Quality Policy

5.1.3.1 Documented in this manual is the Quality policy. See Section 1.1 Quality Policy.

5.1.3.2 Top management establishes, implements, and maintains the Quality Policy. In formulating it, the following must be ensured:

a. it is appropriate to the purpose and context of the organization and supports its strategic direction;

b. it provides framework for setting quality objectives;

c. it includes a commitment to satisfy applicable requirements;

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d. it includes a commitment to continual improvement of the QMS.

5.1.3.3 The Quality Policy is maintained as documented information. At the company facility, the policy is available to interested parties, as appropriate, and posted throughout for personnel. At general orientation training, all personnel discuss with quality personnel the purpose of the quality policy.

5.1.4 Organizational roles, responsibilities, and authorities

5.1.4.1 Top management ensures that the organization communicates and understands the responsibilities and authorities for assigned, relevant roles within the company. A company organizational chart is located in an addendum to this manual, see MAN-ADD-01, Organization Chart.

5.1.4.2 Executive Management is ultimately responsible for oversight of the quality system, making available the resources and personnel necessary to maintain the system and for the operation and control of its processes, and understanding the needs and expectations of interested parties. Additionally, Executive Management ensures that the company avoids derogatory or questionable activities that would diminish confidence in its competence, impartiality, judgment, or operational integrity.

5.1.4.3 The Quality Assurance Manager has the authority and responsibility for:

a. ensuring that the QMS conforms to ISO requirements;

b. ensuring that the processes are delivering their intended outputs;

c. reporting on the performance of the QMS and on opportunities for improvement (OFI’s), in particular to top management;

d. ensuring the promotion of customer focus throughout the organization;

e. ensuring that the integrity of the QMS is maintained when changes to the QMS are planned and implemented.

5.1.4.4 The Laboratory Manager is responsible for administering the NIST Handbook 150 requirements within the Laboratory Department.

5.1.4.5 The Laboratory Manager and Quality Assurance Manager are responsible for ensuring compliance with NIST Handbook 150.

5.1.5 Internal communication

5.1.5.1 Internal communication regarding the quality system flows in the following way:

• Top management communicates to personnel the quality policy and objectives; requirements; specifications; and instructions on how to implement and use the quality system, when necessary.

• Personnel communicates to top management the information and data regarding quality performance, the effectiveness of the quality

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system, customer satisfaction, and opportunities for improvement.

5.1.5.2 Information is communicated through:

• Paper or electronic documents (e.g. manuals, procedures, instructions, drawings, specifications, quality records, reports, etc.)

• E-mails, memos, and meetings • Training and awareness programs • Employee suggestions, surveys, and feedback

5.1.6 External communication (i.e. customers and suppliers)

5.1.6.1 The Marketing department is responsible for developing and controlling the company's brochures, catalogs, website, and other forms of promotional and product/service informational material directed towards the customer. These materials are based on technical specifications developed by R&D.

5.1.6.2 Only designated personnel are authorized to communicate with customers regarding product and service information, see Section 8.2.3.

5.1.6.3 Only designated personnel are authorized to communicate with external providers regarding product and service information, see Section 8.4.3.

PLANNING - SECTION 6

6.1 ACTIONS TO ADDRESS RISKS AND OPPORTUNITIES

6.1.1 When planning for the QMS, the issues referred to in Section 4.1, and the requirements in Section 4.2, are considered to determine the risks and opportunities that need to be addressed to give assurance that the QMS can achieve its intended results, enhance desirable effects, prevent (or reduce) undesired effects, and achieve improvement.

6.1.2 Actions to address risks and opportunities are planned to include how to integrate those actions into the QMS, and evaluation of the effectiveness of those actions.

6.2 QUALITY OBJECTIVES

6.2.1 During management review, top management establishes the quality objective(s) at relevant functions, levels, and processes needed for the QMS.

6.2.2 The objectives shall be consistent with the quality policy, be measureable, take into account applicable requirements, be relevant to conformity of products and services to enhance customer satisfaction, and be monitored, communicated, and updated as appropriate.

6.2.3 To achieve quality objectives, the planning phase is necessary to understand what is to be done, what resources will be required, who will be responsible, when it will be completed, and how the results will be evaluated.

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6.3 PLANNING OF QMS CHANGES

6.3.1 Changes to the Quality Management System are processed in a planned manner; see Section 8.5.4 Control of changes.

SUPPORT - SECTION 7 7.1 RESOURCES

7.1.1 General

7.1.1.1 Top management determines and provides the resources needed for the establishment, implementation, maintenance, and continual improvement of the QMS.

7.1.1.2 The following is considered:

• the capabilities of, and constraints on, existing internal resources;

• what needs to be obtained from external providers.

7.1.1.3 Persons necessary for the effective implementation of the QMS and for the operation and control of its processes is determined.

7.1.1.4 Determination of resource needs for specific activities is integrated with the process of defining and planning the activity. It may take the form of materials, personnel assignments, allocation of space or equipment, training, procurement decisions, information, budgets, etc.

7.1.1.5 Depending on the type and nature of the operation or activity, resource requirements are defined in:

• quality manual, quality system procedures, and work instructions; • product specifications and production plans; • job descriptions and training programs; • Management review minutes, quality objective records, and corrective

action requests.

7.1.2 Buildings and associated utilities

7.1.2.1 Infrastructure and facilities necessary for the operation of the company and its processes are appropriate, and properly maintained to achieve conformity to products and services. Infrastructure can include buildings and utilities, equipment (including hardware and software), transportation resources, and information and communication technology.

7.1.2.2 Departmental managers are responsible for identifying the need and communicating to top management the needs for new, and/or modification or repair of existing infrastructure and facilities in their departments.

7.1.2.3 External contractors typically perform regular, scheduled maintenance of buildings and facilities (e.g. lighting systems, air conditioning and heating

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systems, landscaping, and cleaning).

7.1.3 Supporting services

7.1.3.1 Supporting services required by GEX Corporation include transportation, communication, and IT services:

• Transportation services are purchased from parcel delivery and courier services, and from trucking or other transportation companies, as required.

• Communication services are provided by various telephone, wireless, and internet access companies. Admin is responsible for administrating and coordinating these contracts.

• External consultants manage the IT system, while the day-to-day operating of systems are the responsibility of top management, who selects IT consultants and administers IT contracts.

7.1.4 Environment for the operation of processes

7.1.4.1. Executive management determines and provides the environment. Top management maintains the environment necessary to achieve conformity of products and services, and for the operation of its processes.

7.1.4.2. Admin and departmental managers are responsible for ensuring suitable physical, social, and psychological conditions in the workplace. Includes aspects such as temperature, lighting, and cleanliness.

7.1.4.3. Production and Quality Assurance are responsible for identifying those operations where extreme environmental conditions could affect quality performance of personnel and result in product/service nonconformities. Where appropriate, limits of exposure and/or mitigating measures are defined, controlled, and implemented for these operations.

7.1.4.4. Admin is responsible for the health and safety management system, which is independent from the quality management system.

7.1.5 Monitoring and measuring resources

7.1.5.1. Top management determines and provides the resources needed to ensure valid and reliable results, when monitoring or measuring is used to verify the conformity of products and services to requirements.

7.1.5.2. The Technical Services Manager is responsible for oversight of maintaining monitoring and measuring equipment also referred to as critical equipment. The appropriate measuring and monitoring equipment is selected to ensure suitability and reliability, and that measurements are valid when used to verify the conformity of products and services. Equipment used for ensuring and verifying product conformity is maintained and calibrated.

7.1.5.3. Appropriate documented information is retained as evidence of fitness for

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purpose of the monitoring and measurement resources.

7.1.6 Calibration and maintenance program and measurement traceability

7.1.6.1 The scope of the calibration control system extends to the measuring and monitoring, test equipment and software, comparative reference hardware (such as gauges and templates), and other equipment used for:

• the setup, operation, and monitoring of production processes;

• monitoring of environmental conditions;

• verification of product conformity;

7.1.6.2. Technical Services and Quality Assurance are responsible for calibrating and maintaining measuring and monitoring equipment. The status and location of all active and archived equipment is inventoried in a controlled list.

7.1.6.3. Measuring equipment is checked, adjusted, and re-adjusted as necessary; and calibrated or verified (or both), at specified intervals, or prior to use, against measurement standards traceable to international or national measurement standards. When no such standards exist, the basis used for calibration or verification shall be retained as documented information.

7.1.6.4. Calibration results are recorded in a calibration certificate, and the calibrated equipment is labeled with a calibration sticker to identify the calibration status.

7.1.6.5. Measuring and monitoring equipment is safeguarded from adjustments, damage, or deterioration that would invalidate the calibration status and subsequent measurement results.

7.1.6.6. When measuring equipment is not found to conform to requirements, previous measuring results are reassessed, and appropriate action is taken on the equipment and any product affected.

7.1.6.7. Critical process equipment, machines, and hardware/software are regularly maintained in accordance with maintenance plans to ensure their continuing fitness for their purpose.

7.1.7. Organizational knowledge

7.1.7.1. Top management determines, maintains, and makes available the knowledge necessary for the operation of the company’s processes to achieve conformity of products and services and the QMS objectives herein.

7.1.7.2. When addressing changing needs and trends, the current knowledge is considered and how to acquire or access any necessary additional knowledge and required updates are determined.

7.1.7.3. Organizational knowledge is defined as knowledge specific to GEX, and is

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generally gained by experience. It is information used and shared to achieve determined objectives. Organizational knowledge can be based on internal (e.g. intellectual property, capturing and sharing undocumented knowledge and experience, etc.) and external sources (e.g. standards, gathering knowledge from customers or providers, etc.).

7.2 HUMAN RESOURCES

7.2.1 General

7.2.1.1 Personnel performing work affecting product quality or affect the performance and effectiveness of the QMS are competent. Competence is determined based on appropriate education, training, skills and/or experience. Where applicable, actions are taken to acquire the necessary competence, and evaluation of the effectiveness of actions taken is performed. The appropriate documented information is retained as evidence.

7.2.1.2 Admin and the Quality departments are responsible for training and awareness programs for company-wide participation, such as: general orientation, rules and regulations, quality system, safety, and other company-wide systems and issues.

7.2.1.3 Departmental managers are responsible for identifying competency requirements and for providing training in their departments. Departmental training primarily focuses on increasing the level of skills in operating equipment and processes, conducting inspections and testing, and providing skills as appropriate for particular positions and jobs.

7.3 DOCUMENTED INFORMATION

7.3.1 Control of documented information

7.3.1.1 When creating and updating documented information, the organization ensures appropriate identification and description, format and media, and conducts review and approval for suitability and adequacy.

7.3.1.2 Documented information is controlled to ensure it is available and suitable for use, and is adequately protected.

7.3.1.3 The following activities are addressed:

a. Distribution, access, retrieval, and use;

b. Storage and preservation (preservation of legibility);

c. Control of changes (version control)

d. Retention and disposition.

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7.3.1.4. Documented information of external origin determined by GEX to be necessary for the planning and operation of the QMS are identified, as appropriate, and controlled.

7.3.2 Quality System Documentation

• Quality Manual (MAN): Top-level document that defines the company's quality policies and quality objectives, defines the scope of the quality system (including details and justification for any exclusion; see Section 1.4), describes the overall quality system and the sequence of interrelated processes, and references applicable quality system procedures.

• Quality System Procedures (QSP): Second-level documents that define specific quality system processes. Quality system procedures explain the what, when, who, and how for a process, and defines what documented information is required. Quality system procedures are uniquely numbered, QSP-SS-NN. QSP stands for Quality System Procedure. (SS was the section in the quality system to which the procedure pertained, but is no longer applicable to ISO 9001:2015; see Appendix C Correlation Matrix.) NN is the consecutive number of a procedure for the section.

• Quality Forms (QF): Usually one-page forms or matrices defining a "template" for establishing a record. Quality forms are code numbered QF-SS-NN. QF stands for Quality Form, and has the same number format as QSP’s.

• Work Instructions (WI): The purpose of work instructions are to instruct personnel in performing specific tasks (i.e. performing and controlling production processes, handling products, calibrating measuring equipment, conducting tests or inspections, etc.) Work instructions are numbered, WI-SS-NN. WI stands for Work Instruction, and has the same number format at QSP’s.

• Specifications (SPEC): Written specifications surrounding requirements of interested parties including; components, subassembly, assembly, and packaging, bills of materials, software specifications, process flow charts, specifications for equipment calibration and maintenance, and specifications for inspection processes. QSP-42-01, Control of Documented Information provides a more descriptive detail of these documents.

• Customer Communications: Includes manuals, product information and usage sheets (PSU’s), technical informational reports (TIR’s), or any other documented information that GEX determines to be important in communicating product and service information to customers.

• Standards and codes: International/national/local regulations, and standards/codes that define operational, quality, and product/service requirements.

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OPERATION - SECTION 8 8.1 OPERATIONAL PLANNING AND CONTROL

8.1.1 Production

8.1.1.1 Production processes and product verification activities are planned to be suitable for the organization’s operations, and implemented and controlled 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. determining, maintaining, and retaining documented information to the extent necessary to have confidence that the processes have been carried out as planned, and to demonstrate the conformity of products and services to their requirements.

8.1.1.2 Planned changes are controlled.

8.1.1.3 The consequences of unintended changes are reviewed, and actions are taken to mitigate any adverse effects, as necessary.

8.1.1.4 Outsourced processes are controlled; see Section 8.4.

8.2 REQUIREMENTS FOR PRODUCTS AND SERVICES

8.2.1 Customer communication and responsibilities

8.2.1.1 Communication with customers includes:

• providing information relating to products and services (marketing, sales, customer service);

• handling enquiries, contracts, or orders, including changes (sales, admin);

• obtaining customer feedback relating to products and services, including customer complaints (quality, customer service);

• handling or controlling customer property (customer service, quality);

• establishing specific requirements for contingency actions, when relevant (customer service, quality).

8.2.2 Determining the requirements for products and services

8.2.2.1 Products and service requirements are defined to include applicable statutory and regulatory requirements, and those considered necessary by GEX.

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8.2.2.2 GEX ensures that the claims for the products and services offered can be met.

8.2.3 Review of the requirements for products and services

8.2.3.1 Purchase orders are reviewed before committing to supply products and services customers to ensure that the company has the ability to meet the requirements for products and services to be offered. The following is reviewed:

a. Requirements specified by the customer, including requirements for the 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 GEX;

d. Statutory and regulatory requirements applicable to the products and services;

e. Any ambiguities and conflicts in contract or order requirements from those previously defined are resolved.

8.2.3.2 Confirmation of customer requirements is required before acceptance when the customer does not provide a documented statement of their requirements or reference to GEX product part numbers.

8.2.3.3 When changes to requirements for products and services has been determined, the change order and amendment is received and reviewed following the same protocol that applies to initial orders. Change orders are communicated to relevant personnel.

8.2.3.4 Records of the results of reviews, and on any new requirements for products and services are retained.

8.3 DESIGN AND DEVELOPMENT OF PRODUCTS AND SERVICES

8.3.1 General

8.3.1.1 A design and development process has been established, implemented, and maintained to ensure the subsequent provision of products and services. GEX designs some their own standard catalog products and services as well as customer-specified products.

8.3.1.2 Top management and applicable departmental managers or experienced and knowledgeable personnel share responsibilities for the planning of design projects. Planning includes the identification of design, review, verification/validation activities, scheduling, assignment of resources, and control of organizational and technical interfaces.

8.3.2 Design and development planning

8.3.2.1 In determining the stages and controls for design and development, the following is considered:

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a. nature, duration, and complexity of the design and development activities;

b. process stages, including applicable design and development reviews;

c. design and development verification and validation activities;

d. responsibilities and authorities involved in the design and development process;

e. internal and external resource needs in the design and development process;

f. interaction between persons involved in the design and development process;

g. requirements for subsequent provision of products and services;

h. level of control expected for the design and development process by customers and other relevant interested parties;

i. documented information needed to demonstrate that design and development requirements have been met.

8.3.3 Design and development inputs 8.3.3.1 Design input requirements are developed by R&D and Engineering from

product concepts, such as product briefs, sketches, models, rough prototypes, etc.

8.3.3.2 The following is considered for determining the requirements essential for the specific types of products and services to be designed and developed:

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 GEX has committed to implement;

e. potential consequences of failure due to the nature of the products and services (i.e. risk assessment).

8.3.3.3 Design and development purposes are adequate, complete, and unambiguous. Conflicting design and development inputs are resolved. Documented information on inputs and any discussions are retained.

8.3.4 Design and development controls

8.3.4.1 Controls are applied to the design and development process to ensure that:

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a. the results to be achieved are defined;

b. reviews are conducted to evaluate the ability of the results to meet requirements;

c. verification activities are conducted to ensure that the outputs meet the input requirements;

d. validation activities are conducted to ensure that the resulting products and services meet the requirements for the specified application or intended use;

e. any necessary actions are taken on problems determined during the reviews, or verification and validation activities;

f. documented information of these activities is retained.

8.3.5 Design and development outputs

8.3.5.1 Design outputs must meet input requirements, be adequate for the subsequent processes for the provision of products and services, include or reference monitoring and measuring requirements, as appropriate, and acceptance criteria, and specify the characteristics of the products and services that are essential for their intended purpose and their safe and proper provision.

8.3.5.2 Documented information on design and development outputs is retained. Outputs may include samples, models, data, software, etc., which specifies the product and service, and its related manufacturing process, packaging, labeling, installation and servicing.

8.3.6 Design and development changes

8.3.6.1 Design changes are reviewed to ensure that there is no adverse impact on conformity to requirements, and are approved before implementation.

8.3.6.2 Documented information is retained on the design and development changes, the results of reviews, the authorization of the changes, and the actions taken to prevent adverse impacts.

8.3.7 Validation of software

8.3.7.1 Software developed in-house and used for product verification activities is validated beforehand. Commercial software is purchased with validation certificates, where available. Software is re-validated or re-certified when there are functional changes made, and that may affect related processes.

8.4 CONTROL OF EXTERNALLY PROVIDED PROCESSES, PRODUCTS AND SERVICES

8.4.1 General

8.4.1.1 Externally provided processes, products, and services conform to requirements. Controls are determined and applied when:

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a. products and services are intended for incorporation into the organization’s own products and services;

b. products and services provided directly to the customer(s) by external providers on behalf of GEX;

c. a process, or part of a process, is provided by an external provider as a result of a decision by GEX.

8.4.1.2 Purchased products are verified prior to use in production and/or dispatch to customers, whenever necessary. Appropriate methods for purchased product verification and acceptance are determined as part of design control activities.

8.4.1.3 GEX determines and applies criteria for the evaluation, selection, monitoring of performance, and re-evaluation of external providers, based on their ability to provide processes or products and services that meet requirements. Overall supplier quality performance is monitored, and documented information of those activities is retained.

8.4.2 Type and extent of control 8.4.2.1 Top management ensures that externally provided processes, products,

and services remain within the control of the QMS, and do not adversely affect the organization’s ability to deliver conforming products and services consistently.

8.4.2.2 Defined controls are determined, and apply to both the external provider and to the resulting output.

8.4.3 Communication with external providers

8.4.3.1 Applicable personnel ensure the adequacy of requirements prior to communication to the external provider.

8.4.3.2 The following requirements are communicated by GEX: 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. the external providers’ interactions with GEX; e. control and monitoring of the external providers’ performance to be

applied by the organization; f. verification or validation activities that may be performed at their

premises.

8.5 PRODUCTION AND SERVICE PROVISION

8.5.1 General

8.5.1.1 Production and service provision are performed under controlled

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conditions. Controlled conditions include, as applicable:

• availability of 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 (i.e. PRSPEC’s, work instructions, etc.);

• monitoring and measuring equipment;

• implementation of monitoring and measuring activities at appropriate stages;

• use of suitable infrastructure and environment for operation of processes;

• appointment of competent persons, including any required qualification;

• validation, and periodic revalidation of 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;

• implementation of actions to prevent human error;

• implementation of release, delivery, and post-delivery activities.

8.5.2. Identification and traceability

8.5.2.1. Materials, components, and finished products are uniquely identified throughout all stages of product realization and when in storage.

8.5.2.2. Traceability is determined with the identification of unique control numbers, and used to facilitate corrective actions. Documented information necessary to enable traceability is retained.

8.5.2.3. Property belonging to customers or external providers is identified, verified, protected and safeguarded when being used or under the control of GEX. When property is lost, damaged or otherwise found to be unsuitable for use, the owner is notified and documented information retained.

8.5.3. Preservation

8.5.3.1. Handling: production personnel are responsible for ensuring that containers holding products are suitable and identified, and that there is adequate protection during production, transportation, and storage activities.

8.5.3.2. Storage: the department that brings in stock or uses the area manages storage, staging, and holding areas therein. Storage areas are appropriate to ensure adequate preservation and protection of product. Procedures and/or work instructions are established for control of product with limited shelf life or require special storage conditions.

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8.5.4. Control of changes

8.5.4.1. Control of changes for production or service provision are reviewed to the extent necessary to ensure continuing conformity with requirements. Documented information describing results of review, the person(s) authorizing the change, and any necessary actions arising from the review are retained.

8.6. RELEASE OF PRODUCTS AND SERVICES

8.6.1. Product and service requirements are verified at appropriate stages prior to release. Requirements are defined in specifications, production work orders, purchasing documents, and in inspection and testing procedures.

8.6.2. The release of products and services to the customer do not proceed until the planned arrangements have been completed or approved by appropriate and relevant authorities, or by the customer.

8.6.3. Documented information is retained on the release of products and services, and includes evidence of conformity, and traceability to the person(s) authorizing release.

8.6.4. Only personnel performing final product inspections and tests have the authority to release products.

8.7 CONTROL OF NONCONFORMITIES

8.7.1 Identification, documentation, review and disposition

8.7.1.1 Outputs that do not conform to their requirements are identified and controlled to prevent their unintended use or delivery.

8.7.1.2 Nonconforming products and services detected after delivery of products, and during or after the provision of services, results in a customer notification and resolution.

8.7.1.3 Processes that are not conforming to requirements are halted, and any equipment is removed from service until satisfactory resolution of the nonconforming situation.

8.7.1.4 Appropriate actions are taken based on the nature of the nonconformity and its effect or risk of effect on the conformity of products and services.

8.7.1.5 Nonconforming outputs are managed in the following way:

a. correction;

b. segregation, containment, return or suspension of provision of products and services;

c. informing the customer;

d. obtaining authorization for acceptance under concession.

8.7.1.6 Nonconforming products and services are documented in a product

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nonconformity report (PNR), and is retained by Quality Assurance. The report describes the nonconformity, describes the actions taken to contain the nonconformance, disposition decision, and any concessions obtained. The Quality Assurance Manager is responsible for reviewing nonconformities, and deciding on the disposition of nonconforming products. Conformity to the requirements are verified when nonconforming outputs are corrected.

8.7.2 Customer complaints

8.7.2.1 Customer complaints are recorded that allege deficiencies related to the identity, quality, durability, reliability, or performance of a product and service. The results of the investigation and concessions are documented and retained.

PERFORMANCE EVALUATION - SECTION 9

9.1 MONITORING, MEASUREMENT, ANALYSIS, AND EVALUATION

9.1.1 General

9.1.1.1. Measurement and monitoring activities are defined below. Performance of those activities is to verify and ensure product conformity.

9.1.1.2. Top management conducts internal audits and management reviews to monitor and evaluate the performance and effectiveness of the quality system.

9.1.1.3. Quality system performance is measured by customer satisfaction. Obtained data is analyzed to confirm quality system performance and to identify opportunities for improvement.

9.1.1.4. Quality Assurance is responsible for developing suitable indicators of customer satisfaction, and for defining methods for collecting and analyzing the pertinent information.

9.1.2. Customer satisfaction

9.1.2.1 Customer perceptions are monitored and measured with a customer satisfaction survey to ensure that their needs and expectations have been fulfilled. Collected information is analyzed and serves as input into improvement processes.

9.1.2.2 Information and data pertaining to customer satisfaction are collected from the following sources:

• customer satisfaction surveys;

• customer feedback on delivered products and services (complaints and compliments);

• meetings with customers;

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• product returns and warranty claims

9.1.3. Analysis and evaluation

9.1.3.1 Quality assurance analyzes appropriate data and information arising from monitoring and measurement activities. Results are communicated to top management.

9.1.3.2 Quality performance data provides information related to the following:

• Conformity to products and services;

• The degree of customer satisfaction;

• The performance and effectiveness of the QMS;

• If planning has been implemented effectively;

• Effectiveness of the actions taken to address risks and opportunities;

• The performance of external providers;

• The need for improvements to the QMS.

9.1.4 Statistical techniques

9.1.4.1 As applicable, statistical techniques are typically applied to the following types of activities:

• Testing and validation of designs;

• Set up of process equipment;

• Testing and validation of processes;

• Establishment of plans for inspections and testing;

• Evaluation of measurements and measurement systems;

• Analysis of quality performance and other company-level data.

9.1.4.2 Departmental managers are responsible for identifying the need for using statistical techniques in their departments and in other activities for which they are responsible. Quality Assurance may assist other departments in selecting and documenting specific techniques.

9.1.5 Sampling plans

9.1.5.1 Sampling plans for inspections, testing, and other product and process acceptance activities are documented. Quality Assurance reviews and approves proposed sampling plans to ensure they are appropriate and based on valid statistical rationale. Plans may be retained with the inspection/testing instructions to which they pertain, or issued as independently controlled documents.

9.1.5.2 Sampling plans are reviewed and re-evaluated whenever it has been

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observed there is a significant change in reject rates (identified nonconformities) at any given inspection point.

9.2 INTERNAL AUDIT

9.2.1 The Quality Assurance Manager is responsible for oversight of internal audits of the QMS to determine whether the quality system conforms to requirements, as defined in this quality manual and in quality system procedures, and to ensure it is effectively implemented and maintained.

9.2.2 Internal audits are conducted in accordance with a planned program which specifies the frequency, methods, responsibilities, and planning requirements and reporting. Taken into consideration are the importance of the processes concerned, changes affecting the company, and the results of previous audits.

9.2.3 Appropriate correction and corrective actions are taken without undue delay. Departmental managers are responsible for their areas where nonconforming processes and/or practices are identified by the audit. Auditors follow up to ensure that actions taken are implemented and effective.

9.2.4 Documented information is retained as evidence of the implementation of the audit program and the audit results.

9.3 MANAGEMENT REVIEW

9.3.1 General

9.3.1.1 Management reviews of the QMS are conducted on an annual basis at minimum. More frequent reviews are scheduled in periods when organizational, technological, product, process, or other changes require increased attention and input from top management.

9.3.1.2 The purpose of management reviews is to ensure continued suitability, adequacy, effectiveness, and alignment with the strategic direction of the company.

9.3.1.3 Executive Management chairs management reviews. Attendees include departmental managers who represent Quality Assurance, Operations/Production, Customer Service/Administration, Engineering/R&D, and Marketing/Sales.

9.3.2 Review input

9.3.2.1 Inputs into management reviews consist of information and data related to quality performance of the organization. The following inputs are considered:

a. the status of actions from previous management reviews;

b. changes in external and internal issues that are relevant to the QMS;

c. information on the performance and effectiveness of the QMS,

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including trends in:

• customer satisfaction and feedback from relevant interested parties;

• the extent to which quality objectives have been met; • process performance and conformity of products and services; • nonconformities and corrective actions; • monitoring and measurement results; • audit results; • the performance of external providers.

d. the adequacy of resources;

e. the effectiveness of actions taken to address risks and opportunities;

f. opportunities for improvement.

9.3.3 Review output

9.3.3.1 The outputs of management review include decisions and actions related to opportunities for improvement, any need for changes to the QMS, and resource needs.

9.3.3.2 Meeting minutes document the results of management reviews, which are retained by Quality Assurance. The minutes include topics such as improvement actions, assigning responsibilities, and allocating resources for implementation of these actions.

IMPROVEMENT - SECTION 10 10.1 General

10.1.1 Opportunities for improvement are determined and necessary actions implemented to meet customer requirements and enhance customer satisfaction. Actions include:

a. improving products and services to meet requirements and to address future needs and expectations;

b. correcting, preventing, or reducing undesired effects;

c. improving the performance and effectiveness of the QMS.

10.2 Nonconformity and corrective actions

10.2.1 When a nonconformity occurs, corrective actions are taken to control and correct it, and to effectively handle the consequences.

10.2.2 Necessary actions to eliminate the cause(s) of the nonconformity are evaluated in order to prevent recurrence.

The process requirements for evaluating corrective actions includes:

• reviewing and analyzing the nonconformity;

• determining the causes of the nonconformity and if similar nonconformities exist,

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or could potentially occur;

• determining and implementing necessary actions to contain the nonconformance;

• determining and implementing necessary actions to prevent recurrence of the nonconformance or potential similar or related risks that were identified in the investigation;

• reviewing the effectiveness of any corrective action taken;

• update risks and opportunities determined during planning, if necessary;

• make changes to the QMS, if necessary.

10.2.3 Documented information is retained regarding the nonconformities, any subsequent actions taken, and the results of any corrective action.

10.3 Continual improvement

10.3.1 GEX continually improves the suitability, adequacy, and effectiveness of the QMS

10.3.2 Results of analysis and evaluation, and the outputs from management review are considered to determine if there are needs or opportunities that need to be addressed as part of continual improvement.

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APPENDIX A

QUALITY SYSTEM PROCESSES DIAGRAM *Note: numbers in brackets refer to the clauses in ISO 9001:2015.

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APPENDIX B QUALITY AREAS BY FUNCTION

Brief definitions of each area provide the basis for understanding the company structure, and for assigning responsibilities in the form of job descriptions, based around these primary functions:

• Admin: administrative responsibilities of the company including daily office tasks, bookkeeping, human resources, supplier and customer account maintenance, and order processing.

• Customer Service: customer assistance with technical and functional issues beginning with order placement and including product usage communications, facilitation of company services to customers, software support, and education.

• Laboratory: dosimeter measurement and calibration services.

• Management: company sales strategy, resourcing, financing, quality, and technology planning.

• Production: manufacturing and packaging function.

• Purchasing: purchasing and vendor relations function.

• Quality Assurance: management and oversight of all quality operations.

• R & D: research, development, and engineering for the company based on internal and external driving forces.

• Receiving: incoming shipment receipt and verification functions.

• Sales: sales and marketing of the company’s products and services including marketing communications, website design, sales efforts, promotion, and OEM alignment.

• Shipping: shipping functions to include packaging of goods for final shipment, execution of shipments, and monitoring of shipment tracking.

• Technical Services: including equipment calibration and maintenance, management of measurement operations, IT maintenance and support, and facility maintenance operations.

• Warehouse: materials and product storage and inventory functions.

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APPENDIX C CORRELATION MATRIX

ISO 9001:2015 ISO 9001:2008 1 Scope 1 Scope

1.1 General 4 Context of the organization 4 Quality management system 4.1 Understanding the organization and its

context 4 Quality management system 5.6 Management review

4.2 Understanding the needs and expectations of interested parties

4 Quality management system 5.6 Management review

4.3 Determining the scope of the quality management system

1.2 Application 4.2.2 Quality manual

4.4 Quality management system and its processes

4 Quality management system 4.1 General requirements

5 Leadership 5 Management responsibility 5.1 Leadership and commitment 5.1 Management commitment 5.1.1 General 5.1 Management commitment 5.1.2 Customer focus 5.2 Customer focus 5.2 Policy 5.3 Quality policy 5.2.1 Establishing the Quality Policy 5.3 Quality policy 5.2.2 Communicating the Quality Policy 5.3 Quality policy 5.3 Organizational roles, responsibilities and

authorities 5.5.1 Responsibility and authority 5.5.2 Management representative 5.4.2 Quality management system planning

6 Planning 5.4.2 Quality management system planning 6.1 Actions to address risks and opportunities 5.4.2 Quality management system planning

8.5.3 Preventive action 6.2 Quality objectives and planning to achieve

them 5.4.1 Quality objectives

6.3 Planning of changes 5.4.2 Quality management system planning 7 Support 6 Resource management 7.1 Resources 6 Resource management

7.1.1 General 6.1 Provision of resources 7.1.2 People 6.1 Provision of resources 7.1.3 Infrastructure 6.3 Infrastructure 7.1.4 Environment for the operation of

processes 6.4 Work environment

7.1.5 Monitoring and measuring resources 7.6 Control of monitoring and measuring equipment

7.1.5.1 General 7.6 Control of monitoring and measuring

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equipment

7.1.5.2 Measurement traceability 7.6 Control of monitoring and measuring equipment

7.1.6 Organizational knowledge No equivalent clause 7.2 Competence 6.2.1 General

6.2.2 Competence, training and awareness 7.3 Awareness 6.2.2 Competence, training and awareness 7.4 Communication 5.5.3 Internal communication 7.5 Documented information 4.2 Documentation requirements 7.5.1 General 4.2.1 General 7.5.2 Creating and updating 4.2.3 Control of documents

4.2.4 Control of records 7.5.3 Control of documented Information 4.2.3 Control of documents

4.2.4 Control of records 8 Operation 7 Product realization 8.1 Operational planning and control 7.1 Planning of product realization 8.2 Requirements for products and services 7.2 Customer-related processes 8.2.1 Customer communication 7.2.3 Customer communication 8.2.2 Determination of requirements for

products and services 7.2.1 Determination of requirements related to the

product 8.2.3 Review of the requirements for products

and services 7.2.2 Review of requirements related to the

product 8.2.4 Changes to requirements for products and

services 7.2.2 Review of requirements related to the

product 8.3 Design and development of products and

services 7.3Design and development

8.3.1 General 7.3.1 Design and development planning 8.3.2 Design and development planning 7.3.1 Design and development planning 8.3.3 Design and development inputs 7.3.2 Design and development inputs 8.3.4 Design and development controls 7.3.4 Design and development review

7.3.5 Design and development verification 7.3.6 Design and development validation

8.3.5 Design and development outputs 7.3.3 Design and development outputs 8.3.6 Design and development changes 7.3.7 Control of design and development changes 8.4 Control of externally provided processes,

products and services 7.4.1 Purchasing process

8.4.1 General 4.1 General requirements 7.4.1 Purchasing process

8.4.2 Type and extent of control 7.4.1 Purchasing process 7.4.3 Verification of purchased product

8.4.3 Information for external providers 7.4.2 Purchasing information 7.4.3 Verification of purchased product

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8.5 Production and service provision 7.5 Production and service provision 8.5.1 Control of production and service

provision 7.5.1 Control of production and service provision 7.5.2 Validation of processes for production and

service provision 8.5.2 Identification and traceability 7.5.3 Identification and traceability 8.5.3 Property belonging to customers or

external providers 7.5.4 Customer property

8.5.4 Preservation 7.5.5 Preservation of product 8.5.5 Post-delivery activities 7.5.1 Control of production and service provision 8.5.6 Control of changes 7.3.7 Control of Design and Development

Changes 8.6 Release of products and services 7.4.3 Verification of purchased product

8.2.4 Monitoring and measurement of product 8.7 Control of nonconforming outputs 8.3 Control of nonconforming product 9 Performance evaluation 8 Measurement, analysis and

improvement 9.1 Monitoring, measurement, analysis and

evaluation 8 Measurement, analysis and improvement

9.1.1 General 8.1 General 8.2.3 Monitoring and Measurement Processes

9.1.2 Customer satisfaction 8.2.1 Customer satisfaction

9.1.3 Analysis and evaluation 8.4 Analysis of data 9.2 Internal audit 8.2.2 Internal audit 9.3 Management review 5.6 Management review 9.3.1 General 5.6.1 General 9.3.2 Management review input 5.6.2 Review input 9.3.3 Management review output 5.6.3 Review output 10 Improvement 8.5 Improvement 10.1 General 8.5.1 Continual improvement 10.2 Nonconformity and corrective action 8.3 Control of nonconforming product

8.5.2 Corrective action 10.3 Continual Improvement 8.5.1 Continual improvement

8.5.3 Preventive action

REVISION HISTORY - SECTION 11

Date Change Description Revision 01/14/16 Added NIST Handbook 150 references. See ECR #70238 for details. J

02/10/18 Major revision. Updated language and requirements from ISO 9001:2008 to ISO 9001:2015. See ECO# XXXXX. K

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