Quality Policy
Last revised on: November 15, 2024
Table of Contents
1.0 References
2.0 Introduction and Quality Management
2.1 Quality Management Principles
2.2 Process Approach
2.3 Plan-Do-Check-Act Cycle
2.4 Risk-Based Thinking
3.0 Quality Policy
4.0 Context of the Organization
4.1 Understanding the Organization and its Context
4.2 Understanding the Needs and Expectations of Interested Parties
4.3 Quality Management System: Scope, Core Elements and Processes
5.0 Leadership
5.1 Leadership & Commitment
5.2 Customer Focus
5.3 Organizational Roles, Responsibilities, and Authorities
6.0 Planning
6.1 Actions to Address Risks & Opportunities
6.2 Quality Objectives and Planning to Achieve Them
6.3 Planning of Changes
7.0 Support
7.1 Resources
7.2 Competence
7.3 Communication
7.4 Documented Information
8.0 Operation
8.1 Operational Planning and Control
8.2 Requirements for Products and Services
8.3 Design and Development of Products and Services
8.4 Control of Externally Provided Processes, Products, and Services
8.5 Production and Service Provision
8.6 Release of Products and Services
8.7 Control of Nonconforming Outputs
9.0 Performance Evaluations
9.1 Monitoring, Measurement, Analysis, and Evaluation
9.1.2 Customer Satisfaction
9.2 Internal Audit (Program to be developed and implemented in the future)
9.3 Management Review of QMS Processes
10.0 Company Improvement
10.1 General - Determine Opportunities
10.2 Nonconformity and Corrective Action
10.3 Continual Improvement
List of Tables
Table 1: The Needs and Expectations of Interested Parties
Table 2: ISO 9001 Element Responsibilities and IonQ QMS Documents
1.0 References
Number / Title | Name |
---|---|
ISO 9001:2015 | Quality Management Systems —Requirements |
2.0 Introduction and Quality Management
This Quality Manual is issued to ensure compliance with IonQ, Inc. (IonQ) corporate requirements to address quality in everything that we do and is aligned with all the ISO 9001:2015 (ISO 9001) requirements. The Quality Manual describes IonQ’s approach to our Quality Management System (QMS). It describes the structure of our QMS, delineates authorities and responsibilities of personnel who operate within the parameters of the QMS and provides reference to the procedures and processes that comprise it.
The manual identifies the processes in place at IonQ and the role of those processes in the context of the QMS. The details of the processes themselves are not described in the Quality Manual and live within the relevant documents as referenced. The manual is used to familiarize employees, customers, and other interested parties with the controls that have been implemented and to assure them that the integrity of our QMS is maintained and is focused on
2.1 Quality Management Principles
IonQ utilizes Quality Management Principles in the daily operation of the business. All principles should be considered as a whole and not in isolation from each other. No single principle is more important than another in Quality Management.
The Quality Management Principles are:
Customer focus - Connect organizational objectives to customer expectations.
Leadership - Leaders at all levels establish unity of purpose and direction, which enables IonQ to align corporate strategies, policies, values, processes, and resources to achieve company objectives.
Engagement of people - Competent, empowered, and engaged people at all levels are essential to enhance our ability to deliver value.
Process approach - The relationship between processes necessary to understand interdependencies and analyze the impact of changes.
Continuous Improvement - Connect improvement efforts to new product development.
Evidence-based decision making - Strike a balance between evidence, experience and intuition when making decisions.
Relationship management - Understand all relevant relations with suppliers, partners, customers and investors.
2.2 Process Approach
The process approach is the systematic definition and management of processes, and their interactions, done in accordance with the quality policy and strategic direction of the company. Management of the processes is achieved using the Plan-Do-Check-Act (PDCA) cycle (1.3) with an overall focus on risk-based thinking (1.4) aimed at taking advantage of opportunities and preventing undesirable results. Defining and managing interrelated processes as a system improves the company’s ability to achieve its intended results. Systematic definition and management of all relevant processes enables:
Understanding and consistency in meeting requirements;
The consideration of the processes in terms of adding value;
The achievement of effective process performance; and
Improvement activity based on the evaluation of data and information.
Processes will be defined to be as simple as possible with a clear definition of the purpose behind any process and within any step of a process.
2.3 Plan-Do-Check-Act Cycle
The PDCA cycle is a fundamental building block of our QMS system. PDCA closed-loop cycle can be briefly described as follows:
Plan: Establish the objectives relevant to the work, and document the approach ● Do: Implement what was planned
Check: Audit or review the results, determine changes or improvements ● Act: Implement improvement actions
2.4 Risk-Based Thinking
Risk-based thinking is integral to the operation of an effective QMS. Planning and implementation of actions to address both risks and opportunities creates a basis that increases the effectiveness of the QMS, by achieving improved results, and preventing negative effects.
IonQ follows the process defined in the Technical Risk Management Plan (CMPL-002). The risk management plan presents the process for implementing technical risk management as part of the overall execution of engineering design, production, and manufacturing activities.
3.0 Quality Policy
The quality policy provides the direction and framework for establishing key corporate level performance measures, as well as related objectives and targets.
IonQ Quality Policy
IonQ is dedicated to building the world’s best quantum computers to solve the world’s most complex problems. We do this by delivering exceptional, business-sustainable quality and customer value in all aspects of our design, development, and operations.
IonQ is committed to leading the world in high performance quantum computing by staying true to our company core values and setting far-reaching, yet fiscally responsible goals that drive innovation and performance.
Customer Experience: We care greatly about our relationships with our customers, how they feel about their quantum journey, and their level of satisfaction with every product, feature, and service provided by IonQ.
Continuous Improvement: We strive to continually improve our processes and promote a quality-focused culture throughout the organization, based on customer feedback and technological innovation, for the benefit of our customers, our employees, and our shareholders.
The Senior leadership team (S-team) ensures that our quality policy is documented, and that the policy is available to all interested parties as requested. This policy is approved and supported by the S-team, and all employees understand and embrace it. The policy is reviewed periodically to ensure continuing suitability.
4.0 Context of the Organization
4.1 Understanding the Organization and its Context
The ISO 9001 standard contains the requirements for the QMS. The context of the organization refers to the business environment in which the company operates. This includes both internal and external factors that can impact the organization's ability to achieve its objectives. By conducting a thorough analysis of the context of the organization and recognizing and comprehending these factors, IonQ can gain a better understanding of operations, identify risks and opportunities, and develop an effective QMS. This process is critical in meeting the requirements of the standard and achieving ISO 9001 certification.
The S-team will periodically evaluate factors that have an impact on our ability to meet the expectations of our customers and the strategic direction of the organization.
4.2 Understanding the Needs and Expectations of Interested Parties
IonQ is committed to monitoring the needs and expectations of the interested parties that are relevant to our strategic direction and that affect our ability to achieve the intended results of the QMS.
The S-team has established a list of interested parties that can affect or be affected by our operations. The list included in the Table 1 below will be reviewed and revised as necessary to ensure the QMS is supporting their requirements. Only a limited set of their respective needs and expectations are applicable to our operations and QMS.
Table 1 - The Needs and Expectations of Interested Parties
Interested Party/Stakeholder | Possible Needs & Expectations | IonQ Responsible Function/POC | Primary Methods Monitor, Capture, and Review Requirements |
Employees | Satisfaction, security, growth, safety, values | People Team | Employee meetings, engagement surveys, performance reviews |
Customers | Competitive pricing, advanced technology, reliability, value, satisfaction, contract requirements, on time delivery | Customer Success GTMR Engineering | Customer reviews and relationship management, customer feedback, webinars, seminars, employee engagement functions, technical presentations |
Shareholders Suppliers Competitors | Profitability, strategies for growth Productive, beneficial relationships, commercial stability and reliability, communications, capabilities Maintain larger market share, bigger share of Q-Voice in the market | Investor Relations Finance Procurement Supply Chain and Inventory Finance Sales & Marketing | Consultation and engagement forums and meetings Supplier performance evaluations and reviews, relationship management, scorecards Regular market research on competitors and their services, pricing, and technology |
Regulators Local Authorities and Government | Compliance and reporting Consultation and information, regulations adherence | Engineering Quality/EHS Facilities Quality/EHS | Critical product specification issues and conformity Engagement with planning and development issues |
Neighbors and Communities | Social responsibility and engagement, support, respect | Facilities Quality/EHS | Consultation and engagement exercises to identify environmental concerns |
4.3 Quality Management System: Scope, Core Elements and Processes
IonQ has established the scope of our QMS in order to implement our objectives, defined below below:
Design, develop, install, commission, service, and operate quantum computers, quantum programming platforms, and quantum applications in the cloud, within data centers, and on customer premises
IonQ utilizes an approach advocated by ISO for the identification, development, and maintenance of processes. IonQ recognizes that documenting our QMS is the first step towards fully implementing its requirements. The effectiveness of each process and its subsequent output is measured and evaluated. IonQ ensures that our QMS includes the documented information that is required to be maintained and retained by ISO 9001, and additionally, any documented information identified by IonQ that demonstrates the effective operation of our QMS.
5.0 Leadership
5.1 Leadership & Commitment
The S-team, with support of company wide leadership, ensures that all necessary resources, responsibilities and accountabilities are allocated for the continual improvement of the QMS. The S-team has delegated the responsibility and authority for managing our quality processes to the Quality Director to ensure that the necessary financial, technological, and organizational resources are available to implement, monitor and maintain the QMS.
IonQ governance structure provides necessary support for establishing processes that are important for achieving our quality objectives and policies. Governance activities include the systematic verification of QMS effectiveness by analyzing performance data and reviewing trends and key performance indicators (KPIs).
5.2 Customer Focus
The S-team ensures that the focus on improving customer experience is maintained by setting and reviewing objectives related to customer satisfaction.
5.3 Organizational Roles, Responsibilities, and Authorities
To ensure effective administration of the QMS, responsible authorities have been defined and communicated within the organization. The Director of Quality is the Management Representative for the QMS. The primary method of communicating responsibilities and authority to relevant levels of the organization is through QMS documentation. Quality processes define roles, responsibilities and authorities. Table 2 lists the ISO 9001 Element Responsibilities and associated IonQ documents.
Table 2 - ISO 9001 Element Responsibilities and IonQ QMS Documents
Secti on | ISO 9001 Clause - Description | IonQ QMS Document # | Responsible Authority |
4.3 | Quality Management System: Scope, Core Elements and Processes | Future | Quality Assurance |
6.1 | Actions to Address Risks and Opportunities | Technical Risk Management Plan (CMPL-0002) | Engineering & Technology |
6.2 | Quality Objectives and Planning to Achieve Them | IonQ 2024 OKRs (Confluence) | S-Team |
6.3 | Planning of Changes | Change Management SOP - Future | Quality Assurance |
8.1 | Operational Planning and Control | Configuration and Data Management Plan (CMPL-0001) | Systems Engineering |
8.2 | Requirements for Products and Services | IonQ PMRD Process (CMPC-0001) | Product Team |
8.3 | Design and Development of Products and Services | Product Development Lifecycle (CMPR-0001) | Engineering & Technology |
8.4 | Control of Externally Provided Processes, Products, and Services | Future | Procurement and Supply Chain Management (SCM) |
8.5 | Production and Service | Future | Product Engineering |
8.6 | Release of Products and Services | Future | Product Engineering |
8.7 | Control of Nonconforming Outputs | Material Review Board (MRB) Process (QAPC-0001) | Quality Assurance |
9.1 | Monitoring, Measurement, Analysis, and Evaluation | Calibration and Equipment Safeguarding (FCPR-0002) | Facilities |
9.2 | Internal Audit | Future | Quality Assurance |
9.3 | Management Review | Future | S-Team |
10.1 | General - Determine Opportunities | Future | S-Team |
10.2 | Nonconformity and Corrective Action | Future | Quality Assurance |
10.3 | Continual Improvement | Future | Quality Assurance |
The Director of Quality has the authority to ensure that the system is implemented and maintained in accordance with ISO 9001 requirements.
6.0 Planning
6.1 Actions to Address Risks & Opportunities
IonQ follows the process defined in the Technical Risk Management Plan (CMPL-0002). The risk management plan presents the process for implementing technical risk management as part of the overall execution of engineering development and production activities.
6.2 Quality Objectives and Planning to Achieve Them
Quality objectives are established annually, alongside all company objectives. Key Results are defined to measure progress towards the objectives, collectively referred to as OKRs. The progress and performance of the Quality OKRs are tracked and reviewed during periodic Business Reviews.
6.3 Planning of Changes
The QMS is implemented to meet our corporate objectives and the requirements of ISO 9001. The planning process involves establishing and communicating our policies and processes.
Planning for changes to processes, equipment, or facilities will be performed in a controlled manner to ensure the integrity of the QMS is maintained during the transition. Changes are incorporated at all levels. As needs for change are identified, they are captured in the company’s QMS and processed according to internal procedure based on the type of change. Leadership ensures that all personnel are made aware of any changes which affect their process, and that subsequent monitoring is undertaken to ensure that QMS changes are effectively implemented.
7.0 Support
7.1 Resources
Leadership determines and provides the resources necessary to maintain and improve the overall performance of the company. These resources are assessed periodically.
7.2 Competence
To ensure competence of our employees, job descriptions are prepared identifying the qualifications and responsibilities that are required for each position that operate within the scope of the QMS. Appropriate qualifications, previous professional experience, along with the provision of any required training, provide the competence required for each position.
Employee qualifications are reviewed upon hire, role change, or when position requirements change. The People Team maintains records of employee qualifications. If there are any differences between the employee’s qualifications and the requirements for the job, training or other action is taken to provide the employee with the necessary competence. The results of training are evaluated to determine if it was effective.
All employees are made aware of the importance of their activities and how they contribute to the achievement of our policies and objectives. The company maintains records of introductory training of personnel.
Internal Communication relevant to the QMS within the organization can occur between all levels and disciplines supporting product development and delivery. It can be in the form of direct conversations, written documentation, emails, meetings, etc.
External Communications relevant to the QMS typically include (but are not limited to) customers and suppliers. Sales, Front-end engineering, Product and Quality have primary contact with the customers. Customer communication is typically in response to quoting, delivery status, support, and quality issues or concerns. Purchasing, Quality, Engineering, and Operations have primary contact with suppliers. Supplier communication is typically in response to order placement, delivery schedules, product offerings, and responses to quality issues.
7.3 Communication
Internal Communication relevant to the QMS within the organization can occur between all levels and disciplines supporting product development and delivery. It can be in the form of direct conversations, written documentation, emails, meetings, etc.
External Communications relevant to the QMS typically include (but are not limited to) customers and suppliers. Sales, Front-end engineering, Product and Quality have primary contact with the customers. Customer communication is typically in response to quoting, delivery status, support, and quality issues or concerns. Purchasing, Quality, Engineering, and Operations have primary contact with suppliers. Supplier communication is typically in response to order placement, delivery schedules, product offerings, and responses to quality issues.
7.4 Documented Information
The purpose of document control is to ensure that employees have access to the current versions of documents and records, where and when needed. Documented information required to support the effectiveness of our QMS is controlled to ensure it is available, suitable for use, and is adequately protected, both from improper use and to maintain its integrity. Documented information includes documents and records created internally or those of external origin deemed necessary for the QMS.
For the control of documented information, the following activities have been defined:
Identification
Storage
Distribution
Access/retrieval
Protection/control of changes (version control)
Review and approvals
Retention and disposition
IonQ ensures that documented information is appropriately identified and described (e.g. title, date, author, reference number) and is available in an appropriate format and on appropriate media. Documented information is retained to provide evidence of conformity to the requirements specified by ISO standards, customer requirements, and of the effective operation of our QMS.
8.0 Operation
This section indicates QMS approach for products and services.
8.1 Operational Planning and Control
IonQ plans, implements and controls the processes needed to meet the requirements for our products and services, ensuring consistent acceptability of our offerings.
8.2 Requirements for Products and Services
IonQ follows the process defined in the IonQ Product Management Requirements Document (PMRD) Process (CMPC-0001). At the highest level, IonQ offers three categories of products.
Quantum Systems - our physical devices that run the quantum circuits, and on-device software that makes them run.
Quantum Platform - the software platform that makes our quantum computers usable by our customers.
Quantum Applications - applications development, optimization, integrations and more.
The Product Management team owns the product direction by defining the following: what we are building, why we are building it, who the customers are, what their needs are, etc.
8.3 Design and Development of Products and Services
IonQ follows the process defined in the Product Development Lifecycle and Phase-Gate Process (CMPR-0001). The product development life cycle is divided into phases corresponding to specific activities and increasing level of maturity of information and products. Programs, products, and projects are evaluated at specific points, known as gated reviews, to gain formal approval to progress through their life cycle.
8.4 Control of Externally Provided Processes, Products, and Services
All external processes, products, and services must conform to the requirements. The evaluation, selection, and monitoring of external suppliers will be based on their ability to provide processes or products in accordance with the specified requirements. Controls will be applied to external providers of processes, products, or services when they are incorporated in our product, provided directly to our customer on our behalf, or as a result of a management decision.
8.5 Production and Service Provision
IonQ works with customers and partners to determine the necessary requirements before acceptance of an order. Customer requirements may include the following:
Statutory and regulatory requirements related to the product;
Requirements required for delivery and post-delivery activities such as replacement parts; and
Any additional requirements determined by IonQ.
8.6 Release of Products and Services
The Product Engineering team is responsible for implementing the inspection and test activities needed to verify that product requirements are met at appropriate stages. Products are not used until they are inspected or verified as conforming to requirements.
When IonQ uses sampling inspection as a means of product acceptance, the plan is statistically valid and appropriate for use. The plan precludes the acceptance of lots whose samples have known nonconformities. When required, the plan is submitted for customer approval.
Documented information is retained to indicate the person authorizing the release of the product. Product release and service delivery does not proceed until all the arrangements have been satisfactorily completed, unless otherwise approved by a relevant authority.
8.7 Control of Nonconforming Outputs
Where necessary, any product or service output that does not conform to requirements is properly identified and controlled to prevent unintended use. The non-conformity is analyzed and the cause(s) are investigated.
Once the nonconforming outputs are corrected, the outputs are then verified for conformity against requirements. Documented information concerning non-conformances, the resolving authority, and the resulting corrective actions is retained.
Products are not released or delivered until all planned inspections and tests have been completed and that documented information exists to provide evidence of conformity with acceptance criteria and identifying the person(s) authorizing release.
9.0 Performance Evaluations
This section summarizes the QMS approach for performance evaluations for the company as whole.
9.1 Monitoring, Measurement, Analysis, and Evaluation
IonQ monitors, measures, analyses, and evaluates key QMS process outputs to ensure processes are effective. Data is analyzed to assess achievement of the organization’s strategic priorities and customer requirements.
9.1.2 Customer Satisfaction
IonQ monitors information and trends relating to customer perception as to whether the organization has fulfilled the customers’ requirements. Customer Satisfaction Surveys, complaints and other feedback are monitored.
9.2 Internal Audit (Program to be developed and implemented in the future)
IonQ conducts internal audits to provide information on whether the QMS:
Conforms to:
– The requirements of ISO 9001
– IonQ own requirements for its QMSIs being effectively implemented and maintained
Internal audits are performed at least once per year by trained personnel who are independent of the activity being audited, thus ensuring that auditors do not audit their own work. The results of the internal audits are documented and communicated to leadership. Appropriate corrective actions are implemented for any nonconformances discovered.
9.3 Management Review of QMS Processes
To ensure the continuing suitability, adequacy and effectiveness of the QMS the S-team conducts process reviews periodically. The primary inputs reviewed comprise data from target areas and key performance indicators gathered at data points from various processes. Subsequent recommendations for improvement are based on the evaluation of such measurements.
The primary outputs of management reviews are the actions necessary to make changes or improvements to our QMS and the provision of resources needed for implementation.
Responsibilities for required actions are assigned by the S-team . Any decisions made during the review, assigned actions, and their due dates are recorded in the management review.
10.0 Company Improvement
10.1 General - Determine Opportunities
The S-team selects opportunities for improvement and implements actions to meet customer requirements and improve customer satisfaction. This includes improving products to meet future expectations, correcting, preventing, or reducing undesired results, and improving the performance and effectiveness of the QMS.
IonQ drives improvement via the analysis of relevant data in order to implement any necessary actions to meet the requirements of relevant parties, or enhance customer satisfaction. The data inputs for the improvement process may include the following:
Risk and opportunity evaluations;
Assessment of the changing needs and expectations of interested parties;
The conformity of existing products and services;
The effectiveness of our QMS;
Supplier performance;
Reducing unintended consequences;
Increasing beneficial impact and opportunities;
Levels of customer satisfaction, including complaints and feedback;
Internal and external audit results;
Corrective action and non-conformance rates;
Data from process and product characteristics and their trends.
The overall effectiveness of continual improvement programs is assessed through our management review process.
10.2 Nonconformity and Corrective Action
When a nonconformity occurs, IonQ reacts to the nonconformity and, as applicable, takes action to control the situation, minimize the impact, resolve the issue, and prevent it from recurring.
Our corrective action process includes an in-depth analysis, identification of the root cause, development of corrective actions and evaluation of actions taken to assess their effectiveness. We retain documented information related to the nature of nonconformities and subsequent actions taken. If necessary, other responsible parties will be consulted to identify the root cause and plan appropriate action. The results of the corrective action are recorded within the respective corrective action reports and stored.
10.3 Continual Improvement
IonQ continually improves the effectiveness of its QMS through the application of the corporate policies, objectives, auditing and data analysis, corrective actions, risk management, and management reviews.
The continual improvement process begins with the establishment of our corporate policies and objectives for improvement, based on objectives contained in our business plan. Customer satisfaction, internal audit data, process and product performance data, and the cost of poor quality or risk control are then compared against OKRs or KPIs to identify additional opportunities for improvement.
IonQ’s continuous improvement process uses the PDCA cycle to improve the effectiveness of the organization, while reducing the risk. This is achieved through periodic reviews of:
Internal and External Organizational Factors
Strategic Priorities
Critical Success Factors & Risks
Policies / Objectives
Key Performance Indicators
The overall effectiveness of continual improvement programs, including corrective actions taken, as well as the overall progress towards achieving corporate level improvement objectives, are assessed through our management review process.