iso 13485-9004

The organization's strategy must be developed by top management without input from other levels.

Management review outputs must include decisions and actions related to:

The identity of the organization provides a sense of:

Maintenance activities for production equipment must be performed:

Management reviews must be conducted at:

Purchasing information must describe or reference the product to be purchased, including where appropriate:

The process approach helps an organization to manage risks and opportunities

If a complaint is not investigated, the procedure must require that:

The Management Representative must be a member of organizational management, not an external third party.

Deteriorated or unreadable records are acceptable if they are older than 5 years.

The capability of a process is its ability to produce an output that meets requirements

The culture of an organization is the sole responsibility of top management

An organization's culture is a key factor in ensuring employee engagement

An effective strategy should be linked to the organization's:

Leadership is responsible for establishing a positive quality culture within the organization

The quality of the organization is directly related to the engagement of its people

The identity of the organization is a static concept that does not need to change over time

In planning product realization, the organization must establish documented procedures for:

The organization's resources are limited to its financial assets

Software validation for monitoring and measuring equipment is not required if the software is upgraded.

Records of the reviews of product requirements and actions arising from the review must be maintained.

The organization's identity has no impact on its relationships with interested parties

Leadership should ensure that resources are provided to support the organization's objectives

Verification of purchased product can only be performed at the supplier’s facility.

Records of the results of any corrective actions taken must be:

Which document specifies the scope of the QMS, including details of and justification for any exclusions?

Top management must ensure that the quality policy is:

The identity of the organization is defined by its mission and vision statements

The values of an organization are intended to:

The organization must implement corrective actions without unnecessary delay.

An organization's strategy is a one-time document that does not need to be updated

The engagement of people is influenced by:

The mission statement defines:

Outputs of design and development must be in a form suitable for verification against inputs.

The organization must establish documented requirements for medical device installation and acceptance criteria.

The needs and expectations of interested parties are static and do not change over time

An organization's identity is shaped by its:

The organization should determine and provide the necessary resources to:

If national regulations require reporting of adverse events, the organization must document a procedure for reporting to regulatory authorities.

The organization's strategy should be reviewed and revised at fixed intervals, regardless of changes in the environment.

A process should be defined by its:

Design reviews must include representatives of functions concerned with the design stage being reviewed.

Work environment requirements are completely optional for companies manufacturing sterile medical devices.

The engagement of people is crucial for achieving sustained success

Before committing to supply a product to a customer, the organization must review:

Who is responsible for ensuring that regulatory requirements are promoted throughout the organization?

Design Transfer activities ensure that:

The effectiveness of a process is determined by its efficiency

The engagement of people is a result of:

The mission statement provides the long-term aspirations for the organization's future

Effective leaders should provide an environment that promotes:

Customer feedback systems must be documented to provide an early warning of quality problems and to input into:

An effective leader should demonstrate commitment to the quality management system by:

Supplier performance must be monitored regularly, and the results must be recorded.

The organization should establish and manage its processes to:

If customer property (e.g., components, software, tools) is lost or damaged, the organization must:

When a worker requires special cleanroom clothing to enter a production area, this falls under:

The organization should manage its financial resources to:

Records of the nature of nonconformities and any subsequent actions taken must be maintained.

The Unique Device Identification (UDI) system is used primarily to improve:

Management reviews can be skipped if the company achieves zero non-conformities during an annual audit.

To develop an effective strategy, an organization must analyze its:

Traceability is only required if the device is an active implantable medical device.

The quality of the organization is determined by how well its quality management system is implemented

To establish an effective culture, top management should:

Data analysis must include data generated from monitoring, measurement, and other relevant sources.

The role of leadership is only to manage a team

An organization's quality culture is a collection of values, beliefs, and behaviors regarding quality

Personnel performing work affecting product quality must be competent based on appropriate:

The performance of a process can be measured by:

Feedback mechanisms must include provisions for proactive as well as reactive collection of data.

Records of design and development changes must include:

The concept of sustained success is relevant to an organization's:

The ability of an organization to achieve sustained success is based on:

The organization must maintain a record of the validation activities of QMS software.

The organization's environment for the operation of processes includes social, psychological, and physical factors

ISO 13485 requires a documented procedure for the control of documents.

An organization's values are the:

The primary purpose of controlling external documents is to:

A successful organization should prioritize its own financial needs over the needs of its employees

If a nonconforming product is detected after delivery or use has started, the organization must:

The mission and vision statements should be reviewed periodically to ensure they remain relevant

Nonconforming products must be mixed with good products to save warehouse space.

Leadership should be responsible for engaging people by:

An organization should manage its processes by:

The culture of an organization influences its ability to achieve:

Internal audit results do not need to be reported to management responsible for the area audited.

Design verification utilizes clinical trials or simulated use testing in real user environments.

The organization's context should be reviewed to identify:

Infrastructure requirements under Clause 6.3 include:

An organization's strategy is its long-term plan for achieving sustained success

Risk management processes must be active only during the design phase and stopped during mass production.

Top management must provide evidence of its commitment to the development and implementation of the QMS.

The strategy should be communicated to:

A leader who promotes a positive quality culture will :

Validation of QMS software applications must be performed:

Leadership must ensure that the organization's quality policy is only communicated to the quality department

Quality objectives must be:

An organization's sustained success is achieved through effective management of its processes

An organization can enhance its ability to achieve sustained success by using: