iso 13485-9004

The effectiveness of a process is determined by its efficiency

Management reviews must be conducted at:

An organization's identity is shaped by its:

The engagement of people is crucial for achieving sustained success

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

The Management Representative must have the responsibility and authority to:

The values of an organization are intended to:

Product accepted by concession can be released only if:

The performance of a process should be evaluated using only financial metrics

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

The organization should manage its resources to ensure they are:

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

The effectiveness of corrective actions must be verified, but preventive actions do not require effectiveness verification.

The strategy should include an assessment of risks and opportunities

Infrastructure maintenance records must be kept to demonstrate control.

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

For an organization to be successful, it must understand the needs and expectations of its:

When an organization chooses to outsource any process that affects product conformity, it must:

The purpose of a strategy is to:

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

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

Validation of production and service provision processes is required when:

Cleanliness of product requirements apply if:

If an organization does not design medical devices, they can exclude design and development controls with proper justification.

The performance of a process can be measured by:

Corrective action is taken to eliminate the cause of:

For sterile medical devices, the organization must maintain records of:

To establish an effective culture, top management should:

Auditors must not audit:

The leadership clause is only relevant to top management

A good strategy should take into account:

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

The engagement of people is influenced by:

Clinical evaluation or performance evaluation of a medical device is a core part of:

The strategy is a separate document and does not need to be integrated with the quality management system

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

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

The knowledge of an organization should be managed to:

Medical device files must be maintained for each medical device type or medical device family.

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

Effective leaders should provide an environment that promotes:

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

Design Transfer activities ensure that:

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

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

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

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

Leadership should be responsible for engaging people by:

The organization should manage its financial resources to:

The control of nonconforming product procedure must define the responsibilities and authorities for identification, segregation, and disposition.

According to Clause 4.2.4, the minimum retention period for quality records is:

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

The process approach helps an organization to manage risks and opportunities

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

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

The strategy should include the allocation of necessary resources to achieve its objectives

Records of training, skills, and experience must be:

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

Validation of QMS software applications must be performed:

When monitoring and measuring equipment is found not to conform to requirements, the organization must:

A leader should promote a culture of:

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

Changes to documents within the QMS must be reviewed and approved by:

The mission statement defines:

Sustained success is only achieved by satisfying customer needs

The key to sustained success is to maintain a balance between the organization's:

The interaction between processes should be documented to ensure effectiveness

People are the most important resource for an organization to achieve sustained success

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

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

The organization should evaluate its resources to:

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

Sustained success is achieved by maximizing short-term profits

The relationships with interested parties have no bearing on the organization's sustained success

Measuring equipment must be calibrated or verified against:

Design validation is performed to ensure that:

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

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

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

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

Responsibility and authority must be defined and communicated within the organization.

The process approach involves:

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

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

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

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

Organizations can exclude any requirement from Clause 4 if it does not match their company size.

The vision statement defines the organization's aspirations for the future

Top management must ensure that the quality policy is:

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

Internal audits must be conducted to determine whether the QMS:

If an organization determines that customer requirements cannot be met, they can still accept the order and fix it later without notifying the customer.

A process should be defined by its:

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

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

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

An organization's values are the:

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

The engagement of people is a result of: