Iso 13485

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

The organization can use customer property without any special identification or safeguarding.

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

Corrective action is taken to eliminate the cause of:

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

If environmental conditions can have an adverse effect on product quality, the organization must:

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

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

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

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

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

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

Which of the following is a mandatory input for Management Review?

Servicing records, if servicing is a specified requirement, must be analyzed to look for:

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

Maintenance activities for production equipment must be performed:

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

Preventive action records must include results of the review of actions taken.

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

Measuring equipment must be protected from damage and deterioration during handling, maintenance, and storage.

Design verification is performed to ensure that:

If no national or international standard exists for calibration, the basis used for calibration must be documented.

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

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

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

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

Product accepted by concession can be released only if:

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

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

Validation of production and service provision processes is required when:

Internal audits must be conducted to determine whether the QMS:

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

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

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

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

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

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

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

Preventive action is taken to eliminate the cause of:

The Medical Device File (Clause 4.2.3) must contain or reference documents that demonstrate:

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

The organization must implement corrective actions without unnecessary delay.

Management review outputs must include decisions and actions related to:

Design Transfer activities ensure that:

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

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

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

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

Contamination control provisions are necessary if contact between personnel and the product could adversely affect product quality.

An organization must establish a documented procedure for issuing advisory notices.

The documented procedure for corrective action must include requirements for:

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

The Management Representative must have the responsibility and authority to:

Measuring equipment must be calibrated or verified against:

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

Suppliers must be evaluated and selected based on:

ISO 13485 does not require the organization to evaluate the effectiveness of the training provided.

Nonconforming product must be identified and controlled to prevent:

Statistical techniques can be used as a tool for data analysis under Clause 8.4.

Top management must ensure that the quality policy is:

Cleanliness of product requirements apply if:

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

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

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

Records of training, skills, and experience must be:

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

Corrective and preventive actions (CAPA) are considered optional under ISO 13485 if the customer is satisfied.

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

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

Validation of QMS software applications must be performed:

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

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

Management reviews must be conducted at:

Rework activities on a nonconforming product must be performed:

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

Equipment calibration records must include:

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

Auditors must not audit:

Quality objectives must be:

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

Design validation is performed to ensure that:

The primary purpose of controlling external documents is to:

Records of design and development changes must include:

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

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

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

Any software used in production monitoring or process control must be validated before initial use.

When evaluating a corrective action, the organization must ensure that the action:

Which of the following is NOT required to be a documented procedure under Clause 4?

Changes in regulatory requirements are not considered valid inputs for management review.

Infrastructure maintenance records must be kept to demonstrate control.

After rework, a nonconforming product does not need to be re-verified.

Infrastructure requirements under Clause 6.3 include:

Design and development inputs must include:

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

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

The documented procedure for complaint handling must include requirements for:

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

Analysis of data must provide information relating to:

Records must remain legible, readily identifiable, and retrievable.