Iso 13485

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

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

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

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

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

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

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

Maintenance activities for production equipment must be performed:

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

Validation of production and service provision processes is required when:

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

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

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

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

Infrastructure requirements under Clause 6.3 include:

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

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

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

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

Top management must ensure that the quality policy is:

Quality objectives must be:

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

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

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

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

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

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

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

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

Equipment calibration records must include:

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

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

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

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

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

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

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

Design Transfer activities ensure that:

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

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

Design validation is performed to ensure that:

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

Cleanliness of product requirements apply if:

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

Nonconforming product must be identified and controlled to prevent:

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

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

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

Management reviews must be conducted at:

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

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

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

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

Validation of QMS software applications must be performed:

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

Measuring equipment must be calibrated or verified against:

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

The documented procedure for complaint handling must include requirements for:

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

Records must remain legible, readily identifiable, and retrievable.

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

The documented procedure for corrective action must include requirements for:

Product accepted by concession can be released only if:

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

Design verification is performed to ensure that:

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

Design and development inputs must include:

Suppliers must be evaluated and selected based on:

Auditors must not audit:

Preventive action is taken to eliminate the cause of:

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

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

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

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

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

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

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

Management review outputs must include decisions and actions related to:

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

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

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

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

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

Records of design and development changes must include:

Records of training, skills, and experience must be:

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

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

The Management Representative must have the responsibility and authority to:

Infrastructure maintenance records must be kept to demonstrate control.

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

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

The primary purpose of controlling external documents is to:

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

The organization must implement corrective actions without unnecessary delay.

Corrective action is taken to eliminate the cause of:

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

Rework activities on a nonconforming product must be performed:

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

Internal audits must be conducted to determine whether the QMS:

Analysis of data must provide information relating to: