Essentials of ISO 13485:2003

Question 1

The requirements of ISO 13485:2003 accomplish what five (5) things?

Answer 1

These requirements:

1. Are widely applicable to medical devices and related services.
2. Provide for quality management through policy and procedure.
3. Relate directly to process managment
4. Help organizations improve effectiveness
5. Are harmonized with QMS requirements required by regulatory authorities.

Question 2

What five (5) benefits of ISO 13485:2003 do companies receive?

Answer 2

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1. Improved consistency of service and product performance.
2. Improved productivity and effectiveness
3. Improved communication and morale
4. Improved customer perception of organization’s image, culture and performance
5. Regulatory compliance.

Question 3

Who are the Six (6) groups who make up the Interested Parties?

Answer 3

1. Customers, patients and end-users
2. Medical industry professionals
3. People within the organization
4. Owners and investors
5. Suppliers and partners
6. Society

Question 4

Interested Parties are a _____________ having the interest in the _____________ or __________ of an organization

Answer 4

Person or group

performance

success

Question 5

A **Procedure **is a ____________ way to carry out an _________ or _________ - may be ________ or _________

Answer 5

Specified

activity

process

documented

not

Question 6

Define Process:

Answer 6

Set of interrelated or interacting activities which uses resources to transform inputs into outputs

Question 7

What does PDCA stand for?

Answer 7

Plan

Do

Check

Act

Question 8

In PDCA, what five (5) things are involved in the PLAN?

Answer 8

Planning:

1. Activities
2. Controls
3. Documentation
4. Resources
5. Objectives

Question 9

In PDCA, what is involved in the DO?

Answer 9

DO = Deploy and conform with the PLAN

Question 10

In PDCA, what is involved in the CHECK?

Answer 10

Measure and monitor for conformity and effectiveness

Question 11

In PDCA, what three (3) things are involved in ACT?

Answer 11

Actions:

1. Analyze/Review
2. Decide/Change
3. Improve effectiveness

Question 12

What is the benefit of PDCA?

Answer 12

Continual improvement of your process.

Question 13

A **Medical Device **does not achieve it primary intended action by _______, _________, or ____________ means, but which may be ____________ in its function by such means.

Answer 13

Pharmacological

Immunological

Metabolic

Assisted

Question 14

Quality is the

Answer 14

Degree to which a set of inherent characteristics fulfills requirements (ISO 9000:2005 3.1.1)

Question 15

Quality Management is the ________ _______ to ___________ and ________________ an organization with regard to quality.

Answer 15

Coordinated activities

direct

control

Question 16

An Auditor is a person with the ___________ to conduct an audit

Answer 16

competence

Question 17

ISO 9000:2005

Answer 17

QMS - Fundamentals and Vocabulary

Question 18

ISO 9001:2005

Answer 18

QMS - Requirements

Question 19

ISO 9004:2000

Answer 19

QMS - Guidelines for Performance Improvements

Question 20

ISO 19011:2002

Answer 20

Guidelines on Quality and/or Environmental Management Systems Auditing

Question 21

ISO 13485:2003

Answer 21

Medical Devices - Quality Management Systems - Requirements for Regulatory Purpose

Question 22

ISO 14971:2007

Answer 22

Medical Devices - Application of Risk Managment to Medical Devices

Question 23

PD CEN ISO/TR 14969:2005

Answer 23

Medical Devices - Quality Managment Systems - Guidance on the application of ISO 13485:2003

Question 24

The **Process Approach **systematically identifes and manages the ________, __________ and _______ of a system of ____________ within an organization.

Answer 24

linkage

combination

interaction

processes

Question 25

The **Process Approach** emphasizes: * Understanding and meeting \_\_\_\_\_\_\_\_\_ * Looking at ________ in terms of added value * Obtaining _______ of process performance * Continual ___________ of processes

Answer 25

requirements processes results improvement