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AAMI Credentials Institute

Applicant Handbook for Certified Quality System Manager (CQSM)

Q1 Winter Testing Period

Q2 Spring Testing Period

Q3Summer Testing Period

Q4 Fall Testing Period

APPLICATION DEADLINE March 24, 2015 April 25, 2015 July 25, 2015 October 24, 2015

TESTING WINDOW Begins Ends

April 18, 2015 April 25, 2015

June 6, 2015 June 13, 2015

September 5, 2015September 12, 2015

December 5, 2015December 12, 2015

2015 Exam Schedule

About AAMI .............................................................................................................. 1ACI Objective ............................................................................................................. 1ACI Statement Of Fairness And Non-Discrimination.................................................... 1Code Of Conduct ...................................................................................................... 1Types Of Certifications ............................................................................................... 1Testing Agency ........................................................................................................... 1AMP Nondiscrimination Policy .................................................................................... 1Definitions And Scope ................................................................................................ 2Eligibility Requirements .............................................................................................. 2Approved Disciplines .................................................................................................. 2Examination Administration ....................................................................................... 3Exam Schedule ........................................................................................................... 3Assessment Center Locations ..................................................................................... 3Military Personnel ...................................................................................................... 3Special Test Centers Excluding The United States And Parts Of Canada ...................... 3Special Arrangements For Candidates With Disabilities ............................................... 3Telecommunication Devices For The Deaf ................................................................... 4Scheduling An Examination ........................................................................................ 4Application And Examination Fees ............................................................................. 4Transfers, Rescheduling, And Refunds ........................................................................ 4Rescheduling Or Canceling An Examination ............................................................... 5Missed Appointments And Cancellations ................................................................... 5Inclement Weather, Power Failure Or Emergency ........................................................ 5Identification .............................................................................................................. 5Security ...................................................................................................................... 6Personal Belongings ................................................................................................... 6Examination Restrictions ............................................................................................ 6Misconduct ................................................................................................................ 6Cheating .................................................................................................................... 7Copyrighted Examination Questions ........................................................................... 7Detailed Content Outline ........................................................................................... 7References ................................................................................................................. 8Computer Login ......................................................................................................... 8Practice Examination .................................................................................................. 8Timed Examination .................................................................................................... 9Candidate Comments ................................................................................................ 9Reporting Of Results .................................................................................................. 9Confidentiality ......................................................................................................... 10Attainment Of Certification ...................................................................................... 10Appeal And Challenge Procedures ........................................................................... 10Retesting Procedures ................................................................................................ 10Canceled Scores ....................................................................................................... 10Duplicate Score Report ............................................................................................. 10Score Verification ..................................................................................................... 10Application Instructions ............................................................................................ 10Application Checklist ............................................................................................... 11Recertification Requirements .................................................................................... 11Total Points Required ................................................................................................ 12Special Accommodation Form .................................................................................. 13CQSM Application ................................................................................................... 15

HANDBOOK CONTENTS

4301 N. Fairfax Drive Suite 301 Arlington, VA 22203-1633

T +1-703-525-4890 F +1-703-276-0793

[email protected]

Copyright © 2015 Association for the Advancement of Medical Instrumentation All rights reserved

1 ACI 2015 Applicant Handbook for CQSM

ABOUT AAMI

AAMI, the Association for the Advancement of Medical Instrumentation, is a nonprofit organization founded in 1967. It is a diverse community of nearly 7,000 healthcare technology professionals united by one important mission—supporting the healthcare community in the development, management, and use of safe and effective medical technology.

ACI OBJECTIVE

The AAMI Credentials Institute’s (ACI) objective is to be the trusted source for quality professional development and credentials for healthcare technology-oriented professionals and entities in higher education, industry, and healthcare delivery.

ACI STATEMENT OF FAIRNESS AND NON-DISCRIMINATION

ACI adheres to principles of fairness and due process and endorses the principles of equal opportunity. In administering the credentialing programs, ACI shall not discriminate or deny opportunity to anyone on the grounds of gender, age, religion, national or ethnic origin, marital status, veteran status, sexual orientation, or disability.

CODE OF CONDUCT

The Code is designed to provide both appropriate ethical practice guidelines and enforceable standards of conduct for all ACI applicants, certificants, and candidates. The Code also serves as a professional resource for healthcare technology practitioners, as well as for those served by ACI certificants and candidates in the case of a possible ethical violation.

All ACI applicants, candidates, and certificants must agree to comply with the ACI Code of Conduct as outlined below:

• I will conduct my professional activities with honesty and integrity.

• I will uphold my professional conduct to the highest ethical standards.

• I will represent my certifications and qualifications honestly and provide only those services for which I am qualified to perform.

• I will maintain and improve my professional knowledge and competence through regular self-assessments, continuing practice, continuing education or training.

• I will act in a manner free of bias and discrimination against clients, colleagues, or customers.

• I will maintain the privacy of individuals and confidentiality of information obtained in the course of my duties unless disclosure is required by legal authority.

• I will obey all applicable laws, regulations, and codes.

• I will follow all certification policies, procedures, guidelines, and requirements of the ACI.

TYPES OF CERTIFICATIONS

The AAMI Credentials Institute maintains the certification programs for: • Certified Healthcare Technology Manager (CHTM)

• Certified Quality System Manager (CQSM)

• Certified Biomedical Equipment Technician (CBET)

• Certified Radiology Equipment Specialist (CRES)

• Certified Laboratory equipment Specialist (CLES)

TESTING AGENCY

Applied Measurement Professionals, Inc. (AMP) is engaged in educational and occupational measurement and provides examination development and administration to a variety of client organizations. AMP assists the AAMI Credentials Institute in the development, administration, scoring and analysis of the Certified Healthcare Technology Manager (CHTM) examination and the Certified Quality System Manager (CQSM) examination. AMP, located in the greater Kansas City area, is a leading provider of licensing and certification examinations for professional organizations.

AMP NONDISCRIMINATION POLICY

AMP does not discriminate among candidates on the basis of age, gender, race, color, religion, national origin, disability, marital status or any other protected characteristic.


DEFINITIONS AND SCOPE

Quality System Quality system means the organizational structure, responsibilities, procedures, processes, and resources for implementing quality management (FDA 21 CFR 820.3(v)

Quality System Manager A quality system manager oversees all aspects of Quality Assurance including: establishing metrics, applying industry best practices, and developing new tools and processes to ensure quality goals are met. A quality system manager also manages the process and resources for identifying, correcting, and improving non-conformities in product specific policies, procedures, and protocols as well as product specifications. Additionally, all of this is accomplished in a manner that insures compliance to all relevant regulatory requirements. Finally, the quality system manager controls, directs and/or leads the establishment and maintenance of an acceptable quality system and who reports on the performance of the quality system to executive management.

Science The intellectual and practical activity encompassing the systematic study of the structure and behavior of the physical and natural world through observation and experiment.

Engineering Any discipline that teaches the application of scientific and mathematical principles to practical ends such as the design, manufacture, support, and operation of efficient and economical structures, machines, processes, and systems. Some examples are academic degrees in mechanical engineering, electrical/electronic engineering, biomedical engineering, manufacturing engineering, and computing engineering.

ELIGIBILITY REQUIREMENTS

Path 1 10 years managing quality system programs with five years of management work experience prior to application.

Path 2 Bachelor’s degree in the field of engineering, or science plus five years as a quality systems manager.

AAMI Membership is not a prerequisite for certification.

APPROVED DISCIPLINES

The following list of engineering and healthcare disciplines illustrative of the disciplines acceptable for candidacy. Please contact the ACI office if you have a degree that is not listed.

• Biology

• Chemistry

• Physics

• Engineering

• Environmental Engineering

• Chemical Engineering

• Nuclear Science

• Biomedical Engineering

• Industrial Engineering

• Electrical Engineering

• Environmental Engineering

• Biomedical Technology

• Medicine

• Nursing


EXAMINATION ADMINISTRATION

Examinations are delivered by computer at more than 190 AMP Assessment Centers located throughout the United States. Computer examinations are administered by appointment only Monday through Friday at 9:00 a.m. and 1:30 p.m. Saturday appointments may be scheduled based on availability. Available dates will be indicated when scheduling your examination. Candidates are scheduled on a first-come, first-served basis.

ASSESSMENT CENTER LOCATIONS

AMP Assessment Centers have been selected to provide accessibility to the most candidates in all states and major metropolitan areas. A current listing of AMP Assessment Centers, including addresses and driving directions may be viewed at AMP’s website located at www.goAMP.com. Specific address information will be provided when you schedule an examination appointment.

MILITARY PERSONNEL

If an applicant is in the military, lives on a non-domestic US military base and cannot leave that base to take the examination at an established testing center, special arrangements can be made for testing on base. However, examinations must take place during the testing period listed on the cover of the handbook. Complete the request for special test center form (available at www.aami.org/aci) and submit it to ACI at least eight weeks before the examination date. The special testing center fee is not required.

SPECIAL TEST CENTERS EXCLUDING THE UNITED STATES AND PARTS OF CANADA

It may be possible to establish a special testing center to take an ACI examination outside of the United States for an additional fee of $100. Specify your preferred city and country on the exam application. Requests must be received eight weeks before the testing window begins.

If there are no AMP test centers in your province in Canada, you can follow this same procedure or travel to

the closest computerized testing center in the United States to take the examination. All of the applications for a group international test center must be submitted to ACI in one package, with all the fees and original documentation included.

SPECIAL ARRANGEMENTS FOR CANDIDATES WITH DISABILITIES

AMP complies with the Americans with Disabilities Act and strives to ensure that no individual with a disability as defined by the ADA as a person who has a physical or mental impairment that substantially limits one or more major life activities, a person who has a history or record of such an impairment, or a person who is perceived by others as having such an impairment is deprived of the opportunity to take the examination solely by reason of that disability. AMP will provide reasonable

accommodations for candidates with disabilities. Candidates requesting special accommodations must call AMP at +1 888-519-9901 to schedule their examination.

1. Wheelchair access is available at all established Assessment Centers. Candidates must advise AMP at the time of scheduling that wheelchair access is necessary.

2. Candidates with visual, sensory, physical or learning disabilities that would prevent them from taking the examination under standard conditions may request special accommodations and arrangements.

Verification of the disability and a statement of the specific type of assistance needed must be made in writing to AMP at least 45 calendar days prior to your desired examination date by completing the Request for Special Examination Accommodations form. AMP will review the submitted forms and will contact you regarding the decision for accommodations.

EXAM SCHEDULE

Application Deadline

Testing Window Begins

Testing Window Ends

Q1 Winter Testing Period

March 24, 2015 April 18, 2015 April 25, 2015

Q2 Spring Testing Period

April 25, 2015 June 6, 2015 June 13, 2015

Q3 Summer Testing Period

July 25, 2015 September 5, 2015 September 12, 2015

Q4 Fall Testing Period

October 24, 2015 December 5, 2015 December 12, 2015


TELECOMMUNICATION DEVICES FOR THE DEAF

AMP is equipped with Telecommunication Devices for the Deaf (TDD) to assist deaf and hearing-impaired candidates. TDD calling is available 8:30 a.m. to 5:00 p.m. (Central Time) Monday thru Friday at 913-895-4637. This TDD phone option is for individuals equipped with compatible TDD machinery.

SCHEDULING AN EXAMINATION

Examination applications and fees must be submitted to ACI. Once approved, you will receive from AMP a postcard and email with instructions on how to schedule your examination. Once you have received instructions from AMP, there are two (2) ways to schedule your examination.

1. Online Scheduling Go to www.goAMP.com at any time and select “Schedule/Apply for An Exam.” Follow the simple, step-by-step instructions to choose your examination and register for the examination.

OR

2. Telephone Scheduling Call AMP at +1 888-519-9901 to schedule an examination appointment. This toll-free number is answered from 7:00 a.m. to 9:00 p.m. (Central Time) Monday through Thursday, 7:00 a.m. to 7:00 p.m. on Friday, and 8:30 a.m. to 5:00 p.m. on Saturday.

If you contact AMP by 3:00pm Central Time on:

Depending on availability, your examination may be scheduled as early as:

Monday Wednesday

Tuesday Thursday

Wednesday Friday/Saturday

Thursday Monday

Friday Tuesday

When you schedule your examination appointment, be prepared to confirm a location and a preferred date and time for testing. You will be asked to provide your unique identification number that was provided on your scheduling notice. You will be notified of the time to report to the Assessment Center and if an e-mail address is provided you will be sent an e-mail confirmation notice.

If special accommodations are being requested, complete the Request for Special Examination Accommodations forms included in this handbook and submit it to AMP at least 45 days prior to the desired examination date.

APPLICATION AND EXAMINATION FEES

Application Fee (required from all, non-refundable, valid for two years) ............ $ 100

AAMI Members Examination Fee ................ $ 320

Non-members Examination Fee ................... $ 400

Retesting Fee (non-refundable) ................... $ 300

Rescheduling Fee (non-refundable. Exams may be rescheduled once) ................... $ 50

Special Testing Center Fee (non- refundable outside the U.S. or Canada) ....... $ 100

The reduced fee for AAMI members is non-transferable between individuals or within departments and available only to those individuals whose AAMI membership dues are paid in full at the time of exam registration.

TRANSFERS, RESCHEDULING, AND REFUNDS

Cancellations and requests for refunds must be in writing.

Applicants who choose not to take the examination may receive a partial refund of 50% of the application fee if the written request is received within 30 days after the original testing date. Requests for refunds will not be honored after the 30 days.

Applicants unable to take the examination as scheduled may request a transfer to another testing window. Please send a written request with the rescheduling fee of $50 to the ACI within 30 days after the testing period has ended.

The rescheduling fee cannot be refunded. Once applicants choose to reschedule, they cannot request a refund of either the rescheduling fee or of the examination fee(s).

Examinations may be rescheduled once. Please plan accordingly.


RESCHEDULING OR CANCELING AN EXAMINATION

You may reschedule your appointment ONCE at no charge within the same testing window by calling AMP at +1 888-519-9901 at least two business days prior to your scheduled appointment. The following schedule applies.

AMP must be contacted by 3:00pm Central Time to reschedule the Examination by the previous:

If your Examination is scheduled on:

Monday Wednesday

Tuesday Thursday

Wednesday Friday

Thursday Monday

Friday Tuesday

MISSED APPOINTMENTS AND CANCELLATIONS

You will forfeit your examination registration and all fees paid to take the examination under the following circumstances. A new, complete application and examination fee are required to reapply for the examination.

• You wish to reschedule an examination but fail to contact AMP at least two business days prior to the scheduled testing session.

• You wish to reschedule a second time.

• You appear more than 15 minutes late for an examination.

• You fail to report for an examination appointment.

INCLEMENT WEATHER, POWER FAILURE OR EMERGENCY

In the event of inclement weather or unforeseen emergencies on the day of an examination, AMP will determine whether circumstances warrant the cancellation, and subsequent rescheduling, of an examination. The examination will usually not be rescheduled if the Assessment Center personnel are able to open the Assessment Center.

You may visit AMP’s website at www.goAMP.com prior to the examination to determine if AMP has been advised that any Assessment Centers are closed. Every attempt is made to administer the examination as scheduled; however, should an examination be canceled at an Assessment Center, all scheduled candidates will receive notification following the examination regarding rescheduling or reapplication procedures.

If power to an Assessment Center is temporarily interrupted during an administration, your examination will be restarted. The responses provided up to the point of interruption will be intact, but for security reasons the questions will be scrambled.

TAKING THE EXAMINATION

Your examination will be given via computer at an AMP Assessment Center. You do not need any computer experience or typing skills to take the computer examination. On the day of your examination appointment, report to the Assessment Center no later than your scheduled testing time. If you arrive more than 15 minutes late after the scheduled testing time, you will not be admitted.

IDENTIFICATION

To gain admission to the assessment center, you must present two forms of identification. The primary form must be government issued, current and include your name, signature and photograph. No form of temporary identification will be accepted. You will also be required to sign a roster for verification of identity.

• Examples of valid primary forms of identification are: driver’s license with photograph; state identification card with photograph; passport; military identification card with photograph.

• The secondary form of identification must display your name and signature for signature verification (e.g., credit card with signature, social security card with signature, employment/student ID card with signature).

• If your name on your registration is different than it appears on your identification, you must bring proof of your name change (e.g., marriage license, divorce decree or court order).

Candidates must have proper identification to gain admission to the Assessment Center. Failure to provide appropriate identification at the time of the examination is considered a missed appointment. There will be no refund of examination fees.


SECURITY

AMP administration and security standards are designed to ensure all candidates are provided the same opportunity to demonstrate their abilities. The Assessment Center is continuously monitored by audio and video surveillance equipment for security purposes.

The following security procedures apply during the examination:

• Examinations are proprietary. No cameras, notes, tape recorders, pagers, calculators or cellular/smart phones are allowed in the testing room. Possession of a cellular/smart phone or other electronic devices is strictly prohibited and will result in dismissal from the examination.

• No guests, visitors or family members are allowed in the testing room or reception areas.

PERSONAL BELONGINGS

No personal items, valuables or weapons should be brought to the Assessment Center. Only wallets and keys are permitted. Large coats and jackets must be left outside the testing room. You will be provided a soft locker to store your wallet and/or keys with you in the testing room. The proctor will lock the soft locker prior to you entering the testing room. You will not have access to these items until after the examination is completed. Please note the following items will not be allowed in the testing room except securely locked in the soft locker. • Watches • Hats • Wallets • Keys

Once you have placed your personal belongings into the soft locker, you will be asked to pull out your pockets to ensure they are empty. If you bring personal items that will not fit in the soft locker, you will not be able to test. The site will not store or be responsible for your personal belongings.

If any personal items are observed or heard (e.g., cellular/smart phones, alarms) in the testing room after the examination is started, you will be dismissed and the administration will be forfeited.

EXAMINATION RESTRICTIONS

• Pencils will be provided during check-in.

• You will be provided with one piece of scratch paper at a time to use during the examination, unless noted on the sign-in roster for a particular candidate. You must return the scratch paper to the proctor at the completion of testing or you will not receive your score report.

• No documents or notes of any kind may be removed from the Assessment Center.

• No questions concerning the content of the examination may be asked during the examination.

• Eating, drinking or smoking is not permitted in the Assessment Center.

• You may take a break whenever you wish, but you will not be allowed additional time to make up for time lost during breaks.

MISCONDUCT

If you engage in any of the following conduct during the examination you may be dismissed, your scores will not be reported and examination fees will not be refunded. Examples of misconduct are when you:

• Create a disturbance, are abusive or otherwise uncooperative;

• Display and/or use electronic communications devices such as pagers, cellular/smart phones;

• Talk or participate in conversation with other examination candidates;

• Give or receive help or are suspected of doing so;

• Leave the Assessment Center during the administration;

• Attempt to record examination questions or make notes;

• Attempt to take the examination for someone else;

• Are observed with personal belongings, or

• Are observed with unauthorized notes, books or other aids not listed on the roster.

• Falsifying information required for admission to an examination impersonating another examinee

• Taking the examination for any reason other than the purpose of seeking certification


CHEATING

Any applicant failing to adhere to any of the rules as listed above will be considered guilty of cheating and will not be allowed to continue the examination. Fees are forfeited and no grade will be given. Incidents may be referred to the ACI board for adjudication.

COPYRIGHTED EXAMINATION QUESTIONS

All examination questions are the copyrighted property of AAMI Credentials Institute. It is forbidden under federal copyright law to copy, reproduce, record, distribute or display these examination questions by any means, in whole or in part. Doing so may subject you to severe civil and criminal penalties.

DETAILED CONTENT OUTLINE

I. Establishment of a Medical Device Quality System Recall 7 Application 22 Analysis 8 Totals 37%

A. Ensure the Quality System includes 1. Regulatory requirements 2. Business needs 3. Product requirements (for example: product

classification, sterile or non-sterile)

B. Establish metrics and performance indicators to monitor quality outcomes and measure the health of the Quality System 1. Report to management about the effectiveness of the

quality systems 2. Oversee Quality System and evaluate its ongoing

suitability 3. Identify suitable metrics 4. Analyze data

a. Sub-System specific b. Cross-sub system

5. Use statistical techniques 6. Initiate actions based on data analysis

C. Establish validation framework 1. Process 2. Software 3. Device design 4. Test method

D. Ensure the development of training framework applicable to:

1. regulatory compliance and company-specific procedures

2. quality management and quality engineering principles

E. Risk Management 1. Apply risk management tools to the quality system 2. Approve risk management plans and reports 3. Participate in risk management analysis 4. Approving Medical Device Report (MDR) and vigilance

reports 5. Lead Health Hazard Evaluations

II. Medical Device Quality System Compliance Recall 18

Application 5 Analysis 0 Totals 23%

A. Facilitate compliance with regulations and standards 1. 21 CFR

a. 7 b. 801 c. 806 d. 820 e. 803

2. ISO a. Vigilance requirements b.13485 c. 14971

3. Guidance documents a. Global Harmonization Task Force (GHTF/SG3/N99)

quality management systems- process validation guidance

b. FDA General Principles of Software Validation

B. Assess potential organizational impact of changes to

regulations and standards


III. Management Recall 8 Application 8 Analysis 24 Totals 40%

A. Lead the design, development and implementation of compliant quality system

B. Lead the management review process

C. Ensure effective resource planning for the quality system

D. Manage the quality of internal audit sub-systems

E. Develop quality plans

F. Manage Monitoring and feedback 1. corrective and preventive actions (CAPA) 2. Non conformance 3. Complaints 4. Recommend courses of action when non-compliance

is discovered 5. Audits 6. Ensure mechanisms exist to effectively capture, report

and trend customer feedback

G. Establish the quality policy, strategy (objectives), and tactics for the organization

H. Manage quality operations 1. control 2. assurance 3. engineering

I. Act as liaison to support organization’s interactions with notified bodies and regulatory organizations on compliance and management issues

J. Act as liaison to support organization’s external audits and inspections

K. Ensure training needs are assessed

REFERENCES

Global Harmonization Task Force GHTF/SG3/N99-10:2004 - (2nd Edition)

International Standards Organization (ISO) Medical device software - Part 1: Guidance on the application of ISO 14971 to medical device software ISO 13485:2009 ISO 14971:2007

Association for the Advancement of Medical Instrumentation (AAMI) ANSI/AAMI/IEC TIR80002-1:2009 The Quality System Compendium - (2nd Edition)

U.S. Food and Drug Administration (FDA): General Principles of Software Validation 21 CFR 7 21 CFR 801 21 CFR 803 21 CFR 806 21 CFR 820

International Medical Device Regulators Forum (IMDRF)

COMPUTER LOGIN

After your identification has been confirmed, you will be directed to a testing carrel. You will be instructed on-screen to enter your identification number. You will take your photograph which will remain on screen throughout your examination session. This photograph will also print on your score report.

PRACTICE EXAMINATION

Prior to attempting the examination, you will be given the opportunity to practice taking an examination on the computer. The time you use for this practice examination is NOT counted as part of your examination time or score.

When you are comfortable with the computer testing process, you may quit the practice session and begin the timed examination.


TIMED EXAMINATION

Following the practice examination, you will begin the timed examination. You will have two hours to complete the CQSM examination. Before beginning, instructions for taking the examination are provided on-screen.

The computer monitors the time you spend on the examination. The examination will terminate if you exceed the time allowed. You may click on the “Time” box in the lower menu bar on the screen to monitor your time. A digital clock indicates the time remaining for you to complete the examination. The Time feature may be turned off during the examination.

Only one examination question is presented at a time. The question number appears in the lower right of the screen. Choices of answers to the examination question are identified as A, B, C or D. You must indicate your choice by either typing in the letter in the response box in the lower left portion of the computer screen or clicking on the option using the mouse. To change your answer, enter a different option typing in the letter in the response box or by clicking on the option using the mouse. You may change your answer as many times as you wish during the examination time limit.

To move to the next question, click on the forward arrow (>) in the lower right portion of the screen. This action will move you forward through the examination question by question. If you wish to review any question(s), click the backward arrow (<) or use the left arrow key to move backward through the examination.

An examination question may be left unanswered for return later in the examination session. Questions may also be bookmarked for later review by clicking in the blank square to the right of the Time button.

To identify all unanswered and/or bookmarked questions, click on the hand icon. When the examination is completed, the number of examination questions answered is reported. If not all questions have been answered and there is time remaining, you may return to the examination and answer those questions. Be sure to provide an answer for each examination question before exiting the examination. There is no penalty for guessing.

CANDIDATE COMMENTS

During the examination, comments may be provided for any question by clicking on the button displaying an exclamation point (!) to the left of the Time button. This opens a dialogue box where comments may be entered. Comments will be reviewed, but individual responses will not be provided.

FOLLOWING THE EXAMINATION

After completing the examination, you are asked to complete a short evaluation of your examination experience. Then, you are instructed to report to the examination proctor to receive an examination completion report.

REPORTING OF RESULTS

Applicants will receive the results of the examination from AMP within four weeks after the close of the testing period. For information purposes, the results from AMP will include a total composite score and scores for each of the five content areas. Applicants who successfully pass the examination will receive an additional package from the ACI office. NOTE: Examination results will NOT be provided by AMP or ACI to any applicant for any reason, or under any circumstances over the telephone, by email, or by facsimile. Applicants are responsible for promptly notifying ACI and AMP of address or name changes.


CONFIDENTIALITY

Information about candidates for testing and their examination results are considered confidential. Studies and reports concerning candidates will contain no information identifiable with any candidate, unless authorized by the candidate.

It is up to each individual to notify an employer or others if they have passed or failed the examination. Upon inquiry, the ACI will release information regarding the status of an individual’s certification only (i.e. certified or not certified, active or inactive, date certification expires, and date certification was granted). Information regarding scores and whether an individual took the examination will not be released.

ATTAINMENT OF CERTIFICATION

Applicants who pass the examination successfully will receive their scores from AMP and a certification package from ACI. They are authorized and encouraged to use the appropriate acronym (CQSM) to denote certification on business cards, letterheads, at signature, etc.

ACI and AAMI reserve the right to publish the names of those who successfully pass the exams.

Achieving certification does not constitute an AAMI membership.

APPEAL AND CHALLENGE PROCEDURES

Applicants wishing to challenge a particular item on the examination must submit the Appeal/Challenge form to the ACI within 15 days of taking the examination. Applicants must provide as many details as possible regarding the item(s) they wish to challenge.

Applicants wishing to appeal the final score of their examination must submit the Appeal/Challenge form to the ACI within 15 days of receiving the examination results.

RETESTING PROCEDURES

Applicants who do not pass are eligible to retake the examination beginning with the next regularly scheduled testing window.

Individuals may not take the examination for a certification which they currently hold (active or inactive).

CANCELED SCORES

AMP is responsible for the validity and integrity of the scores they report. On occasion, occurrences, such as computer malfunction or misconduct by a candidate, may cause a score to be suspect. AMP reserve the right to void or withhold examination results if, upon investigation, violation of its regulations is discovered.

DUPLICATE SCORE REPORT

You may purchase additional copies of your results at a cost of $25 per copy. Requests must be submitted to AMP in writing. The request must include your name, identification number, mailing address, telephone number, date of examination and examination taken. Submit this information with the required fee payable to AMP in the form of a money order or cashier’s check. Duplicate score reports will be mailed within approximately two weeks after receipt of the request and fee. Requests must be submitted within one year of your examination to be processed.

SCORE VERIFICATION

Score Verification or manual score recheck must be submitted to AMP in writing. The request must include your name, identification number, mailing address, telephone number, date of examination and examination taken. Submit this information with the required $25 fee payable to AMP in the form of a money order or cashier’s check per request. Verified score reports will be mailed within approximately two weeks after receipt of the request and fee. Requests must be submitted within two weeks of receipt of your examination score.

APPLICATION INSTRUCTIONS

The application can be found online at www.aami.org/aci. It is also provided at the end of this handbook.

Complete all information requested unless noted as optional on the Application. Mark one response only unless otherwise indicated.

SIGNATURE: When you have completed all required information, obtain required signatures, date and sign the application in the space provided. Your signature acknowledges that you have read the contents of this handbook and will abide by and ALL ACI policies and procedures.

Applications will be returned if not submitted with the required documentation and fees.


Applications postmarked after the application deadline cannot be guaranteed acceptance.

Applications are valid only for the requested testing window.

Applications MUST be submitted electronically or postmarked by the application deadline as noted in the exam schedule section:

AAMI Credentials Institute (ACI) 4301 N. Fairfax Drive, Suite 301 Arlington, VA 22203-1633

Fax: +1-703-276-0793

[email protected]

NOTE: The name you enter on your application must match exactly the name listed on your current, government-issued photo ID such as driver’s license or passport. Do not use nicknames or abbreviations.

APPLICATION CHECKLIST

a. Completed and signed application by applicant and current supervisor.

b. Official diploma for all collegiate studies.

c. Written statement from human resources department confirming management and supervisory positions held.

d. Official college transcripts evaluated by World Educational Services (WES) www.wes.org for international applicants.

e. Notarized copies of transcripts and statements.

f. Copy of current curriculum vitae (CV) or resume.

g. For current or former Military Personnel: -Officer Record Brief (ORB) or Enlisted Record Brief (ERB) less than 60 days old. -Resume briefly depicting military assignments, military training, supervisory experience, and civilian education.- -Memorandum from the local military personnel service center listing evaluations and record brief as true copies.

APPLICATION AND EXAMINATION FEES

Application Fee (non-refundable, valid for two years .......................................................... $100

Examination Fee for AAMI Members ................. $320

Examination Fee ................................................ $400

Retesting Fee (non-refundable) ......................... $300

Rescheduling Fee (exams may be reschedued once) .............................................. $ 50

Special Testing Center (for applicants outside the U.S. or Canada ............................... $100

The reduced fee for AAMI members is non-transferable between individuals or within departments and available only to those individuals whose AAMI membership dues are paid in full at the time of exam registration

RECERTIFICATION REQUIREMENTS

Certification is initially considered valid through the remainder of the year in which certification is received plus the following full calendar year. At that time, it becomes necessary to renew certification for a fee set by ACI, and upon renewal, certification holders are put on a three-year recertification cycle.

If holding more than one certification from ACI, all certifications will have the same expiration date and the same recertification cycle.

Certificants can maintain their credentials by fulfilling renewal requirements in three categories. The renewal requirements will be documented in a continuing practice journal (CPJ) format.

Category I: Experience, Professional Engagement, Contributions to the Field

• Experience: Certification holders must have been actively employed as a QS manager or as performing management functions at least 50% of his/her time during the certification renewal cycle.

• Professional Engagement: Professional activities must be related directly to the role of a QS manager.

• Publications/Presentations: Content of these publications and presentations must be directly related to QS management functions, knowledge areas, and skills.

Category II: Education, Skills Development, Self-Study

• Academic: Content of the courses attended must be related directly to QS management functions, knowledge areas, and skills

• Continuing Education: Workshops, seminars, symposia designed to improve the QS managerial skills set and knowledge areas.

• Self-Learning: Self-motivated career development activities involving readings, formal discussions, organized meetings with peers and senior staff regarding topics directly related to QS management skills, knowledge areas and tasks.


Category III: Enhancing the Profession

• Providing job-related training, workshops, mentoring in QS management functions, knowledge areas, and skills.

TOTAL POINTS REQUIRED

Once earned, the CQSM will become the main certification. A total of 15 points from the activities listed above is the minimum requirement for successful recertification.

Multiple AAMI/ACI certification holders will be required to submit activities specific to their credentials. Activities cannot be duplicated or used for more than one credential.

NOTES

REQUEST FOR SPECIAL EXAMINATION ACCOMMODATIONS

If you have a disability covered by the Americans with Disabilities Act, please complete this form and the Documentationof Disability-Related Needs on the reverse side and submit it with your application at least 45 days prior to your requested examination date. The information you provide and any documentation regarding your disability and your needfor accommodation in testing will be treated with strict confidentiality.

Candidate InformationCandidate ID # ______________________ Requested Assessment Center:______________________

Name (Last, First, Middle Initial, Former Name)

Mailing Address

City State Zip Code

Daytime Telephone Number Email Address

Special AccommodationsI request special accommodations for the __________________________________________________ examination.

Please provide (check all that apply):

______ Reader

______ Extended testing time (time and a half)

______ Reduced distraction environment

______ Please specify below if other special accommodations are needed.

_______________________________________________________________________________

_______________________________________________________________________________

_______________________________________________________________________________

Comments: _________________________________________________________________________________________

______________________________________________________________________________________

______________________________________________________________________________________

PLEASE READ AND SIGN:I give my permission for my diagnosing professional to discuss with AMP staff my records and history as they relate to the requested accommodation.

Signature: _______________________________________________________ Date: ______________________________

Return this form with your examination application and fee to: Examination Services, AMP, 18000 W. 105th St., Olathe, KS 66061-7543.

If you have questions, call the Candidate Support Center at 888-519-9901.

Rev. 2/4/2015

DOCUMENTATION OF DISABILITY-RELATED NEEDS

Please have this section completed by an appropriate professional (education professional, physician, psychologist, psychiatrist) to ensure that AMP is able to provide the required accommodations.

Professional DocumentationI have known __________________________________________________ since _____ / _____ / _____ in my capacity as a Candidate Name Date

_______________________________________________________________________. My Professional Title

The candidate discussed with me the nature of the test to be administered. It is my opinion that, because of this candidate’s disability described below, he/she should be accommodated by providing the special arrangements listed on the reverse side.

Description of Disability: _______________________________________________________________________________

Signed:____________________________________________________ Title: ____________________________________

Printed Name: _______________________________________________________________________________________

Address:____________________________________________________________________________________________

___________________________________________________________________________________________________

Telephone Number: _____________________________ Email Address: ________________________________________

Date: ________________________________________ License # (if applicable): _________________________________

Return this form with your examination application and fee to: Examination Services, AMP, 18000 W. 105th St., Olathe, KS 66061-7543.

If you have questions, call the Candidate Support Center at 888-519-9901.

Rev. 2/4/2015

ACI 4301 N FAIRFAX DRIVE SUITE 301 ARLINGTON, VA 22203-1633 T +1 703-525-4890 F +1 703-276-0793 WWW.AAMI.ORG /ACI

Application for Examination for Certified Quality System Manager (CQSM)

PERSONAL INFORMATION

YOUR AAMI ID#

TESTING WINDOW Q1 Q2 Q3 Q4

EXAM LOCATION: CITY ____________________________________ STATE ________________ COUNTRY ____________________

HAVE YOU TAKEN THIS EXAM BEFORE? YES NO

PREFIX ______LAST NAME ____________________________________FIRST NAME ______________________________________

MIDDLE NAME _____________________________________________ SUFFIX (Jr, Sr, III, etc) _____

HOME ADDRESS 1 _____________________________________________________________________________________________

ADDRESS 2 ____________________________________________________________________________________________________

CITY ________________________________________________STATE ____________________ ZIP CODE ______________________

FOREIGN PROVINCE _________________________ FOREIGN POSTAL CODE _______________ COUNTRY _____________________

HOME PHONE ______________________________ HOME EMAIL ADDRESS ______________________________________________

COMPANY ____________________________________________________________________________________________________

WORK ADDRESS 1 _____________________________________________________________________________________________

ADDRESS 2 ____________________________________________________________________________________________________

CITY _________________________________________________STATE ____________________ ZIP CODE ______________________

FOREIGN PROVINCE _________________________FOREIGN POSTAL CODE _______________ COUNTRY _____________________

WORK PHONE ______________________________ WORK EMAIL ADDRESS ______________________________________________

OPTIONAL INFORMATION

GENDER Male Female Not specified

AGE RANGE Under 25 25-29 30-39 40-49 50-59 60+

RACE African American Asian Caucasian Hispanic Native American No Response

EMPLOYMENT STATUS Full time Part time Student Not currently employed

IS YOUR EMPLOYER PAYING FOR THIS EXAM? YES NO N/A

IS REIMBURSEMENT OF THE FEE DEPEND ON YOUR PASSING RESULT? YES NO N/A

ACI CQSM Application Form_2.23.15

ACI Application for Examination for Certified Quality System Manager (CQSM) Page 2

WHAT IS THE PRIMARY REASON YOU WISH TO BECOME CERTIFIED?

Preparation for seeking a new position

Required by current employer

To qualify for a higher professional position with current employer

To qualify for a salary increase with current employer

Personal choice/professional pride

Other

EDUCATIONYEAR DEGREE

NAME OF INSTITUTION DEGREE ATTAINED FIELD OF STUDY GRANTED

WORK EXPERIENCE FULL TIME

(F/T)

PART TIME

POSITION TITLE EMPLOYER EMPLOYER TELEPHONE DATE OF EMPLOYMENT

MM/YYYY-MM/YYYY (P/T)

PAYMENT INFORMATION

PAYMENT ENCLOSED (Certified check in US dollars payable

to AAMI)

PLEASE CHARGE MY

MasterCard VISA AmEx

CARD NUMBER _______________________________________________

EXP. DATE ____________________________________________________

CARDHOLDER NAME __________________________________________

ADDRESS ____________________________________________________

AS AN AUTHORIZED USER, I APPROVE THIS CHARGE.

FEES (PLEASE CHECK ALL THAT APPLY)

APPLICATION FEE

(non-refunable, valid for two years) .............$100

EXAMINATION FEE

AAMI Members ...........................................$320

Non-members .............................................$400

RETESTING FEE

(non-refundable) .........................................$300

RESCHEDULING FEE

(exams may be rescheduled once) ...............$ 50

SPECIAL TESTING CENTER FEE

(for applicants outside the U.S. or Canada) ..$100



PATH UNDER WHICH YOU ARE APPLYING PATH 1 10 years managing quality system programs with five (5) years of management work experience prior to

application.

PATH 2 Bachelor's degree in the field of engineering, or science plus five (5) years as a quality system manager.

APPLICANT VERIFICATION/AUTHORIZATIONI certify that all statements given in this Application are true and correct and that ACI, its examination committees, and and/

or its agents are hereby authorized to verify the information in this application and to make inquiries necessary to ascertain the

accuracy of this application and my eligibility for certification. I also authorize any organization and individual listed to validate this

application information. I understand that any misrepresentation of the information I have provided will result in the rejection of

this application and resulting examination. I also certify that I have read the ACI Applicant Handbook and understand and agree

to the policies set forth therein. I understand that I must comply with the ACI code of conduct and the recertification policy. I

release from all liabilities the ACI, its examination committees, and its agents, and I am aware that any certification I may receive

from the AAMI Credentials Institute (ACI) will not constitute and shall not be construed as a license.

NON-DISCLOSURE AGREEMENT AND GENERAL TERMS OF USEThis examination is confidential and proprietary. It is made available to you, the examinee, solely for the purpose of assessing your

competency in the area referenced in the title of this examination. You are expressly prohibited from recording, copying, disclos-

ing, publishing, reproducing, or transmitting this examination, in whole or in part, in any form or by any means, verbal or written,

electronic or mechanical, for any purpose, without the prior express written permission of AAMI Credentials Institute (ACI).

Non-compliance may lead to the revocation of your certification.

NAME OF SUPERVISOR ____________________________________________ PHONE # OF SUPERVISOR _______________________

BY CHECKING THIS BOX, I CERTIFY THAT THE INFORMATION PRESENTED IN THIS APPLICATION AND THE DOCUMENTS

PRESENTED ARE TRUE TO THE BEST OF MY KNOWLEDGE.

SIGNATURE OF SUPERVISOR _____________________________________________________

BY CHECKING THIS BOX, I CONSENT TO ALL THE STIPULATIONS ASSOCIATED WITH SUBMITTING THIS APPLICATION

FOR CONSIDERATION.

SIGNATURE OF APPLICANT ______________________________________________________

DATE OF APPLICATION ________________________________

APPROVED 02242015 JpM



FOR OFFICE USE ONLY

Program Code CQSM

DELIVERY METHOD CBT WEB

APPLICANT STATUS First time Repeat Recert

Completed and signed application by applicant and current supervisor

HR/memorandum/statements

Official college transcripts evaluated by WES

Notarized copies of transcripts, diplomas, and statements

Proof of AAMI membership

Required fees

Request for special accommodations

APPLICATION STATUS Approved Rejected

ELIGIBILITY BEGIN DATE _________________________ELIGIBILITY END DATE _____________________________

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