Quality Management Systems

ICAA/EASA
Amman, May 2017

TE.GEN.00409‐001
 Outline

 INTRODUCTION
 ISO 9001
o VERSION 2015 VS 2008
o STRUCTURE
 QMS IN AVIATION ORGANIZATIONS
o ICAO STANDARDS
o PROCESSES
 CONCLUSION
 KEY ISSUES TO REMEMBER

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 Introduction: History of Quality
• 13th century: Craftsmen began organizing into unions called guilds .
• Early 19th century: Factory system with emphasis on product inspection, started in UK in the 
mid‐1750s and grew into the Industrial Revolution
• Early 20th century: Manufacturers began to include quality processes in quality practices
• World War II: Quality became a critical component (e.g: Bullets manufactured in one place 
had to work in weapons made in another). To simplify and speed up this process without the 
military began to use sampling techniques for inspection aided by the publication of military‐
specification standards.
• 1950s: Quality revolution in Japan. The Japanese welcomed the input of Joseph M. 
Juran and W. Edwards Deming and rather than concentrating on inspection, focused on 
improving all organizational processes through the people who used them.
• 1970s: U.S. response  to Japan´s high‐quality competition.  Emphasize not only statistics but 
approaches for the entire organization (Total Quality Management).
• 2000+: New quality systems have evolved from the foundations. Quality has moved beyond 
manufacturing into services (healthcare, education and government sectors).

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 Introduction: History of Quality

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 Introduction: Evolution of QM Standards

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 Introduction: The Concept of Quality

• TRANSCENDENT: EXCELLENCE
• PRODUCT‐BASED: QUANTITIES OF PRODUCT ATTRIBUTES
• USER‐BASED: FITNESS FOR INTENDED USE. MEETING OR
EXCEEDING USER EXPECTATIONS

• VALUE‐BASED: QUALITY VS. PRICE
• MANUFACTURING: CONFORMANCE TO SPECIFICATIONS

ISO 9000:2000 
DEGREE TO WHICH A SET OF INHERENT CHARACTERISTICS
FULFILS REQUIREMENTS

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 Introduction: International Standard Organisation
• ISO: INDEPENDENT, NON‐GOVERNMENTAL INTERNATIONAL ORGANIZATION WITH A
MEMBERSHIP OF 163 NATIONAL STANDARDS BODIES.

• IT BRINGS TOGETHER EXPERTS TO SHARE KNOWLEDGE AND DEVELOP VOLUNTARY, CONSENSUS‐

BASED, MARKET RELEVANT INTERNATIONAL STANDARDS THAT SUPPORT INNOVATION AND
PROVIDE SOLUTIONS TO GLOBAL CHALLENGES.

• CENTRAL SECRETARIAT LOCATED IN GENEVA, SWITZERLAND

POPULAR STANDARDS

ISO 9001 QUALITY MANAGEMENT ISO 14001 ENVIRONMENTAL MANAGEMENT

ISO 31000 RISK MANAGEMENT ISO 45001 OCCUPATIONAL HEALTH & SAFETY

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 Introduction: Quality System

SET OF MUTUALLY RELATED AND INTERACTING ELEMENTS (PEOPLE,

SYSTEM PROCEDURES AND EQUIPMENT)

SYSTEM THAT ESTABLISHES A POLICY,

MANAGEMENT SYSTEM OBJECTIVES AND PROCESSES FOR THE
ACHIEVEMENT OF THOSE OBJECTIVES

MANAGEMENT SYSTEM TO DIRECT

QUALITY MANAGEMENT SYSTEM AND CONTROL AN ORGANIZATION
WITH RESPECT TO QUALITY

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 Introduction: Quality System
QUALITY
MANAGEMENT

QUALITY QUALITY QUALITY

PLANNING ASSURANCE CONTROL

OBJECTIVES PERFORMANCE AUDIT

DRIVEN DRIVEN DRIVEN

• PROVIDE THE
• LAY OUT OF THE RESPONSIBILITIES, • ADDRESS THE ASSESSMENT
CONFIDENCE (AND
RESOURCES, PROCEDURES, AND CONDUCTED DURING QUALITY
EVIDENCE) THAT THE
PROCESSES TO BE UTILIZED FOR QUALITY ASSURANCE FOR CORRECTIVE
STANDARDS WILL BE
CONTROL AND QUALITY ASSURANCE ACTIONS
MET

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 ISO 9001: ISO 9001:2015 vs 9001:2008 
REASONS BEHIND THE CHANGE FROM ISO 9001:2008 TO 9001:2015
• ISO 9001:2015 NOW FOLLOWS THE SAME OVERALL STRUCTURE AS OTHER ISO MANAGEMENT
SYSTEM STANDARDS (HIGH‐LEVEL STRUCTURE), MAKING IT EASIER FOR ANYONE USING MULTIPLE
MANAGEMENT SYSTEMS. 

• FOCUS ON RISK‐BASED THINKING. ALTHOUGH IT HAS ALWAYS BEEN PART OF THE STANDARD, THE

NEW VERSION GIVES IT INCREASED PROMINENCE.

• PUTS GREATER EMPHASIS ON LEADERSHIP ENGAGEMENT

• HELPS ADDRESS ORGANIZATIONAL RISKS AND OPPORTUNITIES IN A STRUCTURED MANNER
• USES SIMPLIFIED LANGUAGE, PARTICULARLY HELPFUL TO ORGANIZATIONS USING MULTIPLE
MANAGEMENT SYSTEMS

• ADDRESSES SUPPLY CHAIN MANAGEMENT MORE EFFECTIVELY

• IS MORE USER‐FRIENDLY FOR SERVICE AND KNOWLEDGE‐BASED ORGANIZATIONS

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 ISO 9001: ISO 9001:2015 vs 9001:2008   

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 ISO 9001: Structure 
0. INTRODUCTION
0.3 PROCESS APPROACH
0.3.1 GENERAL
• UNDERSTANDING AND MANAGING INTERRELATED PROCESSES CONTRIBUTES TO THE ORGANIZATION´S EFFECTIVENESS IN
ACHIEVING ITS INTENDED RESULTS. THE APPLICATION OF A PROCESS APPROACH IN A QMS ENABLES:
o UNDERSTANDING AND CONSISTENCY IN MEETING REQUIREMENTS
o THE CONSIDERATION OF THE PROCESS IN TERMS OF ADDED VALUE
o THE ACHIEVEMENT OF EFFECTIVE PROCESS PERFORMANCE
o IMPROVEMENT OF PROCESSES BASED ON EVALUATION OF DATA AND INFORMATION

0.3.3  RISK BASED THINKING

PLANNING AND IMPLEMENTATION OF ACTIONS TO ADDRESS RISK AND OPPORTUNITIES TO INCREASE THE EFFECTIVENESS OF
THE QMS
ELEMENTS OF A SINGLE PROCESS
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 ISO 9001: Structure 
4.4. QMS AND ITS PROCESSES
PROCESS IDENTIFICATION

DETERMINE RELATIONSHIPS

ASSIGN RESPONSIBILITIES

IDENTIFY RISKS

DOCUMENT PROCESSES

SELECT INDICATORS IMPLEMENT ACTIONS TO IMPROVE PROCESSES

CAPTURE DATA ANALYSE DATA TO UNDERSTAND PROCESSES

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 ISO 9001: Structure 
0.3.2  PLAN‐DO‐CHECK‐ACT CYCLE
• THE PDCA CYCLE CAN BE APPLIED TO ALL PROCESSES AND TO THE QMS AS A WHOLE. IT CAN BE BRIEFLY DESCRIBED AS
FOLLOWS:
o PLAN: ESTABLISH THE OBJECTIVES OF THE SYSTEM AND ITS PROCESSES, AND THE RESOURCES NEEDED TO DELIVER RESULTS IN
ACCORDANCE WITH CUSTOMERS´ REQUIREMENTS AND THE ORGANIZATION´S POLICIES, AND IDENTIFY AND ADDRESS RISK AND
OPPORTUNITIES
o DO: IMPLEMENT WHAT WAS PLANNED
o CHECK: MONITOR AND (WHERE APPLICABLE) MEASURE PROCESSES AND THE RESULTING PRODUCTS AND SERVICES AGAINST POLICIES, 
OBJECTIVES, REQUIREMENTS AND PLANNED ACTIVITIES, AND REPORT THE RESULTS
o ACT: TAKE ACTIONS TO IMPROVE PERFORMANCE AS NECESSARY

STRUCTURE OF ISO 9001:2015 IN ACCORDANCE WITH PDCA 

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 ISO 9001: Structure 
5. LEADERSHIP 9. PERFORMANCE EVALUATION
5.1. LEADERSHIP & COMMITMENT 9.1. MONITORING, MEASURING, ANALYSIS & 
5.2. POLICY EVALUATION
5.3. ORGANIZATIONAL ROLES, RESPONSIBILITIES & AUTHORITIES 9.2. INTERNAL AUDIT
6. PLANNING 9.3. MANAGEMENT REVIEW
6.1. ACTIONS TO ADDRESS RISKS & OPPORTUNITIES 10. IMPROVEMENT
6.2. QUALITY OBJECTIVES & PLANNING TO ACHIEVE THEM 10.1. GENERAL
6.3. PLANNING OF CHANGES 10.2. NON CONFORMITY AND CORRECTIVE
7. SUPPORT ACTION
7.1. RESOURCES 10.3. CONTINUAL IMPROVEMENT
7.2. COMPETENCE
7.3. AWARENESS
7.4. DOCUMENTED INFORMATION
8. SUPPORT
8.1. OPERATIONAL PLANNING & CONTROL
8.2. REQUIREMENTS FOR PRODUCTS AND SERVICES
8.3. DESIGN & DEVELOPMENT OF PRODUCTS AND SERVICES
8.4. CONTROL OF EXTERNALLY PROVIDED PRODUCTS, PROCESSES & SERVICES
8.5. PRODUCTION AND SERVICE PROVISION
8.6. RELEASE OF PRODUCTS AND SERVICES
8.7. CONTROL OF NONCONFORMING OUTPUTS
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 QMS in Aviation: Quality in ICAO Standards 
DEFINITIONS The totality of features and characteristics of a product or service that
Quality •
bear on its ability to satisfy stated or implied needs

Quality  Documented organizational procedures and policies; internal audit of those

•
policies and procedures; management review and recommendation for
system quality improvement
A management approach focused on the means to achieve product or
•
Quality  service quality objectives through the use of its four key components:
management quality planning; quality control; quality assurance; and quality
improvement
All the planned and systematic actions necessary to provide adequate 
•
Quality  confidence that all activities satisfy given standards and requirements, 
assurance  including the ones specified by the approved training organization in 
relevant manuals
Quality  A systematic and independent examination to determine whether quality
•
activities and related results comply with planned arrangements and
audit whether these arrangements are implemented effectively and are suitable
to achieve objective

Quality  • A system for verifying and maintaining a desired level of quality in a product,
service or process through the effective implementation of documented
control  inspection and testing procedures

. MANUAL OF PROCEDURES FOR ESTABLISHMENT AND

MANAGEMENT OF A STATE’S PERSONNEL LICENSING SYSTEM
ICAO DOC 9379 AN/916 2nd EDITION 2012 

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 QMS in Aviation: Quality in ICAO Standards
SAFETY OVERSIGHT MANUAL (ICAO DOC. 9734 PART A) 

2.4 BALANCED APPROACH TO CONTROL AND

SUPERVISION
2.4.8 …
SOME STATESMAY SHARE SOME OF THE RESPONSIBILITY
FOR MONITORING INTERNAL SAFETY STANDARDS WITH
OTHER ORGANIZATIONS (AIR TRAFFIC AND AERODROME
SERVICE PROVIDERS, OPERATORS, APPROVED
MAINTENANCE ORGANIZATIONS, MANUFACTURERS, ETC.)
THAT HAVE BEEN FOUND TO BE RELIABLE AND TO ACT
RESPONSIBLY.
CRUCIAL TO THE CONFIDENCE THAT THE CAA MAY PLACE
IN CIVIL AVIATION CERTIFICATE HOLDERS AND TO THE
ASSOCIATED FREEDOM AND FLEXIBILITY IT CAN GIVE IS
THE ESTABLISHMENT BY THE CERTIFICATE HOLDERS OF
AN ADEQUATE QUALITY SYSTEM WHICH MUST BE
REVIEWED AND APPROVED BY THE CAA.

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 QMS in Aviation: Quality in ICAO Standards 
ANNEX 8 (INITIAL AIRWORTHINESS) 
2.4 PRODUCTION APPROVAL
2.4.1 WHEN APPROVING PRODUCTION OF AIRCRAFT OR
AIRCRAFT PARTS, THE CONTRACTING STATE SHALL:

a) EXAMINE THE SUPPORTING DATA AND INSPECT THE

PRODUCTION FACILITIES AND PROCESSES SO AS TO
DETERMINE THAT THE MANUFACTURING
ORGANIZATION IS IN COMPLIANCE WITH THE
APPROPRIATE PRODUCTION REQUIREMENTS; AND

b) ENSURE THAT THE MANUFACTURING

ORGANIZATION HAS ESTABLISHED AND CAN
MAINTAIN A QUALITY SYSTEM OR A PRODUCTION
INSPECTION SYSTEM SUCH AS TO GUARANTEE THAT
. EACH AIRCRAFT OR AIRCRAFT PART PRODUCED BY
THE ORGANIZATION OR BY SUB‐CONTRACTORS
AND/OR SUPPLIERS IS AIRWORTHY.

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 QMS in Aviation: Quality in ICAO Standards
ANNEX 6 (CONTINUOUS AIRWORTHINESS) 
8.7.4 MAINTENANCE PROCEDURES AND QUALITY
ASSURANCE SYSTEM
8.7.4.1 THE MAINTENANCE ORGANIZATION SHALL ESTABLISH
PROCEDURES, ACCEPTABLE TO THE STATE GRANTING
THE APPROVAL, WHICH ENSURE GOOD
MAINTENANCE PRACTICES AND COMPLIANCE WITH
ALL RELEVANT REQUIREMENTS OF THIS CHAPTER.
8.7.4.2 THE MAINTENANCE ORGANIZATION SHALL ENSURE
COMPLIANCE WITH 8.7.4.1 BY EITHER
ESTABLISHING AN INDEPENDENT QUALITY
ASSURANCE SYSTEM TO MONITOR COMPLIANCE
WITH AND ADEQUACY OF THE PROCEDURES, OR BY
PROVIDING A SYSTEM OF INSPECTION TO ENSURE
THAT ALL MAINTENANCE IS PROPERLY PERFORMED.

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 QMS in Aviation: Quality in ICAO Standards 
AIRWORTHINESS MANUAL (ICAO DOC. 9760) 
10.5.2 QUALITY MANAGEMENT
10.5.2.1 …. THE MAINTENANCE ORGANIZATION ENSURE COMPLIANCE
BY EITHER ESTABLISHING AN INDEPENDENT QUALITY
ASSURANCE SYSTEM TO MONITOR COMPLIANCE WITH OR
ADEQUACY OF THE PROCEDURES, OR BY PROVIDING A SYSTEM
OF INSPECTION TO ENSURE THAT ALL MAINTENANCE IS
PROPERLY PERFORMED.
10.5.2.2 TO FUNCTION EFFECTIVELY, IT IS ESSENTIAL FOR THE
MANAGER OF THE QUALITY DEPARTMENT TO HAVE DIRECT
ACCESS TO THE ACCOUNTABLE EXECUTIVE ON QUALITY ISSUES.
10.5.2.3 NO SYSTEM OF QUALITY MANAGEMENT IS COMPLETE
WITHOUT AN ELEMENT OF QUALITY ASSURANCE. THIS
PROVIDES, THROUGH AN INDEPENDENT AUDIT SYSTEM, THE
NECESSARY FEEDBACK TO THE MANAGEMENT OF THE
APPROVED ORGANIZATION

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 QMS in Aviation: Quality in ICAO Standards 
ANNEX 1 (PERSONNEL LICENSING) 

4. QUALITY ASSURANCE SYSTEM

THE TRAINING ORGANIZATION SHALL ESTABLISH
A QUALITY ASSURANCE SYSTEM, ACCEPTABLE TO
THE LICENSING AUTHORITY GRANTING THE
APPROVAL, WHICH ENSURES THAT TRAINING AND
INSTRUCTIONAL PRACTICES COMPLY WITH ALL
RELEVANT REQUIREMENTS.

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 QMS in Aviation: Quality in ICAO Standards 
MANUAL OF PROCEDURES FOR ESTABLISHMENT AND MANAGEMENT OF A STATE´S
PERSONNEL LICENSING SYSTEM (ICAO DOC. 9760) 
7.2 REQUIREMENT FOR QUALITY ASSURANCE (QA)
AND SAFETY MANAGEMENT SYSTEMS (SMS)
7.2.1 APPENDIX 2 TO ANNEX 1, PARAGRAPH 5, REQUIRES
THE TRAINING ORGANIZATION TO ESTABLISH A
QUALITY ASSURANCE SYSTEM, ACCEPTABLE TO THE
LICENSING AUTHORITY GRANTING THE APPROVAL,
WHICH ENSURES THAT TRAINING AND
INSTRUCTIONAL PRACTICES COMPLY WITH ALL
RELEVANT REQUIREMENTS. THE STRUCTURE AND
FUNCTIONALITY OF THIS QUALITY ASSURANCE
SYSTEM IS COVERED IN SOME DEPTH IN DOC 9841
(MANUAL ON THE APPROVAL OF FLIGHT CREW
TRAINING ORGANIZATIONS), WITH DETAILED
GUIDANCE PROVIDED IN ITS APPENDIX B.

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 QMS in Aviation: Quality in ICAO Standards 
ANNEX 6 (AIR OPERATORS) 
NO EXPLICIT REQUIREMENTS FOR QMS IMPLEMENTATION. ONLY IMPLICIT
RECOMMENDATIONS IN ANNEX 6 ATTACHMENT G AND DOC. 8335)

ATTACHMENT G. FLIGHT SAFETY DOCUMENTS 
SYSTEM 
SUPPLEMENTARY TO CHAPTER 3, 3.3
4. DESIGN
…
4.5 A FLIGHT SAFETY DOCUMENTS SYSTEM SHOULD
COMPLY WITH THE REQUIREMENTS OF THE
OPERATOR’S QUALITY SYSTEM, IF APPLICABLE.

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 QMS in Aviation: Quality in ICAO Standards 
MANUAL OF PROCEDURES FOR OPERATIONS, INSPECTION, CERTIFICATION AND CONTINUED
SURVEILLANCE (ICAO DOC. 8335) 
3.2.4 MANAGEMENT STRUCTURE AND KEY STAFF MEMBERS.
THE CAA REGULATIONS SHOULD ESTABLISH BASIC
MANAGEMENT POSITIONS AND THE QUALIFICATIONS
FOR THESE POSITIONS, WITH SOME VARIATION IN THE
REQUIREMENT DEPENDENT UPON THE COMPLEXITY OF
THE PROPOSED OPERATION. THE REQUIREMENTS
SHOULD COVER THE FOLLOWING POSITIONS:
CHIEF EXECUTIVE OFFICER OR GENERAL MANAGER;
OPERATIONS MANAGER; CHIEF PILOT; FLEET
MANAGER(S); CABIN CREW MANAGER; SAFETY
MANAGER; TRAINING MANAGER; MAINTENANCE
MANAGER; GROUND SERVICES MANAGER; SECURITY
MANAGER; AND QUALITY MANAGER.
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 QMS in Aviation: Processes 

QUALITY
ASSURANCE

AUDITS

SURVEYS
QUALITY
IMPROVEMENT

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 QMS in Aviation: Audits
AUDITS ARE ASSESSMENTS OF ORGANIZATIONAL PROCESSES THAT MAY BE CONDUCTED BY ENTITIES THAT ARE
EXTERNAL TO THE SERVICE PROVIDER OR INTERNALLY, HAVING THE NECESSARY POLICIES AND PROCEDURES TO
ENSURE ITS INDEPENDENCE AND OBJECTIVITY.

AUDITS ARE USED TO ENSURE THAT::

o ORGANIZATION'S MANAGEMENT SYSTEM HAS A SOUND
STRUCTURE AND ADEQUATE STAFFING LEVELS;
o APPROVED PROCEDURES AND INSTRUCTIONS ARE COMPLIED
WITH;
o THE REQUIRED LEVEL OF PERSONNEL COMPETENCY AND
TRAINING TO OPERATE EQUIPMENT AND FACILITIES, AND TO
MAINTAIN THEIR LEVELS OF PERFORMANCE, IS ACHIEVED;
o EQUIPMENT PERFORMANCE IS ADEQUATE FOR THE LEVELS OF
THE SERVICE PROVIDED;
o EFFECTIVE ARRANGEMENTS EXIST FOR PROMOTING,
MONITORING AND PERFORMANCE;

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 QMS in Aviation: Audits

STEP 1: DOCUMENT REVIEW

STEP 2: AUDIT PLANNING

STEP 3: ON-SITE AUDIT

STEP 4: REPORT AUDIT RESULTS

STEP 5: POST AUDIT ACTIVITIES

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 QMS in Aviation: Audits

STEP 1 STEP 2 STEP 3 STEP 4 STEP 5

ACCOMPLISHMENT
OF THE AUDIT DRAFTING AUDIT
IDENTIFICATION OF FINDINGS
PLAN BY THE FINDINGS IN A
AREAS OF THE APPEALING BY THE
AUDIT TEAM IN WAY THAT
ORGANIZATION TO AUDITED
ACCORDANCE CAPTURES THE
BE AUDITED ORGANISATION
WITH TIME FACTS
REVIEW OF ALLOCATED
MANAGEMENT
DOCUMENTATION AUDIT REPORT
REVIEW OR
GATHERING THE
PREPARATION OF DEVIATION FROM
DETAILS OF THE DEVELOPMENT OF
PROTOCOL THE PLAN, IF THE
AUDIT AND CORRECTIVE
QUESTIONS AND AUDIT
FORWARDED TO ACTION PLAN
CHECKLISTS INVESTIGATION
THE RESPONSIBLE
JUSTIFIES IT
PARTY

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 QMS in Aviation: Audits
COMPLIANCE VS PERFORMANCE AUDITS
• CONFORMANCE AUDITING APPROACH THAT VERIFIES COMPLIANCE TO REQUIREMENTS. THE VALUE IN
THIS TYPE OF AUDITING TECHNIQUE IS THE DIRECT LINKAGE TO LICENSE, CERTIFICATE OR REGULATORY
REQUIREMENTS.

• THIS TECHNIQUE ENSURES THAT PEOPLE ARE AWARE OF THE REQUIREMENTS AND THE ORGANIZATION IS
ADHERING TO THEM.

• PROCESS A SET OF INTERRELATED OR INTERACTING ACTIVITIES THAT TRANSFORMS INPUTS INTO OUTPUTS.
(ISO 9000, QUALITY MANAGEMENT SYSTEMS—FUNDAMENTALS AND VOCABULARY, THIRD EDITION,
2005, CLAUSE 3.4.)
• PROCESS AUDITING APPROACH TO DEMONSTRATE THAT A PROCESS IS BEING CORRECTLY UNDERTAKEN
AND IS PROVIDING THE REQUIRED OUTPUT

• THE USE OF PROCESS TECHNIQUES IS A NATURAL EVOLUTION FROM CONFORMANCE TO PERFORMANCE

AUDITING. WHEN COLLECTING EVIDENCE, AUDITORS ALSO WILL OBSERVE PERFORMANCE ISSUES THAT
WOULD BE OF VALUE.

• PROCESS AUDITING PROVIDE AN ADDED VALUE TO PERFORMANCE BASED SYSTEMS SUCH AS SMS

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 QMS in Aviation: Audits
HOW TO PERFORM PROCESS AUDITS

• THE SAME STEPS THAN FOR COMPLIANCE AUDITS APPLY (CHECKLISTS, AUDIT PLAN, FINDINGS
REPORT ETC.)

• HOWEVER, TO DEVELOP AN UNDERSTANDING OF THE PROCESS MAY REQUIRE THE USE OF

SOME STANDARD ANALYSIS TECHNIQUES IN ORDER TO IDENTIFY FACTORS OF INFLUENCE THAT
COULD LEAD TO DELIVER INADEQUATE OUTPUTS:

o THE SIMPLEST ONE IS TO TALK TO THOSE WHO HAVE A GOOD KNOWLEDGE OF THE
PROCESS OR A DEEP TECHNICAL UNDERSTANDING

o THE MOST COMPLEX MAY REQUIRE TO DEVELOP A PROCESS MODEL BY:

 LISTING INPUTS AND OUTPUTS
 MAPPING THE PROCESS RESPONSIBILITIES ON THE ORGANIZATION´S STRUCTURE
 DISPLAYING PROCESS FLOWS

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 QMS in Aviation: Audits
HOW TO PERFORM PROCESS AUDITS

• Operations 
Unit

• Engineering
•Unit

• Training 
•Unit

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 QMS in Aviation: Audits
CHECKLISTS
THE NEXT STEP IS TO PRODUCE A CHECKLIST CONTAINING A LIST OF QUESTIONS THAT THE AUDITOR WILL WISH
TO SEEK ANSWERS TO DURING THE AUDIT. THERE ARE SEVERAL APPROACHES TO THE DEVELOPMENT OF A
CHECKLIST FOR A PROCESS AUDIT:

o SIMPLY BRAINSTORM A LIST OF QUESTIONS STEMMING FROM CONCERNS THAN THE AUDITOR MAY
HAVE ABOUT THE PROCESS

o USE KEYWORDS TO GUIDE THE PROCESS OF GENERATING QUESTIONS

KEYWORDS LIST (EXAMPLE 1) KEYWORDS LIST (EXAMPLE 2)

PEOPLE PERFORMANCE
• HANDLING
• NUMBERS • PRODUCTION RATE
• IDENTIFICATION
• ATTITUDES • TIMING
• DOCUMENTATION
• SKILLS • QUALITY
• OPERATING INSTRUCTIONS
• TRAINING
• INSPECTION INSTRUCTIONS EQUIPMENT
• SUPERVISION
• TEST INSTRUCTIONS • INSTRUCTIONS
METHODS
• SAMPLING • MAINTENANCE
• PROCEDURES
• ENVIRONMENT • FAILURE
• MAN‐MACHINE INTERFACES
• STORAGE • CONTINGENCY
• DATA ENTRY
• PROTECTIVE MEASURES • AVAILABILITY
• ROOM ALLOCATION
• RECORDS
• HANDLING

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 QMS in Aviation: Surveys

SURVEYS EXAMINE PROCEDURES OR PROCESSES RELATED TO A SPECIFIC

OPERATION. THEY GENERALLY PROVIDE QUALITATIVE INFORMATION THAT MAY
REQUIRE VALIDATION TO DETERMINE APPROPRIATE CORRECTIVE ACTION

• DEFINED AS SYSTEMATIC REVIEWS TO RECOMMEND

IMPROVEMENTS WHERE NEEDED, TO PROVIDE ASSURANCE
OF THE CURRENT ACTIVITIES, AND TO CONFIRM
CONFORMANCE WITH APPLICABLE PARTS OF THE
MANAGEMENT SYSTEM
• THEIR ROLE IS QUITE SIMILAR TO THE ONE PERFORMED BY
AUDITS. BOTH ACTIVITIES ARE CONDUCTED TO CHECK
COMPLIANCE WITH STANDARDS (OR TARGETS) AND
PROCEDURES, DETECT PROBLEMS AND FACILITATE THE
IDENTIFICATION OF SOLUTIONS AND IMPROVEMENTS.
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 QMS in Aviation: Surveys
CHARACTERISTICS (ICAO SMM)
• OBJECTIVES: GOAL CLEARLY DECLARED FOR ALL
RESPONDENTS
• SAMPLE : SIZE SUFFICIENT TO PERMIT VALID CONCLUSIONS
• NEUTRAL: CONDUCTED THROUGH THE USE OF CHECKLISTS,
QUESTIONNAIRES AND INTERVIEWS IN A WAY THAT WILL
ENCOURAGE OPENNESS OF THE PARTICIPANTS
• REDUCING BIAS: RANDOM SELECTION OF THE
PARTICIPANTS
• QUESTIONS: ELICIT SPECIFIC RESPONSES WHICH CAN BE
SCORED
• PRIOR COORDINATION: WITH THE AUTHORITIES
GOVERNING THE TARGET RESPONDENTS, UNIONS AND
PROFESSIONAL ASSOCIATIONS.
• ASSURANCE OF CONFIDENTIALITY: REGARDING THE
INFORMATION COLLECTED THROUGH THE SURVEY.

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 Conclusion: Key Points to Remember
KEY POINTS TO REMEMBER

 QUALITY: CHARACTERISTICS FULFILLING REQUIREMENTS

 QUALITY MANAGEMENT: PLANNING, CONTROL AND ASSURANCE
 ISO 9001:2015
 QMS REQUIRED FOR ATOS, AMOS & MANUFACTURERS
 QUALITY ASSURANCE BASED ON AUDITS AND SURVEYS. 
o AUDITS ARE PROVIDE ASSURANCE OF THE MANAGEMENT SYSTEM FUNCTIONS
o SURVEYS EXAMINE PROCEDURES RELATED TO A SPECIFIC OPERATION. 

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End slide