EUROCONTROL/Quality seminar 14th July 2010 Gaelle Rousseau-Lamour.
-
Upload
william-howard -
Category
Documents
-
view
218 -
download
0
Transcript of EUROCONTROL/Quality seminar 14th July 2010 Gaelle Rousseau-Lamour.
![Page 1: EUROCONTROL/Quality seminar 14th July 2010 Gaelle Rousseau-Lamour.](https://reader031.fdocuments.us/reader031/viewer/2022013004/56649e115503460f94afd6cf/html5/thumbnails/1.jpg)
EUROCONTROL/Quality seminar
14th July 2010
Gaelle Rousseau-Lamour
![Page 2: EUROCONTROL/Quality seminar 14th July 2010 Gaelle Rousseau-Lamour.](https://reader031.fdocuments.us/reader031/viewer/2022013004/56649e115503460f94afd6cf/html5/thumbnails/2.jpg)
A group exercise designed to
promote understanding of
the ISO 9001 requirements and
the approach of an external auditor.
ISO CASE STUDY 1RESULT
![Page 3: EUROCONTROL/Quality seminar 14th July 2010 Gaelle Rousseau-Lamour.](https://reader031.fdocuments.us/reader031/viewer/2022013004/56649e115503460f94afd6cf/html5/thumbnails/3.jpg)
UNDERSTANDINGAND IMPLEMENTING
ISO 9001:2008
![Page 4: EUROCONTROL/Quality seminar 14th July 2010 Gaelle Rousseau-Lamour.](https://reader031.fdocuments.us/reader031/viewer/2022013004/56649e115503460f94afd6cf/html5/thumbnails/4.jpg)
13th & 14th July 2010 4
HOW to IMPLEMENT a QMS?
1. Planning & Designing
4. Improving the QMS
2. Describing
3. Implementing the QMS
FourPhases
![Page 5: EUROCONTROL/Quality seminar 14th July 2010 Gaelle Rousseau-Lamour.](https://reader031.fdocuments.us/reader031/viewer/2022013004/56649e115503460f94afd6cf/html5/thumbnails/5.jpg)
13th & 14th July 2010 5
Get in first by…..Learning about ISOPlanning the project and assigning responsibilities
Make your commitment visible by…..
Providing resourcesRewarding participation in the ISO project
TOP MANAGEMENT
![Page 6: EUROCONTROL/Quality seminar 14th July 2010 Gaelle Rousseau-Lamour.](https://reader031.fdocuments.us/reader031/viewer/2022013004/56649e115503460f94afd6cf/html5/thumbnails/6.jpg)
13th & 14th July 2010 6
TOP MANAGEMENT
Since ISO 9001:2000 there is significantemphasis on the role of Top Management
• “provide evidence of commitment”• “establish the quality policy”• “ensure quality objectives are established”• “conduct management reviews”• “ensure availability of resources”
![Page 7: EUROCONTROL/Quality seminar 14th July 2010 Gaelle Rousseau-Lamour.](https://reader031.fdocuments.us/reader031/viewer/2022013004/56649e115503460f94afd6cf/html5/thumbnails/7.jpg)
13th & 14th July 2010 7
Gaining Management Support
• Education, training– ensure management understand the need for a quality
management system and the potential benefits
• Investments/Dividends– management will understand the concepts of investing
in order to achieve returns– stress the long term cost advantages and potential
improvements in efficiency
TOP MANAGEMENT
![Page 8: EUROCONTROL/Quality seminar 14th July 2010 Gaelle Rousseau-Lamour.](https://reader031.fdocuments.us/reader031/viewer/2022013004/56649e115503460f94afd6cf/html5/thumbnails/8.jpg)
13th & 14th July 2010 8
COST of IMPLEMENTATION
This will depend upon a number of factors, for example:• The size of the organisation• The number of distinct processes and activities that
need to be managed• How well the organisation is managed• The amount of required documentation, e.g. records,
that already exist
![Page 9: EUROCONTROL/Quality seminar 14th July 2010 Gaelle Rousseau-Lamour.](https://reader031.fdocuments.us/reader031/viewer/2022013004/56649e115503460f94afd6cf/html5/thumbnails/9.jpg)
13th & 14th July 2010 9
FOUNDATION
WHAT
WHO
HOW
QUALILTY PRINCIPLES
ISO 9001
QUALITYPOLICY
QUALITY ORGANISATION
PROCESSES PROCEDURES
QMS
THE FIRST STEPS
![Page 10: EUROCONTROL/Quality seminar 14th July 2010 Gaelle Rousseau-Lamour.](https://reader031.fdocuments.us/reader031/viewer/2022013004/56649e115503460f94afd6cf/html5/thumbnails/10.jpg)
13th & 14th July 2010 10
1. Set Policy
4. Define (SMM)
3. Plan 6. Implement
2. Assign Responsibilities
7. Control and survey
5. Disseminate
8. Refine
CONTINUOUS IMPROVEMENT
A POSSIBLE APPROACH
![Page 11: EUROCONTROL/Quality seminar 14th July 2010 Gaelle Rousseau-Lamour.](https://reader031.fdocuments.us/reader031/viewer/2022013004/56649e115503460f94afd6cf/html5/thumbnails/11.jpg)
Planning for ISO 9001Implementation
![Page 12: EUROCONTROL/Quality seminar 14th July 2010 Gaelle Rousseau-Lamour.](https://reader031.fdocuments.us/reader031/viewer/2022013004/56649e115503460f94afd6cf/html5/thumbnails/12.jpg)
13th & 14th July 2010 12
1. Getting a clear picture of how you already comply
2. Developing an Action Plan
Objectives of the Planning & Designing PhasePlanning & Designing Phase:
![Page 13: EUROCONTROL/Quality seminar 14th July 2010 Gaelle Rousseau-Lamour.](https://reader031.fdocuments.us/reader031/viewer/2022013004/56649e115503460f94afd6cf/html5/thumbnails/13.jpg)
13th & 14th July 2010 13
QuickScan
Series of Meetings
Action Plan
Planning and Designing PhasePlanning and Designing Phase: Activities
![Page 14: EUROCONTROL/Quality seminar 14th July 2010 Gaelle Rousseau-Lamour.](https://reader031.fdocuments.us/reader031/viewer/2022013004/56649e115503460f94afd6cf/html5/thumbnails/14.jpg)
13th & 14th July 2010 14
INITIAL SURVEY
Start by reviewing the current situation
• What elements of a QMS are already in place?►Organisation charts►Process documents►Forms and records►Job descriptions
![Page 15: EUROCONTROL/Quality seminar 14th July 2010 Gaelle Rousseau-Lamour.](https://reader031.fdocuments.us/reader031/viewer/2022013004/56649e115503460f94afd6cf/html5/thumbnails/15.jpg)
13th & 14th July 2010 15
IDENTIFY MISSING ELEMENTS
• Identify the items required that are not in place, these may be for example:►some process documents►some necessary records►an internal quality audit process►a formal management review process►a continual improvement process
• In effect you are performing a “Gap analysis”
![Page 16: EUROCONTROL/Quality seminar 14th July 2010 Gaelle Rousseau-Lamour.](https://reader031.fdocuments.us/reader031/viewer/2022013004/56649e115503460f94afd6cf/html5/thumbnails/16.jpg)
13th & 14th July 2010 16
IMPLEMENTATION PLANS
• In order to ensure a successful implementation it must be planned,e.g. as a project
• Resources must be identified• Activities planned and assigned• Time scales agreed and documented• Responsibilities allocated• Progress must be regularly monitored
![Page 17: EUROCONTROL/Quality seminar 14th July 2010 Gaelle Rousseau-Lamour.](https://reader031.fdocuments.us/reader031/viewer/2022013004/56649e115503460f94afd6cf/html5/thumbnails/17.jpg)
13th & 14th July 2010 17
ACTIVITY 1999 2000 M J J A S O N D J F M A M J J
Initial ISO 9001BriefingAssessment ofcurrent systems
Formulate ActionPlans
Appoint Project/Quality CoordinatorISO 9001 trainingfor coordinator
Write procedures/implement systems
Internal QualityAuditor trainingManagement reviewof ISO 9001 systems
Contact ISO 9001Assessment Bodies
Quality AwarenessTraining (all staff)
Implement systems/Internal Audits
Formal ISO 9001Assessment
Typical
ISO
9001
Action
Plan
![Page 18: EUROCONTROL/Quality seminar 14th July 2010 Gaelle Rousseau-Lamour.](https://reader031.fdocuments.us/reader031/viewer/2022013004/56649e115503460f94afd6cf/html5/thumbnails/18.jpg)
Describing ISO 9001Implementation
![Page 19: EUROCONTROL/Quality seminar 14th July 2010 Gaelle Rousseau-Lamour.](https://reader031.fdocuments.us/reader031/viewer/2022013004/56649e115503460f94afd6cf/html5/thumbnails/19.jpg)
13th & 14th July 2010 19
1. Description of What Exists
2. Interfaces
3. Process mapping
Objectives of the Describing PhaseDescribing Phase:
![Page 20: EUROCONTROL/Quality seminar 14th July 2010 Gaelle Rousseau-Lamour.](https://reader031.fdocuments.us/reader031/viewer/2022013004/56649e115503460f94afd6cf/html5/thumbnails/20.jpg)
13th & 14th July 2010 20
Detailed Description
Design of New
Processes
ProcessImprovement
Describing PhaseDescribing Phase: Activities
Interfaces Check
![Page 21: EUROCONTROL/Quality seminar 14th July 2010 Gaelle Rousseau-Lamour.](https://reader031.fdocuments.us/reader031/viewer/2022013004/56649e115503460f94afd6cf/html5/thumbnails/21.jpg)
13th & 14th July 2010 21
QMS FRAMEWORK
The framework of the Quality Management System starts
with Top Management►they set the business objectives►they must then establish an organisation
to put those policies into action►they must ensure that key processes are controlled►they must identify responsibilities and interfaces►they must ensure that resources are provided
![Page 22: EUROCONTROL/Quality seminar 14th July 2010 Gaelle Rousseau-Lamour.](https://reader031.fdocuments.us/reader031/viewer/2022013004/56649e115503460f94afd6cf/html5/thumbnails/22.jpg)
13th & 14th July 2010 22
ISO 9001 FRAMEWORK
ISO 9001 states :• All requirements are intended to be generic• Applicable to all organisations• Where a requirement cannot be applied
it can be considered for exclusion• Exclusions are limited to clause 7
– Must not affect ability to provide product that meets customer and regulatory requirements
![Page 23: EUROCONTROL/Quality seminar 14th July 2010 Gaelle Rousseau-Lamour.](https://reader031.fdocuments.us/reader031/viewer/2022013004/56649e115503460f94afd6cf/html5/thumbnails/23.jpg)
13th & 14th July 2010 23
SUGGESTED APPROACH
• Examine requirements of clause 7• Determine whether any may be
considered for exclusion• Be sure that this can be justified against
the ISO 9001 stated criteria• Document the exclusion and justification in
the Quality Manual
![Page 24: EUROCONTROL/Quality seminar 14th July 2010 Gaelle Rousseau-Lamour.](https://reader031.fdocuments.us/reader031/viewer/2022013004/56649e115503460f94afd6cf/html5/thumbnails/24.jpg)
13th & 14th July 2010 24
SYSTEM DOCUMENTATION
• The framework of the system documentation will depend upon the business structure, e.g.
• The size and complexity of the organisation
• Is there a department or team-based structure?
• A typical documentation structure is shown on the next slide.
![Page 25: EUROCONTROL/Quality seminar 14th July 2010 Gaelle Rousseau-Lamour.](https://reader031.fdocuments.us/reader031/viewer/2022013004/56649e115503460f94afd6cf/html5/thumbnails/25.jpg)
13th & 14th July 2010 25
TYPICAL QMS STRUCTURE
STANDARD - ISO 9001 OR SIMILAR
QUALITY MANUALPolicy, objectives, organisation,outline of quality system
PROCESS DOCUMENTSAND PROCEDURES
INSTRUCTIONS
FORMS
Processes,practices,responsibilities,interfaces
Detailed instructionson how to carry out specific tasks
Qualityrecords
Design IT Support Installation Training
![Page 26: EUROCONTROL/Quality seminar 14th July 2010 Gaelle Rousseau-Lamour.](https://reader031.fdocuments.us/reader031/viewer/2022013004/56649e115503460f94afd6cf/html5/thumbnails/26.jpg)
13th & 14th July 2010 26
DOCUMENT FORMAT
ISO 9001 States:
“The documentation may be in any form or type of medium”
• Therefore it could be in text form or in the form of process maps/flowcharts
• It could be a paper-based system or could be on computer, e.g. accessed via an intranet browser
![Page 27: EUROCONTROL/Quality seminar 14th July 2010 Gaelle Rousseau-Lamour.](https://reader031.fdocuments.us/reader031/viewer/2022013004/56649e115503460f94afd6cf/html5/thumbnails/27.jpg)
13th & 14th July 2010 27
CHOOSING a FORMAT
• Each organisation can choose its own format
• The majority at present have paper-based text documents
• Increasingly organisations are using flowcharts and “computerised” systems– a computer based solution often has
advantages when it comes to document and change control
![Page 28: EUROCONTROL/Quality seminar 14th July 2010 Gaelle Rousseau-Lamour.](https://reader031.fdocuments.us/reader031/viewer/2022013004/56649e115503460f94afd6cf/html5/thumbnails/28.jpg)
Implementing ISO 9001
![Page 29: EUROCONTROL/Quality seminar 14th July 2010 Gaelle Rousseau-Lamour.](https://reader031.fdocuments.us/reader031/viewer/2022013004/56649e115503460f94afd6cf/html5/thumbnails/29.jpg)
13th & 14th July 2010 29
1. Making the QMS Work
2.Involving
Objectives of the Implementation PhaseImplementation Phase:
![Page 30: EUROCONTROL/Quality seminar 14th July 2010 Gaelle Rousseau-Lamour.](https://reader031.fdocuments.us/reader031/viewer/2022013004/56649e115503460f94afd6cf/html5/thumbnails/30.jpg)
13th & 14th July 2010 30
Putting planning
into Action
InternalAuditPlan
CommunicationTraining
Implementation PhaseImplementation Phase: Activities
![Page 31: EUROCONTROL/Quality seminar 14th July 2010 Gaelle Rousseau-Lamour.](https://reader031.fdocuments.us/reader031/viewer/2022013004/56649e115503460f94afd6cf/html5/thumbnails/31.jpg)
13th & 14th July 2010 31
THE QUALITY MANUAL
• Description of the organisation
• Quality Policy, key objectives
• Structure of the organisation►Interfaces, responsibilities
• Overview of the Quality System►show approach to Standard requirements►detail and justify any exclusions
PRODUCING the QMS Documentation
![Page 32: EUROCONTROL/Quality seminar 14th July 2010 Gaelle Rousseau-Lamour.](https://reader031.fdocuments.us/reader031/viewer/2022013004/56649e115503460f94afd6cf/html5/thumbnails/32.jpg)
13th & 14th July 2010 32
PROCESS Documents
• Do we need process documents?• The ISO 9001 standard calls for few
mandatory procedures• The question is do we need documents in
order to effectively control our business processes?
PRODUCING the QMS Documentation
![Page 33: EUROCONTROL/Quality seminar 14th July 2010 Gaelle Rousseau-Lamour.](https://reader031.fdocuments.us/reader031/viewer/2022013004/56649e115503460f94afd6cf/html5/thumbnails/33.jpg)
13th & 14th July 2010 33
Benefits of process documents
• Provide consistency/repeatability• Define responsibility/authority• Continuity when staff change• Assist in staff training• Help identify cause of errors• Benchmark for improvement
PRODUCING the QMS Documentation
![Page 34: EUROCONTROL/Quality seminar 14th July 2010 Gaelle Rousseau-Lamour.](https://reader031.fdocuments.us/reader031/viewer/2022013004/56649e115503460f94afd6cf/html5/thumbnails/34.jpg)
13th & 14th July 2010 34
PROCESS
Definition: Set of inter-related or interacting activities
which transforms inputs into outputs
ISO 9000
![Page 35: EUROCONTROL/Quality seminar 14th July 2010 Gaelle Rousseau-Lamour.](https://reader031.fdocuments.us/reader031/viewer/2022013004/56649e115503460f94afd6cf/html5/thumbnails/35.jpg)
13th & 14th July 2010 35
INPUT OUTPUTPROCESS
PROCESS
Constraints
Resources
![Page 36: EUROCONTROL/Quality seminar 14th July 2010 Gaelle Rousseau-Lamour.](https://reader031.fdocuments.us/reader031/viewer/2022013004/56649e115503460f94afd6cf/html5/thumbnails/36.jpg)
13th & 14th July 2010 36
PROCEDURE
Definition:Specified way to carry outan activity or process
ISO 9000
i.e. describes how a process is performed
![Page 37: EUROCONTROL/Quality seminar 14th July 2010 Gaelle Rousseau-Lamour.](https://reader031.fdocuments.us/reader031/viewer/2022013004/56649e115503460f94afd6cf/html5/thumbnails/37.jpg)
13th & 14th July 2010 37
GOOD PROCEDURE
• Process based - not ISO 9001 clause based► Should not be excessive
• Simple, clear, concise style
• Aimed at education/experience– of personnel using procedure
• Realistic - do not specify the impossible
![Page 38: EUROCONTROL/Quality seminar 14th July 2010 Gaelle Rousseau-Lamour.](https://reader031.fdocuments.us/reader031/viewer/2022013004/56649e115503460f94afd6cf/html5/thumbnails/38.jpg)
13th & 14th July 2010 38
EFFECTIVE IMPLEMENTATION ?
“We have excellent procedures here Smithers - however we do tend to ignore them”
![Page 39: EUROCONTROL/Quality seminar 14th July 2010 Gaelle Rousseau-Lamour.](https://reader031.fdocuments.us/reader031/viewer/2022013004/56649e115503460f94afd6cf/html5/thumbnails/39.jpg)
13th & 14th July 2010 39
PROCEDURE DEVELOPMENT
• Establish current practice• Document current practice• Review current practice• Prepare procedure• Review and approve• Issue procedure
![Page 40: EUROCONTROL/Quality seminar 14th July 2010 Gaelle Rousseau-Lamour.](https://reader031.fdocuments.us/reader031/viewer/2022013004/56649e115503460f94afd6cf/html5/thumbnails/40.jpg)
13th & 14th July 2010 40
PRODUCING PROCEDURES
• Establish standard format/template
• Indicate approval/revision status
• Consider using flow charts or process maps
• Train the procedure writers
![Page 41: EUROCONTROL/Quality seminar 14th July 2010 Gaelle Rousseau-Lamour.](https://reader031.fdocuments.us/reader031/viewer/2022013004/56649e115503460f94afd6cf/html5/thumbnails/41.jpg)
13th & 14th July 2010 41
FLOWCHARTS
Using a flowchart is a very effective way to describe a process
“a picture is worth a thousand words”
![Page 42: EUROCONTROL/Quality seminar 14th July 2010 Gaelle Rousseau-Lamour.](https://reader031.fdocuments.us/reader031/viewer/2022013004/56649e115503460f94afd6cf/html5/thumbnails/42.jpg)
13th & 14th July 2010 42
FLOWCHART SYMBOLS
![Page 43: EUROCONTROL/Quality seminar 14th July 2010 Gaelle Rousseau-Lamour.](https://reader031.fdocuments.us/reader031/viewer/2022013004/56649e115503460f94afd6cf/html5/thumbnails/43.jpg)
13th & 14th July 2010 43
Any process can be represented in the form of a simple flow chart using just two symbols:
Activity or process
Decision
FLOWCHART SYMBOLS
![Page 44: EUROCONTROL/Quality seminar 14th July 2010 Gaelle Rousseau-Lamour.](https://reader031.fdocuments.us/reader031/viewer/2022013004/56649e115503460f94afd6cf/html5/thumbnails/44.jpg)
13th & 14th July 2010 44
FLOWCHART RULES
There is one route into the box
and only one route out for the
process activity boxes
PROCESS
There is one route in and two possible routes out for the
decision boxes
(e.g. yes/no or pass/fail)
Yes
No
Decision
![Page 45: EUROCONTROL/Quality seminar 14th July 2010 Gaelle Rousseau-Lamour.](https://reader031.fdocuments.us/reader031/viewer/2022013004/56649e115503460f94afd6cf/html5/thumbnails/45.jpg)
13th & 14th July 2010 45
PROCESSES and DECISIONS
► Process boxes describe a task, and the text contains a verb
► e.g. file the form, or amend the document
► Decision boxes ask a question, with two possible answers
► e.g. is information correct, or does the product meet the requirements?
![Page 46: EUROCONTROL/Quality seminar 14th July 2010 Gaelle Rousseau-Lamour.](https://reader031.fdocuments.us/reader031/viewer/2022013004/56649e115503460f94afd6cf/html5/thumbnails/46.jpg)
13th & 14th July 2010 46
RECEIVEINFORMATION
VERIFY ACCURACY
IS ITCORRECT?
Yes NoMAKE
CORRECTIONS
INSERTINTO
MANUAL
END
Example
IS ITCORRECT?
![Page 47: EUROCONTROL/Quality seminar 14th July 2010 Gaelle Rousseau-Lamour.](https://reader031.fdocuments.us/reader031/viewer/2022013004/56649e115503460f94afd6cf/html5/thumbnails/47.jpg)
Improving the ISO 9001Implementation
![Page 48: EUROCONTROL/Quality seminar 14th July 2010 Gaelle Rousseau-Lamour.](https://reader031.fdocuments.us/reader031/viewer/2022013004/56649e115503460f94afd6cf/html5/thumbnails/48.jpg)
13th & 14th July 2010 48
1. Checking the QMS
2. Adapting
Objectives of the Improvement PhaseImprovement Phase:
![Page 49: EUROCONTROL/Quality seminar 14th July 2010 Gaelle Rousseau-Lamour.](https://reader031.fdocuments.us/reader031/viewer/2022013004/56649e115503460f94afd6cf/html5/thumbnails/49.jpg)
13th & 14th July 2010 49
Quality assurance
InternalAudit
Management Review
Improvement PhaseImprovement Phase: Activities
![Page 50: EUROCONTROL/Quality seminar 14th July 2010 Gaelle Rousseau-Lamour.](https://reader031.fdocuments.us/reader031/viewer/2022013004/56649e115503460f94afd6cf/html5/thumbnails/50.jpg)
13th & 14th July 2010 50
LUNCHTIME !LUNCHTIME !
![Page 51: EUROCONTROL/Quality seminar 14th July 2010 Gaelle Rousseau-Lamour.](https://reader031.fdocuments.us/reader031/viewer/2022013004/56649e115503460f94afd6cf/html5/thumbnails/51.jpg)
CASE STUDY 2 -GROUP EXERCISE
Produce a process flow-chart based upon the information
provided.
![Page 52: EUROCONTROL/Quality seminar 14th July 2010 Gaelle Rousseau-Lamour.](https://reader031.fdocuments.us/reader031/viewer/2022013004/56649e115503460f94afd6cf/html5/thumbnails/52.jpg)
Internal QualitySystems Audits
![Page 53: EUROCONTROL/Quality seminar 14th July 2010 Gaelle Rousseau-Lamour.](https://reader031.fdocuments.us/reader031/viewer/2022013004/56649e115503460f94afd6cf/html5/thumbnails/53.jpg)
13th & 14th July 2010 53
AUDIT OBJECTIVES
(1) To ensure that procedures are being followed
ie. We are doing what we say we do
(2) To determine the effectiveness of the systems and procedures in meeting the quality objectives
(3) To afford an opportunity to improve the quality system
![Page 54: EUROCONTROL/Quality seminar 14th July 2010 Gaelle Rousseau-Lamour.](https://reader031.fdocuments.us/reader031/viewer/2022013004/56649e115503460f94afd6cf/html5/thumbnails/54.jpg)
13th & 14th July 2010 54
AUDITING STANDARDS
ISO 10011 Guidelines for auditing quality systems
Part 1 : Auditing
Part 2 : Qualification criteria for quality systems auditors
Part 3 : Management of audit programmes
![Page 55: EUROCONTROL/Quality seminar 14th July 2010 Gaelle Rousseau-Lamour.](https://reader031.fdocuments.us/reader031/viewer/2022013004/56649e115503460f94afd6cf/html5/thumbnails/55.jpg)
13th & 14th July 2010 55
ISO 9001:2008
WHAT DOES THE ABOVE STANDARD SAY ABOUT INTERNAL QUALITY SYSTEMS AUDITING?
![Page 56: EUROCONTROL/Quality seminar 14th July 2010 Gaelle Rousseau-Lamour.](https://reader031.fdocuments.us/reader031/viewer/2022013004/56649e115503460f94afd6cf/html5/thumbnails/56.jpg)
13th & 14th July 2010 56
8.2.2 INTERNAL AUDIT
►Verify compliance, effectiveness►Planned audit programme►Independent auditors►Documented procedure►Timely corrective action►Follow-up activities
![Page 57: EUROCONTROL/Quality seminar 14th July 2010 Gaelle Rousseau-Lamour.](https://reader031.fdocuments.us/reader031/viewer/2022013004/56649e115503460f94afd6cf/html5/thumbnails/57.jpg)
13th & 14th July 2010 57
AUDIT PROGRAMME
► Audits planned in advance► Audits are not random spot checks► Scheduled usually by department,
function, or process► Consider the status and importance of
process, and previous results
![Page 58: EUROCONTROL/Quality seminar 14th July 2010 Gaelle Rousseau-Lamour.](https://reader031.fdocuments.us/reader031/viewer/2022013004/56649e115503460f94afd6cf/html5/thumbnails/58.jpg)
13th & 14th July 2010 58
AUDIT TECHNIQUES
INTERVIEW
EXAMINE VERIFY QUESTION
OBSERVE
VERIFY
![Page 59: EUROCONTROL/Quality seminar 14th July 2010 Gaelle Rousseau-Lamour.](https://reader031.fdocuments.us/reader031/viewer/2022013004/56649e115503460f94afd6cf/html5/thumbnails/59.jpg)
13th & 14th July 2010 59
AUDIT REPORT
Summary of results, including :
► Scope, dates, auditors
► Satisfactory areas
► Nonconformities (refer to NCR’s)
► Observations, recommendations
![Page 60: EUROCONTROL/Quality seminar 14th July 2010 Gaelle Rousseau-Lamour.](https://reader031.fdocuments.us/reader031/viewer/2022013004/56649e115503460f94afd6cf/html5/thumbnails/60.jpg)
13th & 14th July 2010 60
FOLLOW-UP
► Auditee responsible for corrective preventive actions
► Auditor follows-up action to ensure it is taken and effective
► Audit actions are closed - records
![Page 61: EUROCONTROL/Quality seminar 14th July 2010 Gaelle Rousseau-Lamour.](https://reader031.fdocuments.us/reader031/viewer/2022013004/56649e115503460f94afd6cf/html5/thumbnails/61.jpg)
13th & 14th July 2010 61
SUMMARY OF AUDIT PROCESS
► PLANNING
Schedule, Preparation, Checklist
► AUDITING
Opening Meeting, Audit, Closing Meeting
► COMPLETION
Report, Corrective action, Follow-up
![Page 62: EUROCONTROL/Quality seminar 14th July 2010 Gaelle Rousseau-Lamour.](https://reader031.fdocuments.us/reader031/viewer/2022013004/56649e115503460f94afd6cf/html5/thumbnails/62.jpg)
13th & 14th July 2010 62
BENEFITS OF AUDITING
► Verifies that procedures are followed
► Reviews effectiveness of system
► Helps to identify problem areas
► Assists transfer of best practice
► Effective mechanism for continuous improvement
![Page 63: EUROCONTROL/Quality seminar 14th July 2010 Gaelle Rousseau-Lamour.](https://reader031.fdocuments.us/reader031/viewer/2022013004/56649e115503460f94afd6cf/html5/thumbnails/63.jpg)
ExerciseRole of the Auditor and
Auditor Responsible
![Page 64: EUROCONTROL/Quality seminar 14th July 2010 Gaelle Rousseau-Lamour.](https://reader031.fdocuments.us/reader031/viewer/2022013004/56649e115503460f94afd6cf/html5/thumbnails/64.jpg)
Preparing forCertification
![Page 65: EUROCONTROL/Quality seminar 14th July 2010 Gaelle Rousseau-Lamour.](https://reader031.fdocuments.us/reader031/viewer/2022013004/56649e115503460f94afd6cf/html5/thumbnails/65.jpg)
13th & 14th July 2010 65
ISO 9001- Steps in Implementation
► Management decision/commitment
► Decide scope of system
► Review current situation - report gaps
► Formulate action plan
► Document & implement processes
► Review and internal audit
► Formal assessment
![Page 66: EUROCONTROL/Quality seminar 14th July 2010 Gaelle Rousseau-Lamour.](https://reader031.fdocuments.us/reader031/viewer/2022013004/56649e115503460f94afd6cf/html5/thumbnails/66.jpg)
13th & 14th July 2010 66
ACTIVITY 1999 2000 M J J A S O N D J F M A M J J
Initial ISO 9001BriefingAssessment ofcurrent systems
Formulate ActionPlans
Appoint Project/Quality CoordinatorISO 9001 trainingfor coordinator
Write procedures/implement systems
Internal QualityAuditor trainingManagement reviewof ISO 9001 systems
Contact ISO 9001Assessment Bodies
Quality AwarenessTraining (all staff)
Implement systems/Internal Audits
Formal ISO 9001Assessment
Typical
ISO
9001
Action
Plan
![Page 67: EUROCONTROL/Quality seminar 14th July 2010 Gaelle Rousseau-Lamour.](https://reader031.fdocuments.us/reader031/viewer/2022013004/56649e115503460f94afd6cf/html5/thumbnails/67.jpg)
13th & 14th July 2010 67
KEY QUESTIONS
Before inviting an external assessmentcheck the following:
►Are the mandatory documents in place - quality manual and procedures?
►Are key processes identified and controlled?►Have internal audits and management reviews been
conducted?►Are results from these satisfactory?
![Page 68: EUROCONTROL/Quality seminar 14th July 2010 Gaelle Rousseau-Lamour.](https://reader031.fdocuments.us/reader031/viewer/2022013004/56649e115503460f94afd6cf/html5/thumbnails/68.jpg)
13th & 14th July 2010 68
FINAL PREPARATION
►Consider a pre-assessment– internal– independent consultant– your assessment body
►Inform all of your staff– explain the process– clarify their responsibilities– seek their feedback regarding any concerns
![Page 69: EUROCONTROL/Quality seminar 14th July 2010 Gaelle Rousseau-Lamour.](https://reader031.fdocuments.us/reader031/viewer/2022013004/56649e115503460f94afd6cf/html5/thumbnails/69.jpg)
The CertificationProcess
![Page 70: EUROCONTROL/Quality seminar 14th July 2010 Gaelle Rousseau-Lamour.](https://reader031.fdocuments.us/reader031/viewer/2022013004/56649e115503460f94afd6cf/html5/thumbnails/70.jpg)
13th & 14th July 2010 70
National Government(e.g. UK DTI)
Regulating Authority(e.g. UKAS, DAR)
Certification Bodies
Companies/Organisations
Regulation of the ISO 9001 Certification Process
![Page 71: EUROCONTROL/Quality seminar 14th July 2010 Gaelle Rousseau-Lamour.](https://reader031.fdocuments.us/reader031/viewer/2022013004/56649e115503460f94afd6cf/html5/thumbnails/71.jpg)
13th & 14th July 2010 71
THE CERTIFICATION PROCESS
STAGE 1: Documentation Review
STAGE 2: Initial assessment of the
Quality System in action
STAGE 3: Continuing assessment by
periodic surveillance
![Page 72: EUROCONTROL/Quality seminar 14th July 2010 Gaelle Rousseau-Lamour.](https://reader031.fdocuments.us/reader031/viewer/2022013004/56649e115503460f94afd6cf/html5/thumbnails/72.jpg)
13th & 14th July 2010 72
STAGE 1
• Company agrees contract with one Certification Body
• Company submits QMS documentation to the Certification Body
• Certification Body reviews the documents against Standard and reports results
• When satisfactory, Certification Body produces plan/schedule for assessment
![Page 73: EUROCONTROL/Quality seminar 14th July 2010 Gaelle Rousseau-Lamour.](https://reader031.fdocuments.us/reader031/viewer/2022013004/56649e115503460f94afd6cf/html5/thumbnails/73.jpg)
13th & 14th July 2010 73
STAGE 2
• Certification Body carry out assessment• Examine all major processes• Interview a cross-section of personnel• The audit is a sampling process
• Result is reported at closing meeting
• If necessary a follow-up visit is arranged
• When successful, an Approval Certificate is issued
![Page 74: EUROCONTROL/Quality seminar 14th July 2010 Gaelle Rousseau-Lamour.](https://reader031.fdocuments.us/reader031/viewer/2022013004/56649e115503460f94afd6cf/html5/thumbnails/74.jpg)
13th & 14th July 2010 74
TYPICALISO 9001
CERTIFICATE
![Page 75: EUROCONTROL/Quality seminar 14th July 2010 Gaelle Rousseau-Lamour.](https://reader031.fdocuments.us/reader031/viewer/2022013004/56649e115503460f94afd6cf/html5/thumbnails/75.jpg)
13th & 14th July 2010 75
• Throughout approval period the Certification Body conducts regular surveillance visits
• Typically every 6/12 months– target specific parts of the system– cover certain core elements every time
• Many Certification Bodies operate a 3-year approval cycle
STAGE 3
![Page 76: EUROCONTROL/Quality seminar 14th July 2010 Gaelle Rousseau-Lamour.](https://reader031.fdocuments.us/reader031/viewer/2022013004/56649e115503460f94afd6cf/html5/thumbnails/76.jpg)
ISO 9001:2008 THE BENEFITS:
In groups discuss the benefits of having a quality management system that meets ISO 9001 requirements.
Consider the benefits to:
a) Your organisation b) The employees c) The customers
![Page 77: EUROCONTROL/Quality seminar 14th July 2010 Gaelle Rousseau-Lamour.](https://reader031.fdocuments.us/reader031/viewer/2022013004/56649e115503460f94afd6cf/html5/thumbnails/77.jpg)
SUMMARY
![Page 78: EUROCONTROL/Quality seminar 14th July 2010 Gaelle Rousseau-Lamour.](https://reader031.fdocuments.us/reader031/viewer/2022013004/56649e115503460f94afd6cf/html5/thumbnails/78.jpg)
13th & 14th July 2010 78
QUALITY MANAGEMENT PRINCIPLES
• Customer focused organization• Leadership• Involvement of people• Process approach• System approach to management• Factual approach to decision making• Mutually beneficial supplier relationships• Continual improvement
![Page 79: EUROCONTROL/Quality seminar 14th July 2010 Gaelle Rousseau-Lamour.](https://reader031.fdocuments.us/reader031/viewer/2022013004/56649e115503460f94afd6cf/html5/thumbnails/79.jpg)
13th & 14th July 2010 79
Key Principles of ISO 9000
1 GET ORGANISED1 GET ORGANISED- define roles, responsibilities, interfaces- define roles, responsibilities, interfaces
2 PROVIDE RESOURCES2 PROVIDE RESOURCES- human resources, training, facilities- human resources, training, facilities
3 DOCUMENT MANAGEMENT SYSTEMS3 DOCUMENT MANAGEMENT SYSTEMS- establish procedures, control documents- establish procedures, control documents
4 CONTROL PROCESSES4 CONTROL PROCESSES- plan processes, control operations- plan processes, control operations
5 KEEP RECORDS OF ACTIVITIES5 KEEP RECORDS OF ACTIVITIES- evidence of effective operation- evidence of effective operation
6 CARRY OUT REGULAR CHECKS6 CARRY OUT REGULAR CHECKS- inspections, tests, surveys, audits- inspections, tests, surveys, audits
7 IMPROVE THE SYSTEMS7 IMPROVE THE SYSTEMS- pro-active continual improvement process- pro-active continual improvement process
![Page 80: EUROCONTROL/Quality seminar 14th July 2010 Gaelle Rousseau-Lamour.](https://reader031.fdocuments.us/reader031/viewer/2022013004/56649e115503460f94afd6cf/html5/thumbnails/80.jpg)
13th & 14th July 2010 80
MAIN ASUMPTION !!!
If the ISO 9001:2008 implementation project is to be successful, then there
MUST be support and commitment from Top Management.
![Page 81: EUROCONTROL/Quality seminar 14th July 2010 Gaelle Rousseau-Lamour.](https://reader031.fdocuments.us/reader031/viewer/2022013004/56649e115503460f94afd6cf/html5/thumbnails/81.jpg)
13th & 14th July 2010 81
DISCUSSION POINTS
Are there any final
questions or points
for discussion?
![Page 82: EUROCONTROL/Quality seminar 14th July 2010 Gaelle Rousseau-Lamour.](https://reader031.fdocuments.us/reader031/viewer/2022013004/56649e115503460f94afd6cf/html5/thumbnails/82.jpg)
13th & 14th July 2010 82
END OF COURSE
Thank you for attending this workshop - we hope that it has fully met your needs and expectations.