Download - Auditing to 19011
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Auditing Skills Update
Conformance to
ISO19011
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Agenda:
Day One: ISO19011: 2002
Principles of auditing Managing an Audit programme
Audit Activities (Part 1)
Day Two:
Audit Activities (Part 2)
Competence and evaluation of auditors
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TutorIntroductions
Who we are
Our background
Our qualifications
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Name Job Title/Responsibility
Knowledge of ISO Standards and Auditing
Reasons/Objectives for Attending
Delegate Introductions
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What are your objectives? 15 min
This training program is yours. It is
important to determine what your objectivesare for this course, and what questions you
may want to address.
In the space below, indicate your teams
objectives and/or questions to be answeredduring this two day course.
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There is a need for a
good standard..and goodauditors
1.1. New standards requires newNew standards requires new
approachesapproaches2.2. Auditors have a realAuditors have a real
opportunity to add value to theopportunity to add value to the
organizationorganization
3.3. Demands for professionalismDemands for professionalism
have never been greaterhave never been greater4.4. Continual ProfessionalContinual Professional
Development (CPD) is the keyDevelopment (CPD) is the key
to continued success.to continued success.
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ISO9000:2000 is not the only new
standard!!
ISO10011ISO10011
QMS AuditingQMS AuditingISO14011ISO14011
EMS AuditingEMS Auditing
ISO19011
System Auditing
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ISO 19011
Auditing Standard
The new structure of ISO 9001:2000
follows in philosophy that of ISO14001
Identifies the requirements of QMSauditing and combines with EMS
auditing
Principles of Auditing
Managing an audit program
Audit Activities Competence of auditors
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3.0 Terms and definitions 15 min
Audit Criteria
Audit evidence Audit findings
Audit conclusion
Audit client
Auditee
Auditor
Audit team Technical expert
Audit programme
Audit plan
Audit scope Competence
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4.0 Principles of auditing
Ethical Conduct: the foundation of professionalism
Fair
Presentation: the obligation to report truthfullyand accurately
Due professional care: the application andjudgment in auditing.
Independence: the basis for the impartiality of the
audit and objectivity of the audit conclusions Evidence-based approach: the rational method for
reaching reliable and reproducible Audit conclusionsin a systematic audit process
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5.0 Managing
an auditprogramme
The organizations top
management should
grant authority for theaudit. Those assigned
for the audit should:
1.Identify the necessary
resources and ensure
they are provided.
2.Establish, implement,
monitor, review and
improve the audit
programme, and
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Audit programme objectives andextent
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5.2.1 Objectives of an auditprogramme
a) management priorities,
b) commercial intentions,c) management system requirements,
d) statutory, regulatory and contractual requirements,
e) need for supplier evaluation,
f) customer requirements,g) needs of other interested parties, and
h) risks to the organization
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5.2.2 Extent of an audit programme
The extent of an audit programme can vary and will be influenced by the size,nature and complexity of the organization to be audited, as well as by thefollowing:
a) the scope, objective and duration of each audit to be conducted;
b) the frequency of audits to be conducted;
c) the number, importance, complexity, similarity and locations of the activities tobe audited;
d) standards, statutory, regulatory and contractual requirements and other auditcriteria;
e) the need for accreditation or registration/certification;
f) conclusions of previous audits or results of a previous audit programme review;
g) any language, cultural and social issues;
h) the concerns of interested parties;
i) significant changes to an organization or its operations.
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Audit programme responsibilities,resources and procedures
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5.3.1 Audit programme responsibilities
Those assigned the responsibility for managing theaudit programme should
a) establish the objectives and extent of the auditprogramme,
b) establish the responsibilities and procedures, andensure resources are provided,
c) ensure the implementation of the audit programme,d) ensure that appropriate audit programme records
are maintained, and
e) monitor, review and improve the audit programme.
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5.3.2 Audit programme resources
When identifying resources for the audit programme, considerationshould be given to
a) financial resources necessary to develop, implement, manageand improve audit activities,
b) audit techniques,
c) processes to achieve and maintain the competence of auditors,and to improve auditor performance,
d) the availability of auditors and technical experts having
competence appropriate to the particular audit programmeobjectives,
e) the extent of the audit programme, and
f) traveling time, accommodation and other auditing needs.
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5.3.3 Audit programme procedures
Audit programme procedures should address the following:
a) planning and scheduling audits;
b) assuring the competence of auditors and audit team leaders;c) selecting appropriate audit teams and assigning their roles and
responsibilities;
d) conducting audits;
e) conducting audit follow-up, if applicable;
f) maintaining audit programme records;
g) monitoring the performance and effectiveness of the auditprogramme;
h) reporting to top management on the overall achievements of theaudit programme.
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Audit programme implementation
Element 5.4
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Implementation points
a) communicating the audit programme to relevant parties;
b) coordinating and scheduling audits and other activities relevant to theaudit programme;
c) establishing and maintaining a process for the evaluation of theauditors and their continual professional development, in accordancewith respectively 7.6 and 7.5;
d) ensuring the selection of audit teams;
e) providing necessary resources to the audit teams;
f) ensuring the conduct of audits according to the audit programme;
g) ensuring the control of records of the audit activities;h) ensuring review and approval of audit reports, and ensuring their
distribution to the audit client and other specified parties;
i) ensuring audit follow-up, if applicable.
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5.5 Audit programme records
a) records related to individual audits, such as
audit plans,
audit reports, nonconformity reports,
corrective and preventive action reports, and
audit follow-up reports, if applicable;
b) results of audit programme review;
c) records related to audit personnel covering subjects such as
auditor competence and performance evaluation,
audit team selection, and
maintenance and improvement of competence.
Records should be retained and suitably safeguarded.
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5.6 Audit programme monitoring and
reviewing
The implementation of the audit programme
should be monitored and, at appropriateintervals, reviewed to assess whether its
objectives have been met and to identify
opportunities for improvement. The results
should be reported to top management.
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Performance Indicators
Performance indicators should be used to
monitor characteristics such as the ability of the audit teams to implement the
audit plan,
conformity with audit programmes and schedules,
and feedback from audit clients, auditees and
auditors.
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Audit Programme Review
a) results and trends from monitoring,
b) conformity with procedures,c) evolving needs and expectations of
interested parties,
d) audit programme records,
e) alternative or new auditing practices, andf) consistency in performance between audit
teams in similar situations.
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Audit Activities
Clause 6.0
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General Requirements
This clause contains guidance on planning and
conducting audit activities as part of an auditprogramme. The figure below provides an
overview of typical audit activities. The extent
to which the provisions of this clause are
applicable depends on the scope andcomplexity of the specific audit and the
intended use of the audit conclusions.
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Initiating the Audit
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Appointing the audit team leader
Those assigned the responsibility for managing the audit
programme should appoint t
he audit team leader for t
hespecific audit.
Where a joint audit is conducted, it is important to reach
agreement among the auditing organizations before the
audit commences on the specific responsibilities of each
organization, particularly with regard to the authority of theteam leader appointed for the audit.
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6.2.2 Defining audit objectives, scope and
criteria
Within the overall objectives of an audit
programme, an individual audit should bebased on documented objectives, scope and
criteria.
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Team Exercise
Determining and Writing a Scope of an
Audit. Time 10 minutes, feedback: 10 minutes)
Your team has been given a Quality Manual,
use the information in Quality Manual to
write-up the scope on the flip chart and beprepared to present to the rest of the class.
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6.2.3Determining the feasibility of theaudit
The feasibility of the audit should be determined,
taking into consideration such factors as the
availability of
sufficient and appropriate information for planning the audit,
adequate cooperation from the auditee, and
adequate time and resources.
Where the audit is not feasible, an alternative shouldbe proposed to the audit client, in consultation with
the auditee.
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6.2.4 Selecting the audit team
When the audit has been declared feasible,
an audit team should be selected, taking intoaccount the competence needed to achieve
the objectives of the audit. If there is only oneauditor, the auditor should perform allapplicable duties of an audit team leader.
Clause 7 contains guidance on determiningthe competence needed and describesprocesses for evaluating auditors.
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International Accreditation Forum (IAF)
Guide
Certificated entity:Certificated entity:
Number ofNumber ofemployeesemployees
Initial assessmentInitial assessment
(AuditorDays)(AuditorDays)
Annual surveillanceAnnual surveillance
visits (AuditorDays)visits (AuditorDays)
ReRe--assessment visitsassessment visits
(AuditorDays)(AuditorDays)
TotalTotal OnOn--sitesiteminimumminimum
TotalTotal OnOn--sitesiteminimumminimum
TotalTotal OnOn--sitesiteminimumminimum
less than 5less than 5 22 11 11 0.5*0.5* 1.51.5 1155--99 2.52.5 1.51.5 11 0.5*0.5* 1.51.5 11
1010--1919 33 22 11 11 22 112020--2929 44 2.52.5 1.51.5 11 33 223030--5959 66 4.54.5 22 11 44 2.52.5
6060--9999 77 55 22 1.51.5 44 33100100--249249 88 66 2.52.5 22 55 33250250--499499 1010 77 33 22 66 4.54.5
500500--999999 1212 99 44 33 88 5.55.51,0001,000--1,9991,999 1515 1212 55 44 1010 6.56.52,0002,000--3,9993,999 1818 1414 66 55 1212 884,0004,000--7,9997,999 2121 1717 77 55 1414 99
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EXERCISE: Selecting the Audit Team
Part 1 0f 2
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EXERCISE: Selecting the Audit Team
Part 2 0f 2
Time: 30 min preparation; 15 min
presentation
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6.2.5 Establishing initial contact with
the auditee
The initial contact for the audit with the
auditee may be informal or formal, but shouldbe made by those assigned responsibility for
managing the audit programme or the audit
team leader.
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6.3 Conducting document review
Prior to the on-site audit activities the
auditees documentation should be reviewedto determine the conformity of the system, as
documented, with audit criteria.
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6.4 Preparing for the on-site auditactivities
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6.4.1 Preparing the audit plan
The audit team leader should prepare an audit plan
to provide the basis for the agreement among the
audit client, audit team and the auditee regarding the
conduct of the audit. The plan should facilitate
scheduling and coordination of the audit activities.
The amount of detail provided in the audit planshould reflect the scope and complexity of the audit.
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6.4.2 Assigning work to the audit team
The audit team leader, in consultation with the auditteam, should assign to each team member
responsibility for auditing specific processes,functions, sites, areas or activities. Suchassignments should take into account the need forthe independence and competence of auditors andthe effective use of resources, as well as different
roles and responsibilities of auditors, auditors-in-training and technical experts. Changes to the workassignments may be made as the audit progressesto ensure the achievement of the audit objectives.
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Date Paul J. Robere Nithisit M. Srinuan S.
1st Jun 01 Opening MtgOverview of QMS
EngineeringLunchEngineering (cont.)Team Review
Opening MtgOverview of QMS
South shopLunchSouth shop (cont.)Team Review
2nd Jun 01 PurchasingContracts/SalesLunchProduct Support
Write-up & closingMeeting
CalibrationChemical/Met Laps
Lunch
Personnel /TrainingCustomer ServiceWrite-up & closingMeeting
MaintenanceDoc/Date contol
Lunch
Internal AuditCA/PAWrite-up & closingMeeting
Start times 09:00, finish times 17:00. Lunch to be determined. This is only an outline plan and may besubject to change. A wash up meeting will be held on the evening of the first day. Each Assessorshould have a guide to accompany them at all times. This will help facilitate the audit and ensure thesafety of the team.
Sample Audit ScheduleS.C. Lap Limited
Lead Auditor : Paul J. Robere
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Sample Audit Sch
eduleproPrint Bureau ServicesproPrint Bureau ServicesEaling SiteEaling SiteLEAD AUDITOR: PAUL ROBERELEAD AUDITOR: PAUL ROBERE SECOND AUDITOR: KHUN ONTEERASECOND AUDITOR: KHUN ONTEERA
DAY ONEDAY ONE
OPENING MEETING Overview of QMS MtgOPENING MEETING Overview of QMS Mtg 9.009.00
PurchasingPurchasing P280P280 10.0010.00 PrePre--Sales TeamSales Team P470P470 10.0010.00
Contractor ServicesContractor Services PP291291 11.0011.00 Design TeamDesign Team P465P465 10.4510.45
MarketingMarketing PP310310 11.3011.30 Tech. ServicesTech. Services P468P468 11.3011.30
LUNCHLUNCH
EstimatingEstimating P312P312 13.3013.30 Operator TeamOperator Team PP420420 13.3013.30
Contract ReviewContract Review P314P314 14.3014.30 Job ShipmentJob Shipment PP472472 14.3014.30
Requirements DefinitionRequirements Definition P315P315 15.3015.30 Customer SupportCustomer Support P500P500 15.3015.30
DAY ONE ROUND UPDAY ONE ROUND UP 17.0017.00 DAY ONE ROUND UPDAY ONE ROUND UP 17.0017.00
DAY TWODAY TWO
LEAD AUDITORLEAD AUDITOR SECOND AUDITOR SECOND AUDITOR
Project ManagementProject Management PP405405 09.0009.00 Web Development TeamWeb Development Team P410P410 09.0009.00
Development ControlDevelopment Control P420P420 11.3011.30 Admin ServicesAdmin Services P440P440 1010..3030
P490P490 12.0012.00
LUNCHLUNCH 12. 0012. 00 LUNCHLUNCH 1212..0000
Resource ManagementResource Management P200P200 14.0014.00 Design ControlDesign Control P400P400 14.0014.00
Quality ManagementQuality Management P250P250 14.3014.30 Configuration ManagementConfiguration Management P403P403 15.0015.00
Preparation for ClosingPreparation for Closing
MeetingMeeting
16.0016.00 Preparation for ClosingPreparation for Closing
MeetingMeeting
16.0016.00
CLOSING MEETINGCLOSING MEETING 17.0017.00 CLOSING MEETINGCLOSING MEETING 17.0017.00
12.0012.00 12.0012.00LUNCHLUNCH
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EXERCISE: Audit Schedule
Time: 45 minutes. Feedback: 30 Minutes
Imagine you are part of a team conducting an third party audit.
The lead auditor asks you to come up with an audit schedule detailinghow you might cover the core activities as indicated in the informationgiven in the Quality Manual
Include a daily programme for the auditor(s) involved, remembering toconsider: Opening and closing meetings
Logistics
Breaks
Contingency planning.
Be prepared to discuss the thinking behind your plan with the class.
The exercise is intended to make you think about the planningnecessary for an effective audit in a situation of real-world complexity.
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6.4.3Preparing work documents
The audit team members should review the
information relevant to their auditassignments and prepare work documents
as necessary for reference and for recording
audit proceedings.
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EXERCISE Checklists
Time: 60 minutes. Feedback: 30 minutes.
Produce a checklist on the templateprovided to cover the training process as
detail in the given quality manual.
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6.5 Conducting on-site audit activities
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6.5.1 Conducting the opening meeting
An opening meeting should be held with theauditees management or, where appropriate, those
responsible for the functions or processes to beaudited.
The purpose of an opening meeting is to confirm the audit plan,
to provide a short summary ofhow the audit activities will be
undertaken, to confirm communication channels, and
to provide an opportunity for the auditee to ask questions.
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Exercise Opening Meeting
Time: 60 minutes, feedback 30 minutes.
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6.5.2 Communication during the audit
Depending upon the scope and complexity ofthe audit, it can be necessary to make formalarrangements for communication within theaudit team and with the auditee during theaudit.
The audit team should confer periodically toexchange information, assess auditprogress, and to reassign work between theaudit team members as needed.
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6.5.3 Roles and responsibilities of
guides and observers
Guides and
observers mayaccompany the
audit team but are
not a part of it. They
should not influenceor interfere with the
conduct of the audit.
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Collection Methods
Methods to collect information include
interviews, observation of activities, and
review of documents.
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Practical help Conducting
interviews
Interviews are one of the important means ofcollecting information and should be carried
out in a manner adapted to the situation and
the person interviewed.
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6.5.5 Generating audit findings
Audit evidence should be evaluated
against the audit criteria to generatethe audit findings.
Audit findings can indicate either
conformity or nonconformity with
audit criteria.
When specified by the auditobjectives, audit findings can identify
an opportunity for improvement.
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EXERCISE Recording
Non-conformities
Time: 60 minutes. Feedback: 30 minutes
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EXERCISE: GRADING NCRs
Time : 45 minutes Feedback: 30 minutes.
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6.5.6 Preparing audit conclusions
The audit team should confer prior to the closing meeting
a) to review the audit findings, and any other appropriateinformation collected during the audit, against the auditobjectives,
b) to agree on the audit conclusions, taking into account theuncertainty inherent in the audit process,
c) to prepare recommendations, if specified by the auditobjectives, and
d) to discuss audit follow-up, if included in the audit plan.
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6.5.7 Conducting the closing meeting
A closing meeting, chaired by the audit team
leader, should be
held to present t
he auditfindings and conclusions in such a manner
that they are understood and acknowledged
by the auditee, and to agree, if appropriate,
on the timeframe for t
he auditee to present acorrective and preventive action plan.
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Exercise Closing Meeting
Time: 60 minutes, feedback 30 minutes.
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6.6 Preparing, approving anddistributing the audit report
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6.6.1 Preparing the audit report
The audit team leader should
be responsible for thepreparation and contents of
the audit report.
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Findings Summary Part 1
This Company has a Quality Management System which is well documented
and generally in conformance with the requirements of ISO 9001:2000.
However,the systems and procedures have not been fully
implemented in the contract, project management and product
shipment areas.
The audit found 33 non-conformities and particular concern is felt for:
Lack of application of the system for review of the quality
requirements of contracts.
Evidence of a lack of disciplined control toward customercomplaints and related follow-up actions.
Lack of quality awareness on the part of project and senior
management personnel.
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Findings Summary Part 2
No significant problems were found in the activities of either the
Design or pre-sales teams.
There is a need for more frequent review of the Quality Manual and
project management procedures.
It will therefore be necessary for the company to undertake
corrective action on the deficiencies raised and for a further audit
to be carried out to verify that it has been taken before the
company can be awarded a certificate. Corrective action should
be effected with
in th
ree month
s from today.
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6.6.2 Approving and distributing the
audit report
The audit report should be issued within the agreed time period.If this is not possible, the reasons for the delay should be
communicated to the audit client and a new issue date s
houldbe agreed.
The audit report should be dated, reviewed and approved inaccordance with audit programme procedures.
The approved audit report should then be distributed torecipients designated by the audit client.
The audit report is the property of the audit client. The auditteam members and all report recipients should respect andmaintain the confidentiality of the report.
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6.7 Completing the audit
The audit is completed when all activities described
in the audit plan have been carried out and the
approved audit report has been distributed.
Documents pertaining to the audit should be retained
or destroyed by agreement between the participating
parties and in accordance with audit programme
procedures and applicable statutory, regulatory andcontractual requirements.
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6.8 Conducting audit follow-up
The conclusions of the audit may indicate the
need for corrective, preventive orimprovement actions, as applicable. Such
actions are usually decided and undertaken
by the auditee within an agreed timeframe
and are not considered to be part of theaudit. The auditee should keep the audit
client informed of the status of these actions.
C ti A ti PC ti A ti P
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ACCEPT
Corrective Actions ProcessCorrective Actions Process
Initiation of Non-conformity
Provide Programme of CA
Submit CA Programme to Auditor
Analysis of CAProgramme
Monitoring,Reviewing,Auditing
Verify and closing
Auditor
Auditee
Auditee
Auditee
Auditor
Auditor
Stage 1
Stage 5
Stage 2
Stage 6
Stage 3
Stage 4
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7 Competence and evaluation ofauditors
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7.1 General Requirements for
Competence and Evaluation
Confidence and reliance in the audit processdepends on the competence of thoseconducting the audit. This competence isbased on the demonstration of: the personal attributes described in 7.2, and
the ability to apply the knowledge and skills
described in 7.3 gained through the education,work experience, auditor training and auditexperience described in 7.4.
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7.2 Personal attributes
Auditors should possess
personal attributes to enablethem to act in accordance
with the principles of auditing
described in clause 4.
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7.3 Knowledge and skills
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7.3.1 Generic knowledge and skills of qualitymanagement system and environmental management
system auditors
Auditors should have knowledge and skills in
the following areas.1. Audit principles, procedures and techniques
2. Management system and reference documents
3. Organizational situations
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Audit principles, procedures and
techniques
Audit principles, procedures and techniques:
to enable the auditor to apply t
hoseappropriate to different audits and ensure
that audits are conducted in a consistent and
systematic manner
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Management system and reference
documents
1. to enable the auditor to comprehend the
scope of the audit and apply audit criteria.
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Organizational situations:
To enable the auditor to comprehend the
organization's operational context.
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Applicable laws, regulations and other
requirements relevant to the discipline:
to enable the auditor to work within, and be
aware of, th
e requirements th
at apply to th
eorganization being audited
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7.3.3 Specific knowledge and skills of
quality management system auditors
Quality management system auditors should have
knowledge and skills in the following areas.
a) Quality-related methods and techniques: to enable
the auditor to examine quality management systems
and to generate appropriate audit findings and
conclusions.
b) Processes and products, including services: toenable the auditor to comprehend the technological
context in which the audit is being conducted..
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7.3.4 Specific knowledge and skills of
environmental management system auditors
Environmental management system auditors
sh
ouldh
ave knowledge and skills in th
efollowing areas.
a) Environmental management methods and
techniques
b) Environmental science and technology
c) Technical and environmental aspects of
operations
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Environmental management methods
and techniques:
to enable the auditor to examine
environmental management systems and togenerate appropriate audit findings and
conclusions.
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Environmental science and technology
to enable the auditor to comprehend the
fundamental relationships between human
activities and the environment.
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Technical and environmental aspects
of operations:
to enable the auditor to comprehend the
interaction of the auditees activities,
products, services and operations with the
environment.
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7.4 Education, work experience,auditor training and audit experience
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7.4.1 Auditors Qualification
They should have completed an education
sufficient to acquire the knowledge and skills
They should have work experience
They should have completed auditor training
They should have audit experience
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7.4.2 Audit team leaders
An audit team leader should haveacquired additional audit experience to
develop the knowledge and skillsdescribed in 7.3.2. This additionalexperience should have been gainedwhile acting in the role of an audit team
leader under the direction and guidanceof another auditor who is competent asan audit team leader.
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7.4.3 Auditors who audit both quality and
environmental management systems
Must have training and
work experience and
Have conducted audits in
the second discipline under
direction of an auditor.
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7.4.4 Levels of education, work experience,
auditor training and audit experience
Organizations should establish the levels of
the education, work experience, auditor
training and audit experience an auditor
needs
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7.5 Maintenance and improvement ofcompetence
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7.5.1 Continual professional development
Continual professional development is
concerned with the maintenance and
improvement of knowledge, skills and
personal attributes.
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7.5.2 Maintenance of auditing ability
Auditors should maintain and demonstrate
their auditing ability through regular
participation in audits of quality and/or
environmental management systems.
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7.6 Auditor evaluation
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7.6.1 General
The evaluation of auditors and audit team
leaders should be planned, implemented andrecorded in accordance with audit
programme procedures to provide an
outcome that is objective, consistent, fair and
reliable. The evaluation process shouldidentify training and other skill enhancement
needs.
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7.6.2 Evaluation process
A four-step process:
1. Identify the personal attributes, and t
heknowledge and skills to meet the needs of
the audit programme
2. Set the evaluation criteria
3. Select the appropriate evaluation method
4. Conduct the evaluation
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An International Provider ofAuditor
Certification andAuditor Training Certification
Programmes
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A worldwide activity
60,000 a year
24,000 since 1984
100 countries 100 providers
London, UK
QMS 2000 & 1994
EMS
OH&S
FSMS
ISMS
SectorP
rogrammes
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Why become an
IRCA certified auditor?
Recognize your competenceIncrease your credibility
International recognition
Increase earning potential
Improve your CV / resume
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Which grade?
Internal Auditor
Provisional Auditor
Auditor
Lead Auditor
Principal Auditor
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What are the requirements?
AuditorTraining Course
Education & Qualifications
Work experience (general and specific)
Auditing experience
+
ContinuingP
rofessionalD
evelopment
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What now?
Contact IRCA to apply for auditor certification:
www.irca.org
or
Or
www.irca.co.th
telephone +66 (2) 661-9955
or
66 (2) 661-9957
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Evaluation Methods
D
O NOT
D
ELET
E
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TABLE 3
DO NO
TD
ELET
E
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Thank you for your participation
For additional information or support
Contact:Paul Robere, IRCA Certified Principle Auditor
at:
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Any Questions?Any Questions?Any Questions?Any Questions?