Audit

Lead Auditor Training - IRCA Certified

Network: 
Life Sciences Skillnet
Location of Course Limerick
Sligo
Athlone
Trainer Martin Reddington
Irish Quality Centre Galway & Sligo
Kelamc Group Clonmel
Methods of Assessment Theory and Practical
Learning Outcomes By the end of the course participants will be able to:
• Describe the purpose of a quality management system and explain the 8 principles of quality management.
• Explain the purpose, content and interrelationship of ISO 9000, ISO13485, ISO 9004 and ISO 19011.
• Interpret requirements of ISO 13485 in the context of an audit.
• Manage an audit programme.
• Understand the different types of audits.
• Describe the roles and responsibilities of auditors and lead auditors.

• Plan and conduct an audit in accordance with ISO 19011, demonstrating ability to:
a) plan and prepare effectively
b) gather objective evidence, through effective interviewing,
observation, sampling and note taking.
c) analyse and interpret information in order to determine
conformance with requirements.

• Report the audit, including writing valid, factual and value-adding non-conformity reports.
• Undertake audit follow-up activities, including evaluating the effectiveness of corrective action.
• Professionally liaise with external auditors.

Eligibility Lead Auditor Training IRCA Certified Course During the 5 days participants will acquire knowledge and skills in auditing. However, auditing like any other acquired skill requires practice. The best place to practice and extend your experience is during actual audits.
Further Enquiries Michelle Reinecke-Quain
Life Sciences Skillnet Administrator
Email: michelle.reinecke-quain@ibec.ie
Phone: 061 431802
Entry Requirements Working with quality systems
Careers or Further Progression Professional Certified Lead Auditor
Course Content Lead Auditor Training IRCA Certified Course During the 5 days participants will acquire knowledge and skills in auditing. However, auditing like any other acquired skill requires practice. The best place to practice and extend your experience is during actual audits.
Enrolment and Start Dates Comment Enrol by Friday 31 May 2013
Course Dates:
Limerick - 18 June 2013
Sligo - 4 June 2013
Athlone - 8 October 2013
Subjects Taught Fundamentals Of Quality, Drug GMP Requirements, Regulation, Auditing.
Duration 5 days
Comment The programme is internationally approved by IRCA – International Registration Scheme for certified training programme and Auditors.
Number of Places 10
Course Fee Life Sciences Members €600 / person
Available to Job Seekers: 
No
Certified: 
No

ISO13485 Refresher Course

Network: 
Life Sciences Skillnet
Methods of Assessment Theory and Practical
Learning Outcomes By the end of the course participants will be able to:
• Describe the purpose of a quality management system and explain the 8 principles of quality management.
• Explain the purpose, content and interrelationship of ISO 9000, ISO13485, ISO 9004 and ISO 19011.
• Interpret requirements of ISO 13485 in the context of an audit.
• Manage an audit programme.
• Understand the different types of audits.
• Describe the roles and responsibilities of auditors and lead auditors.

• Plan and conduct an audit in accordance with ISO 19011, demonstrating ability to:
a) plan and prepare effectively
b) gather objective evidence, through effective interviewing,
observation, sampling and note taking.
c) analyse and interpret information in order to determine
conformance with requirements.

• Report the audit, including writing valid, factual and value-adding non-conformity reports.
• Undertake audit follow-up activities, including evaluating the effectiveness of corrective action.
• Professionally liaise with external auditors

Further Enquiries Michelle Reinecke-Quain
Life Sciences Skillnet Administrator
Email: michelle.reinecke-quain@ibec.ie
Phone: 061 431802
Course Content Why change and what are the main new requirements
Structure & Content of ISO 13485:2003
Quality management system
Resource management
Product realisation
Measurement, analysis and improvement
Enrolment and Start Dates Comment Course runs on demand
Duration 1 day
Comment Introduction to ISO13485:2003 Medical Devices Directive
Book on line: Life Sciences - Book your event
Number of Places 15
Course Fee Life Sciences Skillnet members Members €150.00
Free of Charge to Job Seekers
Available to Job Seekers: 
Yes
Certified: 
Yes

Internal QMS Auditor

Network: 
MBE Skillnet
Methods of Assessment Continual Assessment throughout the course.
Learning Outcomes This two-day course provides learners with an understanding of the purpose and structure of ISO 9001 and then facilitates the learner in developing the skills necessary to be an effective internal auditor.
Further Enquiries MBE Network Manager
t: 043 668 5872

e: info@mbeskillnet.ie
e: martina@mbeskillnet.ie

Course Content Introduction to Quality Systems, ISO 9000,9001,9004,19011 standards. The purpose & structure of ISO 9001. The Process Approach. Roles & Responsibilities of internal auditors. Audit Preparation - pre-audit activities. Audit checklists. Conducting the audit - gathering evidence. Interview techniques/questioning skills. Behavioural aspects of auditing. Reporting the audit and follow-up. Corrective action.
Financial Support
Enrolment and Start Dates Comment Start Date: 06th March 2013
Finish Date: 07th March 2013
Duration 2 day training programme.
Comment This course has been certified by IRCA. The International Register of Certificated Auditors (IRCA) is the world's original and largest international certification body for auditors of management systems.
Number of Places 8
Course Fee €450.00 per candidate (cost includes training cost, certification, course manual & refreshments on each day)
Available to Job Seekers: 
Yes
Certified: 
Yes

Auditing Refreshers

Network: 
CPA Ireland Skillnet
Location of Course Galway: Clayton Hotel
Killarney: The Malton
Limerick: Strand Hotel
Mayo: Harlequin Hotel, Castlebar
Further Enquiries Susannah McNally
CPA Ireland Skillnet
e: smcnally@cpaireland.ie
t: 01 425 1031
Duration 3 hours, 5.00pm - 8.00pm.
Course Fee €100
Available to Job Seekers: 
No
Certified: 
No

Quality Auditor Training

Network: 
HPSU Skillnet
Location of Course Galway
Learning Outcomes A working knowledge quality auditing
Further Enquiries Philip Kelly
Network Manager
m: 086 814 6060
e: hpsuskillnet@gmail.com
Course Content Participants will learn to :
• Understand the ISO 9001:2008 standard requirements - value added approach.
• Apply auditing best practices using key principles, interpersonal skills and techniques.
• Plan for effective auditing and management system reviews
• Use the audit process and outcomes for QMS planning, management system improvements and bottom line results.
Financial Support Please contact Philip Kelly
Enrolment and Start Dates Comment Start and enrollment date is the 16th April 2013,
The course will be held on the following dates:
16th and 17th April,
23rd and 24th April
16th and 17th May
28th and 29th May
Subjects Taught As per course contents
Duration 4.5 days
Number of Places 12
Course Fee Please contact Philip Kelly
Available to Job Seekers: 
Yes
Certified: 
No
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