ISO 17025:2017 LEAD AUDITOR COURSE

Assignment 3
No.

Name Identify and analyse internal and external issues.

Name of
the
Participan
t

Purpose To test participant’s ability to understand context of the organization, identify interested parties and their needs & expectations
for the given case studies. Especially:
1. Organization’s purpose / objectives
2. Needs and expectations of Interested parties
3. Internal issues relevant to the purpose and its strategic direction ( values, culture, knowledge and performance of the
organization)
1. External issues relevant to the purpose and its strategic direction (PESTEL) / Impartiality / Confidentiality
2. Process and activities that can impact organization’s quality management system
3. Interfaces and dependencies between activities performed by the organization
4. Interfaces and dependencies between activities performed by other organizations

Resources You may use the template given in the following pages.

LA: 17025 © CG Page 1 of 4

 ISO 17025:2017 LEAD AUDITOR COURSE

Exercise
1. Steric Laboratories provide analytical testing services for:

 Cosmetic Analysis
 Bacterial Endotoxin Testing (LAL)
 Drug Product Release Testing
 Raw Material Analysis
 Elemental Impurities Analysis
 Method Development and Validation Services
 Stability Studies
 Residual Testing Solutions

2. Biomed Limited supports the medical device and pharmaceutical industries with a global, comprehensive offering of
microbiology testing services.

3. TempCal provides calibration services for temperature and humidity calibrations for data loggers. 

4. Alternatively, participants can take/assume their own organization.

Please prepare a presentation and submit.

LA: 17025 © CG Page 2 of 4

 ISO 17025:2017 LEAD AUDITOR COURSE

QMS Interested Party Internal/Extern Needs Issues Process /activities

Objective al /Expectations impacted

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 ISO 17025:2017 LEAD AUDITOR COURSE

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