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Guest user Created:   Aug 31, 2020 Last commented:   Aug 31, 2020

Expert queries

1) techniques of extracting objective evidence in auditing

2) how to improve on my auditing competency

3) how do you relate ISO 9001 with other quality ISO like ISO 15189:2012? Do i need ISO 9001 to implement ISO 15189:2012?

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ISO 17025 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 17025 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

Expert
Tracey Evans Aug 31, 2020

You asked About

1) techniques of extracting objective evidence in auditing

Objective evidence is obtained by starting with a well define purpose and scope for the specific audit. For each activity you should specify the audit criteria, meaning what the requirements are that you will compare your audit evidence to,  in order to determine if audit criteria are met or not (finding of compliance or noncompliance). The techniques to obtain objective evidence involve making factual observations during a witnessing of a process; interviewing personnel to obtain statements; as well as document and record review by cross checking that stipulated data and information is available and controlled .

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2) how to improve on my auditing competency

You can improve you auditing skills and competency by the following means

  • Undergo internal auditing training and or study the standard ISO 19011:2018 - Guidelines for auditing management systems.
  • Being part of an audit as an auditee (person being audited) or observing third party audits of your laboratory, say by your accreditation body.
  • Assisting the person responsible with evaluating the efficiency of the audit programme to identify areas of improvement in how they are planned and performed
  • Being part of the audit team for your organisation (auditor) and auditing internally, using various techniques (e.g vertical assessments) including techniques and checklists based on those your accreditation body uses.
  • Understanding and leaning how to apply a risk based approach to requirements and findings.

You also asked

3) how do you relate ISO 9001 with other quality ISO like ISO 15189:2012?

The ISO 9001 principles (for example evidence based decision making, process approach) are incorporated into ISO 15189 and many other standards (including ISO 17025). Further more the management requirements such as corrective actions, are part of both standards.

You also asked

Do I need ISO 9001 to implement ISO 15189:2012?

No you do not, however a knowledge of the standard would be useful.

For more information on Auditing, see the Expert Advice Q&A to Auditing impartiality https://community.advisera.com/topic/auditing-impartiality/
 

The ISO 17025 toolkit at https://advisera.com/17025academy/iso-17025-documentation-toolkit/, covers the requirements for ISO 17025.  
The separate ISO 17025 document templates and links to their related documents are available as follows:

Internal Audit Procedure is available at https://advisera.com/17025academy/documentation/internal-audit-procedure/ 
Addressing Risks and Opportunities Procedure is available at at https://advisera.com/17025academy/documentation/addressing-risks-and-opportunities-procedure/

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Aug 31, 2020

Aug 31, 2020

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