External third party audits

Johnny 3484

Quality Manager
#1
Hello, i am interested in understanding individuals thoughts on current third party audit companies, and how they perceive them to be either as a loss of good money or as an added value to the business
 
Elsmar Forum Sponsor

Johnny Quality

Quite Involved in Discussions
#2
I believe the reasoning for certification is more relevant to the value add to the business rather than the third party audit companies themselves. As in, why would an organization want third party certification? For some business sectors it's a prerequisite for business (IATF for automotive for example), or at least continued business. In these cases it's not that the organization wants certification, it's that it needs it.

Another example would be ISO 9001; it's sold under the marketing that it's applicable to all organizations regardless of context, sector or size. But why would a business that sells directly to the general public be interested in certification to 9001? Only if they believe it would make their business better.

It depends on where the motivation for certification comes from, within the organization or outside. I believe an organization will find much more value if there's internal motivation rather than a customer pushing for a certification.

Organizations, big and small, have existed and thrived long before third party audit companies existed.
 
Thread starter Similar threads Forum Replies Date
C Template for External Auditing/Third Party Assessments such as FDA or ISO? Internal Auditing 2
LincolnQA AS9100D, Clause 8.4.1.1d - actions to take when external providers do not meet requirements AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 18
P IATF16949 External Lab Calibration -CIPM MRA IATF 16949 - Automotive Quality Systems Standard 1
T OASIS and External Audits AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
T External Audit Notification List AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
T External Audit Plan Email Template AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
Q External providers assessment - ISO 14001 ISO 14001:2015 Specific Discussions 4
M External audit non conformity related to applicable regulations ISO 13485:2016 - Medical Device Quality Management Systems 7
O 61010-1 Annex D Protection between HAZARDOUS LIVE circuits and ACCESSIBLE external TERMINALS Other Medical Device Regulations World-Wide 0
M Gravimetric blender for resin in automotive industry - periodical calibration via external lab with certification Reliability Analysis - Predictions, Testing and Standards 0
T Company AS9100D External Audit Preparation AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 17
D IATF16949 7.1.5.3.2 External Laboratory IATF 16949 - Automotive Quality Systems Standard 17
J 7.1.3.5.2 External laboratory - CIPM MRA IATF 16949 - Automotive Quality Systems Standard 3
W 7.1.5.3.2. External laboratory Sanctioned Interpretation IATF 16949 - Automotive Quality Systems Standard 4
T Internal and external communication procedure for Food Safety Food Safety - ISO 22000, HACCP (21 CFR 120) 2
J Biocompatibility for endoscope external handle/grip US Food and Drug Administration (FDA) 3
D 8.5.1.2 Validation and control of special processes requirements for Heat Treat External Processor AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
D IATF16949 external audit plan IATF 16949 - Automotive Quality Systems Standard 3
H Regarding external surface temperature limit requirement for lab incubators. CE Marking (Conformité Européene) / CB Scheme 2
A How to monitor new versions of external standards in your business Various Other Specifications, Standards, and related Requirements 2
Quality Specialist Quick question on the sequence of ISO 17025 external audits ISO 17025 related Discussions 14
M IATF external audit NC closure IATF 16949 - Automotive Quality Systems Standard 4
dubrizo Good Documentation Practice (GDP) as it Applies to External Contractors or Vendors Document Control Systems, Procedures, Forms and Templates 4
qualprod External consultant into a QMS ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 15
W External PSU Providing a MOOP -- Will This Necessitate Conducted Emissions Testing? IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
L AS9100 Section 8.4.2 - External provider test reports AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 10
Mikey324 External calibration - Finding in our 3rd party audit General Measurement Device and Calibration Topics 58
D Help Me. Non conformitty in External Audit IATF 16949 - Automotive Quality Systems Standard 13
P Is the second factor authentication (2FA) required for external users? Qualification and Validation (including 21 CFR Part 11) 1
J State of the Art for Documents of External Origin ISO 13485:2016 - Medical Device Quality Management Systems 17
D IATF 16949 SI 10, External non-accredited lab IATF 16949 - Automotive Quality Systems Standard 4
S Recommended software to send Quality scorecards to suppliers (external providers) Supplier Quality Assurance and other Supplier Issues 3
J External Standard Services Document Control Systems, Procedures, Forms and Templates 12
Ed Panek External Standards List - Should this document include previously revised standards? ISO 13485:2016 - Medical Device Quality Management Systems 4
F Logistic/shipping companies as external providers AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
J Help settle a disagreement: Should external providers of preventive maintenance be on your ASL? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
J Requirement for Retention of Records of Withdrawn Documents of External Origin Document Control Systems, Procedures, Forms and Templates 3
M Calibration Certificate Result issued by an accredited external laboratory General Measurement Device and Calibration Topics 9
L IATF external audit virtual (remote) IATF 16949 - Automotive Quality Systems Standard 13
A IEC 62304 safety classification, External Controls and off-label use related risks IEC 62304 - Medical Device Software Life Cycle Processes 5
R External Audit and Certificate prorogation due to the pandemic General Auditing Discussions 10
N Audit non-compliance API Q1 - Use of External Documents 4.4.4 in Product Realization Oil and Gas Industry Standards and Regulations 8
J 510(k) for a control kit for an external IVD test kit 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
R Is it required to have an SOP for external audits? Medical Device and FDA Regulations and Standards News 7
Pmarszal External Standards and Regulations Management Process Document Control Systems, Procedures, Forms and Templates 10
I What kind of wine best complements the Friday that you close out your external audit findings? Opinions are welcome. Coffee Break and Water Cooler Discussions 12
B How to apply external voltage to SIP/SOP IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
P Qualifying commercial off the shelf (COTS) external suppliers ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
B Internal and external auditor competency to CSR's IATF 16949 - Automotive Quality Systems Standard 20
N IATF 16949:2016 7.1.5.3.2 External Laboratory - How to approve the Testing Laboratory without accreditation scope IATF 16949 - Automotive Quality Systems Standard 2

Similar threads

Top Bottom