SBS - The best value in QMS software

Audit boundaries - Is a Registrar permitted to audit a company's QMS by visiting their suppliers?

lorenambrose

Quality Assurance Manager
#1
A quick question........

Is a Registrar permitted to audit a company's QMS by visiting their suppliers? Is there an actual prohibition regarding this?
 
Elsmar Forum Sponsor

Al Rosen

Staff member
Super Moderator
#4
8.4.3 l addresses this.

The organization shall ensure the adequacy of requirements prior to their communication to the external provider.
The organization shall communicate to external providers its requirements for:

l. the right of access by the organization, their customer, and regulatory authorities to the applicable areas of facilities and to applicable documented information, at any level of the supply chain;
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#6
l. the right of access by the organization, their customer, and regulatory authorities to the applicable areas of facilities and to applicable documented information, at any level of the supply chain;
The right of access does not include the customer’s CB, though. No CB should be visiting suppliers without the registrants awareness and approval.

In the regulated medical device sector, critical suppliers, e.g. sterilization service providers can be audited in unannounced audits. But that’s not the normal practice.
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#10
The post is in the AS9100 discussion forum. So is the context for the answers so far. The OP has posted most questions in this Forum.
 
Thread starter Similar threads Forum Replies Date
D Supplier audit Medical Device and FDA Regulations and Standards News 2
M Go Live With New ERP System before Recertification Audit General Auditing Discussions 6
A Add MDSAP to Internal Audit Schedule Medical Device Related Regulations 0
A Define timeline for Major and Miner Audit finding General Auditing Discussions 4
J IATF 16949 Internal Audit question - Auditor's responsibility Internal Auditing 6
A API Monogram audit review process Oil and Gas Industry Standards and Regulations 4
S IATF 16949 Internal Audit Example IATF 16949 - Automotive Quality Systems Standard 7
B Remote IATF 16949 audit preparation IATF 16949 - Automotive Quality Systems Standard 9
M AS9100D Registrar pre-audit requirements AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 15
I Do I need to sign off my annual audit calendar? Internal Auditing 2
R AS9100D internal audit checklist or ISO 9001 2015 to AS9100 D AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
M Nice and simple invitation email to an audit kickoff meeting Internal Auditing 1
M IATF 16949 - Audit of Remote Location/Support Site and IT IATF 16949 - Automotive Quality Systems Standard 4
Q IATF audit - Root Cause Analysis results IATF 16949 - Automotive Quality Systems Standard 5
Q Self-assessment audit information Quality Management System (QMS) Manuals 6
Le Chiffre Online training available for ISO/IEC 17021-1: Requirements for bodies providing audit and certification of management systems Training - Internal, External, Online and Distance Learning 3
xfngrs NIOSH Audit for N95 respirators US Food and Drug Administration (FDA) 1
Sidney Vianna IATF 16949 News Risked Based Audit Day Calculation IATF 16949 - Automotive Quality Systems Standard 2
T AS9100 audit due to facility move AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
M ISO 13485:2016 internal audit checklist Medical Device and FDA Regulations and Standards News 5
A Internal Audit Questions ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
B SAP Audit trail Periodic Review EU Medical Device Regulations 1
N What are the software audit and control steps Reliability Analysis - Predictions, Testing and Standards 2
R Gap Audit Aerospsace and Rail QMS Quality Manager and Management Related Issues 0
salaheddine96 Internal audit planning Internal Auditing 2
A MDSAP Audit Questionnaire Medical Device and FDA Regulations and Standards News 7
H Obligations as a contract manufacturer during an MDSAP audit ISO 13485:2016 - Medical Device Quality Management Systems 5
M What are the basics of Medical Device Single Audit Program (MDSAP)? ISO 13485:2016 - Medical Device Quality Management Systems 7
Sidney Vianna IATF 16949 News Update on the IATF CARA Project (“Common Audit Report Application”) - 12/2020 IATF 16949 - Automotive Quality Systems Standard 1
R ISO 17025 vertical audit checklist wanted Document Control Systems, Procedures, Forms and Templates 2
Z Rapid audit template for plastic parts manufacturing process Manufacturing and Related Processes 12
M ISO 9001 Major Nonconformance Internal Audit Schedule/COVID-19 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 18
S Quality Audit Training Activities Quality Manager and Management Related Issues 2
G IATF Rules for COVID 5th revision - Re-certification audit timing IATF 16949 - Automotive Quality Systems Standard 3
E MDR internal audit Medical Device and FDA Regulations and Standards News 0
Ed Panek Remote Audit GOTOMEETING thoughts Coffee Break and Water Cooler Discussions 22
B ISO 9001 - "Remote Audit Fee" Registrars and Notified Bodies 13
L IATF external audit virtual (remote) IATF 16949 - Automotive Quality Systems Standard 12
M Audit Criteria Training Materials Internal Auditing 1
K New supplier audit as per V3.1 by French Automotive OEM General Auditing Discussions 2
S Complexity Rating - CB adding another audit day for "high complexity" AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
U Internal Auditor not trained but done Audit for some process Nonconformance and Corrective Action 5
B Looking for 10 Internal Audit Online Training Participants ISO 17025 related Discussions 2
K MDSAP Audit Approach 2020 for Brazil Other Medical Device Regulations World-Wide 1
K MDSAP Audit Approach 2020 ISO 13485:2016 - Medical Device Quality Management Systems 3
J Audit Checklist for Integrated Management System for ISO 9001:2015, ISO 14001 & OHSAS18001 (IMS) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
B IATF16949 audit requirement - Auditor request UCL and LCL must be show Xbar-R, IATF 16949 - Automotive Quality Systems Standard 7
T COVID, Furlough and ISO9001 Surveillance Audit Coffee Break and Water Cooler Discussions 2
R External Audit and Certificate prorogation due to the pandemic General Auditing Discussions 10
Dean Bell Implementation of Controls as per SOA for Stage 2 Audit IEC 27001 - Information Security Management Systems (ISMS) 0

Similar threads

Top Bottom