3rd Party Sorting and Inspection Company Certification

Marge Hursh

Registered
Are you the 3rd party company? Are you trying to become certified to ISO 9001:2015?
Yes. I have been working a gap assessment. Alot of questions. Only 11 members of leadership and management. Associates are hired and put at various locations (several different auto plants) to sort and inspect the customers parts. The corporate office is in a different state. Most of the process is hiring and filling positions. Nothing really in purchasing, contract review is very small. We follow the customers work instructions. There is no design, no outsourcing. Even non-conforming is confusing at this point. I have taken another company through ISO before but this is some what different. It was warehousing. Even choosing a registrar where would they do the auditing? I really need some direction.
 

Al Rosen

Leader
Super Moderator
Yes. I have been working a gap assessment. Alot of questions. Only 11 members of leadership and management. Associates are hired and put at various locations (several different auto plants) to sort and inspect the customers parts. The corporate office is in a different state. Most of the process is hiring and filling positions. Nothing really in purchasing, contract review is very small. We follow the customers work instructions. There is no design, no outsourcing. Even non-conforming is confusing at this point. I have taken another company through ISO before but this is some what different. It was warehousing. Even choosing a registrar where would they do the auditing? I really need some direction.
Think outside the box. Start here:
Review Contract > Hire > Train to Customer Instructions > Supply Manpower (your product).
 
Thread starter Similar threads Forum Replies Date
A Non-Conformances Found After 3rd Party Sorting Supplier Quality Assurance and other Supplier Issues 12
P Is there a TS/ISO 16949 requirement for 3rd Party Sorting companies? Customer and Company Specific Requirements 4
L Evaluation of Readiness of Organization for 3rd Party Audit ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 14
L 3rd party audit issues - No audit agenda received a week before the audit Registrars and Notified Bodies 7
A " I, as a 3rd party auditor, retain the obligation to determine whether or not the process is "effective"... Discuss. Registrars and Notified Bodies 5
L Acquiring software from 3rd party company IEC 62304 - Medical Device Software Life Cycle Processes 8
K 3rd party auditor for ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 4
H Starting my own 3rd party inspection company Service Industry Specific Topics 6
Mikey324 External calibration - Finding in our 3rd party audit General Measurement Device and Calibration Topics 58
A Becoming an ISO27001 3rd Party Auditor Career and Occupation Discussions 4
G Do HIPAA Rules Apply to a 3rd Party Logistics Shipper? Other US Medical Device Regulations 2
J Extent of 2017/745: providing 3rd party mass produced devices to NHS patients EU Medical Device Regulations 0
S AIAG CQI Auditor Qualification and 3rd Party Certification Requirements General Auditing Discussions 2
W Internal Auditing carried out by a 3rd party - Review of previous audits AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
D Auditing Our Outsourced 2nd-3rd Party Internal Audit Company ISO 13485:2016 - Medical Device Quality Management Systems 6
M CE self-certify, or needs testing by 3rd party? CE Marking (Conformité Européene) / CB Scheme 12
A CAR from 3rd party AS9100D auditor - Root cause dilemma AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 45
S ISO 9001:2015 Gap Analysis - In-House or 3rd Party? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
O IATF 16949 3rd party auditor training sources IATF 16949 - Automotive Quality Systems Standard 1
M IATF 16949 - Multiple Locations - 3rd party audit scope IATF 16949 - Automotive Quality Systems Standard 1
J 3rd Party Certification and QMS Revisions Registrars and Notified Bodies 4
Sidney Vianna Proposed Change to 3rd Party Audit Process - Limiting Scope of Audit Registrars and Notified Bodies 19
armani How to 3rd Party Audit ISO 9001 Clause 7.1.6 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
armani How to approach ISO 9001:2015 Clause 7.1.6 when 3rd Party Auditing ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
Stijloor Calculating (3rd Party) Audit Days for Company with Seasonal Employees General Auditing Discussions 3
L Release of Audit Results Report to 3rd Party ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
C 60601-1 13.1.2 - Passive Device Energized by 3rd Party Device IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
C Looking for 3rd party audit firm for unique contract, have RFP General Auditing Discussions 1
Manix Should a 3rd Party Auditor Audit against IATF rules and not just the ISO standard? General Auditing Discussions 4
S AAMI EC57 for ECG Medical Device - Seeking 3rd Party Test Laboratory US Food and Drug Administration (FDA) 5
V Is the CQI-9 Heat Treat Assessment performed by a 3rd Party Auditor APQP and PPAP 1
D AS 9104/1 has New Requirements for 3rd Party Auditors AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
A 3rd Party Audit Finding Not Clear - 4.1 Outsourced Processes AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 36
R 3rd Party Audit Comment - Identify ISO Clauses/Sub Clauses to each Process Quality Management System (QMS) Manuals 45
J Contents of DMR (Device Master Record) when manufacturing is by 3rd party 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
C Measuring Equipment on Injection Machine should be Calibrated by 3rd party? General Measurement Device and Calibration Topics 21
C Policy for 3rd Party Auditing of Sequencing Facilities IATF 16949 - Automotive Quality Systems Standard 6
D Using IMDS database with 3rd party Intermediate Trade Company RoHS, REACH, ELV, IMDS and Restricted Substances 2
S ANVISA Audit by 3rd Party? Other Medical Device Regulations World-Wide 4
W Do 3rd party testing labs need NRTL certification to perform testing for FDA conforma ISO 13485:2016 - Medical Device Quality Management Systems 3
Howard Atkins ISO/TS 16949 3rd Party Automotive Auditors Group on LinkedIn ASQ, ANAB, UKAS, IAF, IRCA, Exemplar Global and Related Organizations 1
S Customer Requesting 3rd Party Audit Report (AIB) - Help! Quality Manager and Management Related Issues 17
QMMike Telephone Billing - Cramming Scheme 3rd party billing company Coffee Break and Water Cooler Discussions 5
Howard Atkins Right to Appeal 3rd Party (Registrar aka CB) Findings General Auditing Discussions 23
V TS 16949 3rd Party (Certification Body) Audits of Remote Sites IATF 16949 - Automotive Quality Systems Standard 11
V 18001 2nd stage 3rd party Top Management Questions (Training Assignment) General Auditing Discussions 8
E Should FDA implement 3rd party (PMAs) reviews? What are the pros and cons of doing so Other US Medical Device Regulations 2
Y 3rd Party Sterilization Validation for Reusable Medical Devices Other Medical Device Related Standards 7
somashekar A question on 3rd Party Sustainability Audit Cost Misc. Quality Assurance and Business Systems Related Topics 5
M Validating 3rd Party Software which Tracks Archived Samples Qualification and Validation (including 21 CFR Part 11) 2

Similar threads

Top Bottom