How to address IATF 16949 clause 5.1.1.1 in my Quality Manual

jimmymustang06

Involved In Discussions
#1
I'm trying to figure out how to address this clause in my Quality Manual. Our company is owned by a very large and very well known corporation that owns many many many businesses all over the world. But, we don't have corporate policies written at our level, they are sent out as brochures to all of the companies that this corporation owns, complete with hotline numbers etc... So, how do I write that into my QM?

Thanks for any help
Jimmy
 
Elsmar Forum Sponsor

Golfman25

Trusted Information Resource
#2
I would just reference and "adopt" them from corp hq. They write them, you use them. I assume you get them and flow them down to your employees.
 
#3
We reference them on Training Outlines- that way we ensure each employee receives corporate policies upon hire. They also get them annually.
 

Howard Atkins

Forum Administrator
Staff member
Admin
#4
There is no need to reference them in any document.
The standards states
"5.1.1.1 Corporate responsibility
The organization shall define and implement corporate responsibility policies, including at a minimum an anti-bribery policy, an employee code of conduct, and an ethics escalation policy (whistle-blowing policy"). "

The auditor will ask if you have these and you will show the brochures- end of issue.

There is no need to put them in the Quality Manual which ONLY needs to include the following 4 items and not to regurgitate the standard

7.5.1.1 Quality management system documentation
The organization’s quality management system shall be documented and include a quality manual,
which can be a series of documents (electronic or hard copy).
The format and structure of the quality manual is at the discretion of the organization and will
depend on the organization's size, culture, and complexity- If a series of documents is used, then a
list shall be retained of the documents that comprise the quality manual for the organization.
The quality manual shall include, at a minimum, the following:
The quality manual shall include, at a minimum, the following:
a) the scope of the quality management system, including details of and justification for any
exclusions;
b) documented processes established for the quality management system, or reference to them;
c) the organization's processes and their sequence and interactions (inputs and outputs], including
type and extent of control of any outsourced processes;
d) a document (i.e., matrix for example, a table, a list, or a matrix) indicating where within the organization’s quality management system their customer-specific requirements are addressed.
their customer-specific requirements are addressed.
NOTE a matrix of how the requirements of this Automotive QMS standard are addressed by the organization's processes may be used to assist with linkages of the organization's processes and this Automotive QMS.
i.e., matrix see IATF-16949-Sanctioned-Interpretations-1-9-SIs_Final
 

Golfman25

Trusted Information Resource
#5
So anybody have some simple policies for a small company. I am looking to incorporate them in my employee handbook. Don't need much more than a good paragraph really.
 
#7
I'm trying to figure out how to address this clause in my Quality Manual. Our company is owned by a very large and very well known corporation that owns many many many businesses all over the world. But, we don't have corporate policies written at our level, they are sent out as brochures to all of the companies that this corporation owns, complete with hotline numbers etc... So, how do I write that into my QM?

Thanks for any help
Jimmy
As others seem to suggest, you don't put it in your QM. It's common practice for large(r) corporations to have such things in place - although sometimes overlooked following receipt of the employee handbook etc. A simple internal audit will ensure if people realize the thing exists.
 
Thread starter Similar threads Forum Replies Date
R Where does IATF 16949 address Process mapping? IATF 16949 - Automotive Quality Systems Standard 3
E Received a Major finding during IATF Surveillance audit for loss of BIQS Level 3 (more than 6 SPPS in 6 months)...how should we address SYSTEMIC CA? IATF 16949 - Automotive Quality Systems Standard 11
M Address change for a company with CE/ISO13485 EU Medical Device Regulations 2
J FDA notification of address change US Food and Drug Administration (FDA) 2
N Address of Legal Manufacturing Site in ISO 13485 certificates? ISO 13485:2016 - Medical Device Quality Management Systems 1
Ajit Basrur Physical Address on Product Labels (EU MDR perspective) EU Medical Device Regulations 2
A How to address Environmental & OHS Opportunities? ISO 14001:2015 Specific Discussions 6
Q Legal Manufacturing Address Change – multiple registrations at same address 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
K Changing the Address in 510(K) Approved Product 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
M Manufacturer address on the label Other US Medical Device Regulations 18
M GDPR - Is anonymizing sufficient to address right to erasure? Medical Information Technology, Medical Software and Health Informatics 3
K Implant Card - Full Manufacturer's Address - Space issues EU Medical Device Regulations 4
I Importer Address in addition to Manufacturer details on label EU Medical Device Regulations 13
S Medical Device Initial Importer (DII) Requirements - Delivery Address 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
B Manufacturing Company Address Change - implications for FDA Other US Medical Device Regulations 1
M Informational USFDA – Efforts to evaluate materials in medical devices to address potential safety questions Medical Device and FDA Regulations and Standards News 0
M Putting AR's name and address on label - Authorized Representative Labeling Requirements CE Marking (Conformité Européene) / CB Scheme 0
S Risk Approach doesn't address External Issues (Auditor's Comment) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 30
M Medical Device News FDA's Policies and Procedures Should Better Address Postmarket Cybersecurity Risk to Medical Devices Other US Medical Device Regulations 0
Marc Email Addresses - Changing your email address Elsmar Xenforo Forum Software Instructions and Help 0
B ISO 17025 8.5 Actions to address risks and opportunities ISO 17025 related Discussions 7
TheMightyWife Address Change - Medical Device Packaging Labelling Requirements EU Medical Device Regulations 7
M "Minor" Address Change Implications on Product Labeling Requirements Misc. Quality Assurance and Business Systems Related Topics 2
K Labeling - New company address Canada Medical Device Regulations 6
S How to address and implement OH&S opportunities in ISO 45001:2018? Occupational Health & Safety Management Standards 12
qualprod ISO 9001:2015 - Right method to address clause 6.1? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
Q ISO 14001:2015 Clause 6.1: Actions to address Risks & Opportunities ISO 14001:2015 Specific Discussions 2
Q ISO 9001:2015 - Clarification in 6.1.2 Note 1 (Options to Address Risks) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
P Requirements/guidance on what constitutes the Manufacturers "Address" EU Medical Device Regulations 7
M FDA Email Address needed for CECATS 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
R Actions To Address Risks and Opportunities IATF 16949 - Automotive Quality Systems Standard 1
V 21 CFR 820 Compliant way to use Kaizen to address Nonconformances Nonconformance and Corrective Action 9
R Is PFMEA (Process FMEA) for OEM sufficient to address Risk? ISO 13485:2016 - Medical Device Quality Management Systems 7
S Change of Medical Device Company Registered Address - Implications Quality Manager and Management Related Issues 3
R How to address unresolved Medical Device Software Anomalies? IEC 62304 - Medical Device Software Life Cycle Processes 2
B Different Label Address Required for EU? EU Medical Device Regulations 7
M How to communicate the change in company address to CFDA ? China Medical Device Regulations 1
C Appropriate ways to address Competency? Generic vs Specific ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
K Customer Address on ISO 17025 Test Report - Is email address okay? ISO 17025 related Discussions 9
R How to address an audit of another facility that is not ISO/TS 16949 ? IATF 16949 - Automotive Quality Systems Standard 9
S Cost of business lost / opportunity lost? How to address? Quality Tools, Improvement and Analysis 13
M ISO 9001:2008 Clause 7.6 - How to address in Software Industry ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
Marc Report: Facebook e-mail switch changed address books After Work and Weekend Discussion Topics 2
R Outsourcing of a Semi-Finished Product - Which major things to address in the QMS ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
B ISO 13485 & Change of Address/Location ISO 13485:2016 - Medical Device Quality Management Systems 8
P CMC Decision 3 - Manufacturers Address Content Requirements EU Medical Device Regulations 4
Q How would you address a Validation Gap/Escape (Product is in the Field) Qualification and Validation (including 21 CFR Part 11) 2
J Class IIa Medical Device - Can I over label to change an address? ISO 13485:2016 - Medical Device Quality Management Systems 3
M Manufacturing Address - Section 5.3 of EN 591 - In Vitro Diagnostic IFU EU Medical Device Regulations 4
A Canadian Address - Do we need an address in Canada for the Canadian license? Canada Medical Device Regulations 2

Similar threads

Top Bottom