Who approves the Quality Manual and Quality Policy?

Q

QMSvigilanti

#1
Hello all,

ISO 13485 indicates (paraphrasing) that top management is responsible for ensuring that the quality management system is in place, and establishing the quality policy and quality objectives, etc. I was told today that the quality manual is a 'policy' and therefore, top management needed to approve this document, which is in our company under change control. However, after reading section 5.0, I believe they need to sign the 'Quality Policy', which may be included in the Quality Manual, but is a separate document, different from the Manual. In our case, we've had managers and directors of different disciplines approve the Quality Manual on an ECO, but have not included top management. My question is, is it a requirement that both the Quality Manual and Quality Policy be approved by top management? Thanks for your help clarifying this.
 
Elsmar Forum Sponsor

Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#2
Re: Who approves the Quality Manual?

Welcome to the Cove! :bigwave:

Since the top executive is widely considered to set policy and culture in a given organization, standards very often require evidence of that person's acknowledgment of responsibility to the management system via signing the Quality Policy.

But the policy and the Quality Manual are different documents. The Quality Manual does very often include the Quality Policy, but it does a good deal more than that. Its contents will likely address organization-wide subjects and as such it's worth considering the department heads be included in the approval list, at least for initial drafts and major changes.

I hope this helps!
 

qusys

Trusted Information Resource
#3
Hello all,

ISO 13485 indicates (paraphrasing) that top management is responsible for ensuring that the quality management system is in place, and establishing the quality policy and quality objectives, etc. I was told today that the quality manual is a 'policy' and therefore, top management needed to approve this document, which is in our company under change control. However, after reading section 5.0, I believe they need to sign the 'Quality Policy', which may be included in the Quality Manual, but is a separate document, different from the Manual. In our case, we've had managers and directors of different disciplines approve the Quality Manual on an ECO, but have not included top management. My question is, is it a requirement that both the Quality Manual and Quality Policy be approved by top management? Thanks for your help clarifying this.
In any ISO standards you 'll find that it is not needed a signature or what else on policy or Quality Manual. It depends on the documentcontrol procedure you set as well as roles, responbilities and aithorities.
 
Last edited:

Jim Wynne

Staff member
Admin
#4
In any ISO standards you 'll find that it is needed a signature or what else on policy or Quality Manual. It depends on the documentcontrol procedure you set as well as roles, responbilities and aithorities.
I think you meant "...not needed..."?
 

RoxaneB

Super Moderator
Super Moderator
#6
In my experience, having top management sign off on the manual is one way of showing their committment to the management system.
 

qusys

Trusted Information Resource
#7
In my experience, having top management sign off on the manual is one way of showing their committment to the management system.
In the substance you are right RCBeyette, we also do it in electronic way with a sign off of the top mgmt members as well as mgt representative, but this has been establishe din the documented procedure for document control.
For example, another way could be making the signing by pen .
However the signature is no an explicit requirment of the standard, but it is up to the organziation show how the commitment is done.:bigwave:
 

RoxaneB

Super Moderator
Super Moderator
#8
In the substance you are right RCBeyette, we also do it in electronic way with a sign off of the top mgmt members as well as mgt representative, but this has been establishe din the documented procedure for document control.
For example, another way could be making the signing by pen .
However the signature is no an explicit requirment of the standard, but it is up to the organziation show how the commitment is done.:bigwave:
In my case, top management signed off electronically and their names appeared at the front of the manual when a hard copy was printed off for the external auditors.

I avoided hardcopy (aka pen) signoffs as much as possible. Too much running around for my liking.
 

kgott

Quite Involved in Discussions
#9
Hello all,

My question is, is it a requirement that Quality Policy be approved by top management? Thanks for your help clarifying this.

In my view, 'authorised', 'approved' or 'endorsed' yes but signed no.

There is nothing wrong with stating in the policy something like 'this policy is authorised' or 'endorsed by executive management.' This removes the need to keep re-signing it each time personnel change.

Correct me if Im wrong but I dont think there is any need to sign it or even date it at all.

I have said in our manual that the policy is reviewed only when:

  • There is a change in legislation that may affect the contents of the policy
  • A change in company strategy may indicate a need to review the policy
  • Investigation of events indicates that the root cause may be linked to a possible shortcoming in the policy
  • Any other reason management deems a review of the policy necessary
  • That any review of the policy may result in no change to the policy
 
Thread starter Similar threads Forum Replies Date
E Who approves work by the quality engineer? ISO 13485:2016 - Medical Device Quality Management Systems 7
M Documentation of Who Approves a Level 2 Procedure Document Control Systems, Procedures, Forms and Templates 3
Ajit Basrur FDA approves Influenza A (H1N1) 2009 vaccines Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 1
Stijloor Senate approves tax break for auto loan interest World News 11
SteelMaiden FDA approves 1st drug for obese dogs World News 6
S Looking for Quality Content to Build Medical Device Curriculum - Concept to Commercialization Training - Internal, External, Online and Distance Learning 4
M Quality Metrics Questions Lean in Manufacturing and Service Industries 2
F Quality manual for trading company ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
John Broomfield Informational Terms used in quality management [Deleted] Misc. Quality Assurance and Business Systems Related Topics 6
D Imaging/Image Quality Standards Other Medical Device Related Standards 1
D Quality Team Structure ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
V Quality Objectives - ISO 9001 2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 26
E Best way to keep up with pharmaceutical quality knowledge and current affairs Service Industry Specific Topics 1
C Quality assurance in Pharmacovigilance Document Control Systems, Procedures, Forms and Templates 0
I Quality Policy and Objectives examples Elsmar Cove Forum Suggestions, Complaints, Problems and Bug Reports 4
Miner Quality checks of product QR codes FMEA and Control Plans 2
S ISO 13485 Lead Auditor - Debate between our Quality Team and Regulatory Auditor - Internal Auditor Training ISO 13485:2016 - Medical Device Quality Management Systems 15
M Operational (free) simulation games for manufacturing and quality Lean in Manufacturing and Service Industries 5
I Help: QFD House of Quality Quality Tools, Improvement and Analysis 1
F Risk for Quality Assurance Department in a Hospital - Hospital Incident Reporting ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
I New to LEAN but not to Quality - How to run Kaizen events Lean in Manufacturing and Service Industries 1
T Ideas for developing a Supplier Quality Management System, non automotive ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
S SOP for ISO 13485:2016 Quality related Software validation ISO 13485:2016 - Medical Device Quality Management Systems 8
S Cost of Poor Quality (CoPQ) - Scrap element of calculation includes lost margin? Misc. Quality Assurance and Business Systems Related Topics 7
S Quality manager considering data science Quality Manager and Management Related Issues 19
M Specific Values of Quality Objectives Benchmarking 7
J How to make Quality Control plans Quality Tools, Improvement and Analysis 5
P VDA AIAG FMEA - Slides for Quality Audience FMEA and Control Plans 4
T Question about Quality Department employee position titles Quality Manager and Management Related Issues 7
C Quality Manager vs Warranty (service) Manager - Authorities & Responsibilities Customer Complaints 2
S Proposed Quality Improvement - Thoughts? Medical Device and FDA Regulations and Standards News 3
K A proposal for the model Quality Management - I need help for the project ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
was named killer CLOUD BASED QUALITY DOCUMENTATION vs. SERVER BASED Document Control Systems, Procedures, Forms and Templates 5
M MDR requires the NB to perform "tests in order to check that the quality management system" EU Medical Device Regulations 3
W Air Quality Measurement Hardware and Software General Measurement Device and Calibration Topics 11
B Seven Basic Quality Tools (January 23) [Paid] Training - Internal, External, Online and Distance Learning 1
Q Quality Objectives Not Met - Resources promised by investors ISO 13485:2016 - Medical Device Quality Management Systems 4
E Resources for Planning for top quality Business Continuity & Resiliency Planning (BCRP) 6
V What plans have been put in place to achieve quality objectives? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
B Include cost of quality (and other wastes) in an ISO 9001 system? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
R CQA Primer by the Quality Council of Indiana ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
A Objectives in Quality Policy ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 15
B Corrective and Preventive Action (CAPA) A Key Process of the Quality Management System Dec 17... Training - Internal, External, Online and Distance Learning 0
I Good resources for learning statistics (quality engineering related) Statistical Analysis Tools, Techniques and SPC 10
B What is the role of Quality Engineer in APQP and PPAP APQP and PPAP 3
A Supplier Quality Standard vs Senior Management Direction Supplier Quality Assurance and other Supplier Issues 2
Ron Rompen Internal Quality Alert Program Document Control Systems, Procedures, Forms and Templates 0
C Quality at Logistical Service Provider Service Industry Specific Topics 0
F Process Review - What is the ISO requirement for reviewing SOPs and quality documentation? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
U Manufacturing solutions and keeping records on quality Content CE Marking (Conformité Européene) / CB Scheme 3
Similar threads


















































Top Bottom