SBS - The best value in QMS software

How and When to Update a Company Quality Policy

V

vanputten

#11
Knowing how and when to update a policy is not "improvement?"

I stick by my feedback, even asking us how and when to "update" the policy is a mis-directed question. The organiation should determine that for themselves.

Anyone in my organization can submit a change via an Engineering Change Notification (ECN). The ECN may or may not be approved but that is the structure we argreed upon internally because our policy is a document that is controlled through our formnal document control system.

When, how, why, who, questions for a Quality Policy should be answered internally by the owning organization.

Regards,

Dirk
 
Elsmar Forum Sponsor

al40

Quite Involved in Discussions
#12
Good point! Furthermore, this represents a great opportunity to engage your management and have them understand the relevance of the policy to the business and market position. I'd strongly suggest that you don't rewrite it nor have us offer suggestions for reasons already posted. Rarely in companies is it proper for anyone but management to set policy. Especially since you're new to the organization. It could be a career limiting move!

Sure, many lower placed individuals have written a quality policy, but that doesn't make it right. Management might endorse it without truely understanding what they are signing up for.

I recommend that you set a meeting with them, outlining the agenda and deliverables. Set a reasonable timeframe and timing. Get them to attend and, drive them to setting and agreeing policy and objectives. Ensure they are linked to the business performance metrics they are focused on. Beware of having them set overly agressive policy/objective statements like 'zero defects', 'exceeding customer expectations' etc.

:2cents:
Good job Andy,

MY President and VP have taken ownership of our quality policy and it's paid off in more ways than one.

By the leaders in the company owning and setting the quality policy they then drive it down throughout the organization and support it more, I have seen the president asking employess about our policy and quizing them on how it effects their job and day to day activites.

Best regards,

Al40
 
#13
Good job Andy,

MY President and VP have taken ownership of our quality policy and it's paid off in more ways than one.

By the leaders in the company owning and setting the quality policy they then drive it down throughout the organization and support it more, I have seen the president asking employess about our policy and quizing them on how it effects their job and day to day activites.

Best regards,

Al40
I found it quite illuminating to watch a 'top' manager and their team ponder over policy. It really did make them understand the conceptual linkage between what the customer 'perceived' of them and their 'vision' for themselves..........

Fortunately, I was able to help them, since I'd been a customer..............
 
Thread starter Similar threads Forum Replies Date
Z Quality Manual Revision - Update - Changing our company name Quality Management System (QMS) Manuals 4
A Timeframe for Product Label Update after Company Name Change 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
M Requirement for an Update Audit if Company Site Changes ISO 13485:2016 - Medical Device Quality Management Systems 8
R Ownership of ISO 13485:2003 company changing - Anyone to update? ISO 13485:2016 - Medical Device Quality Management Systems 5
P Company Acquisition - What do we need to update with our registrar? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
L Is it mandatory to update all controlled documents if a company gone through a merger ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
A When will ISO13485 Update be Released? EU Medical Device Regulations 1
S ISO9001:2015 Implementation / update plan template ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
Sidney Vianna IATF 16949 News Update on the IATF CARA Project (“Common Audit Report Application”) - 12/2020 IATF 16949 - Automotive Quality Systems Standard 1
M Trigger to update of TLL VDA Standards - Germany's Automotive Standards 0
O IATF 16949 News Ford Motors Customer Specific Requirements Update - Nov 2020 IATF 16949 - Automotive Quality Systems Standard 5
D GMDN code update - Canada - Do you know if there is guidance? Canada Medical Device Regulations 0
Ninja Windows 10 100 % disk use after update Coffee Break and Water Cooler Discussions 33
mike10 QMS Update - Rev. up or start over? Document Control Systems, Procedures, Forms and Templates 3
M Do we need to create a new CER or can we just update the existing CER EU Medical Device Regulations 3
dgrainger Informational MHRA guidance update on withdrawal of Notified Bodies Medical Device and FDA Regulations and Standards News 0
F Software development plan for SW update IEC 62304 - Medical Device Software Life Cycle Processes 2
M Informational Update on ISO TC 210 JWG 1 activities Medical Device and FDA Regulations and Standards News 0
M Informational EU – October 2019 update – State-of-play of joint assessments of Notified Bodies in the medical device sector Medical Device and FDA Regulations and Standards News 2
M Informational US FDA Final and update guidances – Software Medical Device and FDA Regulations and Standards News 2
M Informational From Medtech Insight – QSR/ISO 13485 Harmonization Update: FDA Enforcement Discretion Likely When New Rule Stands Up; Draft Reg Coming By Year’s End; Medical Device and FDA Regulations and Standards News 0
M Informational Update from GOV.UK – Regulating medical devices in the event of a no-deal Brexit – UK Responsible Person Medical Device and FDA Regulations and Standards News 0
M Informational Device Shortages Update – The US FDA Announces Two New Innovation Challenges on Device Sterilization Medical Device and FDA Regulations and Standards News 0
J Where can I find the latest update to Reach and ROHS? REACH and RoHS Conversations 9
M Informational Update – MDR and IVDR implementing measures rolling plan – 2 more NBs designated under the new regulations Medical Device and FDA Regulations and Standards News 0
M Informational US FDA – Digital Health Update: Mid-Year Update on Software Precertification Program Medical Device and FDA Regulations and Standards News 0
M Informational US FDA – Device Shortages Update: Challenges to encourage the development of new approaches to device sterilization Medical Device and FDA Regulations and Standards News 0
M Informational MHRA update – Medical devices: guidance for manufacturers on vigilance - June 2019 Medical Device and FDA Regulations and Standards News 0
M Is it compulsory to update the obsolete GMDN codes in ARTG? Other Medical Device Regulations World-Wide 4
M Informational USFDA – Digital Health Update: The FDA Announces an Opportunity for Test Case Volunteers for the Test Plan for the Software Precertification Program Medical Device and FDA Regulations and Standards News 0
M Informational US FDA Guidance update – Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program Medical Device and FDA Regulations and Standards News 0
M Informational TGA – Webinar: An update on the consultation for the Regulation of Software, including Software as a Medical Device (SaMD) Medical Device and FDA Regulations and Standards News 0
M Informational EU – Update on state-of-play of joint assessments of Notified Bodies in the medical device sector Medical Device and FDA Regulations and Standards News 1
E Gamma Sterilization Product Update Manufacturing and Related Processes 2
M Informational EU – April 2019 update of the MDR and IVDR implementing measures rolling plan Medical Device and FDA Regulations and Standards News 0
B IEC 62304 - Update Checklist IEC 62304 - Medical Device Software Life Cycle Processes 2
M Informational ISO 14971 / ISO TR 24971 revision update – atualizações sobre a revisão Medical Device and FDA Regulations and Standards News 1
M Informational IMDRF – Proposed update to Clinical Evaluation documents Medical Device and FDA Regulations and Standards News 0
M Informational USFDA Draft Guidance – Review and Update of Device Establishment Inspection Processes and Standards Medical Device and FDA Regulations and Standards News 0
C Do we need to make a new OFI (Opportunity for Improvement) for each document/form we update? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 23
M Medical Device News Last update of the MDR and IVDR implementing measures rolling plan – December 2018 Medical Device and FDA Regulations and Standards News 0
M FDA News USFDA Digital Health Update – New actions and documents Medical Device and FDA Regulations and Standards News 0
M FDA News Digital Health Update: USFDA Report on Non-Device Software Functions Now Available Medical Device and FDA Regulations and Standards News 0
M Medical Device News Letter to the health and care sector: update on preparations for a potential no-deal Brexit Medical Device and FDA Regulations and Standards News 0
Marc Software Update 23 November 2018 Forum News and General Information 1
M Medical Device News Joint Action On Market Surveillance Of Medical Devices (JAMS) Releases Progress Update EU Medical Device Regulations 0
Marc Attachment List Update - 2018-11-16 Forum News and General Information 0
K Medical Device Software Update in Field of AIMD IEC 62304 - Medical Device Software Life Cycle Processes 1
M Medical Device News Health Canada update - Applications for Medical Device Investigational Testing Authorizations Canada Medical Device Regulations 0
M Medical Device News IMDRF update - 26-09-18 - Cybersecurity, Premarket Reviews, Personalized Devices Other Medical Device Regulations World-Wide 0

Similar threads

Top Bottom