Making Amendments to a Quality Manual

M

musgrove

#1
We have an uncontrolled copy of Issue 1 of our Quality Manual; when making amendments should these be typed and then Issue 1 reprinted?

Many thanks
 
Elsmar Forum Sponsor
#2
We have an uncontrolled copy of Issue 1 of our Quality Manual; when making amendments should these be typed and then Issue 1 reprinted?

Many thanks
Hi - welcome to the Cove

Can I first ask, what does your document control procedure state? When you state "uncontrolled", why are you asking about making changes to an uncontrolled document?

Also, if you make a change, it can't remain at "issue 1" can it? It was approved at issue 1 and now isn't the same - which usually means "issue 2" - but your own controls should describe this. Some may tell you it is now "1a" or similar, so your organization has to decide and put it in the document control (or similar) procedure...
 
P

pldey42

#3
If the quality manual is currently uncontrolled and there is a risk of two copies in existence, different, and both identified as issue 1, there are several risks:


  1. People will follow the wrong issue 1 instead of the correct issue 1;
  2. The documented procedure for document control referenced in the quality manual is somehow wrong (cannot be understood, omits elements of 4.2.2, isn't effective, etc.);
  3. The quality manual sets a poor example of quality management within the organization;
  4. The quality manual demonstrates an inability to control documents should customers see it.
The quality manual must, according to clause 4.2.2 include "the documented procedures established for the quality management system, or reference to them." It must therefore include or reference the procedure for controlling documents.

I would suggest getting document control properly described in a documented procedure in accordance with 4.2.2 and approving it, before issuing the amended version.

It may be that you are constructing a QMS from scratch and do not yet have document control in place. If so, it's common practice in my experience to establish document control first, to avoid confusion in documentation as the system is built - before writing the quality manual.

Hope this helps
Pat
 
Thread starter Similar threads Forum Replies Date
J Masters Degree - Advice about a decision I"m going to be making Career and Occupation Discussions 9
U What is the process for making updates to our Processes? Design and Development of Products and Processes 11
M Informational US FDA Final Guidance – Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classificati Medical Device and FDA Regulations and Standards News 0
K Verifying gas tight glass syringe used for making standards General Measurement Device and Calibration Topics 4
M Informational US FDA – Patient-Reported Outcomes (PROs) in Medical Device Decision Making Medical Device and FDA Regulations and Standards News 0
M Informational US FDA – Patient Preference Information (PPI) in Medical Device Decision-Making Medical Device and FDA Regulations and Standards News 0
U Electronic templates for making paper control charts Reliability Analysis - Predictions, Testing and Standards 2
K Turtle diagram or process interaction chart - Making it easier for an auditor Process Maps, Process Mapping and Turtle Diagrams 19
E CSR SHIPPING - Need suggestions for making SOP/WI for our shipping dept (automotive)... Customer and Company Specific Requirements 11
O Reinstating a disqualified supplier—questions to ask before making a decision Supplier Quality Assurance and other Supplier Issues 2
D Controlled Documents & Note Making ISO 13485:2016 - Medical Device Quality Management Systems 4
I Making a process PFMEA, no DFMEA (non-automotive toll manufacturer) FMEA and Control Plans 1
M IATF 16949 Cl. 8.7.1.4 - Risk analysis for decision making about rework IATF 16949 - Automotive Quality Systems Standard 2
D Help needed for Compliance Road-Map - Startup making their first device (IVD) IEC 62304 - Medical Device Software Life Cycle Processes 1
C IATF 16949 Cl. 8.4.1.2 d) Multidisciplinary Decision Making IATF 16949 - Automotive Quality Systems Standard 2
G Is it compulsory to make DFMEA for proto parts making organisation APQP and PPAP 1
L Making a Medical Devices Registration Database - Help and Suggestions Wanted Other Medical Device and Orthopedic Related Topics 2
B Making a Safety Culture Chart Occupational Health & Safety Management Standards 3
Marc ISO 9001:2015 vs. 2008 - Internal Audits - What changes are you making? Internal Auditing 44
4 Customer Making Changes to a 510k Device They Purchased 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
M Making a change to an approved Medical Device Other US Medical Device Regulations 9
V Making a choice of Simple vs Comprehensiveness of Procedure/System of any Process Document Control Systems, Procedures, Forms and Templates 4
K Making a Quality Requirements Handbook for Employees Training - Internal, External, Online and Distance Learning 10
D ROHS 2 - Medical Device: Placing vs Making Available on the market EU Medical Device Regulations 3
J Keyboard issue in Word - Making me nuts Coffee Break and Water Cooler Discussions 5
W Chinese Distributor Making Counterfeit Products - Class I sterile products China Medical Device Regulations 2
P Making Quality and Compliance Invisible Imported Legacy Blogs 0
AnaMariaVR2 Structured Approach to Benefit-Risk Assessment in Drug Regulatory Decision-Making Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 0
Proud Liberal Making a simple Sampling Plan by Variables Inspection, Prints (Drawings), Testing, Sampling and Related Topics 2
N Decision Making... (joke) Funny Stuff - Jokes and Humour 1
G The right approach for making the transition from ISO9001 to AS9100 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 9
M AS 9100 4.2.4 Process for making changes to records is not fully effective Quality Manager and Management Related Issues 4
V Making Solar cells, Module, String - Which Cleanroom Level? Various Other Specifications, Standards, and related Requirements 2
P Outsourced Manufacturing - Making Subcontractors comply with TL9000 TL 9000 Telecommunications Standard and QuEST 2
G Free ASTM Standards? Recent Court Ruling making their standards free? Various Other Specifications, Standards, and related Requirements 10
U ISO 13485 mandatory for a factory making Medical Devices for EU? EU Medical Device Regulations 6
B Categorization of Customer Complaint: Making Customers feel they are Top Priority Customer Complaints 4
E Starting Nadcap Accreditation and making an Implementation Timeline AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
C Making a Box Plot in Excel Excel .xls Spreadsheet Templates and Tools 3
V Ideas, Measures/Metrics for making Quality Proactive? US Food and Drug Administration (FDA) 2
D 3D Printers - Making Replicas Coffee Break and Water Cooler Discussions 11
E Third party auditor's statement about SPC - Steel Making - EAF Statistical Analysis Tools, Techniques and SPC 11
K Seeking help in making a decision - Project behind schedule Quality Manager and Management Related Issues 11
Q Making a Dashboard for the KPI of our department Misc. Quality Assurance and Business Systems Related Topics 2
F Making a REACH statement - Plastic Injection Moulding RoHS, REACH, ELV, IMDS and Restricted Substances 9
W What are the Rules for making Organograms? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
AnaMariaVR2 Office Prank - Making an Office Disappear Funny Stuff - Jokes and Humour 0
Wes Bucey Making the case to the C-level suite Career and Occupation Discussions 1
M Trepanning Operation for making inner and outer races of bearings Manufacturing and Related Processes 1
Wes Bucey "Making the case" & Networking - Do's & Don't's Career and Occupation Discussions 2

Similar threads

Top Bottom