Quality Procedures - General Detail Level and Record Keeping Requirements

M

medicalqm

#1
Hello,

I took responsibility for implementing (and achieving certification for) an ISO 9001 system for a very small (10< employees) UK manufacturer a few months ago. So far I've drafted a quality manual, distinguished and documented the primary and secondary supporting processes, and, in co-operation with my colleagues, written the first 9-10 work instructions. Now I want to turn to the quality procedures, and I'm wondering how many to include.

Some people say you can 'get away with' perhaps only 6-8, including the six 'mandatory' procedures relating to control of documents, records, corrective and preventive action, etc. In addition to this, it's up to to the company to decide how much of their operations to document and control under the QMS with the quality procedures.

What I'd like to know is, if I choose to have quality procedures for, say, sales account handling, or order processing, or technical file management, or product storage, how much detail do I then have to provide in them, and do there have to be designated records? I'd like to include these important activities, but I may not be able to justify it if I then have to include an unnecessary level of detail and impose yet more record-keeping requirements on my colleagues.

I'm quite new to ISO 9001, so sorry if this question doesn't quite make sense! Thanks in advance for any advice this forum can provide - it must be a question a few people have considered in the past.
 
Last edited by a moderator:
Elsmar Forum Sponsor
F

fiona_young

#2
every department like HR,FIN,ADM, R&D...should have responsibility in accordance with ISO. Read ISO carefully, and list the requirements and assign the requirements to related deparment. ask department leaders to write their procedures. You can modify them. although there are less than 10 employee, you should have "department"(even if there is only one person).
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#3
every department like HR,FIN,ADM, R&D...should have responsibility in accordance with ISO. Read ISO carefully, and list the requirements and assign the requirements to related deparment. ask department leaders to write their procedures. You can modify them. although there are less than 10 employee, you should have "department"(even if there is only one person).
Sorry, but you are not correct. As long as you think departments rather than processes, you won't have understood one of the ISO 9000 principles of process approach to a quality management system. Too many companies go through the motions of "implementing" ISO 9001 without understanding the basics. The end result? Dysfunctional and low performing systems that never make an impact on the organization's business and fail to gather top management support.
 
E

esalsan

#4
medicalqm,

The procedures need to work for you. I write procedures that are one page long with 4 columns: 1) species who is responsible for doing it
; 2) contains a workflow diagram with key activities; 3) contains a brief description of the activity; 4) specifies what record is generated (if any); 5) where that record is stored.

Plus title of procedure, code, revision number and a box in the footer providing a summary of changes (should changes be made...)

Keep it simple, you can always add detail when you needed it. Hope it helps!
 
M

medicalqm

#5
Thanks very much elsalsan - I'll bear those elements in mind as I compose the procedures with colleagues. I think noting your recommendation to make procedures work for me I'm going to restrict the number of formal QPs to avoid controlling more activities than the QMS in fact needs to.
 
#6
Medicalqm - welcome. Interesting that you'd go for work instructions first, and not the procedures...in the conventional sense, WIs give more detail to certain aspects of a process or procedure.

You've asked for general detail level which I don't believe is being answered. I've used the example of a recipe to describe the level of detail:

My Marks and Spencer cake baking book tells me to "beat sugar and butter until light and fluffy, then gradually add egg". It doesn't tell you what do to stop the mixture curdling, which it will, if too much egg is added, too quickly. What is it relying upon? Experience! So, write your documents - as you've described 'with' other people, to get this balance of competency and detail.
 
M

medicalqm

#7
AndyN, thanks very much for your response. Yes it might seem a little odd to do the WIs first, but there were some fairly low-level things like the instructions for ensuring traceability when delivering equipment for product trials that we were already doing and that our directors wanted to have formalised quickly.

I'll take on board the balance between competency and detail you illustrate so graphically!
 
Thread starter Similar threads Forum Replies Date
M Quality System Processes without Documented Procedures Document Control Systems, Procedures, Forms and Templates 39
P How to have employees buy-in of quality procedures. Best practices? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
I Concerning procedures within Quality Manual ISO 17025 related Discussions 10
A AS9100D Quality Manual & Procedures needed Quality Management System (QMS) Manuals 4
S ERP Software and Quality Department Procedures Integration Misc. Quality Assurance and Business Systems Related Topics 4
T Does your Quality Dept Control Procedures Outside the Scope of ISO 9001? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
I Quality Procedures (as required by ISO 9001) for Inspection Bodies ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
Y ISO 13485:2003 &FDA QSR (21 CFR 820) Quality Manual,34 Procedures and Form Book, Video, Blog and Web Site Reviews and Recommendations 8
V Can Regulatory Head Initiate/Trigger the Change Control for Quality Procedures US Food and Drug Administration (FDA) 9
T Standard Procedures vs Quality Procedures ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
T ISO 9001:2008 Mandatory Procedures in Quality Manual ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 26
A Online Navigation of Procedures and Quality System Documents Document Control Systems, Procedures, Forms and Templates 3
H ISO Quality Procedures for a Small Shop Document Control Systems, Procedures, Forms and Templates 44
M Quality Manual - ISO 17025 required Mandatory and Operational Procedures ISO 17025 related Discussions 7
M The System engineering procedures is it considerd as Quality Assurance Procedurcs ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
L Storage Cabinets for Quality Documentation (Procedures and Records) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
K Creation of Quality Manual, Procedures Manual, Work Instructions and Guidelines ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
R Quality Assurance procedures for EMC (Electromagnetic Compatibility) Compliance CE Marking (Conformité Européene) / CB Scheme 4
F Review of a Quality/Procedures Manual for a Ministry in Kuwait Quality Manager and Management Related Issues 8
K Quality System Roll Out Proposal Procedures and Content Quality Manager and Management Related Issues 13
F Must the AS9100C quality manual contain the procedures and QMS documents? AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 4
M Mixed Use of Corporate and Site Level Procedures and Forms in the Quality System ISO 13485:2016 - Medical Device Quality Management Systems 1
A Can I Audit Quality Procedures if I come from the Quality Department Internal Auditing 5
J Lock-out / Tag-Out Procedures as Quality Controlled Documents? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 25
V Quality Procedures and Quality Manual Changes and Amendments Document Control Systems, Procedures, Forms and Templates 9
E Quality Manual and Standard Operating Procedures - File attached Document Control Systems, Procedures, Forms and Templates 15
D Helping rewrite the Quality Manual and Procedures - Hints wanted IATF 16949 - Automotive Quality Systems Standard 8
K Procedures and Quality Manual written - Where next? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 14
S Quality Procedures Manual (ISO 9001:2008) for Construction Industry wanted Document Control Systems, Procedures, Forms and Templates 13
A Is the Project Consultant allowed to see our internal quality procedures?? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
S Quality Manual Review - Should the manual link all procedures Quality Management System (QMS) Manuals 5
P Quality Operating Procedures - Eliminating the term 'Quality' Document Control Systems, Procedures, Forms and Templates 34
C Quality Manual and Procedures Manual for Small Service Business Quality Management System (QMS) Manuals 11
I Short SOPs (Standard Operating Procedures) or Add to Quality Manual? Quality Management System (QMS) Manuals 10
C Can we do changes in the quality manual procedures ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
M Write Quality Manual before Procedures? Document Control Systems, Procedures, Forms and Templates 19
D Procedures or Quality System relative to a Telecommunication Organization TL 9000 Telecommunications Standard and QuEST 3
M Totally confused over changes to issue numbers - Quality & procedures manuals Document Control Systems, Procedures, Forms and Templates 12
R Quality Assurance Procedures vs. Standard Operating Procedures Document Control Systems, Procedures, Forms and Templates 15
D ISO 9001 - Hierarchy List of Procedures Starting with the Quality Policy ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
P One page quality procedure - Changing format of our quality procedures Document Control Systems, Procedures, Forms and Templates 1
E Quality Calibration Procedures - Frequency of equipment calibration - ISO 17025 ISO 17025 related Discussions 11
S Quality manual, Procedures, WI & process mapping for oil field chemical & Eqpt.trader Process Maps, Process Mapping and Turtle Diagrams 1
D Quality Manual and Procedures incorporated in same document Document Control Systems, Procedures, Forms and Templates 8
S Documents / Following Procedures - FDA 21 CFR Part 820 Quality System Regulation 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 12
Y What is the difference between Quality System & Quality Procedures? Document Control Systems, Procedures, Forms and Templates 13
D Quality Manual - Where the cross referenced procedures fit in? Quality Management System (QMS) Manuals 4
A I have to CITE the ISO clause in BOTH my Quality Manual and in department procedures? Quality Management System (QMS) Manuals 16
N Electronics - Telecommunication Manufacturing Quality Manual and Procedures Quality Management System (QMS) Manuals 5
Gman2 Can Quality Procedures be in Flowchart format? Document Control Systems, Procedures, Forms and Templates 29
Similar threads


















































Top Bottom