QMS - Could someone give me a down to earth explanation of QMS?

Elsmar Forum Sponsor
D

David Mullins

#2
WHAT IS AN ISO 9001 MANAGEMENT SYSTEM?

A management system is like an egg. It is made up of 3 distinct parts, it is easily broken when mis-treated, it has many uses and it will be useless if left on the shelf too long.

The 3 distinct parts relate to having a quality system of work where we say what we do (YOLK), do it and record it (ALBUMEN), and compare the record of what we did against what we said we would do (SHELL). The yolk represents our policies, procedures, etc. The albumen represents the work that we do and the records that we keep. The shell represents quality control or feedback of our compliance to intended arrangements – did we achieve what we intended to and did we give the customer what they wanted.

WHAT DO WE HAVE TO DO?

ISO 9001 requires us to have:
· Adequate guidance documentation and trained/skilled personnel to ensure consistency in methods and outcomes, correct problems that arise and prevent possible problems;
· Adequate records of activities to provide proof of what was done, designed, supplied, purchased or resulted from activities; and
· Feedback mechanisms such as internal audits, corrective actions, contract reviews and management reviews to monitor the “state of compliance” (i.e. did we achieve what was intended, and carry out any actions required)

ISO 9001 requires us to look after the egg. This means providing the resources to look after our products, and any items supplied by our customers, at all stages through to final delivery. This means we have to adequately monitor, measure and control our processes to reduce variation to achieve expected outcomes in terms of quality, price and delivery.

ISO 9001 requires us to monitor customer satisfaction. This brings our attention to the customer’s perception of our performance in relation to our products and services, highlighting areas of concern and opportunities for improvement, and we must act, or rationalise inaction, in relation to these concerns and opportunities.

Finally ISO requires us to focus on Continuous improvement. This means improving the effectiveness of the management system itself to work towards eliminating any gap between the intended outcomes/arrangements and the current performance of our products and processes.

To achieve the things above, ISO 9001 requires that the guidance, records and information that make up the management system are readily accessible to those personnel that need to use it.

WHAT DOES A MANAGEMENT SYSTEM ACTUALLY DO FOR US?

“If you don’t control what goes in, you may be able to predict what comes out, but you won’t like the prediction”.

Three simple rules of quality are:
· Every process has variation;
· You can’t improve something you don’t control; and
· If you don’t measure it, you can only change it, you don’t know if you improved it.

The management system provides us with a baseline of performance from which continuous improvement can occur. The policies, procedures, instructions, forms and records constitute the baseline of performance. They, along with the feedback/monitoring systems provide the necessary controls to reduce variation to an acceptable level.

The management system also provides us with the tools to take corrective action when variation exceeds acceptable limits, or preventive action where that possibility has been recognised.

By monitoring and measuring our processes and products we know what our performance is, and can trial potential improvements to determine their actual impact against previous performance.

WHAT ARE THE BENEFITS?

The expected benefits not only include increased efficiency, increased profitability, reduced waste, greater job security, greater control over processes and consistently meeting expectations, but also credibility, marketability, providing a competitive edge, providing regular tune-ups for our organisation, corporate pride and prestige.


Down to Earth enough? (And for the purists, I know it doesn't cover everything!)


------------------
 
Thread starter Similar threads Forum Replies Date
B What is the implication for someone who does not meet the 70% pass mark for QMS-Lead. Professional Certifications and Degrees 2
ebrahim QMS as per ISO 13485, Clause 4.2 Requirements for regulatory purposes for Medical Devices Authorized Representatives. ISO 13485:2016 - Medical Device Quality Management Systems 3
J Quality Objective for QMS prior to Certification AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
V Remote QMS Coordinator Position Job Openings, Consulting and Employment Opportunities 0
A How to prepare QMS manual for purchasing department Quality Management System (QMS) Manuals 5
GreatNate Master Control QMS software Quality Tools, Improvement and Analysis 0
GreatNate Anyone using the Intellect QMS software? Quality Assurance and Compliance Software Tools and Solutions 1
A Electronic forms QMS Document Control Systems, Procedures, Forms and Templates 7
supadrai Remote Opportunity - Large Scale Glove Factory QMS / RA / Legal Job Openings, Consulting and Employment Opportunities 0
C Retention of QMS Plans and Reports ISO 13485:2016 - Medical Device Quality Management Systems 5
Q New QMS...Old Projects ISO 13485:2016 - Medical Device Quality Management Systems 5
JoCam Certified QMS for MDR - Class I medical device manufacturers EU Medical Device Regulations 4
M ERP / QMS related software standards for Validation IEC 62304 - Medical Device Software Life Cycle Processes 6
T Help with BS EN ISO - IEC 80079-34 2020 (Explosive atmospheres QMS) Other ISO and International Standards and European Regulations 0
R Gap Audit Aerospsace and Rail QMS Quality Manager and Management Related Issues 0
S AS9120 Store QMS packages AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
J Disappointed in leadership buy-in to QMS Quality Manager and Management Related Issues 67
E ISO 13485 QMS certification as a Supplier ISO 13485:2016 - Medical Device Quality Management Systems 8
T How you ensure that QMS is effective and efficient? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
J Implementing an ISO 13485 QMS Software ISO 13485:2016 - Medical Device Quality Management Systems 6
D ISO 9001 certificate issued by QMS International for 10 years - legit? Registrars and Notified Bodies 17
S Is QMS like a set of rules and regulations that a company follows? ISO 13485:2016 - Medical Device Quality Management Systems 10
B Timeframe for updating QMS / transitioning from ISO 14971:2012 to ISO 14971:2019 ISO 14971 - Medical Device Risk Management 10
W Using tailoring guidelines to tailor a QMS procedure ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
D Offsite storage of QMS documents ISO 13485:2016 - Medical Device Quality Management Systems 9
L Exemption from the Regulation COVID-19 and QMS requirements EU Medical Device Regulations 2
DuncanGibbons Model-Based procedures and Architecting the QMS as a System Document Control Systems, Procedures, Forms and Templates 2
SocalSurfer Can you recommend an enterprise QMS for new AS9100 startup AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
H Expanding our business and the implications to our QMS Manufacturing and Related Processes 2
SocalSurfer AS9100 new certificate, but need QMS software, help Quality Assurance and Compliance Software Tools and Solutions 2
M IT validation for a paper based MD repair company QMS ISO 13485:2016 - Medical Device Quality Management Systems 6
M QMS for a repair/servicing company ISO 13485:2016 - Medical Device Quality Management Systems 2
DuncanGibbons Should the requirements FAA/EASA Part 21 be addressed within the QMS and AS9100D quality manual? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
A Is there a better way to do a complete assessment of our QMS? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
qualprod Managing a "special" customer into the QMS? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
Q AS9100:2016 D - Intent of 8.4.3 (K) - Implement QMS AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
qualprod From paper to Electronic (records) in the QMS ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
A QMS Overhaul - Reorganizing and Renaming Documents - Internal References Document Control Systems, Procedures, Forms and Templates 24
qualprod Documented actions and changes in the QMS by COVID 19 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
DuncanGibbons Enterprise Architecture for QMS Conceptualization AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
O Adding ISO 13485 to an AS9100 QMS ISO 13485:2016 - Medical Device Quality Management Systems 13
S Class I MDR Article 10 – QMS EU Medical Device Regulations 1
I Drupal for QMS Quality Tools, Improvement and Analysis 26
D ISO 9001:2015 4.3 Determining the Scope of the QMS ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
M Scope of Combined ISO 9001 and IATF 16949 QMS - Non-automotive customers ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
S Validation Records - Very young QMS Qualification and Validation (including 21 CFR Part 11) 2
E Sharepoint for ISO 13485 QMS for small IVD company ISO 13485:2016 - Medical Device Quality Management Systems 11
GreatNate Where to get a KPI dashboard for QMS processes Quality Tools, Improvement and Analysis 5
mike10 QMS Update - Rev. up or start over? Document Control Systems, Procedures, Forms and Templates 3
U QMS for medical device startups ISO 13485:2016 - Medical Device Quality Management Systems 26

Similar threads

Top Bottom