Beginner's Understanding - The Purpose and Applications of QMS/ISO Standards



Hello! I am a college student working as a QA intern this summer with no experience in a manufacturing environment or with quality control.

I am working for a mid-size company that has a goal of obtaining ISO-9001 certification for the first time in the next 3-4 years. They currently employ a full-time Quality Director (my dad) and another quality empoyee at another plant location.

For the past three weeks I've been trying to learn the ISO standards and think of preliminary ways that they might apply to our company (where I have a whopping three weeks experience). :frust:

My dad pointed me here to Elsmar Cove to do some reading, and I am so thankful for the wealth of information, healthy debate, and years of experiential wisdom at my fingertips.

As I've tried to understand what QA is all about, I've pieced together my thoughts in a document attached below. I would greatly appreciate any comments, correction, kudos, tips, tricks, and insights you might have to help me achieve a better general understand the purpose and applications of QMS/ISO standards. :thanks:


Elsmar Forum Sponsor


Trusted Information Resource
Daddy's a smart man.

Do you have a copy of ISO 9001:2008? If not, you need to get it and read it. The questions will be plenty, even for those of us that have been doing this for a long time.

Kales Veggie

People: The Vital Few
Nice job.

Somethings to think about and expand on in your cliff notes:

- process approach
- PDCA cycle
- processes and their interactions
- measuring process performance through metrics
- driving continuous improvement through setting objectives and tracking process metrics
- (not in the ISO 9001 standard) maturity of these processes

ISO 9001 is just one ISO standard. There are 1000s of ISO standard, so be specific when you mention ISO.


The overall tone of your paper is right on and your opening sentence is especially impressive. Many companies never get this. I've seen companies that are certified to ISO9000 or AS9100 or other related standards and their quality system does nothing to improve quality. Likewise, it is possible to have great quality without getting certified to any standard.

Certification provides credibility to your customers that you take quality seriously. The key will be to build your system in a way that meets the standard AND improves quality. The standard provides great flexibility to implement processes in a way that provides value to your business. If you find yourself implementing a process or form ONLY to meet a requirement of the standard there is probably a better way to implement it that provides better value.

I used a consultant to help design my first system but discussion boards such as this can go a long way toward getting your questions answered to make sure you're headed in the right direction. Focus on implementing quality processes to solve real problems within your company and you'll have a great system.

Sidney Vianna

Post Responsibly
Staff member
As I've tried to understand what QA is all about, I've pieced together my thoughts in a document attached below.
The best piece of advice that I can offer you is an epiphany I had several years ago and many organizations struggle with the concept.

The quality system is NOT the system of the quality department, but, instead, the quality component of the BUSINESS PROCESSES of the organization. The sooner an organization understands that and make everyone in the organization co-accountable to the conformity of goods and services and customer satisfaction, the better.

Even ISO TC 176 SC 2 WG 24 saw the light :tg:
In the ISO 9001:2015 Committee Draft they now state:
Top management shall demonstrate leadership and commitment with respect to the quality management system by

c)ensuring the integration of the quality management system requirements into the organization?s business processes;


I so agree with Sidney! The QMS should NOT be considered something the Quality Manager or the Quality Department owns - it needs to be embraced by the business process owners (and the whole team, actually) as "how they do business". A company needs to identify and understand its processes (inputs, outputs, controls, etc.), and have process owners that accept and drive ensuring their processes meet their QMS requirements. To be truly successful with your QMS, it can't be treated as "seperate entity". Good luck!

And, thanks for the excerpt from the 2015 draft - like seeing that!


Looking for Reality
Trusted Information Resource
I always just figured people put the verbal pause in the wrong place...

Quality management system is not a system that manages quality (Quality-management ... system)

Quality management system is the system that Management (those of any quality) use.

It is the Quality(<--adjective, not noun) Managers who build a productive and effective system. and one would hope that the folks up top have some beneficial qualities.

Writing the same words over and over...I can't seem to say the emphasis correctly through the keyboard...I hope that made sense up above...:cfingers:
Thread starter Similar threads Forum Replies Date
K Beginner in ISO 45001 here! Three questions Occupational Health & Safety Management Standards 6
S Beginner trying to OEM a medical device - Branded Electric Acupuncture Pen EU Medical Device Regulations 3
B Histogram beginner dilemma - Manual Calculation vs. JMP 7 Quality Tools, Improvement and Analysis 12
K Training the absolute beginner to understand AQL Training - Internal, External, Online and Distance Learning 1
F Supplier Quality Engineer Beginner - Potential Interview Questions Supplier Quality Assurance and other Supplier Issues 3
A Function for Effects - Beginner in usage of the IQRM FMEA and Control Plans 3
C Help a beginner in the CE Marking world! (Semi long post) CE Marking (Conformité Européene) / CB Scheme 2
Q A Beginner's Questions about ISO 9001:2008 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
E Internal audit checklist for beginner auditors Internal Auditing 3
L Recommend a PPAP training course for a beginner APQP and PPAP 6
B Help for beginner - PPAP (Production Part Approval Process) APQP and PPAP 9
M Basic ISO 9001 information for a beginner ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
N How to determine Type-B uncertainty?What distribution?With Calibration beginner guide Measurement Uncertainty (MU) 11
W Six Sigma for the Beginner Six Sigma 19
M ISO 12944 Understanding the thickness guidlines Oil and Gas Industry Standards and Regulations 0
N Help with understanding Process Controls Manufacturing and Related Processes 7
Q Understanding "free movement" for CE-marked products EU Medical Device Regulations 2
D High level understanding of EUDAMED EU Medical Device Regulations 3
A 60601-1 understanding of stationary device IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
N Help with basic understanding of Competence requirements ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
D Surface Roughness understanding Inspection, Prints (Drawings), Testing, Sampling and Related Topics 1
P Understanding DFMEA and PFMEA - Supplier Related IATF 16949 - Automotive Quality Systems Standard 21
DuncanGibbons Understanding the applicability of Design of Experiments to the IQ OQ PQ qualification approach Qualification and Validation (including 21 CFR Part 11) 5
B Measuring and monitoring equipment - Understanding which procedures to be compliant with ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 6
M Informational Health Canada has launched an e-Learning tool to aid in understanding the premarket regulatory requirements for medical devices in Canada Medical Device and FDA Regulations and Standards News 0
S Understanding UDI requirements - Class 2 medical device (hearing aids) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
M Informational Understanding Costs And Risks For HFE Usability Studies — Part 1: Testing In-House Medical Device and FDA Regulations and Standards News 0
P Understanding FDA draft "Management of Cybersecurity in Medical Devices" Medical Information Technology, Medical Software and Health Informatics 3
J Properly understanding SPC - Newbie SPC questions Statistical Analysis Tools, Techniques and SPC 34
S Understanding control chart and measurement capability Statistical Analysis Tools, Techniques and SPC 2
P Minitab Data Analysis - Understanding if a Process is in Control or Not Using Minitab Software 2
R Understanding a few points on ISO 9001's Design and Development Planning ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
Z Understanding Cycle Time - Why the time of the other activities are left out Lean in Manufacturing and Service Industries 11
J Understanding ISO 9001:2015 - 10.3 Continual Improvement ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
J Understanding ISO9001:2015 - 8.3: Design and Development of Products and Services ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
E Root Cause Analysis - Is Insufficient Understanding an acceptable Root Cause? General Auditing Discussions 9
E Understanding of TS 16949 Clause 7.6.2 IATF 16949 - Automotive Quality Systems Standard 5
K Understanding IEC 60601-2-68 requirements ISO 13485:2016 - Medical Device Quality Management Systems 1
A Training material for interpretation & understanding Part 11 requirements 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
N Understanding the absolute uncertainty specification for a Fluke 5500A Measurement Uncertainty (MU) 3
N Understanding, Challenging & Approving Supplier Control Plans FMEA and Control Plans 7
M Definition Recommendations - Understanding "recommendations" and "recommended corrective action" Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 8
S Understanding UDI (Unique Device Identification) Other US Medical Device Regulations 10
T Understanding USP <1112> Water Activity as applicable to Medical Devices Other Medical Device and Orthopedic Related Topics 4
K Understanding Risk Management Requirements according to AS9100 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 11
S MIL-HDBK-217 - Understanding the various Environmental Conditions Reliability Analysis - Predictions, Testing and Standards 1
D What is your understanding or interpretation of TS16949 IATF 16949 - Automotive Quality Systems Standard 6
C Understanding the relationship between 62304 and the MDD ER IEC 62304 - Medical Device Software Life Cycle Processes 7
S Understanding Subgroup Size - Multi Cavity (Minitab) Statistical Analysis Tools, Techniques and SPC 4
R Understanding clause d) of amendment 1:2012? IEC 60601 - Medical Electrical Equipment Safety Standards Series 7

Similar threads

Top Bottom