Quality System Procedures
Document-controlled SOPs, work instructions, flowcharts, and forms written for a regulatory-compliant quality manual down to the people doing the jobs.
Quality & Regulatory Consulting
Quality Expertise, on the Days You Need It.
You know you need quality — regulators and customers demand it — and you cannot justify a full-time quality professional. Frankly, at this point you do not need one. You need someone who can tell you what has to be done, and then do it.
Systems built and audited to
- ISO 13485
- ISO 9001
- 21 CFR Part 820
- MDR 2017/745
- ISO 14971
- IEC 62366
- cGMP
$7M
Defense rejection overturned
Root cause investigation at the DPSC laboratory and Aberdeen Proving Grounds
$25
Solution that eliminated a 3-year bonded warehouse Defense requirement
Adopted by the US Army
3
Laboratories qualified
Admitted to the Defense Personnel Support Center's Qualified Laboratory List
30+
Years in regulated industries
Medical devices and pharmaceuticals through defense, consumer, and automotive
What QES Does
Your Quality Pinch-Hitter
Just as you use a CPA, a lawyer, or a banker on an as-needed basis, QES provides the expertise you need when you need it — a one-time project, a regulatory submission, the gradual building of a quality management system, or an extra pair of qualified hands.
An Expert Pair of Eyes
Internal auditing with reporting your management review can act on, and a straight answer about where you stand before the registrar arrives.
- Internal Audit Schedule and Reports
- Gap Analysis Against Your Standard
- Management Review Pack
Corrective Action/Preventative Action (CAPA)
CAPAs are the remedial requirements to bring the QMS into an optimal state. Stop putting out the fires that should never have happened in the first place. Determine the root cause so the actions you take correct and prevent their occurrence again.
- Root Cause Investigation Report
- Preventive Action Plan with Effectiveness Checks
- Closure Package for Your External Auditor
Training with Impact
Built by someone whose master's specialization is adult education — not a slide deck downloaded from a standard.
- Role-Specific Training Material
- Delivered Sessions and Records
- Competence Assessment Forms
Identify and Optimize Process Flows
Correct process gaps. Bring system into compliance. Eliminate the unnecessary. Reduce costs and downtime by addressing confusion, redundancy, and rework.
- Process Flowcharts of How Work Runs Now
- Forms That Capture Data Once
- Prioritized List of What to Fix First
Vet & Maintain Suppliers
Supplier and offshore quality from someone who has run inspection teams across China, Hong Kong, Taiwan, Korea, Indonesia, the Philippines, Thailand, and Haiti.
- Supplier Qualification and Audit
- Incoming Inspection Criteria
- Corrective Action Instructions They Can Use
The Approach
When the Contract Specifies the Test Method
In 1987, the Philadelphia Defense Textile laboratory rejected chemical-warfare protective fabric worth $4 million to the prime contractor and $3 million to the subcontractor. Ms. Weeden was adamant that the failure was impossible if the testing had been done according to the contract requirements.
Insisting on being present for the retest, Ms. Weeden discovered that the laboratory had exceeded the test method's heat specification, altered the test solution's strength by increasing it above its specification, and performed calibration using pH buffering solutions three years past their expiration dates, which had been stored in a small room next to a boiler.
The test fabric was sewn into chemical protective suits, which were run on dummies with live agents at Aberdeen Proving Grounds for two weeks — against an original test of four hours — with no sign of failure. The $7 million rejection was overturned.
Investigation Determinations
Seven distinct failures contributed — none caused by the fabric product itself. The root cause was systemic failure to follow multiple test specifications and standard laboratory procedures.
ISO 9001:2026
What Documented Information Is Required?
ISO 9001:2026 requires the following documented information:
- QMS scope (Clause 4.3)
- Quality policy (Clause 5.2)
- Quality objectives (Clause 6.2)
- Operational and support documentation needed for processes
- Mandatory records, including:
- Competence records
- Monitoring & measurement results
- Internal audit program & results
- Management review results
- Nonconformity & corrective action records
- Contract review records
- External provider evaluation records
- Release and production/service provision records
- Calibration records
- Evidence of product/service conformity
Why Some Organizations Still Use a Quality Manual
Even though it is not required,
- Customers (especially aerospace, defense, automotive) may expect a quality manual during supplier qualification.
- Auditors may find a manual helpful for navigating the QMS, though they cannot require it.
Summary
ISO 9001:2026 does not mandate a quality manual. Organizations must instead maintain required documented information and records that demonstrate an effective QMS.
Published Framework
Quality Documentation Specifics Change with Every Level
Marcia's article Pyramid Scheme was selected as one of ASQ's 50 best Back-to-Basics articles from 2001 to 2015. Its argument: an SOP that tries to be both an overview and work instructions fails the people who need the big picture and the people who do the work.
The pyramid is the structure most ISO 9001 and ISO 13485 systems use. Each level answers one question for one reader, so the levels above stay short and the levels below carry the detail.
Quality
ManualWhy
ManualWhy
ProceduresWhat, Who, When, Flowcharts
Work InstructionsHow
Forms, Records, and DrawingsProof
Quality Manual and PolicyWhy
For Top Management, Customers and Auditors
Quality policy, quality objectives, scope, and the process map. ISO 13485 requires a quality manual (clause 4.2.2); ISO 9001 has not required one by name since 2015, but many companies keep it as the map of the system.
Procedures (SOPs)What, Who, When, and Flowcharts
For Process Owners and Supervisors
Document control (ISO 9001 clause 7.5), corrective action (10.2), internal audit (9.2) and supplier evaluation (8.4). One process per procedure, with the owner and the trigger named.
Work InstructionsHow, Step by Step
For the Person at the Workstation
Machine setup, an inspection method, a gauge calibration method, packaging, and labeling. Written in the order the work is done, with photographs or sketches where words are slow.
Forms, Records, and DrawingsProof It Was Done
For Auditors, Customers and Regulators
Inspection and test records, calibration certificates, training records, CAPA, and audit reports. A form becomes a record the moment it is filled in, and records are what an auditor samples.
One System, Three Faces
Turn One Face and the Others Move.
Most small manufacturers are told they have three quality systems to build. They have one, with three faces, and a good many tiles sit on more than one face. Build it once, correctly, and each regulator sees the face it came for. Select a face.
Shared Requirement ISO Only FDA Only EU Only
ISO · International
ISO 9001:2026
The sixth edition keeps the Harmonized Structure and the core requirements, and puts more weight on areas that were hard to audit before: climate relevance, ethical behavior, and a quality culture that top management must be able to demonstrate.
- Clause 5 — Quality Culture, Ethics, Policy Tied to Strategy
- Clause 6 — Risks and Opportunities Split Into Separate Subclauses
- Clause 7 — Awareness Now Includes Quality Culture and Ethical Behavior
- Clause 4 — Climate Change Relevance Considered and Recorded
“Her work was always well organized, accurate, and always on time. Essential to our very fast-paced environment.”
Jim Donahue — Senior Design Engineer, DePuy, a Johnson & Johnson company
About QES
Thirty Years in the Industries That Get Audited.
Marcia M. Weeden has performed quality consulting since 1993, across automotive and Defense through to medical device and pharmaceutical manufacturing.
She holds an MS from the University of Rhode Island with specializations in quality assurance and adult education, eighteen years as an ASQ Certified Quality Engineer, and lifetime standing as an ASQ Certified Quality Technician.
As the former QA Director for two multi-site companies she has served on national government, consumer, Defense, and technical committees where international harmonization was always the priority — the US Consumer Product Safety Commission, Toy Manufacturers of America, and the AATCC. She has traveled extensively for on-site supplier work in Hong Kong, mainland China, Taiwan, Indonesia, Thailand, the Philippines, South Korea, and Haiti.
- Pfizer · Drug Product Design
- Johnson & Johnson · DePuy
- CertainTeed
- Dell · BCBSRI Account
- US Navy · Natick
- Instrumentation Laboratory
Marcia now leads QES alongside Conner Davidson, senior consulting partner for enterprise risk, cybersecurity, and IT audit.
Published Work
Peer-Reviewed, and Read by 77,000 Quality Professionals
Quality Progress is the American Society for Quality's flagship monthly. These articles are peer reviewed; the book is published by ASQ's Quality Press.
Book · ASQ Quality Press
Failure Mode and Effects Analysis for Small Business Owners and Non-Engineers
Determining and preventing what can go wrong. November 2015.
Offered to ASQ's 77,000+ members as a monthly benefit in July 2023. Held by WorldCat libraries including Brown University.
Quality Progress · December 2024
Proof Positive
Documentation structure for regulatory compliance.
Quality Progress · December 2013
Pyramid Scheme
A framework for stronger standard operating procedures.
One of ASQ's 50 best Back-to-Basics articles, 2001–2015, in the Documentation category.
Quality Progress · November 2014
Full Circle
Systematically review and revise your standard operating procedures.
Six Sigma Forum · May 2015
Who Believes in This Nonsense
Six Sigma — walking the walk or talking the talk.
Speaking
ASQ Sections and Conferences
Quality, Risk & FMEAs — ASQ Reliability & Risk Division, Hartford CT, 2022. MDR 2017 Honeycomb of Standards — Portland/Vancouver ASQ, 2022.
“To this day I find myself revisiting her work and finding areas I can apply, even though I have moved on from that role.”
“She requires little direction once objectives are defined and is proactive in asking the right questions when clarification is needed.”
References
Four People Who Have Had to Rely on the Work
Every line below is quoted from a written reference on file, with the date it was given. Nothing here is paraphrased, composed, or assembled from several sentences. Ask and you can read the letters.
“Marcia consistently produces clear, accurate, and well-structured technical documentation. She has a strong ability to understand complex technical concepts quickly and translate them into language that is accessible to a wide range of audiences.”
“I strongly recommend her without reservation.”
“Marcia’s work was excellent! She never complained and managed well while working a very diverse group of engineering, supply chain, quality, manufacturing personnel, and senior management. Her work was always well organized, accurate, and always on time.”
“Much of her work set the expectations for many procedural writings even today.”
“Marcia incorporated several evaluation tools and good interview skills. This coupled with her industry and quality background ensured the study was grounded in reality.”
“To this day I find myself revisiting her work and finding areas I can apply, even though I have moved on from that role.”
“I could always count on Marcia to get her part of a project done quickly, accurately, and very neatly. She was always willing to contribute in a positive manner, slow to criticize (if ever), but also able to hold the rest of us accountable for the work we needed to deliver.”
Further references, from Pfizer, are held on file and available on request. Pfizer’s policy precludes it from giving formal references, so those are not published here.
Contact
Start Now, Because Quality Really Is a Must.
If your vision is “quality like the big guys,” realize that quality did not just happen for them. They planned for it. As your quality grows, so will your company.
How an Engagement Starts
A free twenty-minute call with Marcia. If there is work to do, a fixed-price gap assessment on your floor, from $4,200. You keep the findings whether or not you engage further.
- +1 (401) 246-3204
- +1 (401) 252-9653
- mweeden@qesisbest.com
-
18 Maple Avenue, Ste. 148
Barrington, RI 02806
United States of America