Leanraqa QMSR 2024 Final

michelle@leanraqa.
com Copyright © 2024 Lean RAQA – All Rights Reserved 1

Speaker Introductions
- Àngel Buendía, Knowledge Manager at Scilife

- Michelle Lott, RAC, Principal & Founder, Lean RAQA
- Sean Smith, Publisher, MedTech Leading Voice
¿What is Scilife?
Àngel Buendía, Knowledge Manager at Scilife

angel.buendia@scilife.io
Smart Quality
vs Traditional Quality
v traditional
v quality
Scilife
v
Smart QMS (sQMS)
All-in-one, centralized system
● Traceability Design & Audits Document

Development Control
● Inspection readiness
● Seamless integrated QA
Trainings Change
Control
processes Quality Process
Designer
Events
● Global vision/monitoring: Equipment Print &
Reconciliation
○ Corrective
Supplier
& Preventive KPIs (AI) Management KPIs
○ Task management
○ Automated notifications Competences
Record
Management Risk
CAPAs
Management
Scilife
Scilife - Compliance
● Audit Trails
● Version Control
● Electronic Signatures
● FDA 21 CFR part 11 / Annex 11
6
Standards & Regulations
• FDA 21 CFR Part 11
• FDA 21 CFR 820

• GAMP 5
• GMP, GDP, GLP, GCP
• EU Annex 11
• ISO 13485
• ISO 14971
• ISO 15189
• ISO 17025
Scilife
Thanks!
Àngel Buendía, Knowledge Manager at Scilife
angel.buendia@scilife.io
www.scilife.io
QMSR
Masterclass
Michelle Lott, RAC

Principal & Founder, leanRAQA
About leanRAQA
Expert in RAQA for ~ 20 years

Advisor on FDA GMP Advisory Committee
Master Grief Counselor
Michelle Lott
Principal and Founder
Morty Chopper Lucy Lilly King

Chief Entertainment Officer Chief Fun Officer Chief Therapy Officer Chief Mischief Officer
Agenda
QMSR: the Facts
What’s in a Name?
All Your Burning Questions
Secrets to Success
michelle@leanraqa.com 11
QMSR: the Facts
Historical Timelines
(1978)
Published
1996
FDA QSR
Feb 2, 2024
Today
Published
2003 Update 2016 Update
1996
ISO 13485
2016 Prac>cal Guide Released
Published
1998 2007 Update
ISO 14971
Why Now?
Eliminate the redundancy and
inefficiency
FDA also estimates that

harmonization will save medical
device companies at least $439
million over the next decade
Harmonization of FDA QSR and ISO 13485
Published Feb 2, 2024
Challenge of training staff with a

different inspection approach
– Think outside of the 21 CFR 820 "box"
• External training for various ASQ
certifications including lead auditor, six
sigma, and CQIA.
Teaching an old dog
new tricks
!
Feb 2024
Published
But is it really teaching an old dog new tricks? Everyone will
likely be new!
FDA turnover
due to COVID-19
Constantly
Evolving
QSIT Inspectors may retire, making room Many are new
for new inspectors who may have expertise

in other systems
It was All About the Preamble
Ø The preamble is ~70 pages of
"recommendations" at the start
of the existing QSR
Ø The preamble is longer than the QSR

itself, but is NOT regulation
Ø HOWEVER, the FDA makes reference to

the preamble when responding to
questions about harmonization
with the QSR with both ISO13485 and
ISO 14971
How elaborate does a compliant QMS need to be?
Commensurate with:
– Risk presented by the device
– Complexity of device and manufacturing processes

• What if manufacturing processes are outsourced?
– Size and complexity of organization
Let’s look to FDA’s comments for insight …
QMSR Comment 9
QMSR Comment 10
Quality Management System Regulation
QMSR Comment 9
If ISO If ISO
9000*, 13485,
then ISO then ISO
13485 9000
*NOTE: FDA is NOT codifying ISO 9000 outside of clause 3.

Regulation v Expectation*
QMSR Comment 9
If ISO If ISO 9000,

13485, then then ISO
Notes* 13485
QMSR Comment 10
If ISO 13485, then

ISO 14971*
*NOTE: FDA is NOT codifying ISO 14971 or Notes to 13485
Risk and 21 CFR 820 vs Preamble
Risk is mentioned 36 times in the preamble alone
21 CFR 820
Preamble
What does ISO say?
Control of
Risk is mentioned 32 times in Suppliers
ISO 13485: 2016 Software

Validation
Notably: Training
– 4.1.2 The organization shall: Design

- Apply a risk-based approach to the control of the Controls
appropriate processes needed for the quality Management

management system Review
Purchasing
Process
Validation
Monitoring +
Measurement
Risk and 21 CFR 820 + Preamble vs ISO 13485
Risk is mentioned 32 times in ISO 13485
32
37 ISO 13485
21 CFR 820 +
Preamble
Regulation v Expectation*
If ISO 13485,
If ISO 9000,
then Prac>cal
then 13485
Guide*
If ISO 13485,
If ISO 13485,
then ISO
then Notes*
14971*
*NOTE: FDA is NOT codifying ISO 14971, Practical Guide or the Notes.
Risk and ISO Practical Guide vs ISO 13485
Risk is mentioned 246 times in the Practical Guide to ISO 13485
ISO 13485
Prac.cal Guide
to ISO 13485
Risk and 21 CFR 820 + Preamble v ISO 13485 +
Practical Guide
Risk is mentioned 278 times in the Practical Guide to ISO 13485 + ISO
13485
37
21 CFR 820 + 278

Preamble
Prac.cal Guide
278 to ISO 13485 +
ISO 13485
The Big Picture
If QMSR, then
If ISO 9000,
QMSR
then 13485
Comments*
IF ISO 13485, If ISO 13485,

then PracLcal then ISO
Guide* 14971*
If ISO 13485,
then Notes*
*NOTE: FDA is NOT codifying ISO 14971, Notes to 13485, Practical Guide, or comments to QMSR.
The Similarities
FDA Subparts ISO 13485 Clause
• Subpart A – General Provisions • Clause 1 Scope, Clause 4. Quality
• Subpart B QS Requirements Management System
• Subpart C– Design Controls • Clause 4 QMS, Clause 5 Management
• Subpart E – Purchasing Controls Responsibility, Clause 6 Resource
• Subpart F – Identification and Management, Clause 8 Measurement
Traceability Analysis and Improvement
• Subpart G – Production and Process • Clause 7 Product Realization
Controls
• Subpart H – Acceptance Activities
• Subpart I - Nonconformities
• Subpart J – Corrective and Preventive
Action
• Subpart L - Handling, Storage,
Distribution and Installation
• Subpart O – Statistical Techniques
For More Details…
AAMI Quality Systems White Paper: Comparison of 21 CFR 820 to ISO 13485:2016
Source: AAMI Quality Systems White Paper – Comparison of 21 CFR Part 820 to ISO 13485: 2016
Search for the Holy Grail
Your search continues…
…Compliance with ISO

13485 does NOT mean you
will fulfill QMSR
Commensurate with:
– Risk presented by the device
– Complexity of device and manufacturing processes

• What if manufacturing processes are outsourced?
– Size and complexity of organization
The Bigger Picture
Except If ISO 9000,

For... then 13485
If QMSR, If ISO 13485,

then QMSR then ISO
Comments* 14971*
IF ISO
13485, then If ISO 13485,
Practical then Notes*
Guide*
*NOTE: FDA is NOT codifying ISO 14971, Notes to 13485, Practical Guide, or comments to QMSR.
The Differences
FDA Subparts ISO 13485 Clause Proposed Modification
• Subpart D – Document Control • Clause 4 Quality Management • Add signature and date requirements
System to ISO
• Add requirements in 21 CFR 803
• Subpart M – Records • Clause 4 Quality Management Reporting to complaint and servicing
System activities
• Subpart N – Servicing • Clause 7 Product Realization • UDI is still required
• Retain clarification from part
820.180 regarding confidentiality of
records FDA receives
• Subpart K – Labeling and • Clause 7 Product Realization • Retain existing requirements in 820
Packaging Control that strengthen control for labeling and
packaging
michelle@leanraqa.com
34
What’s In A Name?
Differences in Interpretation
Device Master Record Safety and Performance

VS VS
Medical Device File Safety and Efficacy
Design & Development Procedure may need to be Updated
– Medical Device File rather than Device Master Record
QMSR Comment 31
Main Diﬀerence: Addition of Intended Use
On the surface, transitioning to MDF does not appear overly burdensome

if only reading ISO 13485, but….
Design outputs used to Material and component data
fulﬁll appropriate RA used in the construction of
requirements the device
Practical Guide also suggests:
Practical Guide also suggests:

Records of risk Changes during the lifetime
management including RBA with any associated V&V data
Procedures related to Description of accessories

maintenance of product
Standards applied or methods

Record of language variants to demonstrate conformance
with applicable GSPRs
Clinical data …and then some!
NOTE: The Practical Guide is not a regulation but likely expectation.

Safety & Performance v Safety & Efficacy
Safety & Efficacy Safety & Performance
Required by section 520(f) of the FD&C Used by ISO 13485
Act QMSR clarifies: Means “assessment of the
performance of the device to assure the device
is safe and effective”
Webster Definition “effectiveness” (n): Webster Definition “performance” (n): the

producing a decided, decisive, or desired execution of an action the fulfillment of a claim,
effect promise, or request
QMSR Comment 51
Difference in Definitions
21 CFR 820:
Establish means define, document (in
writing or electronically), and implement
ISO 13485:
Establish: When a requirement is required to Define
be “documented”, it is also required to be
implemented and maintained
Do
Document
(Implement)
Definitions: Customer
ISO 9000 “customer”
3.2.4 customer
person or organization (3.2.1) that could or does receive a product (3.7.6) or
a service (3.7.7) that is intended for or required by this person or organization
EXAMPLE:
Consumer, client, end-user, retailer, receiver of product or service from an
internal process (3.4.1), beneficiary and purchaser.
Note 1 to entry: A customer can be internal or external to the organization.
ISO 13485/QMSR “customer”

FDA has adopted for the final QMSR the definitions set forth in ISO 9000, including the term
“customer”. With respect to the definition of “customer”, when considering the
requirements related to customer property, manufacturers must comply with this
provision….to assure the safety and effectiveness of the devices being manufactured
michelle@leanraqa.com QMSR Comment 36 41

Customer Property
QMSR Comment 26
What does this mean for supplier controls?

Definitions: Top Management
Management with Executive

Responsibility…..
…is now Top Management
Because of…a Culture of Quality?
QMSR Comment 27
Source: Dilbert by Scott Adams, Tuesday, June 8, 2021
Definitions: Correction
“Correction”
– “Correction” should be specified as internal or impacts product in the field
– Products corrected in the field must be done so per 21 CFR part 806
ISO 13485 21 CFR Part 806
QMSR Comment 29
Definitions: Labeling and Marketing
“Labeling” – use definition from FD&C
ISO 13485 FD&C
“Marketing”
QMSR Comment 37
Definitions: What about the Rest?
Missing in Action…
QMSR Comment 29
Must understand concepts and intents
Recommend to use other available resources, such as the

Practical Guide
It’s not all bad news!
Ø No more independent design reviewer! QMSR comment 46
Ø For manufacturers who distribute to more than only the US, QMSR
claims to align more closely with global harmonization initiatives
Ø View-only free versions of ISO 13485 and ISO 9000 are provided here:
https://ibr.ansi.org/Standards/iso1.aspx
Any changes to standards?
QMSR Comment 42 - FDA recognizes, however, that organizations

are seeking guidance and clarification on FDA’s expectations
regarding an organization’s implementation of, and compliance
with, the QMSR. To help facilitate understanding, FDA is in the
process of evaluating its existing policies, procedures, and
guidance for industry to be consistent with the QMSR.
Answers to Your Burning Questions
The Burning Questions
Will FDA accept ISO What about QSIT? What

13485 Certifications in will be the new
lieu of audits? technique?
What happens if
ISO 13485 is Are records like supplier
revised? audits, internal audits,
etc. still protected?
Are Quality
Manuals a
Intended
timeline? Requirement?
Q&A: Accepted Certifications
No, FDA will conduct independent

Will FDA accept ISO audits separate from ISO 13485
13485 Certifications in certification audit
lieu of audits?
Note: FDA will accept MDSAP audit
reports
However, you will still need to modify

your QMS to meet ISO 13485:2016,
but not required to seek certification if
you only sell in the US Market
Q&A: Intended Timeline
The rule is effective two years after publication in
the Federal Register. Until then manufacturers are
required to comply with the QS regulation.
The FDA will begin to enforce the QMSR

Intended requirements upon the effective date, February 2,
timeline? 2026.
RY
ATO
AND
M
Q&A: Records
QMSR Update: FDA can now
inspect Management Review,
Are records like supplier
audits, internal audits, Internal Audit and Supplier
etc. still protected? Audit records
No more exemptions!
Verify the completeness of your

management review agenda – including
risk management!
Under QSR, FDA typically had visibility to
Internal audit Supplier audit Management Review
• Audit agenda (date, • Audit agenda (date, • Meeting agenda (date,
attendance, etc.) attendance, etc.) attendance, etc.)
• Report • Report • Presentation content

and minutes
• CAPA • SCAR
• Raw data
Under QMSR, FDA has visibility to
Internal audit Supplier audit Management Review
• Audit agenda (date, • Audit agenda (date, • Meeting agenda (date,
attendance, etc.) attendance, etc.) attendance, etc.)
• Report • Report • Presentation content

and minutes
• CAPA • SCAR
• Raw data
Available Records: Why change now?
QMSR published rule states FDA intends to align with global
harmonization and alignment
QMSR Comment 51
FDA Global Harmonization

Q&A: ISO 13485 Revisions
Now that FDA has incorporated
What happens if
ISO 13485:2016, any future
ISO 13485 is revisions to this standard would
revised? need to be evaluated to determine
the impact of the changes and
whether the QMSR should be
amended.
Future Timelines
(1978)
Published Feb 2, 2024
1996
FDA QSR
Published
1996
ISO 13485
13485:
XXXX
2016 Practical Guide Released
Published
1998 2007 Update
ISO 14971
Q&A: Quality Manuals
QMSR Update: Yes, and they
should follow ISO 13485
Are Quality requirements
Manuals a
Requirement? Level 1:
Quality Defines approach and
Manual &
Policy responsibilities
Procedures
(SOPs)
Work Instructions,
forms, templates
Records
(logs, notebooks, travelers)
Q&A: Inspection Technique
QMSR Update: Audits may look
more similar to MDSAP moving
What about QSIT? What
will be the new
forward
technique?
QSIT inspections are technically
being eliminated under the QMSR
and will be replaced by a new
inspection approach yet to be
determined.
Note: FDA will not be issuing

QMSR compliance certificates
Questions: Answered
Will FDA accept ISO What about QSIT? What

13485 Certifications in will be the new
lieu of audits? technique?
What happens if
ISO 13485 is Are records like supplier
revised? audits, internal audits,
etc. still protected?
Are Quality
Manuals a
Intended Requirement?
timeline?
Conclusions: Secrets to Success
Secrets to Success
QMSR comments and Practical Guide are essential for understanding
real applications of ISO 13485
Be Proactive! Don’t wait

– 2 years is right around the corner
– Need a runway for transition of procedures and compliant records before
implementation date
Set up Mock Audit once procedures and records are transitioned
Tentatively become familiar with MDSAP Audit Model (similar option

highly likely to be adopted by FDA)
Update at least these:
Quality Manual
Management Review
Monitoring and Measurement of Processes
Design, Development
CAPA and Non-Conforming Product
Definitions, definitions, definitions
Get a New Cheat Sheet!
There's a LOT to remember with QMSR.
Which is why we're working on a new cheat sheet:

US - Only v ISO 13485 - Compliant Systems – Manufacturer Checklist
Want a copy? We'll send you one as soon as it's completed.
Just drop your email in the chat or send us an email at team@leanRAQA.com
Free download
• Regulatory Pathway Assessment (RPA)
• Business Market Assessment (BMA)
• … And More
leanraqa.com/free-guides
Questions?
Your regulatory strategy
Your regulatory submissions
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and compliance
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https://leanraqa.com/time
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- Àngel Buendía, Knowledge Manager at Scilife

Àngel Buendía, Knowledge Manager at Scilife

● Traceability Design & Audits Document

• FDA 21 CFR Part 11

• FDA 21 CFR 820

Michelle Lott, RAC

Expert in RAQA for ~ 20 years

Morty Chopper Lucy Lilly King

All Your Burning Questions

2016 Prac>cal Guide Released

2000 Update 2019 Update

FDA also estimates that

Challenge of training staff with a

QSIT Inspectors may retire, making room Many are new

for new inspectors who may have expertise

Ø The preamble is longer than the QSR

Ø HOWEVER, the FDA makes reference to

– Complexity of device and manufacturing processes

– Size and complexity of organization

*NOTE: FDA is NOT codifying ISO 9000 outside of clause 3.

If ISO If ISO 9000,

If ISO 13485, then

*NOTE: FDA is NOT codifying ISO 14971 or Notes to 13485

ISO 13485: 2016 Software

– 4.1.2 The organization shall: Design

appropriate processes needed for the quality Management

21 CFR 820 + 278

IF ISO 13485, If ISO 13485,

…Compliance with ISO

– Complexity of device and manufacturing processes

– Size and complexity of organization

Except If ISO 9000,

If QMSR, If ISO 13485,

Device Master Record Safety and Performance

Main Diﬀerence: Addition of Intended Use

On the surface, transitioning to MDF does not appear overly burdensome

Practical Guide also suggests:

Procedures related to Description of accessories

Standards applied or methods

Clinical data …and then some!

NOTE: The Practical Guide is not a regulation but likely expectation.

Webster Definition “effectiveness” (n): Webster Definition “performance” (n): the

ISO 13485/QMSR “customer”

michelle@leanraqa.com QMSR Comment 36 41

What does this mean for supplier controls?

Management with Executive

…is now Top Management

Because of…a Culture of Quality?

ISO 13485 21 CFR Part 806

ISO 13485 FD&C

Must understand concepts and intents

Recommend to use other available resources, such as the

QMSR Comment 42 - FDA recognizes, however, that organizations

Will FDA accept ISO What about QSIT? What

No, FDA will conduct independent

However, you will still need to modify

 The FDA will begin to enforce the QMSR

Verify the completeness of your

• Report • Report • Presentation content

• Report • Report • Presentation content

FDA Global Harmonization

FDA also estimates that

Challenge of training staff with a

QSIT Inspectors may retire, making room Many are new

ISO 13485/QMSR “customer”

What does this mean for supplier controls?

Must understand concepts and intents

Recommend to use other available resources, such as the

No, FDA will conduct independent

The FDA will begin to enforce the QMSR

Note: FDA will not be issuing

Be Proactive! Don’t wait

Set up Mock Audit once procedures and records are transitioned

Tentatively become familiar with MDSAP Audit Model (similar option

Monitoring and Measurement of Processes

CAPA and Non-Conforming Product

Definitions, definitions, definitions