QualAudit 2

Albert Rego, Ph.D. Quality System Audit QA-Nr.
:
27001 La Paz Road, Suite 312 Checklist
Mission Viejo, CA 92691 (ISO 9001/2, EN 46001/2, FDA QSR’s, and
USA 93/42/EEC)
Audited firm Annex of the directive Standards Type of consideration

 Annex ll  ISO 9001 / 2  certification audit  follow up-audit
 Annex V  EN 46001 / 2  pre-audit  re-audit
 Annex Vl  FDA QSR’s  surveillance-audit
Telephone-Nr. Documentation review/report from Reference document of the firm
Telefax-Nr. On-site audit carried out on (date)
Lead auditor Co-auditor / technical expert Co-auditor
Audited section/area (area of validation)

Products:
SUMMARY STATEMENTS:
Scope and Aim of the Quality Audit
The audit performed on __________ at __________________ located in _________________ is

designed to evaluate the quality system implemented according to the FDA Quality System
Requirements (QSR’s) as given in 21 CFR § 820, ISO 9001/2, and EN 46001/2. There was a
particular emphasis on the use of the ISO 9001/2, EN 46001/2 audit check list provided by this
author of this report.
The scope and aim of the audit is for the qualification of this Company (at this one facility only). Any
other facility must be evaluated on its own merits.
Critical Observations: __
Major Observations: __ (None have an impact on Safety, Form, Fit, Function)
Minor Observations : __
Recommendations: __
Date / Signature of Auditor(s)
Scoring (Sc.): co = Conforms / pc = Conforms with slight deficiencies / nc = Non-conformance / na = Not applicable
Quality Assurance Document page 1 / 56

Albert Rego, Ph.D. Quality System Audit QA-Nr.:
USA 93/42/EEC)
SUMMARY OF ASSESSMENT
QM-SECTION QSR-SECTION SCORE N/C NO.
1. Management responsibility Subpart A - § 820.20 Management responsibility
2. Quality management (QM)-system Subpart B - § 820.5 Quality System
3. Contract review
4. Design control Subpart C - § 820.30 Design controls

5. Document and data control Subpart D - § 820.40 Document controls
6. Purchasing Subpart E - § 820.50 Purchasing controls
7. Control of customer-supplied product
8. Product identification and traceability Subpart F - § 820.60 Identification § 820.65 Traceability
9. Process control Subpart G -§ 820.70 Production and process controls
§ 820.75 Process validation
10. Inspection and testing
11. Control of inspection, measuring and test equipment Subpart G -§ 820.72 Inspection, measuring, and test
equipment
12. Inspection and test status Subpart H - § 820.80 Receiving, in-process, and finished
device acceptance
§ 820.88 Acceptance status
13. Control of nonconforming product Subpart I - § 820.90 Nonconforming product
14. Corrective and preventive action Subpart J - § 820.100 Corrective and preventive action
15. Handling, storage, packaging, preserv. and delivery Subpart K - § 820.120 Device labeling
§ 820.130 Device packaging
Subpart L - § 820.140 Handling
§ 820.150 Storage
§ 820.160 Distribution
§ 820.170 Installation
16. Control of quality records Subpart M - § 820.180 General requirements
§ 820.181 Device master record
§ 820.184 Device history record
§ 820.188 Quality system record
§ 820.198 Complaint files
17. Internal quality audits Subpart A - § 820.22 Quality audit
18. Training Subpart A - § 820.25 Personnel
19. Servicing Subpart N - § 820.200 Servicing
20. Statistical techniques Subpart O - § 820.250 Statistical techniques
Date / Signature of Auditor(s)

USA 93/42/EEC)
QM-Section 4.1 - Management responsibility / 1

QUESTIONS COMMENTS
(ISO 9001/2 - EN 46001/2 ) (FDA QSR’s - 21 CFR 820 et.al.) Where Documentation Sc Practice Sc
found
§ 820.20 Management Responsibility

4.1.1 Quality policy (a)Quality Policy
 1.Management with executive
 Is this defined and documented?
responsibility has established a policy
 Is there understanding at all demonstrating its objectives for and
levels of the organization? (e.g. commitment to quality.
through a circular letter, management  2.Management with executive
assembly, notices, training programs,
seminars) responsibility has ensured that the
policy is understood, implemented,
and maintained at all levels of the
organization.
 Reviews are documented.
4.1.1 Quality Goals

 Does this quality policy provide
clear directions on quality goals and
commitment?
Is there surveillance of these goals?
Are these goals adapted or adjusted?

4.1.2.1 Organization (b)Organization
/Responsibility/Authority
 The manufacturer has established
 Is the responsibility, authority and and maintained an adequate
the interrelation of personnel who organizational structure.
manage, perform and verify work
affecting quality (clearly) defined and
documented? (1)Responsibility and authority
 1.The manufacturer has established
For example in the organizational the appropriate responsibility,
structure, job description, matrices, authority, and interrelation of all
workplace description.
personnel who manage, perform, and
assess work affecting quality.
 2.The manufacturer has provided the
independence and authority
necessary to perform these tasks.
820.25- Personnel
4.1.2.2 Resources (a)General
 There are sufficient personnel with the
 Is there identification of resource
requirements? necessary education, background,
training, and experience to assure that
 Is there provision of adequate all activities required by this part are
resources? correctly performed.
 Is there provision of trained
personnel (e.g. internal audits) ? § 820.20 Management Responsibility
(2)Resources
 The manufacturer has provided
adequate resources, including the
assignment of trained personnel, for
management, performance of work,
and assessment activities, including
internal quality audits.

USA 93/42/EEC)
QM-SECTION 4.1 - MANAGEMENT RESPONSIBILITY / 2

QUESTIONS COMMENTS
found

4.1.2.3 QM representative (3)Management representative
 Is there a QM representative
appointed?  Management with executive
responsibility has appointed and
documented a member of
 Has the QM representative the management who, irrespective of
necessary authority and competence? other responsibilities, has established
authority over and responsibility for:
 Ensuring that quality system
requirements are effectively
established and maintained in
accordance with this part;
 Reporting on the performance of
the quality system to
management with executive
responsibility for review,

4.1.3 Management review (c)Management review
 Is there revision/review of the
quality system, by the suppliers  1.Management with executive
management, at defined intervals? responsibility has reviewed the
suitability and effectiveness of the
quality system at defined intervals and
 Is this review documented? with sufficient frequency according to
established procedures to ensure that
the quality system satisfies the
 Were records of such QM
reviews maintained? requirements and the established
quality policy and objectives.
 Please refer to records in Section  2.The dates and results of quality
4.16 systems reviews are documented.

USA 93/42/EEC)
QM-SECTION 4.2 - QUALITY MANAGEMENT SYSTEM / 1

QUESTIONS COMMENTS
found
§ 820.5 Quality System

4.2.1 QM-manual
 Is a QM-manual available?
 Does this include or make and maintained an appropriate quality
reference to the quality system system.
procedures?
 Does this outline the structure of
the documentation used in the quality
system?
(eventual reference to ISO 10013)
Particular requirements for all medical

devices (EN 46001/2)
 Are the specified requirements

established and documented?
Note: When the quality system is used, the

relevant requirements of the regulations
should be included in the specified
requirements.

4.2.2 Quality system procedure Quality system procedures

 Does the QM manual contain
documented procedures? quality system procedures and
instructions.
 When no, are references made  2.An outline of the structure of the
to document procedures? documentation used in the quality
system has been established.
 In the documented procedures is
reference made to work instructions
that define how an activity is
performed?

Does there exist for each product/product

group a file (technical document/product
file) containing, at least, the following:
 product specifications
 classification of the medical
products
 manufacturing specifications
 quality assurance specifications.
The records that are not in a central archive

shall, within these files, refer to the location
of these records.

USA 93/42/EEC)
QM-Section 4.2 - Quality management System / 2

QUESTIONS COMMENTS
found

4.2.3 Quality planning (d)Quality planning
(QM Plan: document, in which are the
specific quality procedures and means of  1.The manufacturer has established a
assistance and even task/activity quality plan which defines the quality
description practices, resources, and activities
 Is there description, in the quality plan,
for customers products and service relevant to devices that are designed
requirements? and manufactured.
how the requirements for quality will
be met.
Is there consideration, in the quality plan,

given to the following sections:
 Report on the managerial and

testing process.
 Identification of suitable
verification at appropriate stages in
the realization process.
 Development of new
instrumentation
 Identification of any
measurement requirement involving
capability that exceeds the known
state of the art.
 Clarification of standards of
acceptability for all features and
requirements , inclusive of those
which contain a subjective section.
 Identification and preparation of

quality records.

USA 93/42/EEC)
QM-Section 4.3 contract review

QUESTIONS COMMENTS
found
4.3.1 General
 Is the procedure for contract
review established?
Are there established and maintained
documented procedures for contract
review and for the coordination of
these activities?
4.3.2 Review
 Is the statement of requirements
adequately defined and documented?
 Does a review take place
before making an offer in respect to
acceptance of a contract/order?
 Are requirements adequately
defined and documented?
 Will differences between the
contract or the order requirements and
those in the tender be resolved?
 Is it ensured that requirements
can be fulfilled/kept?
 In the instance of an order
received by verbal means (word of
mouth/telephone), does there exist
an insurance of requirements agreed
before acceptance?
4.3.3 Amendment to a contract

 Are all concerned functions
informed?
4.3.4 Records
 Are the quality records in Section 4.16
taken in consideration?
 Are channels for communication
and interfaces with the customer’s
organization in these contract matters
established? (see comment 9 of
standard)

USA 93/42/EEC)
QM-SECTION 4.4 - DESIGN CONTROL / 1

QUESTIONS COMMENTS
found
§ 820.30 Design controls

4.4.1 General (a)General
 Are there sufficient established
and documented procedures to  (1)The manufacturer of any class III
control and verify the design of the or class II device, and the class I
product? (are there presently devices listed in paragraph (a)(2) has
documented procedures or a
manual?) established and maintained
procedures to control the design of
the device in order to ensure that
specified design requirements are
met.
 (2)The following class I devices are

subject to design controls:
 Devices automated with computer

software; and
 The devices listed in the following
chart.
_________________________________
Section Device
868.6810 Catheter, Tracheobronchial
Suction,
878.4460 Glove, Surgeon’s,
880,6760 Restraint, Protective.
892.5650 System, Applicator,
Radionuclide, Manual.
892.5740 Source, Radionuclide,
Teletherapy

4.4.2 Design and development planning (b)Design and development planning
present?
 Will development plans be  1.The manufacturer has established
updated as the design evolves? and maintained plans that describe or
reference the design and development
 Are the design and development activities
activities assigned to qualified
personnel?
 Are adequate resources
available for the development
process?

USA 93/42/EEC)

QUESTIONS COMMENTS
found

4.4.3 Organizational and technical
interfaces
 2.The plans identify and describe the
 Are the organizational and interfaces with different groups or
technical interfaces between different activities that provide, or result in,
groups which input into the design input to the design and development
process defined?
process.
 Is necessary written  3.The plans are reviewed, updated,
information documented, and approved as design and
transmitted and regularly reviewed? development evolves.

4.4.4 Design input (c)Design input
 Are design input requirements
defined and documented?  1.The manufacturer has established
and maintained procedures to ensure
 Are inputs from the contract that the design requirements relating
testing considered? to a device are appropriate and
address the intended use of a device,
 Are the requirements complete
and unambiguous? including the needs of the user and
patient.
 2.The procedures include a
mechanism for addressing
incomplete, ambiguous, or conflicting
requirements.
 3.The design input requirements are
documented and reviewed and
approved by a designated
individual(s).
 4.The approval, including the date and
signature of the individual(s)
approving the requirements, is
documented.

USA 93/42/EEC)
QM-Section 4.4 - Design control / 3

QUESTIONS COMMENTS
found
4.4.4 CONTINUATION

devices (EN 46001)
 Is there identification of requirements
that are related to the safety of the
medical device and include such
requirements as design input data?
DIRECTIVE 93/42/EEC
ANNEX I / essential requirements
 Is there a record of how the essential
requirements are to be fulfilled?
 Does there exist a record/list of

relevant standards?
ANNEX lX / classification criteria

 Is classification stipulated according
to the annex IX of the directive?
 Are the definitions for the
classification rules applied?
ANNEX X / clinical evaluation

 Is clinical evaluation necessary?
 If yes, is there clinical evaluation
according to EN 540?
 Will a clinical evaluation be
undertaken?
 Does the evaluation adhere to:
 market experience,
 scientific literature and their
evaluation

USA 93/42/EEC)
QM-Section 4.4 - Design control / 4

QUESTIONS COMMENTS
found
4.4.4 CONTINUATION
ANNEX 1, 13 / Information supplied by the
manufacturer
 Are the requirements for the
symbol considered (13.3 a to m, e.g.
Symbols w.r.t. EN 980)?
 Is the intended purpose (13.4)
obvious or is this clearly stated?
 Are all the necessary instructions
covered (13.6 a to p)?

4.4.5 Design output (d)Design output
 Is the design output documented
and expressed in terms that can be  1.The manufacturer has established
verified and validated against the and maintained procedures for
design input requirements? defining and documenting design
 Will the design input
requirements be meet? output in terms that allow an adequate
 Are acceptance criteria defined? evaluation of conformance to design
input requirements.
 Are characteristics of the design  2.Design output procedures contain or
that are crucial to the safe and proper
functioning identified? make reference to acceptable criteria
and ensure that those design outputs
that are essential for the proper
functioning of the device are identified.
 3.Design output is documented,
reviewed, and approved before
release.
 4.The approval, including the date and
approving the output is identified.

4.4.6 Design review (e)Design review
 At appropriate stages of design
are reviews of the design results  1.The manufacturer has established
planned and conducted? and maintained procedures to ensure
that formal documented reviews of the
 Will these reviews be documented? design results are planned and
conducted at appropriate stages of the
 Are the participants, at each
design review, including device’s design development.
representatives of all functions  2.The procedure ensures that
concerned with the design stage, been participants at each design review
reviewed?
include representatives of all functions
 Are specialist personnel concerned with the design stage
necessary? being reviewed and an individual(s)
who does not have direct
responsibility for the design stage
being reviewed, as well as any
specialists needed.
 3.The results of a design review,
including identification of the design,
the date, and the individual(s)
performing the review, are
documented in the design history file
(DHF).

USA 93/42/EEC)

QUESTIONS COMMENTS
found

4.4.7 Design verification must at (f)Design verification
appropriate stages of design be
performed.
 Through the design verification, and maintained procedures for
how will the developmental results and verifying the device design.
corresponding design phase of the
requirements be fulfilled :  2.Design verification confirms that the
 Performing alternative design output meets the design input
calculations requirements.
 Comparing the new design with a
similar proven design, if  3.The results of the design
available verification, including identification of
 Undertaking tests and the design, method(s), the date, and
demonstrations
 Reviewing the design stage the individual(s) performing the
documents before release verification , are documented in the
DHF.

devices (EN 46001)
 Are there documented and
maintained records (see Section 4.16)
of all design verification activities
including those where clinical
investigation was involved?

4.4.8 Design validation (g)Design validation
 Will a conclusive validation be
performed? and maintained procedures for
validating the device design.
For example. :  2.Design validation is performed
 After successful verification; under defined operating conditions on
 Under defined operating
conditions; initial production units, lots, or
 Necessary in earlier stages prior batches, or their equivalents.
to product completion  3.Design validation ensures that
devices conform to defined user
 Will this ensure that the product
conforms to defined user needs and/or needs and intended uses and
requirements? includes testing of production lots
under actual and simulated use
conditions.
 4.Design validation includes software
validation and risk analysis, where
appropriate.
 5.The results of the design validation,
including identification of the design,
method(s), the date, and the
individual(s) performing the validation,
is documented in the DHF.

QUESTIONS COMMENTS

USA 93/42/EEC)
(ISO 9001/2 - EN 46001/2 ) (FDA QSR’s – 21 CFR 820 et.al.) Where Documentation Sc Practice Sc
found

4.4.9 Design changes (h)Design transfer
 Are all design changes and
modifications identified and and maintained procedures to ensure
documented? that the device design is correctly
translated into production
 Will all design changes be specifications.
reviewed and approved by authorized
personnel before their implementation? (i)Design changes
and maintained procedures for the
 Have the records in Section 4.16 been identification, documentation,
considered? validation or where appropriate,
verification, review, and approval of
the design changes before their
implementation.
(j)Design history file
 1.Each manufacturer has established
and maintained a DHF for each type
of device.
 2.The DHF contains or references the
records necessary to demonstrate that
the design was developed in
accordance with the approved design
plan and the requirements of this part.

USA 93/42/EEC)
QM-SECTION 4.5 DOCUMENT AND DATA CONTROL / 1

QUESTIONS COMMENTS
found
4.5.1 General/documented procedures Subpart D - § 820.40 Document controls

 Are there established and
maintained document procedures to  The manufacturer has established
control all documents and data? and maintained procedures to control
all documents that are required by this
 Are documents of external part. The procedures provide for the
origin (to the extent applicable) in
data control systems integrated? following:
For example
 Standards,
 Customer drawings,
 Laws,
4.5.2 Document and data approval and

issue
§ 820.40 Document controls
 Is there a master list or (a)Documentation approval and distribution
equivalent control procedure
identifying the current revision status  1.The manufacturer has designated
and is available to preclude the use of
invalid and/or obsolete documents? an individual(s) to review for adequacy
and approve prior to issuance all
 Are there authorized personnel documents established to meet the
that review and approve for adequacy, requirements of this part.
documents and data prior to
issue?  2.The approval, including the date and
approving the document, is
 The control shall ensure that: documented.
 3.Documents established to meet the
 the pertinent issues of requirements of this part are available
appropriate documents are
available at all relevant at all locations for which they are
locations? designated, used, or otherwise
 invalid and/or obsolete documents are promptly removed
documents are promptly
removed from all points of issue from all points of use or otherwise
or use? E.g. changing of prevented from unintended use.
collecting list
 the current revision status is
made known?
 any obsolete documents retained
for legal and/or knowledge-
preservation purposes are
suitably identified?

 Is there a defined period where

obsolete documents shall be retained?
 Does this period insure that
specifications are available for at least
the lifetime of the medical device?
 Please refer to Section 4.16?

USA 93/42/EEC)
QM-SECTION 4.5 DOCUMENT AND DATA CONTROL / 2

QUESTIONS COMMENTS
found
4.5.3 Document and data changes § 820.40 Document controls

(b)Document changes
 Are changes to documents and data
reviewed and approved by the same
functions/organizations that performed  1.Changes to documents are reviewed
the original review and approval? and approved by an individual(s) that
performed the original review and
approval, unless specifically
 Is the nature of the change identified
in the document or the appropriate designated otherwise.
attachments (Where is this feasible)?  2.Approved changes are
communicated to the appropriate
personnel in a timely manner.
 3.The manufacturer maintains records
of changes to documents.
 4. Change records include a
description of the change,
identification of the affected
documents, the signature of the
approving individual(s), the approval
date, and when the change becomes
effective.
DIRECTIVE 93/42/EEC
ANNEX II 6., V 5., VI 5.
The following administrative provisions
must, at least, after the manufacture of the
last product be controlled:
 declaration of conformity,
 documentation concerning the QM
system
 alterations/changes to the QM system,
 documentation for the product
construction (only w.r.t. annex II),
 technical documentation,
 all decisions and reports from the
notified body
Note:
Documents are input, where they serve as a
revision to a standard.
Data is defined as digitized documents or
records.
 The standard makes explicit reference
to the least quality record in a QM
system (see Section 4.16).

USA 93/42/EEC)
QM-SECTION 4.6 PURCHASING / 1

QUESTIONS COMMENTS
found
4.6.1 General/documented procedures Subpart E – Purchasing Controls

§ 820.50 Purchasing controls
maintained documented
procedures to ensure that purchased  The manufacturer has established
products conform to specified and maintained procedures to ensure
requirements? (Is the procedure
sufficiently detailed?) that all purchased or otherwise
received product and services
conform to specified requirements.
4.6.2 Evaluation of subcontractors § 820.50 Purchasing controls

 Will the evaluation and selection
of subcontractors be based on their (a)Evaluation of suppliers, contractors, and
ability to meet subcontract consultants
requirements?
and maintained the requirements,
including quality requirements, that
must be met by suppliers, contractors,
and consultants.
 2.The manufacturer has:
 Evaluated and selected potential
suppliers, contractors, and
consultants on the basis of their
ability to meet specified
requirements, including quality
requirements. This evaluation is
documented.
 Define the type and extent of
control to be exercised over the
product, services, suppliers,
contractors, and consultants,
based on the evaluation results.
 Establish and maintain records
of acceptable suppliers,
contractors, and consultants.
 Current evaluation?
 Who will evaluate and select
subcontractors on their ability to meet
requirements including quality systems
and any specific quality assurance
requirements?
 What other aspects and requirements

are taken into evaluation ?
 Is the type and extent of control

exercised by the supplier over
subcontractors defined?
E.g. quality audit reports and/or quality
records, performance of
subcontractors.

QUESTIONS COMMENTS

USA 93/42/EEC)
found
4.6.3 Purchasing data § 820.50 Purchasing controls

(b)Purchasing data
 Do the purchasing documents
contain data that clearly describes the
product ordered?  1.The manufacturer has established
and maintained data that clearly
In so far as applicable the describe or reference the specified
purchasing data shall contain the
following: requirements, including quality
 Precise identification of the requirements, for purchased or
product otherwise received product and
 Title or other positive
identification, and application services.
issues of specifications,  2.Purchasing documents include,
drawings?), where possible, an agreement that the
 Requirements for the product
process; suppliers, contractors, and
 Release procedures; consultants agree to notify the
 Requirements for personal; manufacturer of changes in the
 Requirements for approval or
qualification of product. product or service so that the
manufacturer may determine whether
the changes may affect the quality of a
finished device.
 3.Purchasing data is approved in
accordance with § 820.40.

USA 93/42/EEC)

QUESTIONS COMMENTS
found
4.6.3 CONTINUED

 With reference to traceability, is there

retention of copies of relevant
purchasing documents (Section 4.16)?
4.6.4 Verification of purchased product

4.6.4.1 Supplier verification at
subcontractor’s premises (denoted
in the standard as the supplier)
 Is the purchased product verified
at the subcontractor’s premises?
 If yes, are the verification
arrangements and the method of
product release in the purchasing
documents specified?
4.6.4.2 Customer verification of

subcontracted product
 Where specified in the contract, is the
supplier’s customer or the customer’s
representative afforded the right to
verify at the subcontractor’s premises
and the supplier’s premises that the
subcontracted product conforms to the
specified requirements?
 If yes, how has the customer right to
verification?
Note:
Verification by the customer shall not
absolve the supplier of the responsibility to
provide acceptable product, nor shall it
preclude subsequent rejection by the
customer.

USA 93/42/EEC)
QM-Section 4.7 - control of customer supplied product

QUESTIONS COMMENTS
found
4.7 Is there established and documented

procedures for control of
 verification
 storage
 maintenance
of customer supplied products?
(Products that are provided for
incorporation into the supplies or of
related activities)
 Is there consideration how
products are recorded and
reported to the customer in the case
of loss or damage?
 Is such a process documented?
 Is the filing from this

documentation systematic and
ordered? (see Section 4.16)
 Are there contractual agreements

(Section 4.3/contract review), where by
the handling of the products are
documented?

USA 93/42/EEC)
QM-Section 4. 8 - product identification and traceability / 1

QUESTIONS COMMENTS
found
4.8 Product identification and

traceability
 Are procedures for identifying
the product established and
documented (where is this
appropriate?)
 Is the identification clearly

defined?
 Is the traceability a stipulated

requirement?
 If yes, are the responsibilities
stipulated for identification of the
respective products?
 Are these in accordance with the
requirements?
 Is the identification clearly stipulated?
 Will records be kept of such?

 please refer to Section 4.16
DIRECTIVE 93/42/EEC
Annex ll 3.2.d
 Does there exist adequate product
identification procedures?
 Can it be stipulated that the product
identification procedures are kept up to
date (from drawings, specifications) at
every stage of construction?

USA 93/42/EEC)
QM-Section 4. 8 - Product Identification and traceability / 2

QUESTIONS COMMENTS
found
4.8 CONTINUATION § 820.60 Identification

Particular requirements for all medical  The manufacturer has established
devices (EN 46001/2) and maintained procedures for
identifying product at all stages of
Identification receipt, production, distribution, and
Is there a procedure to ensure that medical installation to prevent mixups.
devices received for refurbishing are
 identified
 distinguished at all times from
normal production?
Traceability § 820.65 Traceability

 Is there an established and
documented procedure for traceability?  1.The manufacturer of a critical device
 Does the procedures define the extent has established and maintained
of traceability and facilitate corrective procedures for identifying with a
action? control number each unit, lot, or batch
of finished devices and where
appropriate, components.
 2.The procedures facilitate corrective
action.
 3.Such identification is documented in
the DHR.
Additional requirements for active

implantable medical devices and
implantable medical devices
 Is the extent of traceability sufficiently

stipulated?
 Does this extent of traceability include

all components and materials used,
and records of the environmental
conditions (see Section 4.9), when
these would cause the medical device
not to satisfy specified requirements?

USA 93/42/EEC)
QM-Section 4. 9 - Process control / 1

QUESTIONS COMMENTS
found
4.9 Production, installation, and

servicing processes
 Are the production,
installation, and servicing
processes, which directly affect
quality, identified and planned?
Subpart G - § 820.70 Production and

 Are these processes carried out process controls
under controlled conditions?
(a)General
Are the following points addressed?  1.The manufacturer has developed,
conducted, controlled, and monitored
 Are the production, installation, the production processes to ensure
and servicing processes defined that a device conforms to its
in documented procedures?
specifications.
 Is there use of suitable  2.Where deviations from device
production, installation and specifications could occur as a result
servicing processes? of the manufacturing process, the
manufacturer has established and
 Is the work environment suitable?
maintained process control
 Is there compliance with procedures that describe any process
reference standards/codes, controls necessary to ensure
quality plans and/or documented conformance to specifications.
procedures?
 3.Where process controls are needed,
 Is there monitoring and control of they include:
suitable process parameters and  Documented instructions,
production characteristics? standard operating procedures
 Is there inclusion of approval of (SOP’s), and methods that
processes and equipment, as define and control the manner of
appropriate? production;
 Monitoring and control of
 How are the criteria for process parameters and
workmanship documented?
component and device
 Is there a clear and unambiguous characteristics during
manner/criteria stipulated? (e.g. production;
written standards, representative  Compliance with reference
samples or illustrations?)
standards or codes;
 Is there a suitable maintenance  The approval of processes and
process documented? process equipment; and
 Criteria for workmanship which
is expressed in documented
standards or by means of
identified and approved
representative samples.
(b)Production and process changes

and maintained procedures for
changes to a specification, method,
process, or procedure.
 2.Such changes are verified or where
appropriate validated according to §
820.75, before implementation and
these activities are documented.
 3.Changes are approved in

USA 93/42/EEC)
QM-Section 4.9 Process control / 2

QUESTIONS COMMENTS
found
§ 820.70 Production and process controls

4.9 CONTINUED (3)Adjustment
 The manufacturer ensures that any
Processes with beforehand qualification
(also referred to as „special process“) inherent limitations or allowable
tolerances are visibly posted on or
 Will the processes be undertaken by near equipment requiring periodic
qualified operators? adjustments or are readily available to
personnel performing these
 When no, will the processes be
continually monitored and controlled? adjustments.
(h)Manufacturing material
 Are records maintained for qualified  1.Where a manufacturing material
processes, equipment and personnel? could reasonably be expected to have
an adverse effect on product quality,
 Has there been consideration of
Section 4.16/control of quality records? the manufacturer has established and
maintained procedures for the use
and removal of such manufacturing
material to ensure that it is removed or
limited to amount that does not
adversely affect the device’s quality.
 2.The removal or reduction of such
manufacturing material is
documented.
(i)Automated processes
 1.When computers or automated data
processing systems are used as part
of production of the quality system,
the manufacturer has validated
computer software for its intended use
according to an established protocol.
 2.All software changes are validated
before approval and issuance.
 3.These validation activities are
documented.
Particular requirements for all medical (d)Personnel
A) Personnel and maintained requirements for the
 Are there established, documented and health, cleanliness, personal
maintained requirements for practices, and clothing of personnel if
 health contact between such personnel and
 cleanliness product or environment could have an
 clothing adverse effect on product quality.
of personnel if contact between such  2.The manufacturer ensures that
personnel and product or environment maintenance and other personnel who
could adversely affect the quality of are required to work temporarily under
product? special environmental conditions are
appropriately trained or supervised by
a trained individual.
QM-SECTION 4.9 PROCESS CONTROL / 3

QUESTIONS COMMENTS
found
Subpart G - § 820.70 Production and

B) Environmental control in process controls
manufacture

USA 93/42/EEC)
 Are there environmental controls (c)Environmental control

established and documented for
medical devices:  1.Where environmental conditions
a) that are supplied sterile? could reasonably be expected to have
b) that are supplied non-sterile and an effect on product quality, the
intended for sterilization before manufacturer has established and
use? maintained procedures to adequately
c) where the microbiological and/or control these environmental
particulate cleanliness or other conditions.
environmental conditions are of  2.Environmental control system(s) are
significance in their use? periodically inspected to verify that the
d) where the environmental system, including necessary
conditions are of significance in equipment, is adequate and
their manufacture? functioning properly.
If appropriate, are the environmental  3.These activities are documented
conditions controlled and/or and reviewed.
monitored?
C) Cleanliness of product § 820.70 Production and process controls

 Are there established, documented (e) Contamination control
and maintained requirements for
cleanliness of the product if:  The manufacturer has established
a) (a) the product is cleaned by the and maintained procedures to prevent
supplier prior to sterilization contamination of equipment or product
and/or its use? by substances that could reasonably
b) (b) the product is supplied non- be expected to have an adverse effect
sterile to be subjected to a on product quality.
cleaning process prior to
sterilization and/or its use? (f)Buildings
c) (c) the product is supplied to be
used non-sterile and its
cleanliness is of significance in  Buildings are of suitable design and
use? contain sufficient space to perform
d) (d) process agents are to be necessary operations, prevent mixups,
removed from the product during and assure orderly handling.
manufacture?
Important: If appropriate, (g)Equipment
product cleaned in accordance
with a) or b) above need not to be
subject to the preceding particular  The manufacturer ensures that all
requirements, i.e. A) personnel equipment used in the manufacturing
and B) environmental control in
manufacture, prior to the cleaning process meets specified requirements
procedure. and is appropriately designed,
constructed, placed, and installed to
facilitate maintenance, adjustment,
cleaning, and use.

USA 93/42/EEC)

QUESTIONS COMMENTS
found

4.9 CONTINUATION
(1)Maintenance schedule
D)Maintenance  1.The manufacturer has established
Are there established and documented and maintained schedules for the
requirements for maintenance activities adjustment, cleaning, and other
if such activities possibly affect product maintenance of equipment to ensure
quality? that manufacturing specifications are
 Are records of such maintenance kept met.
(see Section 4.16)?  2.Maintenance activities, including the
date and individual(s) performing the
maintenance activities, are
documented.
(2)Inspection
 1.The manufacturer conducts periodic
inspections in accordance with
established procedures to ensure
adherence to applicable equipment
maintenance schedules.
 2.The inspections, including the date
and individual(s) conducting the
inspections, are documented.
.
§ 820.170 Installation
E)Installation
 If appropriate, are there  1.The manufacturer of a device
established and documented, requiring installation has established
both instructions and acceptance and maintained adequate installation
criteria for : and inspection instructions, and
 installing and, where appropriate, test procedures.
 checking the medical device?  2.Instructions and procedures include
 Will records of such be retained see directions for ensuring proper
Section 4.16? installation so that the device will
perform as intended after installation.
 3.The manufacturer distributes the
instructions and procedures with the
device or otherwise make them
available to the person(s) installing the
device.
 (b)The person installing the device

ensures that the installation,
inspection, and any required testing
are performed in accordance with the
manufacturer’s instructions and
procedures and document the
inspection and any test results to
demonstrate proper installation.

QUESTIONS COMMENTS
found
§ 820.75 Process validation

USA 93/42/EEC)
F) Special processes
 If, when necessary, the quality tests  1.Where the results of a process
can not be reviewed in complete cannot be fully verified by subsequent
scope/comprehensively, will these inspection and test, the process is
processes be performed through validated with a high degree of
quality personnel and/or the process assurance and approved according to
parameters be constantly reviewed? established procedures.
 2.The validation activities and results,
 Do the quality records identify: including the date and signature of the
a) the work instructions used?, individual(s) approving the validation
b) the date the special process was and where appropriate the major
performed?, equipment validated, are documented.
c) the identity of the operator of the
special process?  (b) The manufacturer has established
monitoring and control of process
parameters for validated processes to
ensure that the specified requirements
continue to be met.
 (1)The manufacturer has ensured that
the validated processes are performed
by qualified individual(s).
 (2)For validated processes, the
monitoring and control methods and
data, the date performed, and where
appropriate, the individual(s)
performing the process or the major
equipment used is documented.
 (c) 1.When changes or process

deviations occur, the manufacturer
reviews and evaluates the process
and performs revalidations where
appropriate..
 2. These activities are documented.

 Is the sterilization process validated?
 Are all the control parameters of the

sterilization process stipulated? (
see Section 4.16)

USA 93/42/EEC)
QM-Section 4.10 - inspection and testing / 1

QUESTIONS COMMENTS
found
4.10.1 General
 Are the inspection and testing
procedures sufficiently detailed in
writing?
 Are the required inspection and
testing, and the records to be
established, defined in a quality plan
or documented procedures?
Subpart H - Acceptance Activities

4.10.2 Receiving inspection and testing § 820.80 Receiving, in-process, and
finished device acceptance
4.10.2.1
 Is it ensured that incoming
products have been inspected or (a)General
otherwise verified as conforming to
specific requirements?
4.10.2.2 acceptance activities.
 Will consideration be given to the
amount of control exercised at the (b)Receiving acceptance activities
subcontractor’s premises and the
recorded evidence of conformance  1.The manufacturer has established
provided? and maintained procedures for
acceptance of each incoming product.
4.10.2.3  2.Incoming product is inspected,
 Does there exist an incoming
product released for urgent tested, or otherwise verified as
production purposes prior to conforming to specified requirements.
verification?  3.Acceptance or rejection is
 If yes, is there identification in documented.
order to permit immediate recall ?

4.10.3 In process inspection and § 820.80 Receiving, in-process, and
testing
 Are there in-process inspection and
testing as required by the quality plan (c)In-process acceptance activities
and/or documented procedures?
 Will untested products be held back
until the required inspection and tests and maintained acceptance
have been completed or necessary procedures, where appropriate, to
reports have been verified? ensure that specified requirements for
 When no, has the product been
released under positive-recall in-process product are met.
procedures ( see Section 4.10.2.3)?  2.Such procedures ensure that in-
process product is controlled until the
(Note, release under positive-recall required inspection and tests or other
procedures shall not preclude the activities
outlines in Section 4.10.3a above) verification activities have been
completed, or necessary approvals
are received, and are documented.

USA 93/42/EEC)
QM-Section 4.10 inspection and testing / 2

QUESTIONS COMMENTS
found

4.10.4 Final inspection and testing § 820.80 Receiving, in-process, and
 Is all final inspection and
testing carried out in accordance with
the quality plan and/or documented (d)Final acceptance activities
procedures?  1.The manufacturer has established
 Has the final inspection and
testing been fulfilled? finished device acceptance to ensure
 Is there evidence of conformance that each production run, lot, or batch
of the finished product to the specified of finished devices meets acceptance
requirements in accordance with the
quality plan or documented criteria.
procedures?  2.Finished devices are held in
quarantine or otherwise adequately
controlled until released.
 3.Finished devices are not released
for distribution until:
 The activities required in the
DMR are completed;
 The associated data and
documentation is reviewed;
 The release is authorized by the
signature of designated
individual(s);
 The authorization is dated.

4.10.5 Inspection and test records § 820.80 Receiving, in-process, and
 Please refer to Section 4.16.
(e)Acceptance records
 Is it evident from the records,  1.The manufacturer documents the
 where the responsible testing acceptance activities.
place is?  2.These records include:
 that the products have fulfilled
the necessary criteria?  The acceptance activities
 that whereby non-conforming performed;
products, that failed to pass any  The dates the acceptance
inspection and/or test, the
procedures for control of non- activities are performed;
conforming product apply?  The results;
 The signatures of the
individual(s) conducting the
acceptance activities;
 Where appropriate, the
equipment used.
 3.These records are part of the DHR.
Particular requirements for active

medical devices and implantable
medical devices (EN 46001/2)
 Where are the identity records of

personnel performing inspections
or testing?
 Is there a requirement for

storage/keeping of identity records
(see Section 4.16, Identification)?
QM-Section 4. 11 - control inspection, measuring and test equipment / 1

QUESTIONS COMMENTS
found

USA 93/42/EEC)
4.11.1 General 820.70 Inspection, measuring, and test

 Are there documented
procedures for the equipment
 control (a)
 calibration Control of inspection, measuring, and test
 maintenance of inspection
in the measuring and test equipment? equipment
1.
The manufacturer ensures that all
inspection, measuring, and test equipment,
including mechanical, automated, or
electronic inspection and test equipment, is
suitable for its intended purposes and is
capable of producing valid results.
3.
The procedures include provisions for
handling, preservation, and storage of
equipment so that its accuracy and fitness
for use are maintained.
4.
These activities are all documented.
 In the control, inspection,

measuring and testing are the
following used:
 test software
 comparative references
When yes, will they be
 checked prior to release for use
during production?
 rechecked at prescribed
intervals?
 establishment of the extent and
frequency of such tests?
4.11.2 Control procedure

 Is there determination of the
measurements to be undertaken?
 What is the accuracy required?
 Is there selection of the
appropriate inspection,
measuring and test
equipment?
 How is the selection of such
appropriate inspection,
measuring and test equipment?
 Is this selection of the appropriate
inspection, measuring and test
equipment capable of the
necessary accuracy and
precision?
QM-Section 4. 11 - control inspection, measuring and test equipment / 2

QUESTIONS COMMENTS
found
 Are all inspection, measuring and 820.70 Inspection, measuring, and test
test equipment
 identified, equipment

USA 93/42/EEC)
 calibrated or (b)
 adjusted?
Is this undertaken at prescribed intervals or Calibration
prior to use? 1.
 Is the inspection, measuring and test Calibration procedures include specific
equipment calibrated and adjusted
against certified equipment having a directions and limits for accuracy and
known valid relationship? (With precision.
respect to internationally or nationally 2.
recognized standards!).
 In the case where no such standards When accuracy and precision limits are not
exist, is the basis used for calibration met, there are provisions for remedial action
documented? to reestablish the limits and to evaluate
whether there was any adverse effect on
the device’s quality.
3.
These activities are documented.
(1)
Calibration standards
Calibration standards used for inspection,
measuring, and test equipment are
traceable to national or international
standards. If national or international
standards are not practical or available, the
manufacturer uses an independent,
reproducible standard. If no applicable
standard exists, the manufacturer has
established and maintained an in-house
standard.
 Is the calibration process defined?

(including details of equipment type,
unique identification, location,
frequency of checks, check method,
acceptance criteria and the action to be
taken when results are unsatisfactory)

USA 93/42/EEC)
QM-SECTION 4. 11 - CONTROL OF INSPECTION, MEASURING AND TEST EQUIPMENT / 3

QUESTIONS COMMENTS
found
4.11.2 CONTINUATION 820.70 Inspection, measuring, and test

equipment
 How is the process which is
employed for the calibration of (2)Calibration records
inspection, measuring and test  (b)1.The equipment identification,
equipment defined? calibration dates, the individual
(e.g. equipment type, color code,
unique identification ) performing each calibration, and the
next calibration date are documented.
 Where are the calibration records for 820.70 Inspection, measuring, and test
inspection, measuring and test
equipment maintained? equipment
 2.These records are displayed on or
 Please refer to Section 4.16? near each piece of equipment or are
readily available to the personnel
using such equipment and to the
individuals responsible for calibrating
the equipment.
820.70 Inspection, measuring, and test

 Will the validity of previous inspection equipment
and test results when inspection,
measuring and test equipment, is
found to be out of calibration, be (b)Calibration
accessed and documented?  2.When accuracy and precision limits
(if necessary new tests)
are not met, there are provisions for
remedial action to reestablish the
limits and to evaluate whether there
was any adverse effect on the device’s
quality.
 3.These activities are documented.
 Are the environmental conditions

suitable for the calibrations,
inspections, measurements and
tests being carried out?
(e.g. is a climatizied room necessary or
practical?)
 Is it ensured that the handling, 820.70 Inspection, measuring, and test

preservation and storage of inspection,
measuring and test equipment equipment
(inclusive of test hardware and (a)Control of inspection, measuring, and
software) is such that the accuracy test equipment
and fitness for use are maintained?
 How is the inspection, measuring and maintained procedures to ensure
and test facilities, including both the that equipment is routinely calibrated,
test hardware and software, inspected, checked, and maintained.
safeguarded from adjustments that
would invalidate the calibration setting?  3.The procedures include provisions
for handling, preservation, and storage
of equipment so that its accuracy and
fitness for use are maintained.
 4.These activities are all documented.
QM-Section 4.12 inspection and test status

QUESTIONS COMMENTS
found
Subpart H - § 820.80 Receiving, in-

4.12 Inspection and test status process, and finished device acceptance
§ 820.88 Acceptance status

USA 93/42/EEC)
 How is the identification and test  1.The manufacturer has identified by

status maintained?
suitable means the acceptance status
of product.
 2.The identification of acceptance
status is maintained throughout
manufacturing, packaging, installation,
and servicing of the product to ensure
that only product which has passed
the required acceptance activities is
distributed, used, or installed.
 Is the identification of inspection

and test status maintained throughout
production, installation and servicing of
the product? (e.g. in the quality plan
and/or documented procedures)
 Is such identification defined in

the quality plan and/or documented
procedures?
 How is it ensured, in the case of

products (produced, installed or
serviced) that are released under an
authorized concession (see Section
4.13.2)?

USA 93/42/EEC)
QM-Section 4.13 - control of nonconforming product / 1

QUESTIONS COMMENTS
found
4.13.1 General Subpart I – Nonconforming Product -

820.90
 How is it ensured that products that do
not conform to specified requirements
are prevented from unintended use (a)Control of nonconforming product
or installation? (e.g. in documented  1.The manufacturer has established
procedures)
and maintained procedures to control
 How does this control provide for . product that does not conform to
 identification, specified requirements.
 documentation,  2.The procedures address the
 evaluation,
 segregation (when practical), identification, documentation,
disposition of nonconforming evaluation, segregation, and
product and for notification to the disposition of nonconforming product.
functions concerned?
 3.The evaluation of nonconformance
includes a determination of the need
for the persons or organizations
responsible for the nonconformance.
 4.The evaluation and any investigation
is documented.
4.13.2 Review and disposition of (b)Nonconformity review and disposition

nonconforming product
 Is the responsibility for review and and maintained procedures that define
authority for the deposition of the responsibility for review and the
nonconforming product defined? authority for the disposition of
nonconforming product.
 Is it ensured (in accordance with  2.The procedures set forth the review
documented procedures) how a
nonconforming product is reviewed? and disposition process.
This review maybe
 reworked  3.Disposition of nonconforming
 accepted with or without repair by
concession product is documented.
 regarded for alternative
application
 rejected or scrapped
 Shall repaired/reworked product  5.The manufacturer has established

conditions be newly tested?
rework, to include retesting and
reevaluation of the nonconforming
product after rework, to ensure that
the product meets its current
approved specifications.
 Where required by the contract,

shall the proposed use or repair of
product, which does not conform to
specified requirements, be reported for
concession to the customer or
customer’s representative?
 How is the accepted description of

nonconformity, and of repairs,
recorded to denote the actual
condition?
 (see Section 4.16?)

USA 93/42/EEC)
QM-Section 4.13 - control of nonconforming product / 2

QUESTIONS COMMENTS
found
4.13.2 CONTINUATION

 How is it stipulated that a

nonconforming product is accepted by
concession only if regulatory
requirements are met?
 4.Documentation includes the

 Where is recorded the identity of the justification for use of nonconforming
person authorizing the concession? product and the signature of the
individual(s) authorizing the use.
 Is the reworking of a product in a  6.Rework and reevaluation activities,

work instruction documented? including a determination of any
adverse effect from the rework upon
 Has this rework, of a product, in a the product, is documented in the
work instruction undergone the same DHR.
authorization and approval procedure
as the original work instruction?

USA 93/42/EEC)
QM-Section 4.14 - corrective and preventive action / 1

QUESTIONS COMMENTS
found
4.14.1 General  1. The manufacturer has established

maintained documented procedure for implementing corrective and
implementing corrective and preventive preventive action.
action?
4.14.2 Corrective action  2.The procedures include

 Do the procedures for corrective
action include the following aspects: requirements for:
 an effective handling of customer  Analyzing processes, work
complaints and reports of product operations, concessions, quality
non-conformities?
 Failure analysis w.r.t. audit reports, quality records,
 product, service records, complaints,
 process and returned product, and other
 QM-system also?
sources of quality data to identify
 Will results of such investigations be existing and potential causes of
recorded (Section 4.6)? nonconforming product, or other
 Is there determination of corrective quality problems;
action needed to eliminate the cause
of non-conformities?  Investigating the cause of
 Is there application of controls to nonconformities relating to
ensure that corrective action is taken product, processes, and the
and that it is effective?
quality system;
 Identifying the action(s) needed
to correct and prevent
recurrence of nonconforming
product and other quality
problems;
 Verifying or validating the
corrective and preventive action
to ensure that such action is
effective and does not adversely
affect the finished device;
 Implementing and recording
changes in methods and
procedures needed to correct
and prevent identified quality
problems;
 Ensuring that information related
to quality problems or
nonconforming product is
disseminated to those directly
responsible for assuring the
quality of such product or the
prevention of such problems;
 Submitting relevant information
on identified quality problems, as
well as corrective and preventive
actions, for management review.
 (b) All activities required under this
section, and their results, are
documented.
QM-Section 4.14 - corrective and preventive action / 2

QUESTIONS COMMENTS

USA 93/42/EEC)
found

devices (EN 46001/2)  (a)1.The manufacturer maintains
complaint files.
 Is there an established and maintained  2.The manufacturer has established
documented feedback system to
provide early warning of quality and maintained procedures for
problems and for the input into the receiving, reviewing, and evaluating
corrective action system complaints by a formally designated
unit.
 Is this corrective action system in  3.Such procedures ensure that:
compliance with the regulatory  All complaints are processed in a
requirements of the authorities in the uniform and timely manner;
different countries  Oral complaints are documented
upon receipt; and
DIRECTIVE 93/42/EEC (ARTICLE 10)
 Complaints are evaluated to
 Can also characteristics/marks and determine whether the complaint
instructions be recalled/withdrawn? represents an event which is
required to be reported to FDA
under part 803 or 804, MDR.
 (b) 1.The manufacturer reviews and

evaluates all complaints to determine
whether an investigation is necessary.
When no investigation is made, the
manufacturer maintains a record
which includes the reason no
investigation was made and the name
of the individual responsible for the
decision not to investigate.
 (c) Any complaint involving the

possible failure of a device, labeling,
or packaging to meet any of its
specifications is reviewed, evaluated,
and investigated, unless such
investigation has already been
performed for a similar complaint and
another investigation is not necessary.
QM-SECTION 4.14 - CORRECTIVE AND PREVENTATIVE ACTION / 3
QUESTIONS COMMENTS
found
4.14.3 Preventive action  (d) 1.Any complaint that represents an

event which must be reported to FDA
 Do the procedures for preventive
action include the following aspects: under part 803 or 804 of this chapter

USA 93/42/EEC)
 use of appropriate sources of is promptly reviewed, evaluated, and

information, such as:
investigated by a designated
processes and work operations individual(s) and is maintained in a
concessions separate portion of the complaint files
service reports or otherwise clearly identified.
audit results
quality records  2.In addition to the information
customer complaints to detect , required by § 820.198(c), records of
analyze and eliminate potential investigation under this paragraph
causes of non-conformities?
include a determination of:
 Are steps determined to deal with any  Whether the device failed to
problems requiring preventive action? meet specifications;
 Whether the device was being
used for treatment or diagnosis;
and
 The relationship, if any, of the
device to the reported incident or
adverse event.
 (e) 1.When an investigation is made
under this section, a record of the
investigation is maintained by the
formally designated unit identified in
paragraph (a) of this section.

QUESTIONS COMMENTS
found
820.198 Complaint files
 (a)1.The manufacturer maintains

complaint files.

receiving, reviewing, and evaluating
complaints by a formally designated
unit.

USA 93/42/EEC)
 3.Such procedures ensure that:
 All complaints are processed in a

uniform and timely manner;
 Oral complaints are documented
upon receipt; and
 Complaints are evaluated to
determine whether the complaint
represents an event which is
required to be reported to FDA
under part 803 or 804, MDR.
 (b) 1. The manufacturer reviews and

evaluates all complaints to determine
whether an investigation is necessary.
When no investigation is made, the
manufacturer maintains a record
which includes the reason no
investigation was made and the name
of the individual responsible for the
decision not to investigate.
 (c) (1) Any complaint involving the

possible failure of a device, labeling,
or packaging to meet any of its
specifications is reviewed, evaluated,
and investigated, unlesssuch
investigation has already been
performed for a similar complaint and
another investigation is not necessary.

QUESTIONS COMMENTS
found
 How is it ensured that relevant  2.The record of investigation includes:

information on actions taken is
submitted for management review  The name of the device;
(4.1.3)?  The date the complaint was
received;
 Any device identification(s) and
control number(s) used;
 The name, address, and phone
number of the complainant;
 The nature and details of the
complaint;
 The dates and results of the
investigation;
 Any corrective action taken; and
 Any reply to the complainant.
 (f) When the manufacturer’s formally

designated complaint unit is located at
a site separate from the
manufacturing establishment, the

USA 93/42/EEC)
investigated complaint(s) and the

record(s) of investigation are
reasonably accessible to the
manufacturing establishment.
 (g)If a manufacturer ‘s formally

designated complaint unit is located
outside of the United States, records
required by this section are
reasonably accessible in the United
States at either:
 A location in the U.S. where the

manufacturer’s records are
regularly kept; or
 The location of the initial
distributor.

USA 93/42/EEC)
QM-Section 4.15 - handling, storage, packaging, preservation and delivery / 1

QUESTIONS COMMENTS
found
4.15.1 General
maintained documented
procedures for handling, storage,
packaging, preservation and delivery of
product?

 Are there documented procedures for

the control of product or products with
a limited shelf life or requiring special
storage conditions?
 Are such special storage conditions
controlled and recorded?
 Are there special provision made for
the handling of used products in order
to prevent contamination of other
product, the manufacturing
environment or personnel (in so far as
achievable)?
§ 820.140 Handling
4.15.2 Handling
and maintained procedures to ensure
 Are the methods such to prevent
product handling and deterioration? that mixups, damage, deterioration,
contamination, or other adverse
effects to product do not occur during
handling.
§ 820.150 Storage
4.15.3 Storage
 Are there designated storage areas or
stock rooms to prevent damage or and maintained procedures for the
deterioration of product, pending use or control of storage areas and stock
delivery? rooms for product to prevent mixups,
damage, deterioration, contamination,
 Are the storage areas or stock rooms
sufficiently clearly identified? or other adverse effects pending use
or distribution and to ensure that no
 Is there appropriate methods stipulated obsolete, rejected, or deteriorated
for authorizing: product is used or distributed.
 receipt?
 store?  2.When the quality of product
 dispatch? deteriorates over time, it is stored in a
manner to facilitate proper stock
rotation, and its condition is assessed
 Are the intervals of stock assessment as appropriate.
appropriate.
 (b)The manufacturer has established
and maintained procedures that
describe the methods for authorizing
receipt from and dispatch to storage
areas and stock rooms.

USA 93/42/EEC)
QM-Section 4.15 - Handling, storage, packaging, preservation and delivery / 2

QUESTIONS COMMENTS
found
§ 820.130 Device packaging

4.15.4 Packaging
 The manufacturer ensures that device
 During the processes of:
 packing, packaging and shipping containers are
 packaging and designed and constructed to protect
 marking processes, the device from alteration or damage
 including materials used
is necessary control exercised? during the customary conditions of
processing, storage, handling, and
 Is this control to such an extent to distribution.
ensure necessary conformance to
specified requirements?
Subpart K - § 820.120 Device labeling

devices (EN 46001/2)  The manufacturer has established and
maintained procedures to control
 How is it assured that; labeling activities.
 the medical device is presented in a
container which maintains the sterility (a)Label integrity
of the medical device?  Labels are printed and applied so as to
 the medical device is capable of being remain legible and affixed during the
presented in an aseptic manner (if its customary conditions of processing,
use so requires)? storage, handling, distribution, and
 the package, or medical device if only where appropriate use.
the inner surface is sterile, clearly
reveals that it has been opened?
(b)Labeling inspection
 1.Labeling is not released for storage
or use until a designated individual(s)
has examined the labeling for
accuracy, including, where applicable,
the correct expiration date, control
number, storage instructions, handling
instructions, and any additional
processing instructions.
 2.The release, including the date and
performing the examination, are
documented in the DHR.
(c)Labeling storage
 The manufacturer stores labeling in a
manner that provides proper
identification and is designed to
prevent mixups.
(d)Labeling operations
 1.The manufacturer controls labeling
and packaging operations to prevent
labeling mixups.
 2.The label and labeling used for each
production unit, lot, or batch is
documented in the DHR.
(e)Control number
 Where a control number is required by
§ 820.65, that control number is on or
accompanies the device through
distribution.
QUESTIONS COMMENTS
found

USA 93/42/EEC)

implantable medical devices (EN
46001/2)
 Where is recorded the identity of
persons who perform the final labeling
operation?
DIRECTIVE 93/42/EEC
ANNEX l / Sterile products or products for
prior sterilization:
 Does the packaging ensure
maintenance of the medical devices
until use (8.3)?
 Is the packaging of non-sterile devices
suitable to ensure a suitable level of
cleanliness until prior sterilization
(8.6)?
 Does the packaging/label distinguish
between identical and similar products
in both sterile and non-sterile
conditions (8.7)?
 Does the label indicate the
recommended word STERILE
according to EN 980 (13.3)?
4.15.5 Preservation
 Are methods appropriate?
 Is there segregation (where necessary)
of the products?
§ 820.160 Distribution
4.15.6 Delivery
 Is there an arrangement for the
protection of the quality of product after and maintained procedures for control
final inspection and test? and distribution of finished devices to
ensure that only those devices
 Is it contractually specified, that this approved for release are distributed
protection shall be extended to include
delivery to destination? and that purchase orders are reviewed
to ensure that ambiguities and errors
are resolved before devices are
released for distribution.
 2.Where a device’s fitness for use or
quality deteriorates over time, the
procedures ensure that expired
devices or devices deteriorated
beyond acceptable fitness for use are
not distributed.
 (b)The manufacturer maintains
distribution records which include or
refer to the location of:
 The name and address of the
initial consignee;
 The identification and quantity of
devices shipped;
 The date shipped; and
 Any control number(s) used.

USA 93/42/EEC)

QUESTIONS COMMENTS
found

implantable medical devices (EN
46001/2)
 Where is recorded the name and

address of the shipping package
consignee?
 Is this record a section of the quality

record (see Section 4.16)?
 Is the audited firm required that any

unauthorized representative maintains
records of distribution of medical
devices and that such records are
available for inspection?

USA 93/42/EEC)
QM-Section 4.16 control of quality records / 1

QUESTIONS COMMENTS
found
4.16 Controf quality records Subpart M - Records

maintained documented procedure 820.180 General requirements
for quality records?
 1. All records required by this part are
 Does the contents of this documented maintained at the manufacturing
procedure include
 identification? establishment or other location that is
 collection? reasonably accessible to responsible
 indexing? officials of the manufacturer and to
 access?
 filing? employees of FDA designated to
 storage? perform inspections.
 maintenance?
 disposition?
(e.g. matrix or list for quality symbols)  2. Such records are legible and are
stored to minimize deterioration and to
prevent loss.
 Through the quality records are the
following demonstrated  3. Those records stored in automated
 conformance to specified
requirements and data processing systems are backed
 effective operation of the quality up.
system?
 Confidentiality
 Is it ensured that quality records are
 legible  (b)Record retention period; All
and records required by this part are
 readily retrievable? retained for a period of time equivalent
 Are the to the design and expected life of the
 facilities device, but in no case less than 2
and years from the date of release for
 conditions commercial distribution by the
for filing and storage, such to provide a
suitable environment to prevent manufacturer.
damage or deterioration and to prevent
loss?
 (c) Exceptions: Upon request of a
designated employee of FDA, an
 Where agreed contractually, are quality employee in management with
records made available for evaluation executive responsibility certifies in
by the customer or the customer’s writing that the management reviews,
representative for an agreed period?
quality audits, and supplier audits
have been performed and
documented, the dates on which they
were performed, and that any required
corrective action has been
undertaken.

USA 93/42/EEC)

QUESTIONS COMMENTS
found
4.16 CONTINUATION 820.181 Device master record

Particular requirements for all medical  1.The manufacturer maintains device
devices (EN 46001/2) master records (DMR’s).
 Are the quality records retained for a
time at least equivalent to the lifetime  2.The manufacturer ensures that each
of the medical device defined by the DMR is prepared and approved in
supplier, but not less than 2 years from accordance with § 820.40.
the date of dispatch from the supplier?
 Is it stipulated, which records -  3.The DMR for each type of device

corresponding to the requirement of includes or refers to the location of the
Section 4.8/traceability - for following information:
 each product,
 each appointment/post,  Device specification including
 each share/portion, appropriate drawings,
which must be kept? composition, formulation,
component specifications, and
 Do the records show the manufactured software specifications;
and released amount?  Production process
 specifications including the
appropriate equipment
specifications, production
methods, production procedures,
and production environment
specifications;
 Quality assurance procedures
and specifications including
acceptance criteria and the
quality assurance equipment to
be used;
 Packaging and labeling
specifications, including
methods and processes used;
and
 Installation, maintenance,
servicing procedures & methods.

USA 93/42/EEC)
 Will the records be verified and signed 820.184 Device history record
(authorized)?
Important: The standard explicitly  1.The manufacturer maintains device
sets down, in each element the least history records (DHR’s).
quality record standard in a QM  2.The manufacturer has established
system. and maintained procedures to ensure
Are there respective standards w.r.t.: that DHR’s for each batch, lot, or unit
 QM-valuation (4.1.3) are maintained to demonstrate that the
 contract review (4.3.4) device is manufactured in accordance
 design control (4.4.6) with the DMR and the requirements of
 design verification (4.4.7) this part.
 evaluation of subcontractors  3.The DHR includes, or refers to the
(4.6.2) location of, the following information:
 control of customer-supplied
product (4.7)  The dates of manufacture;
 identification - where necessary -  The quantity manufactured;
(4.8)  The quantity released for
 process control (4.9) distribution;
 Preliminary release in incoming  The acceptance records which
products (4.10.2.3) demonstrate the device is
 test records (4.10.5) manufactured in accordance
 control of inspection, measuring with the DMR;
and test equipment (4.11.1)  The primary identification label
 calibration (4.11.2 e) and labeling used for each
 concession (4.13.2) production unit; and
 corrective action (4.14.2)  Any device identification(s) and
 results of internal quality audits control number(s) used.
(4.17)
 corrective action in following
audits (4.17)
 training (4.18)
 Are these the minimal considerations

to be observed w.r.t. the quality control
process? 820.188 Quality system record
 1.The manufacturer maintains a

quality system record (QSR).
 2.The QSR includes, or refers to the

location of, procedures and the
documentation of activities required by
this part that are not specific to a
particular type of devices(s),
including, but not limited to, the
records required by § 820.20.
 3.The manufacturer ensures that the

QSR is prepared and approved in

USA 93/42/EEC)
QM-Section 4.17 Internal Quality audits / 1

QUESTIONS COMMENTS
found
4.17 Internal Qulaity Audits Subpart B – Quality System

Requirements
 Are there documented procedures for
planning and implementing internal 820.22 Quality Audit
quality audits?
 Do these procedures comply with  1.The manufacturer has established
planned arrangements/ schedules?
procedures for quality audits and has
conducted such audits.
 Are the internal audits carried out by  2.The quality audits are conducted by
personnel independent of those
having direct responsibility for the individuals who do not have direct
activity being audited? responsibility for the matters being
audited.
 Are the internal audits carried out by

sufficiently qualified personnel (see
paragraph 4.1.2.2)?
 Will the results of the internal audits be  5.The dates and results of quality
 recorded?
 brought to the attention of the audits and reaudits are documented.
personnel having responsibility in
the audited area?
 brought to the attention of the
highest management personnel
( also for the QM
assessment?)
 Do the responsible management  4.A report of each quality audit, and

personnel take timely corrective action
on deficiencies found during the audit? reaudits, are made and reviewed by
management having responsibility for
the matters being audited.
 Do follow-up audit activities verify

and record the implementation and
effectiveness of the corrective
action taken?
 Will the corresponding results of the  3.Corrective action(s), including a

 audits and
 corrective action reaudit of deficient matters, are taken
be registered? (  4.16?) when necessary.
QM-Section 4.17 Internal Quality audits / 2

QUESTIONS COMMENTS

USA 93/42/EEC)
found
4.17 CONTINUATION
DIRECTIVE 93/42/EEC
ANNEX ll, V, VI 3.2 b)
 Will the functioning of the QM system
be regularly investigated?
 In the frame of the internal audit, is the
QM system investigated to see if it is
suited for the quality lay out and
product?
 Will it be invetsigated in internal audits
if the QM system is suited for
identification of non-conforming
products?

USA 93/42/EEC)
QM-Section 4.18 TRAINING

QUESTIONS COMMENTS
found
4.18 Training Subpart B – Quality System

Requirements
 Are there documented procedures
for identifying training needs? 820.25 Personnel
 Is this in an established manner?
 1.There are procedures for identifying
training needs and ensuring that all
personnel are trained to adequately
perform their assigned
responsibilities.
 2.This training is documented.
 3.As part of their training, personnel
are made aware of device defects
which may occur from the improper
performance of their specific jobs.
 4.Personnel who perform verification
and validation activities are made
aware of defects and errors that may
be encountered as part of their job
functions.
 Are the personnel performing activities  3.As part of their training, personnel
affecting quality trained?
are made aware of device defects
 Will the means of training be which may occur from the improper
assessed? performance of their specific jobs.
 Are the personnel performing  4.Personnel who perform verification

specific assigned tasks qualified on
the basis of and validation activities are made
 appropriate education?, aware of defects and errors that may
 appropriate training? and/or be encountered as part of their job
 experience?
functions.

Are personnel
 that work under special environment
conditions,
 who performs special processes or
functions,
appropriately trained?
or is it the case that:

 they are supervised by a trained
person?
 training certificates are recorded and
put in file?
 Is this record a section of the quality

records (see Section 4.16)?

USA 93/42/EEC)
QM-SECTION 4.19 SERVICING

QUESTIONS COMMENTS
found
4.19 Servicing Subpart N - 820.200

 Is servicing a specified
requirement?  (a)Where servicing is a specified
requirement, the manufacturer has
established and maintained
 If yes, are the procedures through instructions and procedures for
performance and testing stipulated?
performing and verifying that the
 Are such documented in a procedure? servicing meets the specified
requirements.
 In the description of the  (b)The manufacturer analyzes service

documented procedures are the reports with appropriate statistical
following considered
methodology in accordance with §
 performance of the activity? 820.100.
 verification of the activity?  (c)The manufacturer who receives a

service report that represents an event
 reporting that the servicing meets which must be reported to FDA under
the specified requirements?
part 803 or 804 of this chapter
automatically considers the report a
complaint and processes it in
accordance with the requirements of §
820.198.
 (d)Service reports are documented

and include:
 The name of the device services;
 Any device identification(s) and
control number(s) used;
 The date of service;
 The individual(s) servicing the
device;
 The service performed; and
 The test and inspection data.

USA 93/42/EEC)
QM-Section 4.20 Statistical techniques

QUESTIONS COMMENTS
found
4.20.1 Identification of need Subpart O - 820.250

 Is the identification of statistical
techniques a need?  (a) Where appropriate, the
manufacturer has established and
maintained procedures for identifying
 How is need for statistical tecnique valid statistical techniques required for
required identified w.r.t.: establishing, controlling, and verifying
establishing, controlling, verifying
process capability and product the acceptability of process capability
characteristics? and product characteristics.


maintained procedures to ensure that
sampling methods are regularly
reviewed in the light of;
 the occurrence of non-conforming
products
 quality audit reports (see Section
4.17),
 feedback information (see Section
4.14),
 and other appropriate considerations?
4.20.2 Procedures Subpart O - 820.250

 Are there documented procedures to
 (b) 1.Sampling plans, when used, are
 implement written and based on a valid statistical
 control rationale.
the application of the statistical  (b) 2.The manufacturer has
procedures?
established and maintained
 Is it stipulated where the respective procedures to ensure that sampling
methods for application originate? methods are adequate for their
intended use and to ensure that when
 Are the concerned personnel changes occur the sampling plans are
sufficiently trained/qualified?
reviewed.
 (b) 3.The activities are documented.

USA 93/42/EEC)
AUDIT - SUMMARY
POSITIVE ASPECTS OF THE QM-SYSTEMS
COMMENTS / POTENTIAL FOR IMPROVEMENTS
DEFICIENCIES
GENERAL COMMENTS

USA 93/42/EEC)
Deviation Nr. of
Examined firm Date Lead Auditor
QM-Standard Aspect (Section of standard/ Council Directive 93/42/EEC)
Stipulated deviations
Corrective procedures from audited firm
Corrective procedures will be carried out until Responsible signature of the audited firm
Corrective procedures carried out on Responsible signature of the audited firm
Endorsement of consideration
Date Signature
Quality Assurance Document Page 53 of 56

USA 93/42/EEC)
List of viewed/copied documents and records
Document / record (title, nr.) Rel.-edition / department/section V C

date location of plant/firm viewed copy

USA 93/42/EEC)
List of the participants
Name Department/section/function Comments

USA 93/42/EEC)
Quality Services Audit Report

Summary
___________________
______________________
_________________________
Date of the Audit: ______________

Representatives: ______________ Lead Auditor
Scope and Aim of the Quality Audit
The audit performed on __________ at ______________ located in ___________ was designed to evaluate the quality
system implemented according to the FDA Quality System Requirements (QSR’s) as given in 21 CFR § 820, ISO 9001/2,
and EN 46001/2. There was a particular emphasis on the use of the Linvatec Supplier Selection Review form, SOP
06204.
The scope and aim of the audit is for the qualification of this supplier for ______________.
Critical Observations: 0
Major Observations: 0 (Major items marked as Form/ Fit Function/ Safety must be corrected)
Minor Observations: 0
Recommendations: 0
City, State
Date
____________________
Lead Auditor and Expert

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Albert Rego, Ph.D. Quality System Audit QA-Nr.

Audited firm Annex of the directive Standards Type of consideration

Telefax-Nr. On-site audit carried out on (date)

Lead auditor Co-auditor / technical expert Co-auditor

Audited section/area (area of validation)

Scope and Aim of the Quality Audit

The audit performed on __________ at __________________ located in _________________ is

Date / Signature of Auditor(s)

Quality Assurance Document page 1 / 56

4. Design control Subpart C - § 820.30 Design controls

20. Statistical techniques Subpart O - § 820.250 Statistical techniques

Date / Signature of Auditor(s)

Quality Assurance Document page 2 / 56

QM-Section 4.1 - Management responsibility / 1

§ 820.20 Management Responsibility

4.1.1 Quality Goals

§ 820.20 Management Responsibility

Quality Assurance Document page 3 / 56

QM-SECTION 4.1 - MANAGEMENT RESPONSIBILITY / 2

§ 820.20 Management Responsibility

§ 820.20 Management Responsibility

Quality Assurance Document page 4 / 56

QM-SECTION 4.2 - QUALITY MANAGEMENT SYSTEM / 1

§ 820.5 Quality System

Particular requirements for all medical

 Are the specified requirements

Note: When the quality system is used, the

§ 820.20 Management Responsibility

 1.The manufacturer has established

Particular requirements for all medical

Does there exist for each product/product

The records that are not in a central archive

Quality Assurance Document page 5 / 56

QM-Section 4.2 - Quality management System / 2

§ 820.20 Management Responsibility

Is there consideration, in the quality plan,

 Report on the managerial and

 Identification and preparation of

Quality Assurance Document page 6 / 56

QM-Section 4.3 contract review

4.3.3 Amendment to a contract

Quality Assurance Document page 7 / 56

QM-SECTION 4.4 - DESIGN CONTROL / 1

§ 820.30 Design controls

 (2)The following class I devices are

 Devices automated with computer

§ 820.30 Design controls

Quality Assurance Document page 8 / 56

QM-SECTION 4.4 - DESIGN CONTROL / 2

§ 820.30 Design controls

§ 820.30 Design controls

Quality Assurance Document page 9 / 56

QM-Section 4.4 - Design control / 3

Particular requirements for all medical

 Does there exist a record/list of

ANNEX lX / classification criteria

ANNEX X / clinical evaluation

Quality Assurance Document page 10 / 56

QM-Section 4.4 - Design control / 4

§ 820.30 Design controls

§ 820.30 Design controls

Quality Assurance Document page 11 / 56

QM-SECTION 4.4 - DESIGN CONTROL / 5

The audit performed on at located in _________ is