QM Rev. F
Quality Manual
Table of Contents
Topic
1.0
2.0
3.0
4.0
5.0
6.0
7.0
8.0
9.0
10.0
11.0
12.0
13.0
14.0
Purpose
Scope
Company background and history
Subpart A – General Provisions
4.1
Sec. 820.5 Quality system
Subpart B – Quality System Requirements
5.1
820.20 Management responsibility
5.1.1
Quality policy
5.1.2
Organization
5.1.3
Management review
5.1.4
Quality planning
5.1.5
Quality system procedures
5.2
820.22 Quality audit
5.3
820.25 Personnel
Subpart C – Design Controls
6.1
820.30 Design Controls
Subpart D – Document Controls
7.1
820.40 Document Controls
Subpart E – Purchasing Controls
8.1
820.50 Purchasing controls
Subpart F – Identification and Traceability
9.1
820.60 Identification
9.2
820.65 Traceability
Subpart G – Production and Process Controls
10.1
820.70 Production and process controls
10.2
820.72 Inspection, measuring, and test equipment
10.3
820.75 Process validation
Subpart H – Acceptance Activities
11.1
820.80 Receiving, in-process, and finished device acceptance
11.2
820.86 Acceptance status
Subpart I – Nonconforming Product
12.1
820.90 Nonconforming product
Subpart J – Corrective and Preventative Action
13.1
820.100 Corrective and preventative action
Subpart K – Labeling and Packaging Control
14.1
820.120 Device labeling
14.2
820.120 Device packaging
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QM Rev. F
Quality Manual
Table of Contents (Continued)
Topic
15.0
Subpart L – Handling, Storage, Distribution, and Installation
15.1
820.140 Handling
15.2
820.150 Storage
15.3
820.160 Distribution
15.4
820.170 Installation
16.0
Subpart M – Records
16.1
820.180 General requirements
16.2
820.181 Device master record
16.3
820.184 Device history record
16.4
820.186 Quality system record
16.5
820.198 Complaint files
17.0
Subpart N – Servicing
17.1
820.200 Servicing
18.0
Subpart O – Statistical Techniques
18.1
820.50 Statistical techniques
19.0
Additional regulatory requirements
19.1
Non-US Regulatory Requirements
20.0
Exclusions/Non-applicability
Management Process
QMS Diagram
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1.0
Purpose
This quality manual (QM) defines LDR Spine policy.
2.0
Scope
The following ‘Regulations’ and ‘Standards’ are applicable to the LDR Spine quality system:
Applicable ‘Regulations’
Where the term ‘Regulations’ is used, it refers to the regulation(s) listed below:

21 CFR Part 820: Food and Drug Administration Quality System Regulations (QSR)
Applicable ‘Standards’
Where the term ‘Standard’ or ‘Standards’ is used, it refers to the quality system standard(s) listed
below:

ISO 13485 (7/2003): Medical devices - Quality management systems - Requirements for
regulatory purposes
Applicable Documents
1. LIST 4-01 LIST, Master list of quality system documents
3.0
Company background and history
LDR Spine was founded in 2004 to focus on US sales and distribution of medical devices
(manufactured by LDR Medical) to treat spinal disorders, and to obtain regulatory approvals for
LDR Medical products in the US market. Products include spinal implants, instruments and
sterilization trays. LDR Spine may also distribute devices for other companies in the spinal market.
LDR Spine functions as a distributor and initial importer of medical devices, and is the US Agent
for LDR Medical. LDR Spine may also design and develop medical devices for distribution in the
US.
LDR Spine is located at:
13785 Research Boulevard, Suite 200
Austin, Texas 78750
LDR Spine is the US entity of the global LDR brand. The majority of design, development, and
manufacturing functions are performed by LDR Medical which is located in Troyes, France.
While LDR Spine has implemented a quality system to address the activities in the US
(specifically control and distribution), many quality system functions are the responsibility of, and
addressed by LDR Medical.
4.0
Subpart A – General Provisions
4.1
Sec. 820.5 Quality system
LDR Spine has implemented and maintains a quality system. The system shall be
maintained and its effectiveness monitored in accordance with the ‘Regulations’ and
‘Standards’. LDR Spine has:

Identified the processes needed for the quality system and their application
throughout the organization

Determined the sequence and interaction of these processes

Determined criteria and methods needed to ensure that both the operation and control
of these processes are effective

Ensured the availability of resources and information necessary to support the
operation and monitoring of these processes

Monitored, measured and analyzed these processes

Implemented actions necessary to achieve planned results and maintain the
effectiveness of these processes
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LDR Spine shall ensure control over processes that are outsourced that may affect product
conformity with requirements. Control of such processes is identified within the quality
system.
The management of LDR Spine is committed to successfully implementing an effective
quality system. This shall be accomplished by:
5.0

Communicating the importance of meeting customer requirements

Communicating the importance of meeting the requirements specified in the
‘Regulations’ and ‘Standards’

Establishing a quality policy and communicating the importance of the quality policy

Establishing quality objectives

Performing management reviews

Ensuring the availability of resources
Subpart B – Quality System Requirements
5.1
820.20 Management responsibility
5.1.1
Quality policy
The quality policy is the defining statement of the commitment to LDR Spine
(including management with executive responsibility) to meet its customer’s
requirements and to comply with all regulatory requirements. LDR Spine has
established the following quality policy:
LDR Spine shall provide safe and effective devices
that improve the quality of spine care and meet
customer & regulatory requirements
Management with executive responsibility shall ensure that the quality policy is
understood, implemented, and maintained at all levels of the organization.
5.1.2
Organization
LDR Spine has established and maintains an adequate organization structure to
ensure that devices are designed, produced, accepted, and distributed in
accordance with the regulatory requirements.
Responsibility and authority
The organizational structure of LDR Spine is contained in the organizational
chart. The chart, along with job descriptions, define and document the
responsibility, authority, and the interrelation of personnel who manage,
perform, and verify work that affects quality. Every employee has
responsibilities for quality as defined in the QM, SOPs and other documentation.
If the responsible party is not available, authorized deputies may substitute for
the responsible party. It is the policy of LDR Spine that the supervisor for
each employee is the authorized deputy for that employee. In addition, an
employee may designate another person to be a deputy by documenting this fact
in writing and providing the documentation to Quality. The designation of a
deputy may be permanent or temporary
It is the responsibility of each deputy to only perform jobs for which they are
qualified. Thus, a deputy may have to be trained (formally or via self-training)
before performing a given job.
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Resources
LDR Spine shall provide resources as needed to implement the quality system
and to maintain its effectiveness, and to meet regulatory and customer
requirements.
Personnel performing work affecting product quality shall be competent on the
basis of appropriate education, training, skills and experience.
Management representative
The management of LDR Spine has designated the VP of Clinical, Regulatory
and Quality as the Management Representative. The Management
Representative has the authority and responsibility for ensuring that the
requirements of the quality system are implemented and maintained in
accordance with ‘Regulations’, ‘Standards’ and this QM. This person has the
organizational authority and responsibility to conduct the following activities:
5.1.3

Ensure that processes needed for the quality system are established,
implemented and maintained

Report on the performance of the quality system to LDR Spine management
and any need for improvement

Control further processing, delivery, or installation of non-conforming
product until the deficiency or unsatisfactory condition has been corrected

Promote awareness of regulatory and customer requirements throughout the
organization
Management review
LDR Spine management reviews the quality system on a regular basis (at least
annually) to ensure its continuing suitability, adequacy and effectiveness. This
review includes assessing opportunities for improvement and the need for
changes to the quality system, including the quality policy and quality
objectives.
At a minimum, the input to management review shall include:

Follow-up actions from previous management reviews

Changes that could affect the quality system

Customer feedback

Process performance and product conformity

Status of preventive and corrective actions

Audit results (internal / external)

Recommendations for improvement

New or revised regulatory requirements
The output from the management review shall include any decisions and actions
related to:
5.1.4

Recommendations for improvements needed to maintain the effectiveness of
the quality system and its processes, or improvement of product related to
customer requirements

Adequacy of resource
Quality planning
LDR Spine performs quality planning to:

Define and document how the requirements for quality specified in the
‘Regulations’ and ‘Standards’ shall be met

Define how the quality policy shall be met
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
To create quality objectives

To ensure that the integrity of the quality system is maintained when
changes to the quality system are planned and implemented
Quality planning is divided into three major areas
1. Strategic planning
LDR Spine management shall establish quality objectives via the strategic
planning process. Quality objectives should be measurable and consistent
with the quality policy. The quality objectives are disseminated to managers
who are responsible for discussing the quality objectives with their
employees. Each LDR Spine employee is responsible to plan and perform
the necessary tasks to implement the strategic plan and to achieve the
quality objectives.
5.1.5
2.
Product planning (product specific)
Product planning is typically done during design control and consists of
establishing a plan for design and creating quality plans for inspection.
LDR Spine has established a design control procedure used to develop new
medical devices, or to make significant changes to an existing device.
3.
Process planning (non-product specific)
Non-product specific planning may be necessary when there are major
production process changes, facility changes, personnel changes, new
products outside the scope of the quality system or other significant changes
to the organization.
Quality system procedures
The quality system includes:

Quality manual (including quality policy)

Quality objectives

Standard operating procedures

Other documents as needed to ensure the effective planning, operation and
control of processes (e.g., forms, lists, work instructions)

Records and any other necessary documentation to show compliance with
the ‘Regulations’ and ‘Standards’
The quality system defined by this QM is applicable to all products designed,
manufactured, and/or distributed by LDR Spine. It is applicable to all LDR
Spine employees working within the U.S. regulatory structure regardless of
location.
Procedures have been created to implement the requirements of the
‘Regulations’, ‘Standards’ and this QM – reference LIST 4-01 for a list of
procedures.
The LDR Spine documentation system is hierarchical.
Level 1: Quality System Policy
Quality Manual (with input from ‘Regulations’ and ‘Standards’)
Level 2: Quality System Procedures
Standard Operating Procedures
Level 3: Other Quality Documents
Forms
Lists
Work Instructions
Level 4: Records
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Records
5.2
820.22 Quality audit
Internal quality audits are a vital part of LDR Spine quality system as they allow LDR
Spine to determine if the quality system is effectively implemented and maintained.
Internal audits shall be performed periodically to determine conformance to:

The requirements of the ‘Regulations’ and ‘Standards’

The LDR Spine requirements as specified in the QM and procedures
Internal audits shall be planned and conducted on the basis of the status and importance of
the activity to be audited as well as the results of previous audits. The internal audit
procedure defines the responsibilities and requirements for planning and conducting
audits, the audit criteria, scope, frequency, methods and the reporting methods. Internal
audits shall be carried out by personnel independent of those having direct responsibility
for the activity being audited.
Management personnel responsible for the audited area shall take timely action to
eliminate detected deficiencies and their causes found during the audit. Follow-up audit
activities shall verify and record the implementation and effectiveness of the actions
taken.
The results of the internal audits are recorded and brought to the attention of the personnel
having responsibility in the area audited. Also, the results of internal quality audits form
an integral part of the input to management review activities.
5.3
820.25 Personnel
LDR Spine shall provide resources as needed to implement the quality system and to
maintain its effectiveness, and to meet regulatory and customer requirements.
Personnel performing work affecting product quality shall be competent on the basis of
appropriate education, training, skills and experience.
LDR Spine shall:

Determine the necessary competence for personnel performing work affecting
product quality

Provide training or take other actions to satisfy these needs

Evaluate the effectiveness of the actions taken

Ensure that its personnel are aware of the relevance and importance of their activities
and how they contribute to the achievement of the quality objectives

Maintain appropriate records of education, training, skills and experience
As part of their training, personnel shall be made aware of device defects which may
occur from the improper performance of their specific jobs. Personnel who perform
verification and validation activities shall be made aware of defects and errors that may
be encountered as part of their job functions.
6.0
Subpart C – Design Controls
6.1
820.30 Design controls
LDR Spine has established design control procedures for devices, or to make significant
changes to an existing device. The LDR Spine procedure establishes specific design
control phases to ensure adequate control. These phases consist of:

Phase 1 – Design Development and Planning

Phase 2 – Output and Verification/Validation

Phase 3 –Transfer to Manufacturing

After Phase 3 – DHF Closure
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The design control process ensures that there is adequate review, verification, validation
and design transfer as appropriate at each design phase.
7.0
8.0
Subpart D – Document Controls
7.1
820.40 Document controls
All quality system documents are controlled. The document control procedure(s) define
the controls needed to ensure the effectiveness of the document control system. This
includes ensuring:

Adequate review & approval of documents prior to issue
Changes to documents are reviewed and approved either by the original approving
function or another designated function which has access to pertinent background
information upon which to base its decisions

Adequate review, updating and re-approval of documents as necessary

That changes and current revision status of documents are identified

That relevant versions of applicable documents are available at points of use

That documents remain legible and readily identifiable

That documents of external origin are identified and their distribution controlled

That the unintended use of obsolete documents is prevented

That obsolete documents are suitably identified when retained

That at least one copy of obsolete documents are retained for the defined period
The retention period shall ensure that documents to which devices have been
manufactured and tested are available for a minimum of the longer of the lifetime of
the medical device or the retention period based on regulatory requirements.
Subpart E – Purchasing Controls
8.1
820.50 Purchasing controls
LDR Spine has established purchasing procedures to ensure that purchased product
(materials and services) conforms to specified requirements.
Suppliers are evaluated and selected based on their ability to supply products / services in
accordance with LDR Spine requirements. The applicable purchasing procedure defines
the criteria for supplier selection, evaluation and monitoring. The amount of control
applied to each supplier (vendor) and purchased product is based on the effect that the
purchased product / service has on the final product.
Records of supplier evaluation are maintained as quality records.
Purchasing data
LDR Spine shall use purchase orders to describe the products / services being purchased.
Purchase orders shall include:

Requirements for approval of product, procedures, processes or equipment including
quality system requirements

An agreement (when applicable) that the supplier agrees to notify LDR Spine of
changes in the product or service so that manufacturers may determine whether the
changes may affect the quality of a finished device.
To ensure that the specified purchase requirements are adequate before they are
communicated to the supplier, the purchase orders must be reviewed and approved.
Applicable purchasing documentation shall be retained to ensure adequate traceability.
9.0
Subpart F – Identification and Traceability
9.1
820.60 Identification
LDR Spine shall identify the product by suitable means throughout product realization,
and has established documented procedures for such product identification.
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LDR Spine has established documented procedures to ensure that medical devices
returned to the organization are received and inspected and that non-conforming products
are identified and distinguished from conforming product.
9.2
820.65 Traceability
LDR Spine has established documented procedures for traceability. Such procedures
define the extent of product traceability and the records required.
Implantable medical devices
LDR Spine shall maintain and shall require that its agents or distributors maintain records
of the distribution of implantable medical devices to allow traceability (e.g., by part
number). Further, such records shall be available for inspection.
10.0
Subpart G – Production and Process Controls
10.1
820.70 Production and process controls
LDR Spine shall ensure that production and process controls are adequately maintained.
LDR Spine may defer responsibility to suppliers for certain production and process
controls, and their procedures establish specific requirements to address the general
requirements as well as the requirements for:

Production and process changes

Environmental control

Personnel

Contamination control

Buildings

Equipment

Manufacturing material

Automated processes
LDR Spine has established procedures to ensure that suppliers responsible for production
and process controls are compliant with regulations and standards, including supplier
approval, monitoring, auditing, and supplier corrective actions.
LDR Spine has provided and maintains the infrastructure needed to achieve conformity to
product requirements. Infrastructure includes, as applicable:

Buildings, workspace and associated utilities

Process equipment (both hardware and software)

Support services (such as transport or communication)
LDR Spine has established documented requirements for maintenance activities,
including their frequency, when such activities or lack thereof can affect product quality.
LDR Spine manages the work environment to ensure conformity to product requirements.
This includes, as appropriate:
10.2

Documented requirements for the work environment conditions and documented
procedures or work instructions to monitor and control these work environment
conditions if work environment conditions can have an adverse effect on product
quality

Documented requirements for the control of contaminated or potentially
contaminated product in order to prevent contamination of other product, the work
environment or personnel
820.72 Inspection, measuring, and test equipment
LDR Spine has established documented requirements for inspection, measuring, and test
equipment. LDR Spine may defer responsibility to suppliers for inspection using suitable
inspection, measuring and test equipment, and their procedures establish specific
requirements to ensure that the necessary requirements are implemented. LDR Spine has
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established procedures to ensure that suppliers responsible for inspection are compliant
with regulations and standards, including supplier approval, monitoring, auditing, and
supplier corrective actions.
LDR Spine shall determine the monitoring and measurement to be undertaken, including
any additional inspection or special measurements in addition to supplier responsibilities
(as applicable) and the devices needed to provide evidence of conformity of product to
determined requirements. Documented procedures shall be used to ensure that monitoring
and measurement is carried out in a manner that is consistent with the monitoring and
measurement requirements.
Where necessary to ensure valid results, measuring equipment shall:

Be calibrated or verified at specified intervals, or prior to use, against
measurement standards traceable to international or national measurement
standards; where no such standards exist, the basis used for calibration or
verification shall be recorded

Be adjusted or re-adjusted as necessary

Be identified to enable the calibration status to be determined

Be safeguarded from adjustments that would invalidate the measurement result

Be protected from damage and deterioration during handling, maintenance and
storage.
LDR Spine shall assess and record the validity of the previous measuring results when the
equipment is found not to conform to requirements, and shall take appropriate action on
the equipment and any product affected. Records of the results of calibration and
verification shall be maintained.
When used in the monitoring and measurement of specified requirements, the ability of
computer software to satisfy the intended application shall be confirmed (i.e. validated).
This shall be undertaken prior to initial use and reconfirmed as necessary.
10.3
820.75 Process validation
LDR Spine has established documented requirements for verification and validation
activities conducted at LDR Spine.
LDR Spine may defer responsibility to suppliers for process validations, and their
procedures establish specific requirements to ensure that the necessary requirements are
implemented. LDR Spine has established procedures to ensure that suppliers responsible
for validation are compliant with regulations and standards, including supplier approval,
monitoring, auditing, and supplier corrective actions.
When used for processes related to product quality or the LDR Spine Quality System, the
ability of computer software to satisfy the intended application shall be confirmed (i.e.
validated). This shall be undertaken prior to initial use and reconfirmed as necessary.
11.0
Subpart H – Acceptance Activities
11.1
820.80 Receiving, in-process, and finished device acceptance
LDR Spine has established documented requirements for acceptance activities conducted
at LDR Spine. LDR Spine may defer responsibility to suppliers for receiving, in-process
and finished device acceptance (in whole or in part), and their procedures establish
specific requirements to ensure that the necessary requirements are implemented. LDR
Spine has established procedures to ensure that suppliers responsible for acceptance
activities are compliant with regulations and standards, including supplier approval,
monitoring, auditing, and supplier corrective actions.
LDR Spine shall perform receiving inspection which shall consist of inspection of the
finished product in accordance with documented requirements. This inspection shall
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consist of, at minimum, verification of ‘kind, count and condition’, or additional
inspection may be performed if applicable.
Evidence of conformity with the acceptance criteria shall be maintained. Records shall
indicate the person(s) authorizing release of product.
Product release and service delivery shall not proceed until the inspection has been
satisfactorily completed.
11.2
12.0
820.86 Acceptance status
LDR Spine identifies by suitable means the acceptance status of product to indicate the
conformance or nonconformance of product with acceptance criteria. The identification of
acceptance status shall be maintained throughout the process to ensure that only product
which has passed the required acceptance activities is distributed.
Subpart I – Nonconforming Product
12.1
820.90 Nonconforming product
LDR Spine ensures that product which does not conform to product requirements is
identified and controlled to prevent its unintended use or delivery. The controls and
related responsibilities and authorities for dealing with nonconforming product are
defined in the applicable procedure.
Nonconforming products shall be addressed in one or more of the following ways:

By taking action to eliminate the detected nonconformity (e.g., rework)
When nonconforming product is corrected, it shall be subject to re-verification to
demonstrate conformity to the requirements.

By authorizing its use, release or acceptance under concession (e.g., Use as Is, demo)
LDR Spine shall ensure that nonconforming product is accepted by concession only
if regulatory requirements are met. Records of the identity of the person(s)
authorizing the concession shall be maintained.

By taking action to preclude its original intended use or application
Records of the nature of nonconformities and any subsequent actions taken shall be
maintained.
When nonconforming product is detected after delivery or use has started, the
organization shall take action appropriate to the effects, or potential effects, of the
nonconformity. This may include no action, stopping shipments, issuing advisory notices
or product recalls as applicable.
13.0
Subpart J – Corrective and Preventive Action
13.1
820.100 Corrective and preventive action
LDR Spine has established procedures to eliminate the cause of nonconformities in order
to prevent recurrence, or potential nonconformities in order to prevent occurrence. LDR
Spine shall perform corrective / preventive action appropriate to the effects of the
nonconformities encountered or the potential effects of potential nonconformities. The
corrective / preventive action procedures define requirements for:

Reviewing nonconformities (e.g., nonconformance reports, customer complaints,
audit findings)

Determining the causes of nonconformities or potential nonconformities

Evaluating the need for action to ensure that nonconformities do not recur or to
prevent occurrence of nonconformities

Determining and implementing action needed

Recording of the results of any investigation and of action taken

Reviewing the corrective / preventive action taken and its effectiveness
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LDR Spine shall maintain quality records documenting the corrective / preventive action
nonconformity or potential nonconformity along with the results of the investigation and
the corrective / preventive action. Further, the results shall be an input to the management
review process.
14.0
Subpart K – Labeling and Packaging Control
14.1
820.120 Device labeling
LDR Spine has established documented requirements for device labeling activities
conducted at LDR Spine. LDR Spine may defer responsibility to suppliers for device
labeling, and their procedures establish specific requirements to ensure that the necessary
requirements are implemented. LDR Spine has established procedures to ensure that
suppliers responsible for labeling are compliant with regulations and standards, including
supplier approval, monitoring, auditing, and supplier corrective actions.
LDR Spine reviews device labels as part of incoming inspection to ensure label integrity,
traceability and identification requirements are met.
14.2
15.0
820.120 Device packaging
LDR Spine has established documented requirements for device packaging activities
conducted at LDR Spine. LDR Spine may defer responsibility to suppliers for device
packaging, and their procedures establish specific requirements to ensure that the
necessary requirements are implemented. LDR Spine has established procedures to ensure
that suppliers responsible for packaging are compliant with regulations and standards,
including supplier approval, monitoring, auditing, and supplier corrective actions.
Subpart L – Handling, Storage, Distribution, and Installation
15.1
820.140 Handling
LDR Spine has established procedures for handling of product to ensure that mix-ups,
damage, deterioration, contamination, or other adverse effects to product do not occur
during handling
15.2
820.150 Storage
LDR Spine has established procedures for control of storage areas for product to ensure
that mix-ups, damage, deterioration, contamination, or other adverse effects to product do
not occur during storage.
Further, LDR Spine has established documented procedures for the control of product to
ensure that no obsolete, rejected, or deteriorated product is used or distributed
15.3
820.160 Distribution
LDR Spine has established procedures for control of distribution of product to ensure that
only those devices approved for release are distributed and that purchase orders are
reviewed to ensure that ambiguities and errors are resolved before devices are released for
distribution.
Further, LDR Spine has established documented procedures for the control of product
with limited shelf life to ensure that no expired devices are distributed.
LDR Spine shall maintain distribution records to provide adequate traceability, and these
records shall 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 (e.g., lot number).
15.4
820.170 Installation
Currently, LDR Spine devices do not require installation. If this changes, LDR Spine
shall establish documented requirements which contain acceptance criteria for installing
and verifying the installation of the medical device.
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Subpart M – Records
16.1
820.180 General requirements
Records shall be maintained at the manufacturing establishment or other location that is
reasonably accessible to LDR Spine personnel and to others as applicable. Records shall
provide objective evidence that the quality system is effective and conforms to the
requirements specified in the ‘Regulations’ and ‘Standards’. Records shall remain legible,
readily identifiable and retrievable. Records stored in automated data processing systems
shall be backed up.
The record retention procedure(s) define the controls needed for the identification,
storage, protection, retrieval, retention time and disposition of records. The record
retention period shall ensure that records are retained for a minimum of the longer of:

The lifetime of the device

Two years from the date of product release from LDR Spine

As specified by relevant regulatory requirements
16.2
820.181 Device master record
LDR Spine has established documented requirements for device master records. LDR
Spine may defer responsibility to suppliers for creating and maintaining the device master
record. LDR Spine has established procedures to ensure that suppliers responsible for
device master record are compliant with regulations and standards, including supplier
approval, monitoring, auditing, and supplier corrective actions. Records shall be
available for review at LDR Spine, or produced by suppliers in a timely manner for
review.
16.3
820.184 Device history record
LDR Spine has established documented requirements for device history records. LDR
Spine may defer responsibility to suppliers for maintaining the device history record LDR
Spine has established procedures to ensure that suppliers responsible for device history
record are compliant with regulations and standards, including supplier approval,
monitoring, auditing, and supplier corrective actions. Records shall be available for
review at LDR Spine, or produced by suppliers in a timely manner for review.
16.4
820.186 Quality system record
LDR Spine shall maintain a quality system record (QSR). The QSR shall include, or
refer to the location of, procedures and the documentation of activities required by this
part that are not specific to a particular type of device(s), including, but not limited to,
the records required by 820.20. Each manufacturer shall ensure that the QSR is prepared
and approved in accordance with 820.40.
16.5
820.198 Complaint files
LDR Spine has established procedures for investigating and documenting all customer
complaints. If an investigation determines that activities outside LDR Spine contributed
to the customer complaint, relevant information shall be exchanged between the
organizations involved (e.g., with suppliers or distributors). If any customer complaint is
not followed by corrective and/or preventive action, the reason shall be documented and
recorded by appropriate personnel.
Each complaint shall be maintained in a complaint file. The process of complaint
handling is documented in LDR Spine procedures and includes procedures for receiving,
reviewing, and evaluating complaints by a formally designated unit. All complaints shall
be 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 of this chapter, Medical
Device Reporting.
QM Rev. F
Quality Manual
CONFIDENTIAL
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Effective: October 22, 2013
Page 14 of 17
LDR Spine has established procedures to ensure that the applicable regulatory authorities
are notified of adverse events that meet specified reporting criteria.
17.0
Subpart N – Servicing
17.1
820.200 Servicing
If applicable, LDR Spine shall establish and maintain procedures and instructions for
performing servicing and verifying that the servicing meets the specified requirements.
Service reports shall be documented and analyzed with appropriate statistical
methodology.
Service reports shall be analyzed to ensure that the applicable regulatory authorities are
notified of adverse events that meet specified reporting criteria.
18.0
Subpart O – Statistical Techniques
18.1
820.250 Statistical techniques
LDR Spine defers responsibility to suppliers for establishing statistical techniques, and
their procedures establish specific requirements to ensure that the necessary requirements
are implemented. LDR Spine has established procedures to ensure that suppliers
responsible for statistical techniques are compliant with regulations and standards,
including supplier approval, monitoring, auditing, and supplier corrective actions.
LDR Spine shall establish and maintain procedures as necessary for identifying valid
statistical techniques required for establishing, controlling, and verifying the
acceptability of process capability and product characteristics. Sampling plans, when
used, shall be written and based on a valid statistical rationale in accordance with
documented procedures.
19.0
Additional regulatory requirements
19.1
Non-US Regulatory Requirements
The scope of the LDR Spine business is limited to distribution in the US. As such,
compliance with non-US medical device regulations is the responsibility of the
suppliers/manufacturers, as applicable to distribution in non-US markets.
20.0
Exclusions/Non-applicability
20.1
The scope of the LDR Spine business is limited to what has been discussed in the
sections above. For details on exclusions and non-applicability, reference the sections
above.
CONFIDENTIAL
CN 0781
Effective: October 22, 2013
Page 15 of 17
QM Rev. F
Quality Manual
Management Processes
Process Inputs
1.
Quality manual & policy (QM)
2.
Quality planning & objectives (SOP 5-02)
3.
Complaints (SOP 8-01, SOP 8-07)
4.
MDRs (SOP 8-11)
5.
6.
Recalls / advisory notices (SOP 8-10)
Corrective / preventive actions (SOP 804)
7.
8.
9.
Internal quality audits (SOP 8-02)
External quality audits (SOP 8-03)
Supplier quality audits (SOP7-14)
9.
Customer order status (SOP 7-04)

Process


Management
review
(SOP 5-01)


Quality
planning
(SOP 5-02)

Process Outputs
1. Attendance list and meeting minutes
* (includes quality system objectives)
2. Action items requiring corrective /
preventive actions
3. Findings to corrective action system (SOP
8-04) optional
10. Non-conforming materials (SOP 8-08)
11. Training compliance (SOP 6-01)
1.
Quality manual & policy (QM)
2.
Management review (SOP 5-01)
4.
Significant facility changes
5.
Other items as applicable
1.
Customer complaints
2.
Other post-market surveillance
3.
Other inputs as applicable

Complaint
handling
(SOP 8-01)
&
Complaint
Trending
(SOP 8-07)
1. Quality plans
2. Quality objectives
1. Complete complaint investigation (SOP 801)
* Assessment, investigation, reply to
complainant

2. Corrective and/or preventive actions
3. Findings to corrective action system (SOP
8-04) optional
4. Medical Device Reports (SOP 8-11)
5. Findings to recall procedure (SOP 8-10) if
applicable
6. Findings to management review meeting
(SOP 5-01)
7. SOP 8-01 is an input to SOP 8-07
1. Corrective and/or preventive actions
1.
Complaint handling system (SOP 8-01)
2.
3.
Complaint trending (SOP 8-07)
Corrective & preventive actions (SOP 804)
4.
External quality audits (SOP 8-03)
5.
Other inputs as applicable

Recall /
advisory notice 
(SOP 8-10)
* Modified procedures
* Modified drawings
* Others as applicable
2. Findings to management review
meeting (SOP 5-01)
3. Findings to regulators (SOP 8-11)
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Effective: October 22, 2013
Page 16 of 17
QM Rev. F
Quality Manual
Management Processes (continued)
Process Inputs
1.
Management review meeting (SOP 5-01)
2.
Complaint handling system (SOP 8-01)
3.
4.
5.
Internal quality audits (SOP 8-02)
External quality audits (SOP 8-03)
Supplier quality audits (SOP7-14)
6.
Non-conforming materials (SOP 8-08)
7.
Other inputs as applicable
1.
Audit Plan
2.
Applicable ‘Regulations’ and ‘Standards’
3.
4.
Quality management system manual
Previous audit findings and corrective
actions

Process

Process Outputs
1. Corrective and/or preventive actions


Corrective &
Preventive
Actions
(SOP 8-04)
* Modified procedures

Internal Quality

Audits
(SOP 8-02)
* Modified drawings
* Training or retraining
* Others as applicable
2. Findings to management review meeting
(SOP 5-01)
1. Audit report and findings
* Corrective actions may include revisions
to procedures, drawings, training or
retraining, others as applicable
2. Findings to management review meeting
(SOP 5-01)
3. Findings to corrective action system (SOP
8-04) optional
4. Effectivity of previous corrective actions
1.
Complaint handling system (SOP 8-01)
2.
3.
Complaint trending (SOP 8-07)
Corrective & preventive actions (SOP 804)
4.
External quality audits (SOP 8-03)
5.
Other inputs as applicable
Medical Device
Reports
(SOP 8-11)


All devices
marketed in US
(excluding IDE)
1. Findings to management review meeting
(SOP 5-01)
2. Report to FDA
QM Rev. C
Quality Manual
Quality Management System Diagram
CONFIDENTIAL
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Effective: March 12, 2013
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