1. finance
2. accounting and auditing

QUALITY MANAGEMENT SYSTEM MANUAL REVISION – Q
ISSUED DATE: 09/03/2014
QMS MANUAL
TAPEMARK
1685 M ar t haler Lane
W est St. Paul, Minnesota 55118-3537 USA
Phone: 800-535-1998 Fax: 651-450-8403
www.tapemark.com
QMS MANUAL APPROVAL SIGN OFF
President & COO
Andy Rensink
09/03/2014
Date
Vice-President, Technical Operations
Steve Rau
08/25/2014
Date
Director, Quality Assurance
Steve Leno
09/03/2014
Date
TAPEMARK COMPANY
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QUALITY MANAGEMENT SYSTEM MANUAL REVISION – Q
ISSUED DATE: 09/03/2014
QMS MANUAL TABLE OF CONTENTS
0100 QMS PURPOSE AND COMPANY OVERVIEW
A) QMS Purpose
B) TM Overview
Page 4
0200 QMS SCOPE AND RESPONSIBILITY
A) QMS Responsibility Statement
B) PROCESS APPROACH (FLOW CHART)
0300 QMS MANUAL INFORMATION
A) QMS Manual Revision Control
B) QMS Manual Control Information
Page 6
Page 8
0400 QUALITY MANAGEMENT SYSTEM
0410 GENERAL REQUIREMENTS
0420 DOCUMENTATION REQUIREMENTS
0421 General
0422 Quality manual
0423 Control of documents
0424 Control of records
Page 9
Page 10
0500 MANAGEMENT RESPONSIBILITY
0510 MANAGEMENT COMMITMENT
0520 CUSTOMER FOCUS
0530 QUALITY POLICY
0531 Vision Statement
0540 PLANNING
0541 Quality objectives
0542 Quality management system planning
0550 RESPONSIBILITY, AUTHORITY AND COMMUNICATION
0551 Responsibility and authority
0552 Management representative
0553 Internal communication
0560 MANAGEMENT REVIEW
0561 General
0562 Review input
0563 Review output
Page 13
Page 13
Page 14
Page 15
Page 16
Page 16
0600 RESOURCE MANAGEMENT
0610 PROVISION OF RESOURCES
0620 HUMAN RESOURCES
0621 General
0622 Competence, awareness, and training
0630 INFRASTRUCTURE
0640 WORK ENVIRONMENT
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ISSUED DATE: 09/03/2014
QMS MANUAL TABLE OF CONTENTS
0700 PRODUCT REALIZATION
0710 PLANNING OF PRODUCT REALIZATION
0720 CUSTOMER-RELATED PROCESSES
0721 Determination of requirements related to the product
0722 Review of requirements related to the product
0723 Customer communication
0730 DESIGN AND DEVELOPMENT
0731 Design and development planning
0732 Design and development inputs
0733 Design and development outputs
0734 Design and development review
0735 Design and development verification
0736 Design and development validation
0737 Control of design and development changes
0740 PURCHASING
0741 Purchasing process
0742 Purchasing information
0743 Verification of purchased product
0750 PRODUCTION AND SERVICE PROVISION
0751 Control of production and service provision
0752 Validation of processes for production and service provision
0753 Identification and traceability
0754 Customer property
0755 Preservation of product
0760 CONTROL OF MONITORING AND MEASURING DEVICES
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0800 MEASUREMENT, ANALYSIS AND IMPROVEMENT
0810 GENERAL
0820 MONITORING AND MEASUREMENT
0821 Customer satisfaction
0822 Internal audit
0823 Monitoring and measurement of processes
0824 Monitoring and measurement of product
0830 CONTROL OF NONCONFORMING PRODUCT
0840 ANALYSIS OF DATA
0850 IMPROVEMENT
0851 Continual improvement
0852 Corrective action
0853 Preventive action
GLOSSARY
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QUALITY MANAGEMENT SYSTEM MANUAL REVISION – Q
0100
ISSUED DATE: 09/03/2014
QMS PURPOSE AND COMPANY OVERVIEW
A) QUALITY MANAGEMENT SYSTEM (QMS) PURPOSE
The Tapemark Company (TM) Quality Management System (QMS) complies with the following referenced standards:
A) ANSI/ISO/ASQ Q9001:2008 Quality Management System Requirements.
B) ISO 13485:2003 Medical devices - Quality Management Systems – Requirements for regulatory purposes.
C) ISO 14971 Medical devices – Application of Risk Management to Medical Devices
D) 21 Code of Federal Regulations: Part 110, Part 111, Part 210, Part 211, Part 820 and Part 11.
E) Council Directives 2003/94/EC (EU GMP) and 2001/83/EC – standards of manufacture for any product
intended for human use
F) EU GMP- EudraLex Volume 4 – Good Manufacturing Practices - Concerning Medicinal Products for
Human and Veterinary use
G) Council Directive 93/42/EEC concerning Medical Devices
Throughout the QMS Manual where the phrase “TM referenced requirements” is stated, the above list of requirements
is also applicable.
The purpose of the QMS manual is to:
A) Describe TM’s quality management business operating system.
B) Define responsibilities, authorities, and interrelationships of the key operation management segments at TM.
C) Provide direction for each of the functional activities at TM.
D) Provide controls that ensure the requirements for quality will be met at TM.
TM’s focus on meeting the needs of its customers through continual improvement and customer satisfaction is
the primary reason for implementing the quality management system. The QMS manual may be used for external
purposes such as third party audits and to provide customers with information concerning the QMS in place at TM.
B) TAPEMARK OVERVIEW
Tapemark is a privately-held contract development and manufacturing organization with multiple facilities in
West St. Paul, Minnesota. In the early 1950’s Tapemark pioneered a technique for printing on clear, self-wound
tape. That innovation coupled with industry advancements in paper and film materials propelled Tapemark into a
leadership position in printing and converting of pressure sensitive labels for product identification and labeling.
Today, Tapemark is a leader in innovative technologies that address unique customer needs. Expanding its
quality commitment, Tapemark is ISO 9001 and 13485 certified, is FDA registered as a Food, Drug, and Device
manufacturer, certified to EU Drug GMPs, and licensed as a DEA Controlled Substance manufacturer.
Tapemark’s integrated converting capabilities include, compounding, coating, printing, die cutting and packaging
of complex components and products for the medical, pharmaceutical, and consumer products markets.
Travanti Medical™, a business entity of Tapemark since 2011, designs, develops, manufactures and markets
medical device products, including the IontoPatch® line of iontophoretic devices.
Tapemark manufactures products in three locations:
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·
1685 Marthaler Lane, West Saint Paul, Minnesota, 55118 USA
·
232 Lothenbach Avenue, West Saint Paul, Minnesota, 55118 USA
·
223 East Marie Avenue, West Saint Paul, Minnesota, 55118 USA
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ISSUED DATE: 09/03/2014
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QUALITY MANAGEMENT SYSTEM MANUAL REVISION – Q
0200
ISSUED DATE: 09/03/2014
QMS SCOPE AND RESPONSIBILITY
A) QMS RESPONSIBILITY STATEMENT:
TM’s management and personnel are responsible to uphold the quality management system based on the TM
referenced requirements as documented in the QMS manual, supporting procedures, and documentation.
For reference, an outline of TM’s quality responsibility and authority is located in section 0550
“Responsibility, Authority, and Communication” of this QMS manual. TM stands behind its commitment for
quality.
B) TAPEMARK PROCESS APPROACH:
Tapemark maintains a process approach to its quality systems utilizing a PDCA (Plan Do Check Act) cycle. It
effectively integrates Continuous Improvement, Quality by Design and Risk Management into all aspects of its
system. See below flow chart:
Overview of Quality System
Continuous Improvement
Trending, SPC, CAPA
Input
Requirements:
Customer
and
Regulatory
Outputs:
Management
Responsibility
Resource
Management
D&D
-Product
Lifecycle
Measurement
and
Analysis
Customer
Satisfaction
and
Quality
Product
Quality by Design
Risk Management
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Tapemark QMS Reference Documents for the process approach defined above include:
INPUT REQUIREMENTS
–
SOP-18.01 – DESIGN CONTROL – TRAVANTI MEDICAL™
–
TMP-72.02 – CUSTOMER MANAGEMENT AND CONTROLS
–
TMP-73.03 – PROJECT DEVELOPMENT AND DESIGN CONTROLS
MANAGEMENT RESPONSIBILITY
–
TMP-41.01 – QUALITY MANAGEMENT SYSTEM
–
TMP-50.01 – TAPEMARK QUALITY POLICY
–
TMP-56.01 – MANAGEMENT REVIEW
RESOURCE MANAGEMENT
–
TMP-62.02 – EMPLOYEE TRAINING
–
TMP- 63.02 – FACILITY QUALIFICATION
–
TMP-63.03 – EQUIPMENT CONTROL
–
TMP-63.04 – CLEANING VALIDATION
–
TMP-63.05 – MATERIALS CONTROL
–
TMP-63.06 – SUPPLIER QUALIFICATION AND MONITORING
–
TMP-64.02 – ENVIRONMENTAL CONTROL AND MONITORING PROGRAM
PRODUCT REALIZATION
–
SOP-18.01 - DESIGN CONTROL – TRAVANTI MEDICAL™
–
SOP-18.02 – RISK MANAGEMENT – TRAVANTI MEDICAL™
–
SOP-30.20 - VERIFICATION
–
TMP-63.06 – SUPPLIER QUALIFICATION AND MONITORING
–
TMP-63.05 – MATERIALS CONTROL
–
TMP-72.02 – CUSTOMER MANAGEMENT AND CONTROLS
–
TMP-73.02 – VALIDATION AND QUALIFICATION OF MANUFACTURING PROCESSES AND TESTING METHODS
–
TMP-73.03 – PROJECT DEVELOPMENT AND DESIGN CONTROLS
–
TMP-75.02 – MANUFACTURING OF PRODUCT FOR COMMERCIAL USE
–
TMP-75.05 – MEASURING AND MONITORING DEVICE CONTROLS
–
TMP-81.01 – RISK MANAGEMENT
MEASUREMENT & ANALYSIS
–
SOP-30.49 – NON-CONFORMANCE MANAGEMENT
–
TMP-75.02 – MANUFACTURING OF PRODUCT FOR COMMERCIAL USE
–
TMP-75.05 – MEASURING AND MONITORING DEVICE CONTROLS
–
TMP-82.02 – AUDITING TAPEMARK OPERATIONS
OUTPUT REQUIREMENTS
–
SOP-36.19 – CUSTOMER SATISFACTION
–
TMP-56.01 – MANAGEMENT REVIEW
CONTINUOUS IMPROVEMENT
–
SOP-30.49 – NON-CONFORMANCE MANAGEMENT
–
SOP-30.72 – SYSTEM IMPACT ASSESSMENT
–
SOP-31.25 – STATISTICAL CONTROL AND ANALYSIS
–
SOP-36.07 – DESIGN REVIEW
RISK MANAGEMENT
–
TMP-81.01 – RISK MANAGEMENT
QUALITY BY DESIGN: A PHILOSOPHY THAT IS INTEGRATED THROUGHOUT TM’S QUALITY MANAGEMENT SYSTEM. THE
QUALITY SYSTEMS TRAINING PROVIDED TO ALL EMPLOYEES EMPHASIZES THIS APPROACH, AND IT IS FURTHER ENFORCED
DURING THE DAY-TO-DAY IMPLEMENTATION OF TM’S QUALITY MANAGEMENT SYSTEM AS DEFINED THROUGHOUT THIS
MANUAL.
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QMS MANUAL INFORMATION
A) QMS MANUAL REVISION CONTROL:
Revisions and amendments to the quality management system (QMS) manual are maintained in Tapemark’s electronic
documentation system. The QMS manual is reviewed at least annually in the management review meeting (see section
0562 Review Input). Any revisions/changes/additions made to the TM’s quality management system manual must be
made with the cooperation and approval of TM management affected.
B) QMS MANUAL CONTROL INFORMATION:
CONTROLLED QMS Manual Copies: TM’s ISO Management Representative assigns controlled copies.
Controlled copies are stamped “CONTROLLED.” Controlled copies are obsolete once revisions have been made to
the master (see section 0300 A) QMS Manual Revision Control for current effective dates). The ISO Management
Representative will distribute revisions to holders of controlled copies
UNCONTROLLED QMS Manual Copies: Quality manuals may be issued by the ISO Management Representative
or delegate for one time use and are considered “reference only” at the time of issue if stamped or marked
“CONTROLLED” in black or not stamped at all as stated in TMP-42.02 DOCUMENT CONTROL SYSTEM.
0300 REFERENCE DOCUMENTATION
TMP-42.02
DOCUMENT CONTROL SYSTEM
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0400
ISSUED DATE: 09/03/2014
QUALITY MANAGEMENT SYSTEM
0410 GENERAL REQUIREMENTS
TM has established and continues to maintain a company-wide QMS, which is continually reviewed for
effectiveness and audited as a means to ensure product conformity to customer specified requirements, as well as
compliance with the TM referenced requirements (see TMP 41.01 - QUALITY MANAGEMENT SYSTEM).
In establishing the QMS, TM has:
A) Identified the necessary processes and their application throughout the organization.
B) Determined the sequence and interaction of the processes.
C) Defined criteria and methods for evaluating the effectiveness of the operation and control of these processes.
D) Ensured availability of resources and information necessary to support the operation and monitoring of these
processes.
E) Established controls to monitor, measure, and analyze the processes within the QMS.
F) Implemented actions to achieve planned results and continual improvement processes.
TM personnel who manage, perform, and verify work-affecting quality are responsible for implementing,
maintaining, and ensuring continued effectiveness of the QMS. The ISO Management Representative is
responsible for coordinating, establishing, monitoring, and auditing the QMS. Implementation of the QMS is
assessed regularly by way of internal and external audits following corrective and preventive action procedures,
as well as QMS management reviews.
If at any time TM has chosen to outsource any process that affects product conformity or contracted
requirements, procedures have been established to ensure control over such processes. These controls are
identified within the QMS and are referred to within processes for management activities, provisions of
resources, product realization, measurement analysis and improvement activities where applicable.
0410 REFERENCE DOCUMENTATION
TMP-41.01
QUALITY MANAGEMENT SYSTEM
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0420 DOCUMENTATION REQUIREMENTS
0421 GENERAL
The quality management system documentation is divided into four levels. The levels are as follows:
Level 1 Document: Level 1 document is limited to the Quality Manual. This document establishes
TAPEMARK’s commitment to control systems, it assigns responsibility for the systems, and links each
system to the other levels of documents that fulfill these commitments routinely.
Level 2 Documents: Level 2 documents provide greater detail on the quality system commitments of the
Quality Manual, and documents that provide product/project specific requirements from customers.
Level 3 Documents: Level 3 documents direct the routine work of development, manufacturing, testing,
etc. They define tasks needed to fulfill the requirements of Level 2 and Level 1 documents.
Level 4 Documents: Level 4 documents are the records created when Level 3 documents are used.
The QMS is an organizational structure consisting of a manual, procedures, and form documentation (or
quality records when completed), which has been established to ensure the effective planning, operation,
and control of its processes. Documentation can be in any form, data, or type of medium. When
necessary, records are maintained to meet the TM referenced requirements.
0422 QUALITY MANUAL
TM has established and maintains a QMS manual that:
A) Includes a quality scope (see section 0200 A) TM Quality Scope Statement) as well as noting any
exclusions to the TM referenced requirements (see section 751 Control of Production and Service
Provision – Post Delivery Servicing).
B) References documentation used to meet the TM referenced requirements.
C) Describes the interaction between the QMS processes.
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0423 CONTROL OF DOCUMENTS
Documents required by the QMS are controlled. Records are a special type of document and controlled
according to established requirements (see section 0424 Control of Records).
Documented procedures have been established that define the controls needed for:
A) QMS Documentation: see TMP-42.02- DOCUMENT CONTROL SYSTEM.
B) Customer-supplied Prints, Databases, or Specifications: see SOP-30.03 - CONTROL OF
EXTERNAL DOCUMENTS.
C) Vendor-supplied Prints, Databases, or Specifications: see SOP-30.03 - CONTROL OF
EXTERNAL DOCUMENTS.
D) Internal Specifications and Forms: see SOP-30.02 – DOCUMENTATION CONTROL
PRACTICES.
E) Internal Design Records: see SOP-18.01 – Design Control – Travanti Medical™ and TMP-73.03 PROJECT DEVELOPMENT AND DESIGN CONTROLS.
These control procedures are documented to ensure:
A) Approval of documents for adequacy prior to use.
B) Reviews and updates are made as necessary and outline the re-approval of documents.
C) Changes and current revision status of documents is identified.
D) Relevant versions of applicable documents and data are available at the locations where operations are
essential for the effective functioning of the TM QMS. Document placement is regulated by documented
procedures.
E) Documents remain legible and are readily identifiable.
F) External documents and specifications are maintained to control the distribution of external specifications
(see).
G) The prevention of unintended use of obsolete documents, and to apply suitable identification to them if
they are retained for any purpose.
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0424 CONTROL OF RECORDS
Records have been established and are maintained to provide evidence of conformity to requirements and
effective operation of the QMS. Records will remain legible, readily identifiable, and retrievable. SOP30.02 - DOCUMENTATION CONTROL PRACTICES defines the controls needed for identification,
storage, protection, retrieval, retention time, and disposition of records.
0420 REFERENCE DOCUMENTATION
TMP-42.02
TMP-73.03
SOP-30.02
SOP-30.03
SOP-18.01
DOCUMENT CONTROL SYSTEM
PROJECT DEVELOPMENT AND DESIGN CONTROLS
DOCUMENTATION CONTROL PRACTICES
CONTROL OF EXTERNAL DOCUMENTS
DESIGN CONTROL – TRAVANTI MEDICAL™
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0500
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MANAGEMENT RESPONSIBILITY
0510 MANAGEMENT COMMITMENT
TM management has demonstrated its commitment to the development and implementation of the QMS, and
continual improvement of its effectiveness by (see SOP-30.18 - MANAGEMENT COMMITMENT):
A) Communicating to the organization of the importance of complying with customer, regulatory, and statutory
requirements through written procedures as referenced in the QMS manual.
B) Establishing and communicating the quality policy throughout the organization (see section 0530 Quality
Policy).
C) Establishing, communicating, and enforcing the quality objectives (see section 0541 Quality Objectives).
D) Conducting QMS management review meetings (see section 560 Management Review).
E) Providing for necessary resources (see section 0610 Provision of Resources).
0510 REFERENCE DOCUMENTATION
SOP-30.18
MANAGEMENT COMMITMENT
0520 CUSTOMER FOCUS
TM management ensures that customer requirements are determined, converted into requirements, and fulfilled
with the aim of achieving customer satisfaction (see sections 0720 Customer-related Processes, 0821
Customer Satisfaction and TMP-72.02 - CUSTOMER MANAGEMENT AND CONTROLS).
0520 REFERENCE DOCUMENTATION
TMP-72.02
CUSTOMER MANAGEMENT AND CONTROLS
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0530 QUALITY POLICY
TM management is responsible to establish the quality policy and quality objectives that are appropriate to the
purposes of the organization. Through the quality policy, a commitment to comply with the quality requirements
and continually improve the effectiveness of the QMS has been established. The quality policy is the framework
from which the quality objectives have been established and will be continually reviewed.
TAPEMARK COMPANY QUALITY POLICY
"COMMITMENT TO EXCELLENCE THROUGH INNOVATION, DESIGN AND
CONTINUOUS IMPROVEMENT"
The Quality Policy is communicated throughout the Tapemark facilities. Training is completed to ensure TM
personnel understand the quality policy and its objectives. Compliance to the quality policy is monitored through
internal and external audits. The quality policy was developed, defined, and is supported by TM Management.
0530 REFERENCE DOCUMENTATION
TMP-50.01 TAPEMARK QUALITY POLICY
0531 VISION STATEMENT
Tapemark’s Vision is a separate but interrelated Statement that is created by Senior Management Staff in an
effort to provide both direction and commitment to fulfilling the intent of the Quality Policy.
‘Tapemark is a premier, quality-focused, values-driven contract manufacturer, supporting customers whose
products are produced in a cGMP and FDA-compliant business environment. Our vision will be achieved
through business relationships with high-growth, market-leading customers that are active in regulated markets;
through continuous investment in, and development of, our existing and emerging manufacturing capabilities; and
through the development, acquisition or accessing of technologies that promote our long-term growth.
Tapemark commits to comply with the requirements of the standards and continually improve the effectiveness
of the QMS.’
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0540 PLANNING
0541 QUALITY OBJECTIVES
TM Management will ensure that the quality objectives, including those needed to meet requirements for
product (see section 0710 Planning of Product Realization) are established at relevant functions and
levels within the organization. The quality objectives are measurable and consistent with the quality
policy. These quality objectives have been established during the quality planning process and are
continually reviewed during the QMS management review process (see TMP-56.01 - MANAGEMENT
REVIEW and SOP-30.16 - QUALITY PLANNING).
0542 QUALITY MANAGEMENT SYSTEM PLANNING
Led by the Head of Quality Assurance and assisted by members of management, TM ensures that:
A) The understanding, planning, and implementation of the QMS is carried out in order to meet the
requirements in section 0541 Quality Objectives as well as the quality requirements (see section
0560 Management Review).
B) The integrity of the QMS is maintained when changes to the QMS are planned and implemented (see
section 0560 Management Review).
0540 REFERENCE DOCUMENTATION
TMP-56.01
SOP-30.16
MANAGEMENT REVIEW
QUALITY PLANNING
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0550 RESPONSIBILITY, AUTHORITY AND COMMUNICATION
0551 RESPONSIBILITY AND AUTHORITY
The responsibility, authority, and the interrelation of personnel, who manage, perform and verify workaffecting quality are listed in the organizational chart and is communicated throughout the organization. Each
individual understands his/her function and has the freedom to bring forth any preventive/corrective actions
necessary to implement and maintain the quality program at TM (see SOP-30.18- MANAGEMENT
COMMITMENT).
0552 MANAGEMENT REPRESENTATIVE (M.R.)
The President/COO, with the support and partnership of TM’s management, is ultimately responsible for
establishing, implementing, and maintaining the quality system for continual improvement. This
management team will also work to ensure the promotion of awareness of customer requirements
throughout the organization. The ISO M.R. (Head of Quality Assurance) is appointed by and reports to
the President/COO. If the appointed ISO M.R. is unavailable, a designated Senior Level Quality
Employee will serve as the Deputy ISO M.R. in the absence of the Head of QA.
0553 INTERNAL COMMUNICATION
TM uses various methods of communicating decision-making and effectiveness of the QMS. This is
achieved through internal memos, newsletters, and company/employee meetings.
0550 REFERENCE DOCUMENTATION
SOP-30.18
MANAGEMENT COMMITMENT
0560 MANAGEMENT REVIEW
0561 GENERAL
Management reviews the QMS periodically to ensure its continuing suitability, adequacy, and
effectiveness. The review meetings will include assessing opportunities for improvement and/or changes to
the QMS, including the quality policy and quality objectives. The intervals between the meetings are planned
and periodically reviewed to ensure the continuing suitability and effectiveness of the QMS. Frequency of
reviews and levels of input will depend on individual circumstances.
The ISO M.R. is responsible for scheduling and conducting these reviews as outlined in the TMP-56.01 MANAGEMENT REVIEW. Detailed records of these meetings are prepared and maintained by the
ISO M.R. or delegate for review and follow up. Records of meeting minutes and attendance are maintained.
0562 REVIEW INPUT
QMS management review meeting agenda items are:
A) Internal feedback: audit results.
B) External feedback: customer complaints and satisfaction information.
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C) Process and/or product conformity results (including delivery performance) and trends (statistical
techniques).
D) Status of corrective/preventive actions: Non-compliances of QMS or consistent non-conformances.
E) Previous QMS meetings: Follow-up action items and meeting notes.
F) Review of any changes at TM that would affect the QMS (i.e., increased growth).
G) Recommendations for improvements.
H) Causes of product non-conformances: internal and external.
I) Adequacy of the organizational structure, including its staffing and resources.
J) Compliance with the QMS documentation, including the QMS manual, quality policy, and quality
objectives.
K) New or revised Regulatory Requirements
Items may be added when judged appropriate or as required. TM management’s focus is to identify
trends of quality successes and/or opportunities for improvement. Should issues arise that have become
chronic problems, these areas receive special attention and more frequent reviews. Issues that arise as a
result of a management review meeting receive prompt attention.
0563 REVIEW OUTPUT
QMS management review meeting agenda will include decision and actions related to:
A) Improvement of the effectiveness of the QMS and its processes.
B) Improvement of the product related to customer requirements.
C) Resources needed.
0560 REFERENCE DOCUMENTATION
TMP-56.01
MANAGEMENT REVIEW
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0600
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RESOURCE MANAGEMENT
0610 PROVISION OF RESOURCES
TM management has the responsibility and authority to ensure there are adequate resources to support the QMS.
Resources necessary to provide adequate equipment and process needs are reviewed by TM management through
management review meetings. Each member of management provides adequate resources to:
A) Implement and maintain the QMS and continually improve on its effectiveness.
B) Enhance customer satisfaction by meeting regulatory and customer requirements.
C) Provide adequate training programs for personnel to carry out the QMS quality policy and quality objectives.
In order to achieve continual improvement and monitor effectiveness, internal audits are performed. Trained quality
auditors are aware of and utilize the QMS manual and procedures when performing internal audits. Records are
evaluated and maintained by the ISO M.R. as the lead quality auditor. Follow up includes corrective actions as
necessary (see section 0822 Internal Audit).
0620 HUMAN RESOURCES
0621 GENERAL
The competence of personnel performing work affecting product quality is determined based on
appropriate education, training, skills, and experience (see TMP-62.02 - EMPLOYEE TRAINING).
0622 COMPETENCE, AWARENESS, AND TRAINING
Tapemark:
A) Determines the necessary competence for personnel performing work affecting product quality
through its established training programs and records.
B) Provides internal and external training programs, through which TM personnel are trained on the
relevance and importance of their activities and how they contribute to the achievement of the quality
objectives.
C) Evaluates the training programs for effectiveness by performing internal audits, documenting the results,
and then reviewing the results with management for corrective and preventive action as needed.
D) Ensures that its personnel are aware of the relevance and importance of their activities and how they
contribute to the achievement of the quality objectives.
E) Maintains the training records on the education, skills, and experiences each employee has achieved that
identify the competency of his/her current position.
F) Ensures that employees performing specific assigned tasks are qualified on the basis of appropriate
education training and/or experience as required.
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G) Ensures that for current employee’s undefined training needs are addressed as the need arises or at the
request of employees or employer for further training needs/advancements.
Procedures are documented and maintained for training needs in each department and/or area. Department
managers/supervisors are responsible for the annual review and evaluation of employees (see SOP-38.01 EMPLOYEE DEVELOPMENT and SOP-38.02 - QUALITY SYSTEMS TRAINING).
0620 REFERENCE DOCUMENTATION
TMP-62.02
SOP-38.01
SOP-38.02
EMPLOYEE TRAINING
EMPLOYEE DEVELOPMENT
QUALITY SYSTEMS TRAINING
0630 INFRASTRUCTURE
TM has determined, provided, and maintains an infrastructure needed to achieve conformity to product requirements.
Infrastructure includes, as applicable:
A) Buildings, workspace, and associated utilities.
B) Process equipment (both hardware and software).
C) Supporting services (such as transport or communications).
TM Maintenance Program:
By operating a preventive and corrective maintenance program and through its safety program, controls are established
to secure suitable work equipment and environment. The Maintenance Supervisor or delegate is in charge of
corrective and preventive equipment maintenance. This manager is responsible to ensure that continued process
capability can be met or resources are allocated to meet these capabilities. Equipment receives prior approval by
appropriate personnel before release/installation to production (SOP-34.05 - PREVENTIVE MAINTENANCE
PROGRAM and SOP-34.06 - WORK ORDER SYSTEM).
0630 REFERENCE DOCUMENTATION
SOP-34.05
SOP-34.06
PREVENTIVE MAINTENANCE PROGRAM
WORK ORDER SYSTEM
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0640 WORK ENVIRONMENT
TM has determined and manages the work environment to assure its suitability for achieving conformity to
product requirements, including product regulatory requirements such as production clean room environments
(see TMP-64.02 - ENVIRONMENTAL CONTROL AND MONITORING PROGRAM AND SOP-30.51 –
PERSONNEL RESPONSIBILITIES IN CONTROLLED ENVIRONMENTS). Product requirements are
determined at the time of the contract review with the customer.
The Safety and Security Manager, who schedules job safety training, reviews safety issues and OSHA
requirements that affect each new employee, current employees, and product safety requirements.
A) TM will establish documented requirements for health, cleanliness, and clothing of personnel if contact
between such personnel and the product or work environment could adversely affect the quality of the product.
B) Where work environment conditions can have an adverse effect on product quality, TM will establish
documented conditions and documented procedures to monitor and control work environment conditions.
C) TM will ensure that all personnel who are required to work temporarily under special environmental
conditions within the work environment are appropriately trained or supervised by trained personnel.
D) Special precautions are established to control contaminated or potentially contaminated product in order to
prevent contamination of other product, the work environment or personnel.
0640 REFERENCE DOCUMENTATION
TMP-64.02
SOP-30.51
ENVIRONMENTAL CONTROL AND MONITORING PROGRAM
PERSONNEL RESPONSIBILITIES IN CONTROLLED ENVIRONMENTS
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0700
ISSUED DATE: 09/03/2014
PRODUCT REALIZATION
0710 PLANNING OF PRODUCT REALIZATION
TM will plan and develop the processes needed for product realization. If a particular development project or
customer request cannot be fulfilled by existing procedures, quality plans are created to ensure that the specific
requirements are met. Planning of product realization will be consistent with the other processes of the QMS (see
TMP-73.03 - PROJECT DEVELOPMENT AND DESIGN CONTROLS). Documented requirements for risk
management throughout product realization are specified in TMP-81.01 – RISK MANAGEMENT and SOP-18.02 –
RISK MANAGEMENT – Travanti Medical™.
In planning product realization, TM has determined the following, as appropriate:
A) Identification and acquisition of necessary controls, equipment, fixtures, resources, and skills needed to achieve
quality objectives and requirements for the product.
B) Provision for procedures, work instructions, inspections, tests, resources, etc. to ensure product is manufactured to
customer expectations and requirements.
C) Required verification, validation, monitoring, inspection, and test activities specific to the product and the criteria
for the product acceptance.
D) Identification and preparation of quality records to provide evidence that the realization processes and resulting
product meet requirements, as well as for the clarification of acceptable standards and requirements of finished
product (see section 0424 Control of Records).
0710 REFERENCE DOCUMENTATION
TMP-73.03
TMP-81.01
SOP-18.01
SOP-18.02
PROJECT DEVELOPMENT AND DESIGN CONTROLS
RISK MANAGEMENT
DESIGN CONTROL – TRAVANTI MEDICAL™
RISK MANAGEMENT – TRAVANTI MEDICAL™
0720 CUSTOMER-RELATED PROCESSES
0721 DETERMINATION OF REQUIREMENTS RELATED TO THE PRODUCT
Contract review activities include the following:
A) TM personnel will work one on one with the customer to clearly achieve an understanding and
document the customer’s requirements as to the product, delivery, post delivery, and other critical
factors needed to meet and exceed expectations (see section 0730 Design and Development).
B) TM will apply all related knowledge not stated by the customer’s requirements to meet or exceed
product expectations.
C) TM is responsible for identifying, documenting, and reviewing design input from the customer,
including statutory and regulatory requirements as contractually agreed upon.
D) TM will include any additional requirements determined for product conformance.
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0722 REVIEW OF REQUIREMENTS RELATED TO THE PRODUCT
TM reviews the requirements related to the product. This review is conducted prior to the commitment of a
quotation or acceptance of an order (see SOP-36.16 - CONTRACT REVIEW). Prior to entering an order
into the TM computer system, verbal or written customer orders are reviewed carefully to ensure that:
A) The order is clearly understood, adequately documented, and product requirements are defined.
B) Any differences between the contract and the quotation with the customer are resolved prior to acceptance.
C) TM has the ability to meet the defined requirements.
Records of contract reviews and actions arising from the review are maintained. When the customer provides
no documented statement of requirement, TM confirms the customer requirements prior to acceptance.
Where product requirements are changed, TM ensures that relevant documents are amended and the relevant
personnel are made aware of the changed requirements.
0723 CUSTOMER COMMUNICATION
TM has determined and implemented effective arrangements for communicating with customers in
relation to:
A) Product information.
B) Inquiries, contracts, or order handling including amendments.
C) Customer feedback, including customer complaints. (see SOP-18.03 – COMPLAINT
PROCESSING AND RESOLUTION – TRAVANTI MEDICAL™ and SOP-30.46 –
CUSTOMER COMPLAINTS)
D) Advisory notices (see 0851)
0720 REFERENCE DOCUMENTATION
SOP-18.03
SOP-30.46
SOP-36.16
COMPLAINT PROCESSING AND RESOLUTION – TRAVANTI MEDICAL™
CUSTOMER COMPLAINTS
CONTRACT REVIEW
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0730 DESIGN AND DEVELOPMENT
0731 DESIGN AND DEVELOPMENT PLANNING
TM plans and controls the design and development of the product. Procedures to control and verify
designs at TM are established and maintained to ensure that customer requirements are met (see the
SOP-18.01 – DESIGN CONTROL – TRAVANTI MEDICAL™ and TMP-73.03 - PROJECT
DEVELOPMENT AND DESIGN CONTROLS).
During the design and development planning, TM will determine:
A) The design and development stage.
B) The review, verification, validation, and design transfer activities that are appropriate to each design
and development stage.
C) The responsibilities and authorities for design and development.
TM will manage the interfaces between different groups involved in design and development to ensure
effective communication and clear assignment of responsibility. Planning output will be updated, as
appropriate, as the design and development progresses.
0732 DESIGN AND DEVELOPMENT INPUTS
Inputs relating to product requirements are determined and records maintained. These inputs include:
A) Functional performance and safety requirements according to intended use.
B) Applicable statutory and regulatory requirements.
C) Where applicable, information derived from previous similar designs.
D) Other requirements essential for design and development.
E) Outputs of risk management (see 0710)
These inputs are reviewed for adequacy and approved. Any incomplete, ambiguous, or conflicting
requirements are resolved. Consideration is given to contract review activities throughout the stages of
the design process (see section 0720 Customer-related Processes).
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0733 DESIGN AND DEVELOPMENT OUTPUTS
Design output is documented in such a manner that it can be verified and validated against design
input requirements prior to release.
Design and development outputs will:
A) Meet the design-input requirements.
B) Provide appropriate information for purchasing, production and for service provision.
C) Contain or reference product acceptance criteria.
D) Specify those characteristics that provide for the safe and proper functioning of the product when
identified by the customer.
Records of the design and development outputs are maintained.
0734 DESIGN AND DEVELOPMENT REVIEW
Design input requirements are reviewed for adequacy prior to developing design output. At suitable
stages, systematic reviews of design and development are performed in accordance with planned
arrangements. These reviews are planned and conducted to evaluate the ability of the results of design
and development to meet requirements, as well as to identify any problems and propose necessary
actions. Participants of design reviews can include representatives of functions concerned with the design
being reviewed, as well as other technical personnel, as required. Records of Design Reviews are
maintained.
0735 DESIGN AND DEVELOPMENT VERIFICATION
Verification is performed in accordance with planned arrangements (see section 0731 Design and
Development Planning), ensuring that design output requirements have been reviewed to the designinput requirements and have been met. Design verification includes activities such as: performing
calculations, comparing new designs with similar designs, conducting tests and experiments, and/or
reviewing the design documents before release as applicable. The verification results and any
necessary follow up actions needed are recorded and maintained.
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0736 DESIGN AND DEVELOPMENT VALIDATION
Design and development validation is performed in accordance with planned arrangements (see section
0731 Design and Development Planning) to ensure that the resulting product is capable of meeting the
requirements for the specified application or intended use where known. Wherever practicable, validation
is completed prior to the delivery or implementation of the product. Quality Assurance maintains records
of the validation approval. (see TMP-73.02 – VALIDATION AND QUALIFICATION OF
MANUFACTURING PROCESSES AND TESTING METHODS)
0737 CONTROL OF DESIGN AND DEVELOPMENT CHANGES
When applicable, design and development changes are identified and records are maintained. Changes
are reviewed, verified, and validated as appropriate, and approved prior to being implemented. The
review of design and development changes will include evaluation of the effect of changes on constituent
parts and/or product already produced when applicable. Quality Assurance maintains records of the
results of changes and any necessary actions.
0730 REFERENCE DOCUMENTATION
TMP-73.02
TMP-73.03
SOP-18.01
VALIDATION AND QUALIFICATION OF MANUFACTURING PROCESSES AND
TESTING METHODS
PROJECT DEVELOPMENT AND DESIGN CONTROLS
DESIGN CONTROL – TRAVANTI MEDICAL™
0740 PURCHASING
0741 PURCHASING PROCESS
TM ensures that purchases product conforms to specified purchasing requirements. The type and extent of
control applied to the supplier and the purchased product will be dependant upon the effective of the purchased
product on subsequent product realization of the final product (see TMP-63.05 - MATERIALS
CONTROL).
TM will evaluate and select suppliers on their ability to supply product (including outsourced processes) in
accordance with the organization’s requirements (see SOP-33.06 - SUPPLIER AND MATERIALS
SELECTION & APPROVAL). Criteria for selection, evaluation, and re-evaluation have been established.
Records of the results of the evaluations and any necessary actions arising from the evaluation are maintained.
0742 PURCHASING INFORMATION
Purchasing information will describe the product to be purchased, including where appropriate:
A) Requirements for approval of product, procedures, processes, and equipment.
B) Requirements for qualification of personnel.
C) Quality management system requirements.
TM will ensure the adequacy of specified purchase requirements prior to their communication to the supplier.
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TM will maintain relevant purchasing records to ensure required traceability.
0743 VERIFICATION OF PURCHASED PRODUCT- Inspection and Testing
TM has established and implemented inspection or other activities necessary for ensuring that purchased
product meets specified purchase requirements (see SOP-31.17 - INCOMING INSPECTION
PROCEDURE).
When TM or its customer intends to perform verification at the supplier’s premises, TM will state the intended
verification arrangements and method of product release in the purchasing information.
0740 REFERENCE DOCUMENTATION
TMP-63.05
SOP-31.17
SOP-33.06
MATERIALS CONTROL
INCOMING INSPECTION PROCEDURE
SUPPLIER AND MATERIALS SELECTION AND APPROVAL
0750 PRODUCTION AND SERVICE PROVISION
0751 CONTROL OF PRODUCTION AND SERVICE PROVISION–GENERAL
REQUIREMENTS (see TMP-75.02 MANUFACTURING OF PRODUCT FOR COMMERCIAL
USE)
07511 CONTROL OF PRODUCTION AND SERVICE PROVISION
TM plans and carries out production under controlled conditions, which will include, as
applicable:
A) Availability of product characteristic description information.
B) Availability of procedural work instructions, where the absence would adversely affect quality.
C) Use of suitable equipment.
D) Availability and use of monitoring and measuring devices.
E) Implementation of monitoring and measuring.
F) Implementation of suitable release, delivery, and post-delivery activities.
G) Implementation of defined operations for labeling and packaging.
TM does not perform post delivery servicing of product, unless service is a direct result of product not
meeting contractual requirements agreed upon at the time of contract acceptance (see section 0721
Determination of Requirements Related to the Product).
TM will establish and maintain a record (see section 0424 Control of Records) for each batch that
provides traceability to the extent specified in (section 0753 Identification and Traceability) and
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identifies the amount manufactured and the amount approved for distribution. The batch record will be
verified and approved.
07512 CONTROL
REQUIREMENTS
OF
PRODUCTION
AND
SERVICE
PROVISION–SPECIFIC
075121 CLEANLINESS OF PRODUCT AND CONTAMINATION CONTROL
TM will establish documented requirements for cleanliness of product if:
A) Product is cleaned by TM prior to sterilization and/or its use, or
B) Product is supplied non-sterile to be subjected to a cleaning process prior to sterilization and/or its
use, or
C) Product is supplied to be used non-sterile and its cleanliness is of significance in use, or
D) Process agents are to be removed from product during manufacture.
If product is cleaned in accordance with A) or B) above, the requirements contained in 0640 A) and
0640 B) do not apply prior to the cleaning process.
075122 INSTALLATION ACTIVITIES
TM currently does not provide any installation activities / services for its customers.
075123 SERVICING ACTIVITIES
TM currently does not provide any servicing activities for its customers.
07513 PARTICULAR REQUIREMENTS FOR STERILE MEDICAL DEVICES
TM currently does not provide contract services for sterile medical devices for its customers.
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0752 VALIDATION OR PROCESSES FOR PRODUCTION AND SERVICE PROVISION
07521 GENERAL REQUIREMENTS
TM will establish processes for production and service requirements when continuous monitoring or
measurement cannot verify the resulting output. This includes any processes where deficiencies become
apparent only after the product has been delivered or in use. Validation is demonstrated by the ability of
these processes to achieve planned results (see TMP-73.02 – VALIDATION AND QUALIFICATION
OF MANUFACTURING PROCESSES AND TESTING METHODS)
TM will establish arrangement for these processes including, as applicable:
A) Defined criteria for review and approval of the processes.
B) Approval of equipment and qualification of personnel.
C) Use of specific methods and procedures.
D) Requirements for records (see section 0424 Control of Records).
E) When necessary, activities are implemented to revalidate a process.
TM has established documented procedures for the validation of computer software (and changes to such
software and / or its application) for production and service provision that affect the ability of the product to
conform to specified requirements. Such software applications will be validated prior to initial use.
Records of validation will be maintained.
07522 PARTICULAR REQUIREMENTS FOR STERILE MEDICAL DEVICES
TM currently does not provide contract services for sterile medical devices for its customers.
0753 IDENTIFICATION AND TRACEABILITY
07531 IDENTIFICATION
TM has established documented procedures for suitably identifying product throughout product
realization.
TM has established documented procedures for identifying and distinguishing returned product from
conforming product.
07532 TRACEABILITY
075321 GENERAL
TM has established documented procedures for traceability which define the extent of product traceability
and the records required.
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Where traceability is required, TM controls and records the unique identification of products.
075322 PARTICULAR REQUIREMENTS FOR ACTIVE IMPLANTABLE MEDICAL
DEVICES AND IMPLANTABLE MEDICAL DEVICES
TM currently does not provide contract services for active implantable medical devices and implantable
medical devices for its customers.
07533 STATUS IDENTIFICATION
TM identifies product status with respect to monitoring and measuring requirements.
TM will identify the product by suitable means throughout the product realization (see SOP-33.02 MATERIAL IDENTIFICATION & TRACEABILITY).
TM will identify the product status with respect to monitoring and measurement requirements (see SOP-30.19
– RAW MATERIAL AND PRODUCT STATUS IDENTIFICATION).
TM will control and record the unique identification of the product (see section 0424 Control of Records).
0754 CUSTOMER PROPERTY
TM maintains and follows documented procedures for controlling, verification, and storage of customer
supplied product used in the production of finished product. Upon receipt of customer-supplied product
(CSP), TM accepts responsibility to identify, verify, protect, and safeguard the product while it is in TM’s
possession (see SOP-36.23 - CUSTOMER PROPERTY).
Damaged, lost, or otherwise unsuitable customer-supplied product is identified, recorded, and reported to the
customer. Receiving procedures are followed (see section 0743 Verification of Purchased Product).
Records will be maintained.
0755 PRESERVATION OF PRODUCT
Procedures are established, documented, and maintained for identification, handling, storage, packaging,
preservation, and delivery of product. Incoming raw material, tooling, and TM manufactured product is
protected up to and during delivery as documented in procedures. These procedures have been developed to
ensure compliance with the customer’s requirements or accepted commercial practices (see SOP-33.09 MATERIAL HANDLING, SOP-33.03 - MATERIAL QUALITY CONTROL AND FLOW, SOP33.05 - SHIPPING)
Preservation will also apply to the constituent parts of a product as applicable.
0750 REFERENCE DOCUMENTATION
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TMP-73.02
TMP-75.02
SOP-30.19
SOP-33.02
SOP-33.03
SOP-33.05
SOP-33.09
SOP-36.23
ISSUED DATE: 09/03/2014
VALIDATION AND QUALIFICATION OF MANUFACTURING PROCESSES AND
TESTING METHODS
MANUFACTURING OF PRODUCT FOR COMMERCIAL USE
RAW MATERIAL AND PRODUCT STATUS IDENTIFICATION
MATERIAL IDENTIFICATION & TRACEABILITY
MATERIAL QUALITY CONTROL AND FLOW
SHIPPING
MATERIAL HANDLING
CUSTOMER PROPERTY
0760 CONTROL OF MONITORING AND MEASURING DEVICES
TM had determined the monitoring and measurement to be undertaken and the monitoring and measuring devices
needed to provide evidence of product conformity to be determined.
TM has established processes to ensure that monitoring and measurement can be carried out and are carried out in a
manner that is consistent with the monitoring and measurement requirements (see TMP-75.05 - MEASURING
AND MONITORING DEVICE CONTROLS).
When necessary to ensure valid results, measuring equipment will be:
A) 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 will be recorded.
B) Adjusted or re-adjusted as necessary.
C) Identified to enable the calibration status to be determined.
D) Safeguarded from adjustments that would invalidate the measurement results.
E) Protected from damage and deterioration during handling, maintenance, and storage.
In addition, TM assesses and records the validity of the previous measuring results when the equipment is found not to
conform to requirements. TM takes appropriate action on the equipment and any product affected. Records of the
results of calibration and verification are maintained
When used in the monitoring and measurement of specified requirements, the ability of computer software to satisfy
the intended application is confirmed (see TMP-63.07 – SOFTWARE VALIDATION AND CHANGE
CONTROL). This is undertaken prior to the initial use and reconfirmed as necessary.
0760 REFERENCE DOCUMENTATION
TMP-63.07
TMP-75.05
SOFTWARE VALIDATION AND CHANGE CONTROL
MEASURING AND MONITORING DEVICE CONTROLS
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0800
ISSUED DATE: 09/03/2014
MEASUREMENT, ANALYSIS AND IMPROVEMENT
0810 GENERAL
TM plans and implements monitoring, measuring, analysis, and improvement processes needed to:
A) Demonstrate conformity of the product.
B) Ensure conformity of the QMS.
C) Continually improve the effectiveness of the QMS.
This will include the applicable methods, including statistical techniques and the extent of their use (see SOP31.25 - STATISTICAL CONTROL AND ANALYSIS).
0810 REFERENCE DOCUMENTATION
SOP-31.25
STATISTICAL CONTROL AND ANALYSIS
0820 MONITORING AND MEASUREMENT
0821 CUSTOMER SATISFACTION
As one of the measurement of the QMS, TM monitors information and maintains records on customer
perception, including satisfaction and/or dissatisfaction as one of the measurements of the QMS’s
performance objectives. The methods for obtaining and using this information are determined during
management review meetings and are documented in the QMS (see SOP-36.19 - CUSTOMER
SATISFACTION).
0822 INTERNAL AUDIT
TM conducts internal audits at planned internals to determine whether:
A) The QMS conforms to the planned arrangements (see section 0710 Planning of Product
Realization) and to the QMS requirements established by TM.
B) The QMS is effectively implemented and maintained.
An audit program is planned, taking into consideration the status and importance of the processes and
areas to be audited, as well as the results of previous audits. The audit criteria, scope, frequency, and
methods are defined. Selections of auditors and conduct of auditors will ensure objectivity and
impartiality of the audit process. Auditors will not audit their own work.
The responsibilities and requirements for planning and conducting audits, and for the reporting results and
maintaining records is defined in SOP-30.92 - INTERNAL AUDITING.
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The management responsible for the area being audited will ensure that actions are taken without undue
delay to eliminate detected nonconformities and their causes. Follow-up activities include the verification
of the actions taken and the reporting of verification results (see section 0852 Corrective Action).
0823 MONITORING AND MEASUREMENT OF QMS PROCESSES
As the need is identified, suitable methods of measuring and monitoring are developed, reviewed, and
maintained to meet internal or external requirements in statistical technique procedures. Statistical techniques
may be used for verification of customer requirements. Special training in statistical techniques may be given
to employees; specific statistical methods are available for application. Statistical technique implementation and
control is defined in documented procedures (see section 0810 General). The customer can request additional
statistical techniques when contractually agreed upon. These methods demonstrate the ability of the processes
to achieve the planned results. When planned results are not met, corrective action is taken as appropriate to
ensure conformity of the product is achieved to meet product requirements.
0824 MONITORING AND MEASUREMENT OF PRODUCT
08241 GENERAL REQUIREMENTS
TM has developed documented procedures for monitoring and measuring the characteristics of product
to verify that product requirements have been met. This will be carried out at appropriate stages of the
product realization process in accordance with the planned arrangements (see section 0710 Planning of
Product Realization, SOP-31.07 - FIRST ARTICLE INSPECTION, SOP-31.40 IN-PROCESS
INSPECTION AND TESTING, and SOP-31.41 - FINAL INSPECTION AND TESTING).
Evidence of conformity with the acceptance criteria will be maintained.
person(s) who authorized the release product.
Records will indicate the
Product release and service delivery will not proceed until the planned arrangements (i.e., inspection and
testing) have been satisfactorily completed, unless otherwise approved by a relevant authority and where
applicable, by the customer.
08242 PARTICULAR REQUIREMENTS FOR ACTIVE IMPLANTABLE DEVICES AND
IMPLANTABLE DEVICES.
TM currently does not provide contract services for active implantable medical devices and implantable
medical devices for its customers.
0820 REFERENCE DOCUMENTATION
SOP-30.92
SOP-31.07
SOP-31.40
SOP-31.41
SOP-36.19
INTERNAL AUDITING
FIRST ARTICLE INSPECTION
IN-PROCESS INSPECTION AND TESTING
FINAL INSPECTION AND TESTING
CUSTOMER SATISFACTION
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0830 CONTROL OF NONCONFORMING PRODUCT
TM has developed procedures that ensure product, which does not conform to requirements are identified and
controlled to prevent its unintended use of delivery. The controls are related responsibilities/authorities for dealing
with nonconforming product are defined (see SOP-30.49 - NONCONFORMANCE MANAGEMENT)
When dealing with nonconforming product, TM follows one or more of these methods:
A) By taking action to eliminate the detected nonconformity.
B) By authorizing its use, release, or acceptance under concession
C) By taking action to preclude its original interned use or applicable.
Product may be accepted by concession only if regulatory requirements are met and records of the identity of the
person(s) authorizing the concession are documented.
Records of non-conformances include information on the nature of the nonconformance and subsequent actions taken,
including concessions obtained. These records are maintained in the documentation area.
When non-conforming product is corrected it will be subject to re-verification to demonstrate conformity to
requirements.
When non-conforming product is detected after delivery or use has started, TM will take action appropriate to the
effects, or potential effects, of the nonconformity.
If product needs to be reworked (one or more times) TM will document the rework process in a work instruction that
has undergone the same authorization and approval procedure as the original work instruction, a determination of any
adverse effect of the rework upon product shall be made and documented.
0830 REFERENCE DOCUMENTATION
SOP-18.03
SOP-18.06
SOP-30.12
SOP-30.49
COMPLAINT PROCESSING AND RESOLUTION – TRAVANTI MEDICAL™
RECALL AND FIELD SAFETY CORRECTIVE ACTION – TRAVANTI MEDICAL™
PRODUCT RECALL
NON-CONFORMANCE MANAGEMENT
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0840 ANALYSIS OF DATA
TM will establish a documented procedure to determine, collect, and analyze appropriate data to demonstrate the
suitability and effectiveness of the QMS and to evaluate where continual improvement of the effectiveness of the QMS
can be made. This will include data generated as a result of monitoring and measurement and from other relevant
sources (see SOP-31.25 - STATISTICAL CONTROL AND ANALYSIS).
The analysis of data will provide information relating to:
A) Customer satisfaction (see section 0821 Customer Satisfaction).
B) Conformity to product requirements (see section 0721 Determination of Requirements Related to the
Product).
C) Characteristics and trends of process and product including opportunities for preventive action.
D) Suppliers (see section 0741 Purchasing Process).
Records of the result of the analysis will be maintained.
0840 REFERENCE DOCUMENTATION
SOP-31.25
STATISTICAL CONTROL AND ANALYSIS
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0850 IMPROVEMENT
0851 CONTINUOUS IMPROVEMENT
TM will continually improve the effectiveness of the QMS through the use of the quality policy, quality
objectives, quality auditing results, analysis of data, corrective / preventive actions, and management
review.
TM takes exception to developing documented procedures to issue and implementation of advisory
notices defined in this portion of clause 8.5.1 of ISO 13485:2003 for all processes/products except
TravantiMedical™. TM will not issue notification of advisory notices for any product other than
TravantiMedical™ (Reference SOP-18.03 – COMPLAINT PROCESSING AN D RESOLUTION
and SOP-18.06 - RECALL AND FIELD SAFETY CORRECTIVE ACTION. Our customer of all
Tapemark contract manufactured products will maintain responsibility for issuing notification of advisory
notices.
Records of customer complaint investigations will be maintained. If investigation determines that the
activities outside the organization contributed to the customer complaint, relevant information will be
exchanged between organizations involved.
If any customer complaint is not followed by corrective and / or preventive action, the reason will be
authorized and recorded.
TM takes exception to developing documented procedures and issuing notification of adverse events
defined in this portion of clause 8.5.1 of ISO 13485:2003 for all processes/products except
TravantiMedical™. TM will not issue notification of adverse events for any product other than
TravantiMedical™ (Reference SOP-18.03 – COMPLAINT PROCESSING AN D RESOLUTION
and SOP-18.06 - RECALL AND FIELD SAFETY CORRECTIVE ACTION. Our customer of all
Tapemark contract manufactured products will maintain responsibility for issuing notification of adverse
events.
0852 CORRECTIVE ACTION
TM will take action to eliminate the cause of nonconformities in order to prevent recurrence. Corrective
Actions will be appropriate to the effects of the nonconformities encountered.
TM has established SOP-30.49 - NON-CONFORMANCE MANAGEMENT and SOP-30.45 –
CORRECTIVE AND PREVENTIVE ACTION (CAPA) to define requirements for:
A) Reviewing nonconformities (including customer complaints).
B) Determining the causes of nonconformities.
C) Evaluating the need for action to ensure that nonconformities do not recur.
D) Determining and implementing action needed, including, if appropriate, updating documentation.
E) Recording the results of any investigation and of action taken (see section 0424 Control of Records).
F) Reviewing corrective action taken and its effectiveness.
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0853 PREVENTIVE ACTION
TM will take action to eliminate the causes of potential nonconformities in order to prevent recurrence.
Preventive Actions will be appropriate to the effects of the potential nonconformities encountered.
TM has established – SOP-30.49 NON-CONFORMANCE MANAGEMENT and SOP-30.45 –
CORRECTIVE AND PREVENTIVE ACTION (CAPA) to define requirements for:
a) Determining the potential nonconformities and their causes.
b) Evaluating the need for action to prevent the occurrence of nonconformities.
c) Determining and implementing action needed.
d) Recording the results of any investigations and of action taken (see section 0424 Control of Records).
e) Reviewing preventive action taken and its effectiveness.
0850 REFERENCE DOCUMENTATION
SOP-18.03
SOP-18.06
SOP-30.45
SOP-30.49
COMPLAINT PROCESSING AN D RESOLUTION – TRAVANTI MEDICAL™
RECALL AND FIELD SAFETY CORRECTIVE ACTION – TRAVANTI MEDICAL™
CORRECTIVE AND PREVENTIVE ACTION (CAPA)
NON-CONFORMANCE MANAGEMENT
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GLOSSARY
GENERAL TERMS:
Customer: The recipient of a product manufactured and supplied by TM.
Entity: That which can be individually described and understood. An entity may be for example: an
activity or process, a product, an organization, a system or a person, or any combination thereof.
Organization: A company, corporation, firm, enterprise or institution, or part thereof, whether corporate or not,
public, or private that has its own function and administrator.
Organization The responsibilities, authorities, and relationships arranged in a pattern, through which an
Structure: organization performs it functions.
Procedure: A specified way to perform an activity, usually in the form of a flowchart.
Process: A set of interrelated resources and activities which transforms input into output.
Product: The result of activities or processes.
a) Product includes service, hardware, processed materials, software, or a combination thereof.
b) A product can be tangible (assemblies or processed materials) or intangible (information on
concepts, or a combination thereof).
c) Product can be intended (offering to customers) or unintended (pollutant or unwanted effects).
Purchaser: The recipient of a product provided by the supplier in a contractual situation.
Service: The results generated by activities at the interface between the supplier and the customer by the
supplier internal activities, to meet the customer needs.
Subcontractor: The organization that provides a product or service to the supplier.
TERMS RELATED TO QUALITY:
Compatibility: The ability of entities to be used together under specific conditions to fulfill relevant requirements.
Conformity: The fulfillment of specified requirements.
Defect: The non-fulfillment of intended requirements, or a reasonable expectation, for use of an entity,
including one concerned with safety.
Inspection of: An activity such as measuring, examining, testing, or gauging one or more characteristics of an
entity and comparing the results with specific requirements in order to establish whether conformity
is achieved for each characteristic.
Outsourced: Process or service that is provided by an outside contractor (eg: contract manufacturing, pest
control, calibration services, laundry services, etc).
Qualified: The status given to an entity when it has been demonstrated that it is capable of fulfilling specified
requirements.
Quality: The totality of characteristics of an entity that being on its ability to satisfy stated and implied
needs.
Requirements for An expressing of the needs of their translation into a set of quantitatively stated requirements for
Quality: the characteristics of an entity to enable its realization and examination.
Safety: The state in which the risk of harm or damage to persons is limited to an acceptable level.
Verified/ Confirmation by examination and provision of objective evidence that specified requirements has
Verification: been fulfilled.
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GLOSSARY (Continued)
TERMS RELATING TO THE QUALITY SYSTEM:
Contract Review: The systematic activities carried out by the supplier before signing/accepting the contract or
purchase order to ensure that the requirements for quality are adequately defined, free from
ambiguity, documented and can be realized by supplier.
Management A formal evaluation by top management of the status and adequacy of the quality system in
Review: relation to the quality policy and objectives.
Quality Control: The operational techniques and activities that are used to fulfill requirements for quality.
Quality The actions taken throughout the organization to increase the effectiveness and efficiency of
Improvement: activities and processes to provide added benefits to both the organization and its customer.
Quality Manual: A document stating the quality policy and describing the quality system of the organization.
Quality Plan: A document setting out the specific quality practices, resources and sequence of activities
relevant to a particular product, project, or contract.
Quality Policy: The overall intentions and direction of an organization with regard to quality as formally
expressed by top management.
Quality System: The organization structure, responsibilities, procedures, processes, and resources needed to
implement quality management.
Record: A document that furnishes objective evidence of activities performed or results achieved.
Specification: A document stating requirements.
Traceability: The ability to trace the history, application, or location of an entity, by means of recorded
identifications.
TERMS RELATING TO TOOLS AND TECHNIQUES:
Corrective Action: An action taken to eliminate the cause(s) of an existing nonconformity, defect, or other
undesirable situation in order to prevent recurrence.
Disposition of The action to be taken to deal with an existing nonconforming entity in order to resolve the
Nonconformity: nonconformity.
Preventive Action: An action taken to eliminate the cause(s) of a potential nonconformity, defect, or other
undesirable situation in order to prevent occurrence.
Quality Audit: A systematic and independent examination to determine whether quality activities and related
results comply with arrangements and whether these arrangements are implemented effectively
and are suitable to achieve quality objectives.
Quality Auditor: A person qualified to perform quality audits.
Rework: The action taken on a nonconforming product so that it will fulfill the specified requirements.
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