GPMG’S MODULAR ISO 13485 QUALITY MANAGEMENT SYSTEM

A LOGICAL AND COST EFFECTIVE APPROACH TO OBTAIN ISO 13485 CERTIFICATION ANDFDA QSR COMPLIANCE

GLOBAL PACIFIC MANUFACTURING GROUP LLC

DOCUMENT

CONTROL

DESIGN

CONTROL

COMPLAINT

HANDLING

RISK

MANAGEMENT

APPLICATIONS

- Existing manufacturers- New divisions or start-ups- Distributors- Brand-only companies outsourcing manufacturing- Contract design companies

- Contract manufacturers

- Contract service providers

MODULAR SYSTEM’S ROOTS

- Developed to expedite factory relocation projects.

- A solution for a need to rapidly address system “gaps” identified during GPMG or FDA audits.

- To develop the ability to support the quality systems needs of start-up companies who often face resource and cost challenges.

ADVANTAGES

- Implementation can follow a logical cost effective sequence

- Increased control over implementation process

- Simplified project management and reduced installation time

- Adaptable to varying organizational structures

What is a modular quality system? The term modular has been used to describe a plethora of products. Therefore, the word modular evokes a variety of thoughts and reactions. GPMG uses the term “modular” to describe a quality system consisting of a series of carefully crafted interlocking procedures that have been grouped into logical modules that follow the ISO 13485 sections.

Organizing the procedures in modules merely provides us, or our clients, the ability to install an entire system following an appropriate sequence. This sequence incorporates lessons learned after multiple site installations around the world. The system modules also enables us to rapidly extract Standard Operating Procedures (SOP’s) needed to address a “gap” identified in an existing system.

A quality system developed piece-meal often becomes a confusing web of overlapping documents difficult to maintain and consumes valuable time attempting to effectively train resources. However, by applying forethought to the varying needs of companies, and the regulatory environment in which they operate, a quality system can be designed to be an asset not a burden.

GPMG’s approach to an effective system installation has always been viewing the project from a manufacturing perspective. The main reason being that if a company is not competitive in today’s global economy a quality system becomes a moot point.

The ideal system installation is one that captures processes a company may have already developed, documented or otherwise. GPMG aligns any such processes with the applicable regulatory space.

Throughout an installation process opportunities for improvement will become evident. Many of those opportunities can be immediately adopted into the system content during installation.

GPMG’s approach is to understand a company’s needs and identify any compliance gaps. We then shape our base modular system to match your organization. Because the GPMG modular system isstraight forward, many of our clients elect to conduct the integration effort on their own, leveraging their own resources, and rely on GPMG to challenge the system post integration.

A quality system is merely the sum of all its operating procedures. GPMG has carefully created each standard operating procedure in a manner that meets the applicable compliance requirements while maintaining the flexibility to efficiently adopt them into a particular organizational structure and the activities a company may be engaged (e.g. design, manufacture, distribution, etc).

How does GPMG install a complete system? The process begins by first gaining an understanding of your company objectives, the nature of your products and services, and the markets in which you currently or intend to operate within (e.g. US, Europe, Canada, etc.).

It is also important to understand any current or future product design activity the company is or will be engaged in and the anticipated regulatory pathways needed for product approval for various countries (e.g. PMA, 510k, CE, etc.).

Why is this important? The GPMG modular base system is all inclusive. The system considers design, manufacture, distribution, etc. After gaining insight to your needs we extract the applicable operating procedures and align them to match a particular situation.

Every company has a varying amounts of resources and different organizational structures. As an example, a start up company may have limited internal resources and may leverage outside resources or consultants. The internal resources may wear several “hats” within the organization. Larger companies typically have an additional layer(s) of managers for each department and will break up departments into separate sub-groups. Regardless of the size of the company the underlying fundamental roles and areas of expertise remain basically the same for most western companies (as shown in chart below). Many Asian companies may have the same structure but departmental authority will vary.

Why is the organizational structure important for us to understand? The GPMG modular system is framed around this assumed organizational structure. Standard operating procedures contain within them certain departmental responsibilities and approval flow / processes. The nature of various activities will demand varying levels of relevant expertise having input throughout an approval process. The organizational structure and the products a company produces accounts for the greatest effort expended on integrating the modular quality system.

Sales and Marketing

Research and Development

PresidentCEO

OperationsQuality Assurance / Regulatory A�airs

Management Representative

Finance

For this reason our focus during the development of the modular system was on creating a framework that captures the fundamental areas of need within every company. Then structure each procedure in a manner that allows for efficient expansion on each process. The final core content of each standard operating procedure, in most cases, will remain very similar to the baseline.

Example: The GPMG procedures governing Design Control may remain virtually the same as the baseline. However, the departmental titles and approval process flow will be adopted into a company’s organization structure and policies. The design phases, review content, and required areas of expertise to adequately review a specific project will be the same under any scenario. How a project is originated or requirements for internal approval of a project will vary with each organization.

How does GPMG address compliance “gaps” within an existing system? GPMG typically will conduct a gap assessment of a company’s current operation to identify compliance gaps. In some cases, gaps may have been previously identified during an audit by a notified body or the FDA. Regardless of the means in which an area of need is identified, one advantage of GPMG’s modular system is the individual procedures are flexible enough to be installed into an existing system with minimal effort.

These situations in fact are quite typical and represent a large percentage of the installation work we perform around the world. Such scenarios were also a major consideration during development of the modular system.

Assumed Organizational Structure

Specifically, How is a modular system installed?

The first step of system development and integration is to understand the company’s overall business objectives and activities, such as product design, classification of the company’s products, and type of services the company may offer. GPMG conducts a “Gap Assessment” of current activities and systems, including understanding any undocumented processes. The gaps are measured against ISO 13485 and FDA QSR requirements. The organizational structure and activities within the facility are also documented during the assessment process.

A quality management system manual is created encapsulating the company activities, the regulations and standards the company is committing to comply with, the documentation structure, quality policy, and organizational responsibilities.

The base GPMG modular system has made assumptions as to the organizational structure. As the system is employed those assumptions are aligned with the specific organizational structure and departmental titles, areas of responsibility, and approval flow. Depending on the situation some of the baseline responsibilities will be either combined or broken into additional departmental groups or sub-groups.

Global Pacific Manufacturing

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Standard Operating Procedure Statistical Techniques Page 1 of 39

ECN #: Effectivity Date:

SOP 8-07 Revision: 1

Confidential:This document contains information that is the confidential and proprietary property of GPMG. Neither this document nor the information therein may be reproduced, used or distributed to or for the benefit of any third party without the prior written consent of GPMG.

1.0 Purpose The purpose of this procedure is to provide established statistical methodologies to be used as the basis for [Company Name] Sampling Plan(s), Quality Improvement, design assurance, problem solving, failure analysis, and general data analysis.

2.0 Scope

The user should have some statistical knowledge and have access to the literature and documents referenced in this procedure. Where sampling is to be carried out for the purpose of establishing product characteristics and/or verifying the acceptability of process capability, the sampling shall be based on established statistical methodologies.

3.0 Reference Documents

3.1 Juran's Quality Control Handbook 3.2 Statistical Software (e.g., Statgraphics, Minitab, etc.) 3.3 SOP 8-08 Non-Conforming Material System 3.4 SOP 8-10 Incoming Quality Assurance (IQA) 3.5 SOP 7-23 Process Validation Procedure 3.6 QMSM Quality Management System Manual

4.0 Responsibility/Authority

4.1 New Product Development

New Product Development (NPD) Engineering is responsible for using statistical methodologies for defining the product characteristics and leading the Project Team in quality product development.

4.2 Quality Assurance

Quality Assurance is responsible for using statistical analysis for product conforming tests and design validation / verification

4.3 Process Engineering

Process Engineering is responsible for verifying the acceptability of process capability based on the process/product specification/characteristics, using statistical methodologies.

4.4 Quality Engineering

Quality Engineering is responsible for establishing Inspection Plans and classifying defects consistent with the requirements and characteristics of the device/part. This ensures that the specification(s) are met, using statistical methodologies.

System Gap Assessment

Quality Manual Development

Align Departmental Responsibilities

Global Pacific Manufacturing

Group, LLC

QUALITY MANAGEMENT SYSTEM MANUAL Page 1 of 18

ECN # Effectivity Date:

QMSM Revision: A

Confidential:This document contains information that is the confidential and proprietary property of GPMG. Neither this document nor the information therein may be reproduced, used or distributed to or for the benefit of any third party without the prior written consent of GPMG.

1.0 Purpose and Scope This quality management system manual (QMSM) specifies requirements and designates responsibility for

processes conducted and products produced at [Company Name] facilities located in [Enter Location(s)]. Reference to any national or international standard implies the latest revision unless otherwise stated. Conformance to these requirements is directed at achieving customer satisfaction by preventing nonconformity at all stages from design to distribution.

2.0 References The policies in this Quality Management System Manual are based on the following regulations and standards as applicable:

21 CFR Part 820: Food and Drug Administration Quality System Regulations (QSR) Medical Devices Act Canadian Medical Device Regulations (CMDR) Council Directive 93/42/EEC (6/1993): Medical Device Directive (MDD) ISO 13485 (7/2003): Medical devices - Quality management systems - Requirements for regulatory

purposes

3.0 Terms and Definitions For the purposes of this Quality Management System Manual, the definitions and vocabulary listed and defined in FDA 21 CFR Part 820.3 annotated as necessary by the definitions and vocabulary listed in current published revisions to EN ISO 13485, MDD 93/42/EEC, CMDR

4.0 Quality management system (QMS) 4.1 General requirements

[Company Name] has implemented a quality management system which has: a) Identified the processes needed for the quality management system and their application

throughout the organization b) Determined the sequence and interaction of these processes c) Determined criteria and methods needed to ensure that both the operation and control of these

processes are effective d) Ensured the availability of resources and information necessary to support the operation and

monitoring of these processes e) Monitored, measured and analyzed these processes f) Implemented actions necessary to achieve planned results and maintain the effectiveness of these

processes

The specific requirements are established and documented. Documents that define the product specifications, including manufacturing and quality assurance procedures and specifications for a medical device, or noting to the location of this information is established and maintained and considered to be the Device Master Record.

The GPMG base modular system utilizes a GPMG numbering system to identify and cross link procedures. When a company elects to use their own unique numbering system GPMG will create a temporary spreadsheet cross referencing the two numbering systems. The next step is to simply swap out the numbering references in a controlled manner so the final documents remain properly linked to each other.

GPMG aligns the modular standard operating procedures with the specific details of how a particular process is executed within a company. Every company will have a unique methods of carrying out a specific task. The modular system is structured to accommodate these modifications with minimal effort.

Each facility will have unique considerations to incorporate into the quality management system such as environmental controls for clean rooms, controls for internal laboratories, and unique controls for various types of process equipment. GPMG has a broad range of procedures in addition to the baseline modular system that can be easily integrated with the quality management system.

Global Pacific Manufacturing

Group, LLC

Standard Operating Procedure Complaint Handling System Page 1 of 8

ECN#: Effectivity Date:

SOP 8-01 Revision: 1

Confidential:This document contains information that is the confidential and proprietary property of GPMG. Neither this document nor the information therein may be reproduced, used or distributed to or for the benefit of any third party without the prior written consent of GPMG.

1.0 Purpose

To establish the handling of device complaints by [Company Name] in compliance with the Food and Drug Administration’s (FDA) 21 CFR 820.

2.0 Scope

This procedure applies to all devices manufactured and/or commercially distributed by [Company Name].

3.0 Applicable Documents

1. FORM 8-05 MDR Decision Tree 2. SOP 8-02 Complaint Trending 3. SOP 8-03 Recall / Advisory Notice 4. SOP 8-04 Corrective and Preventive Action System 5. SOP 8-06 Medical Device Reports (MDRs) 6. FORM 9-01 Vigilance Decision Tree: Incidents 7. FORM 9-03 Incident Decision Tree: Canada 8. SOP 8-14 Vigilance 9. QMSM Quality Management System Manual

4.0 Definitions

4.1 Complaint Report - Any written, electronic, or oral communication that alleges one or more deficiencies related to identity, quality, durability, reliability, safety, effectiveness or performance of one or more a device after it is released for distribution. A Complaint Report contains one or more Complaints or Incidents. Incident – (Same as Complaint)

4.2 Complaint File Number - The number that uniquely identifies each individual complaint for a commercialized device. The number consists of numeric, automatically assigned by the computerized complaint system.

4.3 Lot Number - The unique number assigned to all production. For [COMPANY NAME], the number is coded to indicate the manufacturing date (year, month, day, and shift).

4.4 Device History Record - A compilation of records containing the production history of a finished device.

4.5 Distributor - Furthers the marketing of a device from its original place of manufacturing, and makes final delivery or sale to the ultimate user such as a hospital, clinic or physician

4.6 Evaluate - The careful analysis of a device and related documents to confirm a reported complaint and, whenever possible, determine root cause and corrective action(s).

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Standard Operating Procedure Complaint Handling System Page 7 of 8

ECN#: Effectivity Date:

SOP 8-01 Revision: 1

Confidential:This document contains information that is the confidential and proprietary property of GPMG. Neither this document nor the information therein may be reproduced, used or distributed to or for the benefit of any third party without the prior written consent of GPMG.

10.1 If the complaint evaluation determines that an investigation is required, the investigation will be conducted by Quality Assurance and Engineering or others as needed. The investigation shall be documented on the investigation section of the complaint form.

10.2 Quality assurance will determine if the failure of a device or component meets the requirements of a remedial action or the failure constitutes a reportable event, which necessitates remedial action to prevent an unreasonable risk of substantial harm to the public. (Refer to SOP 8-03).

10.3 If testing is required, investigations wherever possible should use analytical tools such as fault tree analysis, failure mode Effect Analysis, laboratory tests, etc. to determine the root cause of a device failure. A device history record review may also be included. Whenever a device fails to meet a specification, a determination must be documented as to the root cause of the failure. Failure of a device to meet a specification must include corrective action to prevent recurrence, or a written rationale, with the name of the decision maker, why no corrective action is warranted. Corrective action(s) will be handled through the Corrective Action Procedure, SOP 8-04.

10.4 A complaint investigation must include the following elements: Testing Conducted Testing Results and Conclusions Determination if the complaint is confirmed

11.0 Procedure: Closing the Complaint 11.1 A complaint file may be closed when the complaint has been investigated and evaluated and the

corrective action(s) have been initiated. The complaint summary should summarize the complaint investigation. If a corrective action has been initiated, the CAPA number should be documented and referenced in the complaint summary. Minimum required documents are a copy of the complaint form, MDR Decision Tree, Investigation record and when applicable a Euro Decision tree, Canadian Decision tree, Medwatch Form, Baseline and IFU. Any other pertinent complaint information should also be included.

11.2 Complaint status shall be updated and completed in the computer database; the date when the complaint was closed will be entered in the data base.

11.3 A closed complaint file is retained per the Record Retention Procedure, SOP 4-03.

12.0 Procedure: Reviewing the Complaint 12.1 The review shall be done in a timely manner after the closure of the complaint (typically within 30

days).

12.2 The review must be performed by a person with adequate clinical knowledge.

12.3 The purpose of the review is to determine if there is agreement with all aspects of the assessment; MDR, Vigilance decision trees, investigation, conclusion and corrective action.

12.4 If the review is successful, the reviewer shall sign and date the complaint form.

12.5 If any issues are found in the complaint file during the review, the issues shall be addressed and the additional information shall be added to the complaint file.

12.6 When the review is completed, the computer database shall be updated to reflect the complaint status as ‘reviewed’. This may be done by entering the date that the complaint was reviewed

13.0 Procedure: Management Review

Specification Number Format and Linkage

Facility and Process Considerations

Integrate Specific / Unique Process Steps

GPMG has applied the lessons learned from multiple global quality system installations to develop an optimal approach to system installation. The installation sequence and priorities, resource training and development, and the transition from installation to utilization are measured and documented. All activities, action items, resource requirements, milestones, and time lines are controlled via detailed project charts. Project team(s) meet weekly to discuss pressing action items. Team members and management stay informed through meeting minutes published weekly.

Project Management

Quality System Modules

Module #1Quality Management System Manual

Module # 2ISO 13485 Sections: 4.0, 5.0, and 6.0

Documentation Requirements, Management Responsibility, and Resource Management

Module # 3ISO 13485 Section 7.0

Product Realization

Module # 4ISO 13485 Section 8

Measurement, Analysis, and Improvement

Base System Contents Key System Elements

Document ControlRecord Retention

Device Master RecordsManagement Responsibility

Resource ManagementDesign Control

Risk ManagementDesign and Process Validation

Product Labeling and IdentificationComplaint Handling

Medical Device ReportingStatistical Analysis

Corrective and Preventative ActionNon-Conforming Materials

Process ControlsSupplier Approval Process

Module # 1 1 - Quality System Manual

Module # 210 - Standard Operating Procedures

4 - Related Forms

Module # 329 - Standard Operating Procedures

14 - Related Forms

Module # 412 - Standard Operating Procedures

8 - Related Forms

Global Pacific Manufacturing Group LLC www.gpacmfg.com tel. 202.380.9380

Module #1

Module #2

Module #3

Module #4