DyAnsys ISO 13485 Quality Manual(sample)

                                

                                 Table of Contents

S.No                        Topics                                             

I                           Approvals
II                         Revision and Approval Record
1.0                       Scope
2.0                       Company information
3.0                       Terms and definitions
4.0                       Quality management system
5.0                       Management responsibility
6.0                       Resources
7.0                       Product realization
8.0                       Design and development
9.0                       Risk management
10.0                     Sterilization
11.0                     Measurement, analysis and improvement
12.0                     Installation
13.0                     Service

1.0         SCOPE

1.1 General

This International Standard specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services. The primary objective of this International Standard is to facilitate harmonized medical device regulatory requirements for quality management systems. As a result, it includes some particular requirements for medical devices and excludes some of the requirements of ISO 9001 that are not appropriate as regulatory requirements. Because of these exclusions, organizations whose quality management systems conform to this International Standard cannot claim conformity to ISO 9001 unless their quality management systems conform to all the requirements of ISO 9001 (see Annex B).

1.2 Application

All requirements of this International Standard are specific to organizations providing medical devices, regardless of the type or size of the organization. If regulatory requirements permit exclusions of design and development controls (see 7.3), this can be used as a justification for their exclusion from the quality management system. These regulations can provide alternative arrangements that are to be addressed in the quality management system. It is the responsibility of the organization to ensure that claims of conformity with this International Standard reflect exclusion of design and development controls [see 4.2.2 a) and 7.3].

If any requirement(s) in Clause 7 of this International Standard is(are) not applicable due to the nature of the medical device(s) for which the quality management system is applied, the organization does not need to include such a requirement(s) in its quality management system [see 4.2.2 a)].

The processes required by this International Standard, which are applicable to the medical device(s), but which are not performed by the organization, are the responsibility of the organization and are accounted for in the organization’s quality management system [see 4.1 a)].

In this International Standard the terms “if appropriate” and “where appropriate” are used several times. When a requirement is qualified by either of these phrases, it is deemed to be “appropriate” unless the organization can document a justification otherwise. A requirement is considered “appropriate” if it is necessary in order for

1.  The product to meet specified requirements. 
2.  The organization to carry out corrective action. 

2.0  COMPANY INFORMATION

DyAnsys Inc. is a global company, headquartered in the Silicon Valley (California, USA) with subsidiaries in Switzerland and India. We have patented  a novel and accurate Heart Rate Variability (HRV) approach to monitoring the Autonomic Nervous System (ANS) on a beat to beat basis. Our long term objective is to become a leader in providing advanced medical diagnostic and monitoring systems to clinicians in individual practices and hospitals. We will do this by using sophisticated mathematical analysis of the ECG and other electrical signals. The applications focus of our products is currently chronic & acute pain, anesthesia, diabetes and fetal heart monitoring. DyAnsys was founded and is being run by a worldwide team of professionals drawn from the medical, mathematical and IT fields. ANSiscope was our first product followed by our ECScope series of ECG machines. We have recently added a non-narcotic device for treatment of chronic pain, the P-STIM, to our product line.

3.0  TERMS AND DEFENITIONS

The following terms, used in this edition of ISO 13485 to describe the supply chain, have been changed to reflect the vocabulary currently used:

supplier -------------> organization ----------> customer

The term “organization” replaces the term “supplier” used in ISO 13485:1996, and refers to the unit to which this International Standard applies. Also, the term “supplier” now replaces the term “subcontractor”.

Throughout the text of this International Standard, wherever the term “product” occurs, it can also mean

“service”.

Wherever requirements are specified as applying to “medical devices”, the requirements apply equally to related services as supplied by the organization.

The following definitions should be regarded as generic, as definitions provided in national regulations can differ slightly and take precedence.

• Active implantable medical device - Active medical device which is intended to be totally or partially introduced, surgically or medically, into the human body or by medical intervention into a natural orifice, and which is intended to remain after the procedure.

• Active medical device - Medical device relying for its functioning on a source of electrical energy or any source of power other than that directly generated by the human body or gravity.

• Advisory notice - Notice issued by the organization, subsequent to delivery of the medical device, to provide supplementary information and/or to advise what action should be taken in

1. The use of a medical device.
2. The modification of a medical device.
3. The return of the medical device to the organization that supplied it.
4. The destruction of a medical device.

• Customer complaint - Written, electronic or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety or performance of a medical device that has been placed on the market.

• Implantable medical device - Medical device intended 

1. To be totally or partially introduced into the human body or a natural orifice.  
2. To replace an epithelial surface or the surface of the eye.

 

by surgical intervention, and which is intended to remain after the procedure for at least 30 days, and which can only be removed by medical or surgical intervention.

 

NOTE - This definition applies to implantable medical devices other than active implantable medical devices.

• Labeling - Written, printed or graphic matter

1. Affixed to a medical device or any of its containers or wrappers.
2.  Accompanying a medical device, related to identification, technical description, and use of the medical device, but excluding shipping documents.

NOTE -  Some regional and national regulations refer to “labeling” as “information supplied by the manufacturer.”

• Medical device - Any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the specific purpose(s) of 

1. Diagnosis, prevention, monitoring, treatment or alleviation of disease.
2. Diagnosis, monitoring, treatment, alleviation of or compensation for an injury.  Investigation, replacement, modification, or support of the anatomy or of a physiological process.
3. Supporting or sustaining life.
4. Control of conception.
5. Disinfection of medical devices.
6. Providing information for medical purposes by means of in vitro examination of specimens derived from the human body, and which does not achieve its primary intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means.

• Medical device - Any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the specific purpose(s) of

1. Diagnosis, prevention, monitoring, treatment or alleviation of disease.
2. Diagnosis, monitoring, treatment, alleviation of or compensation for an injury.
3. Investigation, replacement, modification, or support of the anatomy or of a physiological process.
4. Supporting or sustaining life.
5. Control of conception.
6. Disinfection of medical devices.
7. Providing information for medical purposes by means of in vitro examination of specimens derived from the human body, and which does not achieve its primary intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means.

• Sterile medical device - category of medical device intended to meet the requirements for sterility

4.0  QUALITY MANAGEMENT SYSTEM

4.1 General

DyAnsys has established, documented, implemented and maintains a Quality Management System with a to continually improve the effectiveness of the system in accordance with the requirement of ISO13485:2003.

• DyAnsys has determined the processes needed for the Quality Management System and their application through out the organization.

DyAnsys also undertakes out of course service of ANS monitor, ECG machine and Nerve stimulator and their sub-assemblies, conversation/ modification/ rehabilitation of above mentioned instruments.  

These process are further divided into various sub processes and their activities are carried out in designated departments. These processes are supported by other allied functions/ departments. Supporting processes associated with the Quality Management System include:

1. Processes for Management Activities
2. Processes for Provision of Resource                             
3. Processes for Product Realization
4. Processes for Measurement, Analysis and Improvement

• DyAnsys has determined the sequence of their processes and various sub-processes and their interactions of these processes. This is done through processes maps or flow process chart developed for each process.

• These process are carried out in accordance with the specification/ instructions issued

Based on the specification/ instruction. Documented procedures and quality plan have been developed to carry out these processes. These processes are controlled/ inspected at various stages of operation and after completion of these processes.

• DyAnsys has ensured the availability of resources and information necessary to support the operation and monitoring of these processes.

• DyAnsys has established system for monitoring, measuring where applicable an analyzing these processes to ensure conformity of product, processes and Quality Management System with the requirements through the use of quality policy, quality objective, audit results, analysis of data, corrective and preventive action and management review.

• DyAnsys has ensured that the above processes are managed in accordance with the requirements of ISO13485:2003.

In case any process is out-sourced, DyAnsys has ensured suitable control over such processes within the Quality Management System.   

  

4.2  Documentation

4.2.1  General

 The Quality Management System documentation of DyAnsys includes: 

1. Quality Policy and Quality Objectives.
2. Quality Manual.
3. Documented procedure and records which are required by ISO13485:2003 and other Quality Management System procedure which are required for the effective operation of the Quality Management System.
4. Other documents like Quality plan, Work instruction, Drawing, Specificationand Manuals are needed to ensure effective planning and opeatiob and control of various processes.
5. Record requires to provide evidence of conformity to requirements which are required by ISO 13485:2003.

4.2.2  Quality manual

DyAnsis has established and maintains a Quality Manual which includes:

1. The scope of the Quality Management System including details of justification for excluding, development purchasing.
2. Reference to Quality Management System procedures.
3. Description of the interaction/ linkage between the processes shows by process amps/ flow process charts.

4.2.3  Control of Documents

All documents pertaining to Quality Management System are controlled in accordance with the document Quality Management System is established for this purpose.

This procedure defines control for approval, issues, review, updating, amendments circulation, identification, etc., of all the documents. This procedure also ensure that documents of externals origin are also determined for planning, operation of Quality Management System and their distribution is controlled. Obsolete documents are promptly removed from all points of issue. Any such documents are retained for any purpose is suitably identified.

4.2.4  Control of Records

DyAnsys has identified, established and maintains records to provide evidence of conformity to requirements of the effective operation of the Quality Management System. A documented procedure has been established to define control needed for identification, storage, protection, retrieval, retention time and disposition of records.                     

5.0  MANAGEMENT RESPONCIBILITY

5.1 Management Commitment

The top management of DyAnsis has established and implemented ISO 13485:2003 the Quality Management System and is committed towards the conditional improving its effectiveness.

The importance of meeting the costumer as well as applicable statutory and regulatory requirements is communicated to all level of the organization through meetings, awareness training programs, monitoring of costumer satisfaction infraction with costumers. The top managements has established a quality policy as required by ISO 13485:2003.   

Management has demonstrated a commitment to the development and implementation of the Quality Management System, and continually improving its effectiveness by:

1.      Communicating to the Company the importance of meeting Customer as well as statutory and regulatory requirements (in particularly, requirements for safety and performance of DyAnsy’s devices).

2.      Establishing the Quality Policy (Refer to the sections below for more details).

3.      Establishing Quality Objectives that are meaningful to DyAnsys’s business model, and reviewing these objectives on a regular basis to ensure that they help to

4.      Improve DyAnsys’s overall quality

5.      Conducting Management Reviews.

6.      Providing the resources needed by the Quality Management System to ensure its proper operation.

5.2 Customer Focus

Management will ensure that Customer requirements are determined and fulfilled with the aim of enhancing Customer Satisfaction. Through DyAnsys’s contract review process all customer orders and extended contracts are reviewed to ensure that DyAnsys can meet all of the customer’s requirements, both stated and unstated.

To ensure that customers are satisfied throughout the lifetime of their purchases,

DyAnsys’s Customer Service Department has been established to provide customers with the services they need. Customers can purchase DyAnsys products with the knowledge that DyAnsys’s Customer Service Department will be available with technical support, order information, and to help the customer obtain repairs as necessary.

5.3 Management Representative

Management has appointed the Quality Manager as the Management Representative for the Quality Management System. The Management Representative has the responsibility and authority that includes:

1.      Ensuring that processes needed for the Quality Management System are established, implemented, and maintained by making use of resources provided by Executive Management and personnel from various departments within the company.

2.      Reporting on the performance of the Quality Management System to Executive Management and any need for improvement (Note: this reporting is aided by the analysis of quality system data obtained through normal monitoring and measurement processes.).

3.      Ensuring the promotion of awareness of Customer requirements throughout the Company.

5.4 Internal communication

Management has established communication processes within the Company to ensure that processes included as part of the Quality Management System are effectively implemented and maintained. This communication ensures that the Quality Management System is effective and accomplishes stated objectives.

This communication process makes use of all computerized resources that are available at DyAnsys, and includes the creation and continuous adaptation of an electronic Information System to provide all departments with the latest information, controlled documents, and Quality Objectives.

Responsibility, authority, and communication are addressed, Management Responsibility.

5.5 Management Review

Management will conduct a review of the Quality Management System on a periodic basis to ensure its continued suitability and effectiveness in accordance with the Quality Policy and Quality Objectives. This review will include assessing opportunities for improvement and the need for changes to the Quality Management System, including the Quality Policy and Quality Objectives. The Management Review meeting will be attended by a variety of management staff throughout DyAnsys to ensure that all relevant information is presented and reviewed.

The input to Management Review will be in the form of a report. This report is prepared using quality system data collected through monitoring and measurement processes, as well as statistical data obtained during analysis. This report includes:

1.      Results of audits.

2.      Customer feedback information.

3.      Process performance and product conformity information (from a variety of sources).

4.      Status of preventive and corrective actions.

5.      Follow-up actions from previous management reviews.

6.      Planned changes that could affect the Quality Management System

7.      Recommendations for improvement.

8.      New or updated regulatory requirements.

The output from Management Review includes any decisions and actions related to:

1.      Improvement of the effectiveness of the Quality Management System and its processes.

2.      Improvement of product related to Customer requirements.

3.      Resource needs.

4.      Corrective and preventive actions as applicable.

5.      This output will be presented in a form that is suitable for the various departments it may affect. Policies created during normal management review will be incorporated into existing work instructions and procedures where appropriate, or documented in new procedures where required.

Management Review is performed in accordance, Management Responsibility. Management Review is documented in separate work instructions that further detail the various inputs and the outputs that are achieved by this meeting.

5.6 Responsibility of officer

5.6.1 Chief Executive Officer

1.     Establish Quality Policy

2.     Ensure that Quality Objective are established and met

3.     Approve Quality Manual

4.     Ensure that customer requirements are determined, communicated with in organization and met

5.     Provide the necessary resources for the implementation of Quality Management System

5.6.2 Chief Personnel Officer

1.     Ensure that Quality objective and requirements relating to products, process and Quality Management System are defined and met.

2.     Provide the necessary resources for the implementation of Quality Management System.

3.     Coordinate for requirement and training.

4.     Maintaining records of officers and supervisors. Ensure monitoring, measurement analysis and improvement of process.

5.6.3 Chief Material Manager

1.     Implement Quality Management System in purchasing and storing Raw material.

2.     Ensure that Quality objective and requirements relating to products, process and Quality Management System are defined and met.

3.     Provide the necessary resources for the implementation of Quality Management System.

4.     Ensure monitoring, measurement analysis and improvement of process.

5.     Approve training needs of supervisor working under his control

5.6.4 Chief Engineer

1.     Implement Quality Management System in Engineering department.

2.     Ensure that Quality objective and requirements relating to products, process and Quality Management System are defined and met.

3.     Provide the necessary resources for the implementation of Quality Management System.

4.     Co-ordinate with different departments to short out inter-departmental problems

5.6.5 Production Engineer

1.     Ensure that Quality objective and requirements relating to products, process and Quality Management System are defined and met.

2.     Provide the necessary resources for the implementation of Quality Management System.

3.     Co-ordinate with different departments.

4.     Ensure monitoring, measurement analysis and improvement of process.

5.     Periodic check calibration of instruments.

5.6.6 Work Manager

1.     Ensure that Quality objective and requirements relating to products, process and Quality Management System are defined and met.

2.     Provide the necessary resources for the implementation of Quality Management System.

3.     Co-ordinate with different departments.

4.     Ensure monitoring, measurement analysis and improvement of process.

5.     Periodic check calibration of instruments.

6.     Approve training needs of supervisor working under his control

5.6.7 Divisional Engineer

1.     Implement Quality Management System in Engineering department.

2.     Provide the necessary resources for the implementation of Quality Management System.

3.     Co-ordinate with different departments.

4.     Ensuring maintaining of records

6.0 Resource Management

6.1 Provision of Resources

Executive Management has determined and provided the resources needed to implement and maintain the Quality Management System and continually improve its effectiveness. These resource requirements are reviewed during normal management review to ensure that they are adequate for all of DyAnsys’s various departments. Executive Management has provided the resources necessary to enhance Customer Satisfaction by meeting customer requirements as well as all applicable regulatory requirements for DyAnsys’s products and services. Provision of resources is addressed, and is also documented in a variety of work instructions that form the Quality Management System.

6.2 Human Resources

Personnel performing work affecting product quality will be competent on the basis of appropriate education, training, skills, and experience.Management has established a Human Resources Department to organize the process of hiring new employees.

1.     Executive Management:

2.     Determines the necessary competence for personnel performing work affecting product quality (This information is included in relevant job descriptions)

3.     Provides training or takes other actions to satisfy these needs.

4.     Evaluates the effectiveness of actions taken through regular training review.

5.     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. This is accomplished through incentive programs, training sessions, and the appropriate communication of the Quality Policy and Quality Objectives.

Has established a system to maintain appropriate records of education, training, skills, and experience. Human resources are addressed. This topic is also documented in a variety of work instructions that form the Quality Management System. This documentation includes official job descriptions, which contain the educational and training requirements needed to perform specific tasks.

6.3 Infrastructure

Management has provided and maintains the infrastructure needed to achieve conformity to product requirements. Infrastructure includes:

1.     Building, workspace, and associated utilities

2.     Process equipment, both hardware and software

3.     Supporting services such as transport or communication

4.     Telephone communication systems and computer databases

5.     As part of Management’s commitment to provide adequate infrastructure a dedicated IT Department has been created to safeguard all electronic data and ensure the uninterrupted operations of DyAnsys’s computer systems.

For those processes that affect product quality, Executive Management has established documented work instructions and procedures to ensure that any equipment that can have an impact on product quality is maintained in an adequate fashion.

.

3.4 Work Environment

Executive Management has established the work environment criteria needed to achieve conformity to product requirements. These criteria include procedures and processes for building cleanliness, process efficiency, and employee safety.

Where the health, cleanliness, or clothing of DyAnsys personnel could adversely affect the quality and/or safety of DyAnsys’s products, criteria have been established to ensure product quality.

Any products produced by DyAnsys that could be adversely affected by environmental conditions will be protected to ensure that product quality and safety does not suffer. Environmental controls necessary to safeguard these products will be documented and maintained as appropriate. Where environmental controls are necessary, the training and skill of employees working in these controlled areas will be documented to ensure the safety of both the employees as well as DyAnsys products.

Executive Management has established a Safety Committee to ensure that relevant employee safety issues are discussed and resolved. This committee is responsible for overseeing all aspects of employee safety, including the handling and/or storage of any hazardous materials.

As part of the procedures and documents created to control the cleanliness and work environment of DyAnsys, contamination (with hazardous OR non-hazardous materials) of product will be controlled to prevent the spread of contamination to other products, the environment, or DyAnsys employees.

Work environment is addressed and is also documented in a variety of work instructions that form the Quality Management System.