quality manual example

Date issued:

SUBJECT: Quality Manual

Revision # of 15 S.O.P #

S.O.P. Subject: Quality Manual

Written by:

Signature: _______________ Date: ________

Approved by:

Signature ________________ Date: ________

Date issued:



TABLE OF CONTENT Page

Section 1.0 ..Introduction and purpose .....................................................................3Section 2.0 ..Distribution and revision ......................................................................4Section 3.0 ..Process approach ..................................................................................4Section 4.0 ..Quality Management System................................................................4

4.1 ...General requirements.......................................................................44.2 ...Documentation requirements ..........................................................4

Section 5.0 ….. Management responsibility..............................................................6 5.1 ...Management commitment ...............................................................6

5.2 ...Customer focus ................................................................................75.3 ...Quality policy ..................................................................................75.4 ...Planning ...........................................................................................75.5 ...Responsibility, authority and communication..................................75.6 ...Management review.........................................................................7

Section 6.0……Resource management ....................................................................86.1 ...Provision of resources .....................................................................86.2 ...Human resources .............................................................................86.3 ...Infrastructure ...................................................................................8

Section 7.0……Product realization ..........................................................................87.1 ...Planning of product realization .......................................................97.2 ...Customer related processes .............................................................97.3 ...Design and development .................................................................97.4 ...Purchasing .......................................................................................97.5 ...Production and service provision ....................................................107.6 ...Control of monitoring and measuring devices ................................10

Section 8.0 ……Management, Analysis and Improvement.......................................118.1 ...General ............................................................................................118.2 ...Monitoring and measurement .........................................................118.3 ...Control of non-conforming product ................................................118.4....Analysis of data ...............................................................................118.5....Improvement ...................................................................................12

Annex 1 ......Quality Policy.......................................................................................13Annex 2.......Organizational Chart.............................................................................14Document change history.......................................................................................... .15

Date issued:



1.0 INTRODUCTION

1.1 Quality Manual Scope

This Quality Manual has been created to demonstrate that [company] has implemented a quality system that indicates its commitment to quality and gives an assurance that the products developed, manufactured and/or distributed comply with the essential requirements of the standard ISO 13485:2003, MDD 93/42/EEC and the FDA Quality System Regulation (21CFR Part 820).

The purpose of this manual is to describe the manner in which the quality system is put into effect at [company].

Instruction and guidance is given to all who are connected with quality. This manual provides details of the overall quality policy of [company].

This manual cannot fully cover all aspects of quality assurance, and [company] publishes it with the knowledge that the quality of the products depends on the everyday action of all the individuals on its staff.

2.0 DISTRIBUTION AND REVISION

2.1 Distribution of this manual will be authorized by the management representative for quality.

2.2 An authorized controlled master copy will be held at [company] office.2.3 Authorized controlled copies shall be clearly marked as such and record will be

kept as to their location.

2.4 All revisions to this manual will be made by the manager within whose responsibility the particular section applies, and according to the company's Document Change Control Procedure.All revisions to this manual will be summarized in the Change History table on the last page.No revision will be issued until all approvals have been obtained from those functions who originally approved the manual or by their delegates.

3.0 PROCESS APROACH

Date issued:



The application of a system of processes within the company, together with the identification and interactions of these processes and their management, are referred to as the "process approach".

4.0 QUALITY MANAGEMENT SYSTEM

4.1 General requirements

4.1.1 [company] has established a quality management system and will maintain and continually improve its effectiveness.

4.1.2 The management of [company] has identified the processes needed for the quality management system and their application throughout the organization.

4.1.3 The management is also committed to ensure the availability of the resources and information needed to support the operation and to monitor the processes.

4.1.4 As some of the processes that affect product conformity with the requirements are outsourced, the management will ensure control over those processes.

4.2 Documentation requirements

4.2.1 The quality management system includes a documentation system consisting of:

- Quality policy statement (See annex 1)- A Quality Manual- Policy procedures detailing the requirements of ISO13485:2003, MDD 93/42/EEC

and FDA Quality System Regulation (21CFR Part 820) and ensure effective planning, operation and control of the processes and compliance with regulatory requirements.

- Forms and records to prove compliance with requirements.- Device Master Records for each product.

The hierarchy of the quality documents can be expressed in the following pyramid:

Quality Manual

Policy procedures

Date issued:



4.2.2 Document Approval and Issue

All documents will be reviewed and approved for the adequacy by authorized personnel prior to issue.All documentation is issued under strict control, which ensures that:

a) The pertinent issues of appropriate documents are available at locations where operations essential to the effective functioning of the quality system are performed.

b) Obsolete documents are promptly removed from all points of issue or use. The obsolete master copy is kept for a period of no less than FIVE YEARS AFTER LAST PRODUCTION or THE PRODUCT LIFE TIME (which ever is longer).

4.2.3 Document and Data Changes

Changes to documents will be reviewed and approved by the same functions that performed the original review and approval, unless specifically designated otherwise. The nature of any change will be identified in the Change History table on the last page of the document. All design changes are fully documented on the Document Change Request Form (FQM-42-002-01) detailing reason for change and affected documents and procedures.

4.2.4 Significant Changes

"Significant changes" must receive regulatory clearance prior to marketing. Significant changes are considered those that affect the safety or effectiveness of the device and/or will affect the scope of the certification received by [company] for its quality system or products. Such changes may be, but are not limited to: changing the intended use of the device, changing material or critical components, etc.

The following are changes that need to be reported to the regulatory authorities:

Product change NB FDA MOHChange in intended use or indications for use √ √ √Increase in safety risk √ √ √Changes in manufacturing process or final acceptance test √ - -

Work Instructions, protocols, specifications

Date issued:



Changes in sterilization method √ √ √Changes or addition of main subcontractors √ √ √Updating EC Declaration of Conformity √ - -Changes in the product labeling (if affect safety or effectivity)

√ √ √

Note: Reporting product changes to the FDA should be evaluated according to the guideline: Deciding when to submit a new 510(k) for a modified product”

4.2.5 Control of records

All records will be stored and maintained so that they remain legible and are easily retrievable. Procedure # QA-42-002 defines the controls needed for identification, storage, protection, retrieval, retention and disposition of records.

5. MANAGEMENT RESPONSIBILITY

5.1 Management commitment

The management of [company] is committed to implement its quality management system and maintain its effectiveness.The management has established a quality policy (See Annex 1) to provide safe and effective products and services to the customers through a commitment to quality that is understood, implemented and maintained at all levels of its organization.Quality objectives are established and reviewed as required through the Management Review procedure.

5.2 Costumer focus

The management has ensured that customer requirements are determined and are met, starting with the product development process. Several parts in the quality management system are implemented in order to prevent customer related problems and meet customer requirements – supplier approval and monitoring, internal audits, corrective and preventive actions, analysis of customer complaints, etc.

5.3 Quality policy

The quality policy of [company] is shown in Annex 1. This policy is available within the company to every employee and is periodically reviewed for its suitability.

Date issued:



5.4 Planning

5.4.1 The management has established measurable quality objectives, which are reviewed on a periodical base. Those objectives include monitoring of supplier quality, results of product testing, reports of internal audits, trend analysis of customer complaints.

5.4.2 Changes to the quality system may be recommended by all employees, but their implementation has to be approved by the CEO. The approval of any change to the quality system will be properly documented and will insure the maintenance of the system integrity.

5.5 Responsibility, authority and communication

5.5.1 The responsibility and authority of quality system functions will be carried out by the relevant managers as designated in the Organization Chart attached in Annex 2, to the Quality Manual.

5.5.2 The management representative, who has the responsibility for ensuring that the requirements of this manual are implemented, is the CEO.

5.5.3 The management maintains open communication channels with all employees in order to insure the effective implementation of the quality system. Those channels include formal and informal meeting of all managers with their employees as well as a periodical communication meetings held by the CEO with all employees.

5.6 Management review

5.6.1 The management reviews the suitability and effectiveness of the quality system every six months, including information on the following subjects:

a) Supplier/ subcontractors assessmentb) Process performance and product conformityc) Internal and external audits d) Customer feedback including complaints, reportable events and recalle) Corrective and preventive actionsf) Follow up action from previous reviewsg) Recommendations for improvementh) New or revised regulatory requirements

5.6.2 The summary report of the management review should include decisions recommending improvement of the effectiveness of the quality system, improvement of the product related to customer requirements and the resources needed.See details in Management Review Procedure (QM-56-001).

Date issued:



6. RESOURCE MANAGEMENT

6.1 Provision of resources

The management shall identify, provide and review the resources needed for implementation and maintenance of the quality system and for meeting regulatory and customer requirements.

6.2 Human resources

6.2.1 The personnel involved in activities which affect product quality have appropriate education, training skills and experience.

6.2.2 The management provides periodical training as detailed in procedure no. QA-61-0016.2.3 Appropriate records of the education and training of the company personnel are kept.

6.3 Infrastructure

6.3.1 The management shall provide and maintain the infrastructure needed to achieve conformity to product requirements. The infrastructure includes buildings, working space, equipment and utilities, supporting services. As the product related processes are performed by subcontractors, the management will ensure their compliance with the quality system requirements.

7 PRODUCT REALIZATION

7.1 Planning of product realization

7.1.1 Quality of procedures and services are planned and controlled at the levels of the organization through working, inspection and testing procedures, process and equipment verification and validation protocols, records to provide evidence that the product meets requirements.

7.2 Customer related processes

7.2.1 The management shall determine and document the requirements specified by the customer (including delivery and post-delivery activities, if applicable), regulatory requirements related to the product and any additional requirement determined by the management.

Date issued:



7.2.2 Prior to the commitment to supply a product to the customer (submission of tenders, acceptance of contracts or orders, etc) the appropriate personnel should ensure that the product requirements are defined, contract requirement differences are resolved and the company has the ability to meet the defined requirements. Records of such reviews are maintained (See procedure for Customer Related Processes no.QM-71-001).

7.2.3 The company shall implement risk management activities in compliance with standard ISO 14971. Records of such activities should be maintained. (See Risk Management procedure no. QA-71-002).

7.2.4 The company has determined and implemented effective communication channels with customers related to product information, contract and order handling, customer feedback (including customer complaints) and advisory notices.

7.3 Design and development

7.3.1 [company] is involved in development of new products and change to existing products. This process is conducted by approved subcontractors according to the Design and Development Control Procedure (QM-73-001)

7.4 Purchasing

7.4.1 The purchasing procedure (QM-74-001) describes the controls applied to the suppliers, sub-contractors and purchased product. The procedure details the criteria for evaluation and selection of suppliers. Records of the evaluation and re-evaluation of the approved suppliers are maintained.

7.4.2 Receiving inspection or other methods required to ensure the quality of the incoming products (as applicable) are described in that procedure.

7.4.3 Authorized representatives of the company may perform initial and/or periodic verification of the supplier or sub-contractor facilities. Such verifications should be conducted in accordance with procedure QM-74-001 and appropriate records should be maintained.

7.5 Production and service provision

7.5.1 The company shall plan and carry out production and service (by itself or by sub-contractors) under controlled conditions, which include:

- description of product characteristics- availability of documented procedures and work instructions- use of suitable equipment

Date issued:



- use of monitoring and measuring devices- implementation of monitoring and measurement - implementation of release, delivery and post-delivery activities- implementation of defined labeling and packaging operations to prevent labeling

errors.

7.5.2 Records should be kept for each batch in order to provide full traceability of components and distribution and identification of the quantity manufactured and the quantity released for distribution. Those records are reviewed and approved prior to release of the batch.

7.5.3 The company or its approved subcontractors shall perform validation of processes where the resulting output cannot be verified by subsequent testing. Validation shall demonstrate the ability of those processes to achieve planned results.

7.5.4 All components and products are properly identified. The identification procedure establishes the extent of traceability of the product and its components.

7.5.5 The status of each component or product is identified during storage in order to ensure that only product that has passed the required tests is released for production or distribution.

7.5.6 The shelf life of the product should be established and properly documented. The shelf life determination should indicate the requirement for any special storage conditions.

7.6 Control of monitoring and measuring devices.

7.6.1 The company shall determine the measuring devices needed to provide evidence of conformity of product and processes to requirements.

7.6.2 Measuring equipment is calibrated at determined intervals (See Control of Monitoring and Measuring Devices procedure QM-76-001), adjusted or re-adjusted as necessary, identified and protected from damage.

8.0 MEASUREMENT, ANALYSIS AND IMPROVEMENT

8.1 General

8.1.1 The company implements monitoring, measurement, analysis and improvement of the processes in order to demonstrate conformity of the product and of the quality management system and to maintain its effectiveness.

Date issued:



8.1.2 Applicable monitoring and analysis methods are established including statistical sampling and analysis.

8.2 Monitoring and measurement

8.2.1 Customer feedback is used to asses the performance of the quality system. A documented feedback system is established to indicate quality problems and for input into corrective and preventive actions.

8.2.2 The company conducts internal audits (See QA-82-001) at planned intervals to determine whether the quality system conforms to the requirements and is effectively implemented and maintained. Auditors conduct the audits with objectivity and impartiality. Actions are taken without delay to correct the discrepancies indicated in the audit report and their causes.

8.2.3 The processes performed in the company are monitored to demonstrate their ability to achieve planned results.

8.2.4 Product is monitored at appropriate stages of production in accordance with written procedures. Records are maintained to indicate conformance of the product to established requirements.

8.3 Control of non-conforming product

8.3.1 All non-conforming products are identified, segregated and evaluated before final disposition. (See Control of Non-Conforming Products Procedure QM-83-001) Appropriate action is taken to eliminate the cause of the detected non-conformity. Records of the non-conformities and subsequent action taken are maintained.

8.4 Analysis of data

8.4.1 The company is collecting and analyzing appropriate quality data to demonstrate suitability and effectiveness of the quality system. That analysis provides data related to customer feedback, conformity of product to requirements, trends of processes and suppliers. Records of that analysis are maintained and presented to the management for review.

8.5 Improvement

8.5.1 The company will issue advisory notices according to a written procedure (See Recall procedure – RA-85-005). Records are maintained for all customer complaints and their investigation results. (See Customer Complaint procedure – QA-85-002). Relevant

Date issued:



regulatory authorities in Israel, USA and Europe should be immediately notified of any reportable severe adverse event involving the company products (See Vigilance and MDR procedure – RA-85-004).

8.5.2 The company takes immediate action to eliminate the cause of any non-conformance in order to prevent its reoccurrence. The effectiveness of such actions is evaluated. (See QM-85-001).

8.5.3 The company determines the actions to be taken in order to prevent potential non-conformances. The effectiveness of such actions is evaluated. (See QM-85-001).

8.5.4 Applicability: The following provisions of standard ISO 13485 are not applicable to the activities carried out by [company] and are therefore excluded:

- Sec. 7.5.4 – Customer property – [company] does not receive or handle in any way products belonging to its customers.

- Sec.7.5.1.2.2 – Installation activities – The products distributed by Micromedic Technologies do not require installation

- Sec. 7.5.1.2.3 – Servicing activities - The products distributed by Micromedic Technologies do not require servicing

Date issued:



Annex 1

Quality Policy

[company] is committed to:

Developing, manufacturing and distributing products of high quality to meet customer requirements, while following international standards and regulations.

Maintaining open channels of communication with our customers.

Setting up a quality management system that defines the organizational structure, responsibilities, procedures and processes necessary for making sure our products are of high quality

Devoting the resources required for implementing this system and maintaining its effectiveness

_______________ XXX , CEO

Date:

Date issued:



Annex 2

Organization chart

Date issued:



Change History

Revision Level

Date Responsible Person Description of Change

1

quality manual example

Documents