ISO 9001 Quality Manual Template

QUALITY MANUAL Aligned to ISO 9001:2008

TABLE OF CONTENTS Page i

Revision No.

Description

Page

Revision History

i

Distribution

ii

Brief Company Profile

iii

Mission/Vision and Quality Policy

iv

Organizational Chart

v

Authorities and Responsibilities

vi

Scope and Exclusion

ix

Normative References

x

Terms and Definition

x

Quality Management System 4.1 General Requirements

1

4.2 Documentation Requirements

2

5.1 Management Commitment

5

5.2 Customer Focus

5

5.3 Quality Policy

5

5.4 Quality Planning

5

5.5 Responsibility, Authority, and Communication

6

5.6 Internal Communication

6

5.7 Management Review

7

6.1 Provision of Resources

8

6.2 Human Resources

8

6.3 Infrastructure & Work Environment

8

7.1 Planning of Product Realization

10

7.2 Customer Related Processes

10

7.3 Design and Development

12

7.4 Purchasing Activities

12

7.5 Production and Service Provision

13

7.6 Control of Monitoring and Measuring Equipment

15

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TABLE OF CONTENTS Page ii

Revision No.

Description

Page

8.1 General

17

8.2 Monitoring and Measurement

17

8.3 Control of Non-Conforming Product

20

8.4 Analysis of Data

21

8.5 Improvement

22

Annex 1 Quality Plan Annex 2 Master List of Quality Records

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DISTRIBUTION LIST Page i

Revision No. Date

Section/ Page/ Paragraph

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Revision No.

Authorized by:

Revision Details

DISTRIBUTION LIST Revision No.

The Quality Manual is distributed as follows:

COPY NO.

COPY HOLDER

1 (original)

Quality Management Representative

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2

Production

3

Department of Trade and Industry

Page ii

BRIEF COMPANY PROFILE Revision No.

Company Name: Plant site: Office Address: Brand name:

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Page iii

VISION, MISSION AND QUALITY POLICY Revision No.

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VISION STATEMENT

MISSION STATEMENT

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QUALITY POLICY

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ORGANIZATIONAL CHART Revision No.

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AUTHORITIES AND RESPONSIBILITIES Revision No.

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The responsibilities and authorities of the personnel involved in the Quality System are as follows: Manager 1. 2. 3. 4.

Approving authority for Quality Policy and quality related documents. Initiates Corporate Planning and Management. Responsible for the over-all operation of the plant. Responsible for securing the safety of the company’s assets, including the safety and health of its personnel. 5. Acts as Purchasing Officer a. Approves purchase requisitions. b. Approves the list of accredited suppliers 6. Ensures that product quality is maintained during all transactions. 7. Acts as Administrative and Personnel Officer a. Responsible for staffing, recruitment/hiring, evaluation of the employees’ performance, salary and benefit administration. b. Approves vouchers, payroll and checks c. Responds to customer complaints. 8. Has the legal personality and authority to enter into a contract in behalf of the company. 9. Allocates resources for the effective implementation of the quality management system. 10. Approves credit transactions and collection activities. 11. Ensures that the quality policy and other company policies are properly communicated and understood within the organization. Salesman 1. Responsible for the sales and marketing operations. 2. Conducts servicing activities. 3. Gathers customer satisfaction feedback.

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Technician 1. Responsible for the production operations. 2. Monitors the key characteristics of the manufacturing process. 3. Has the responsibility to control further processing in the event of nonconformance. a. Initiates actions to prevent the occurrence of any non-conformity relating to product or process. b. Identifies and records any problem relating to product or process and quality system. c. Verifies the implementation of the solution. 4. Inspects incoming materials and supplies. 5. Oversees the quality control related activities in the plant. 6. Performs inspection and testing in accordance with the quality plan 7. Performs other duties that may be required 8. Prepares the calibration program for all monitoring and measuring equipment that affect quality; Secretary 1. 2. 3. 4. 5.

Prepares the purchase orders and delivery receipts. Receives customer orders. Prepares sales invoice/delivery receipts. Receives customer orders. Maintains inspection records

Quality Management Representative 1. Ensures that quality management processes are established, implemented and maintained 2. Reports on the performance of the quality management system 3. Initiates the conduct of quality planning 4. Ensures that members of the organization are aware of customer requirements

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5. Represents the company in its dealings with the Bureau of Product Standards and Department of Trade and Industry in connection with ISO standard requirements and implementation Internal Quality Audit Officer 1. Plan and initiates the conduct of internal quality audit 2. Conducts verification audit to assure that corrective actions have been done on the non-conformances. 3. Maintains records of audits and their results. 4. Summarizes results of IQA and reports summary of findings during Management Review Document Control Clerk 1. Ensures that data and documents needed in the implementation of the quality system are controlled; 2. Coordinates and facilitates the revision of the manuals and other quality – related documents; 3. Records the proceedings of the management review and prepares the minutes of the meeting.

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The only area of the standard that we exclude is the requirement related to product design. The requirements for our products are prescribed in the relevant Philippine National Standard. As such, design and development is not part of our processes.

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TERMS AND DEFINITIONS Revision No.

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This terms and definitions given in ISO 9000:2005 applies to this document. NORMATIVE REFERENCES 2.1 ISO 9000: 2005 Quality Management Systems – Fundamentals and Vocabulary. 2.2 PNS 15-1:1989 2.3 PNS 15:1996 2.4 DAO 04:2008 2.5 ISO 9001:2008

TERMS AND DEFINITION This terms and definitions given in ISO 9000:2005 and DAO 4:2008 applies to this document. User-defined abbreviations and acronyms that are used in this document include the following: DCO – Document Control Officer IQAO – Internal Quality Audit Officer MME – Monitoring and Measuring Equipment QMS - Quality Management System aligned to the current ISO 9001 standard QMR – Quality Management Representative

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4.1 General Requirements The management has identified the following high level processes as well as their sequence and interaction for the quality management system and their application: The criteria and methods to ensure the effective implementation of Quality Management System processes is documented in a Quality Plan as shown in Appendix A. Management monitors, measures, and conducts analyses of these processes through Internal Quality Audits and other suitable methods. The management implements actions necessary to achieve planned results per procedures on Corrective and Preventive Action and Continual Improvement. Continual improvement of the quality management system

Management System related Processes

Requirements

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Product Realization Processes

Product (Output)

Customer (Satisfaction)

Customer

Measurement, Analysis and Improvement Processes

Resource Management Processes

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Documentation Requirements 4.1.1 General Our documented quality system includes the following: a. quality policy statement, b. quality objectives, c. quality manual, d. documented procedures required by ISO 9001, e. other documents needed to ensure effective planning, operation and control of processes, and f. records required by ISO 9001. The documented system ensures product conformance to customer requirements and conformance to the requirements of the standard. The documentation follows the hierarchy shown below

Quality Manual

Procedures Manual

Work Instructions

Technical Data, Forms, Logbooks, Records

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4.1.2 Quality Manual The quality manual includes the following: • The scope of the quality management system including details of and justification for any exclusions; • and

reference to all documented Quality System Procedures;

• A description of the interaction between the processes which make up the quality management system. 4.1.3 Control of Documents Documents required by the quality management system are controlled in accordance with the documented procedure. The procedure ensures that •

Documents are approved for adequacy prior to issue;

• Documents are reviewed at the start of every year and updated as necessary and that documents are re-approved; • Changes and the current revisions of documents are identified; • Relevant versions of applicable documents are available at points of use; •

Documents remain legible and readily identifiable;

• Documents of external origin that are necessary for the planning and operation of the quality management system are identified and their distribution controlled; and • Obsolete documents are managed to prevent unintended use and that documents retained for any purpose are suitably identified. A designated Document Control Officer is responsible for ensuring that the documents required by the quality management system are properly controlled.

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The manager reviews and approves all applicable documents for adequacy prior to issue. The Document Control Officer maintains a Master Document List that reflects the effective date and current revision level of all quality related documents. 4.1.4

Control of Records

Records are controlled in accordance with the established procedure for the identification, storage, protection, retrieval, retention and disposition of records. The secretary keeps a list of the Quality records maintained in the plant.

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5.1 Management Commitment Management commitment to support the development and implementation of the quality management system and its efforts for the continual improvement of its effectiveness is shown in the following manner: •

Conduct of meetings with personnel and staff to communicate the importance of meeting customer as well as statutory and regulatory requirements;

•

Establishment of quality policy;

•

Establishment of quality objectives;

•

Conduct of management reviews;

•

Ensuring the availability of resources.

5.2 Customer Focus The Manager ensures that customer requirements are determined and are met to enhance customer satisfaction. This is done by determining the requirements related to the product, as discussed in 7.2.1 and monitoring and measuring customer satisfaction, as discussed in 8.2.1. 5.3 Quality Policy Our quality policy shows our commitment to comply with requirements and to continually improve the effectiveness of our quality management system. It provides a framework for establishing and reviewing quality objectives. The QMR ensures that it is understood within the organization and is reviewed for continuing suitability. 5.4 Quality Planning The Manager ensures that quality objectives, including those needed to meet requirements for products, are established at relevant functions and levels within the organization. These objectives are measurable and consistent with the quality policy.

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Objectives and targets that are not achieved as planned are addressed with corrective actions. Top Management ensures that the integrity of the quality system is maintained when changes to the quality management system are planned or implemented. 5.5 Responsibility, Authority and Communication 5.5.1 Responsibility and Authority The responsibilities and authorities of staff at all levels are defined in the Organizational Chart. Job descriptions describe additional specific responsibilities and authorities of the personnel. 5.5.2 Quality Management Representative (QMR) The appointed QMR, irrespective of other responsibilities, has the responsibility and authority to: • Ensure the quality management system is established, implemented, and maintained, • Promote awareness of customer requirements throughout the organization. • Report to the top management on the performance of the quality system, including needs for improvement. • Coordinate communication with external parties on matters relating to the quality management system. 5.6 Internal Communication Communication processes are established via staff/departmental meetings and Management Review meetings. These activities also provide venue to communicate to the staff the effectiveness of the quality management system.

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5.7 Management Review A management reviews is conducted at least once a year, preferably one week after the conduct of the Internal Quality Audit to ensure that the quality management system is adequate, effective and still suitable to meet changing requirements. The review involves identifying improvement opportunities for and possible need for changes, including the quality policy and objectives. The agenda for the review include the following: • results of audits; • customer feedback; • process performance and product conformity; • status of corrective and preventive action; • follow-up actions from previous management reviews; • changes that could affect the QMS; and • recommendations for improvement. Outputs of the management review include decisions and actions leading to • • •

improvement of the effectiveness of the QMS and its processes; improvement of product related to customer requirements; and identified resource needs.

Personnel are informed of the management review schedule by the QMR through a memo. During the review, assigned personnel takes down the minutes according to the prescribed format. Records from management reviews are maintained by the secretary.

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6.1 Provision of Resources Resource requirements are identified and provided in order to implement and maintain the quality management system and continually improve its effectiveness. It is also done to enhance customer satisfaction and meet customer requirements. 6.2 Human Resources 6.2.1 General The manager ensures that personnel performing work affecting conformity to product requirements and customer satisfaction are competent on the basis of education, training, skills and experience. 6.2.2 Competence, Training and Awareness The Manager determines the necessary competence for personnel performing work affecting conformity to product requirements. Where applicable, management provides training or takes other actions to achieve the necessary competence. Where such is provided, the effectiveness of the actions taken is evaluated. Personnel are made aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objectives. Appropriate records of education, trainings, skills and experiences are maintained for all employees. 6.3 Infrastructure and Work Environment The Manager determines, provides and sees to the maintenance of the infrastructure necessary to achieve conformity to product requirements. The infrastructure includes, as applicable, buildings, workspace, and associated utilities, process equipment (both hardware and software), and supporting services such as transport, communication, or information systems. Approved for use by:

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The manager ensures that the work environment needed to achieve conformity to product requirements are determined and managed. Assigned personnel see to it that the workspace and the work environment are clean and well-maintained.

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Planning of Product Realization Top Management plans and develops the product realization processes in consonance with the requirements of the other processes of the quality management system. Planning involves the determination of the following: a) quality objectives and requirements for the product; b) processes, responsibilities, documents, and resources specific to the products; c) required verification, validation, monitoring, measurement, inspection and test activities specific to the product and the criteria for product acceptance; and d) records needed to provide evidence that the realization processes and resulting product meet the requirements.

7.2

Customer-Related Processes 7.2.1 Determination of Requirements Related to the Product Everyone in the organization takes efforts to determine a) The requirements specified by the customer, including requirements for delivery and post-delivery activities (e.g. actions under warranty provisions, contractual obligations such as maintenance services, and supplementary services such as recycling or final disposal); b) Requirements not stated by the customer but necessary for specified or intended use, where known; c) Statutory and regulatory requirements applicable to the product, and d) Any additional requirements considered necessary by the organization.

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7.2.2 Review of Requirements Related to the Product Authorized personnel reviews the requirements related to the product prior to making the commitment to supply the product to the customers (e.g. submission of tenders, acceptance of contracts or orders, acceptance of changes to contracts or orders). Review of requirements ensure that a) product requirements are defined, b) contract or order requirements differing from those previously expressed are resolved, and c) the ability of the organization to meet defined requirements. Records of the results of the reviews and actions arising from the reviews are maintained. In cases where the customer provides no documented statement or requirements, the customer requirements are confirmed before acceptance. This confirmation is recorded in a designated logbook. In cases where product requirements are changed, authorized personnel amend the relevant documents and inform relevant personnel of the changed requirements. 7.2.3 Customer Communication Management implements an established and effective arrangement to communicate with customers in the following areas:

7.3

•

product information,

•

enquiries, contracts or order handling, including amendments, and

•

customer feedback including customer complaints.

DESIGN AND DEVELOPMENT We exclude product design from the scope of our quality system. We do not implement product design. We manufacture products to fulfill

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customer-provided standards. 7.4

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specifications

or

broadly-accepted

reference

PURCHASING ACTIVITIES 7.4.1 Purchasing Process We ensure that purchased product conforms to specified requirements. The type and extent of control applied to the supplier and the purchased product is dependent upon the effect of the purchased product on subsequent product realization or the final product. We evaluate and select suppliers based on their ability to supply product in accordance with the requirements. Criteria for selection, evaluation and re-evaluation are established. Records of the results of evaluations and any necessary actions arising from the evaluation are maintained per Procedure on Control of Quality Records. 7.4.2 Purchasing Information Purchasing information describes the product to be purchased, including, where appropriate: • requirements for approval of product, procedures, processes and equipment, •

requirements for qualification of personnel, and

•

quality management system requirements.

The secretary ensures the adequacy of specified purchase requirements prior to their communication to the supplier. 7.4.3 Verification of Purchased Products Authorized personnel conduct inspection and other activities necessary to ensure that purchased products meets specified purchase requirements. Verification includes examination of supplierprovided test reports. Data contained in those reports may be verified Approved for use by:

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where necessary to indicate that that the material meets all applicable specifications. Should we or our customers intend to perform verification at our supplier’s premises, we will indicate the verification arrangements and methods of product release in the purchasing information. 7.5

PRODUCTION AND SERVICE PROVISION 7.5.1 Control of Production and Service Provision Production and service provision are planned and carried out under controlled conditions. Controlled conditions include, as applicable: •

the availability of information characteristics of the product;

•

the availability of work instructions, as necessary;

•

the use of suitable equipment;

•

the availability and use of monitoring and measuring equipment;

•

the implementation of monitoring and measurement; and

•

the implementation of release, delivery and post-delivery activities.

that

describes

the

7.5.2 Validation of Processes for Production and Service Provision Processes for production and service provision where the resulting output cannot be verified by subsequent monitoring or measurement, and as a consequence, deficiencies become apparent only after the product is used, are validated to demonstrate the ability of these processes to achieve planned results. For such processes, arrangements include the following: •

Defined criteria for review and approval;

•

Approval of equipment and qualification of personnel;

•

Use of specific methods and procedures,

•

Appropriate records, and

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revalidation

7.5.3 Identification and Traceability Products are identified by suitable means throughout product realization. Product status is identified with respect to monitoring measurement requirements throughout product realization.

and

Where traceability is a requirement, the unique identification of the product is controlled and records are maintained. 7.5.4 Customer Property Customer property maybe firecrackers and pyrotechnic units sent by customers to the company for check-up or for refilling. These units are identified, verified, protected and safeguarded. If any customer property is lost, damaged or found to be unsuitable for use, authorized personnel report this to the customer and maintain records. 7.5.5 Preservation of Products The product is preserved during internal processing and delivery to the intended destination in order to maintain conformity to requirements. Personnel are properly trained to provide identification, ensure proper handling, appropriate packaging, storage and protection of the product. Preservation also applies to the constituent part of the product such as parts and accessories. 7.6 Control of Monitoring and Measuring Equipment Monitoring and measurement activities are undertaken based on the quality plan. Management provides the necessary monitoring and measuring equipment to provide evidence of conformity of product to determined requirements. Established processes 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. To ensure valid results, measuring equipment is Approved for use by:

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a) calibrated or verified or both, at specified intervals, or prior to use, against measurement standards traceable to international and national measurement standards; where no such standards exist, the basis used or calibration or verification will be recorded; b) adjusted or re-adjusted as necessary; c) identified in order to determine its calibration status; d) safeguarded from adjustments measurement result; e) protected from damage maintenance and storage.

or

that

would

deterioration

invalidate during

the

handling,

When the equipment is found not to conform to requirements, authorized personnel will assess and record the validity of the previous measuring results. Appropriate actions will be taken on the equipment and any product affected. The production personnel maintain records of the results of calibration and verification.

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GENERAL Measurement, Analysis and Improvement Processes for monitoring, measurement, analysis and improvement are planned and implemented to a) demonstrate conformity to product requirements, b) ensure conformity to product requirements, and c) continually improve the effectiveness of the quality management system. Planning includes the determination of applicable methods, including statistical techniques, and the extent of their use.

8.2

Monitoring and Measurement 8.2.1 Customer Satisfaction As one of the measurement of the performance of the quality management system, authorized personnel will monitor information relating to customer perception as to whether we have met customer requirements. Appropriate methods to collect and use information include the deployment and collection customer satisfaction surveys, determination of customer data on delivered product quality, compliments, warranty claims and analysis of repeat business. 8.2.2 Internal Audits Internal audits are conducted at least once a year to determine whether the quality management system a) conforms to planned arrangements (product realization plans) to the requirements of ISO 9001:2008, the relevant PNS, and to the established quality management system requirements b) is effectively implemented and maintained.

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The internal audit officer prepares the audit programme, taking into consideration the following: •

status and importance of the processes and areas to be audited, and

•

results of the previous audit.

The audit programme indicates the audit criteria, scope, frequency, and methods to be used. The selection of auditors and the conduct of the audit process are done in a manner that will ensure objectivity and impartiality of the audit process. Auditors will not audit their own work. An established documented procedure defines the responsibilities and requirements for planning and conducting audits, establishing records and reporting results. Records of the audits and their results are maintained by the Quality Management Representative. The management responsible for the area being audited ensures that necessary corrections and corrective actions are taken without undue delay to eliminate detected nonconformities and their causes. Follow up activities include verification of the actions taken and the reporting of verification results (see 8.5.2). 8.2.3 Monitoring and Measurement of Processes The quality management system processes, especially: sales, production, internal quality audit, document control, records control, control of nonconforming products, corrective action, and preventive action are continually monitored and, where applicable, measured, using suitable methods to demonstrate the ability of the processes to achieve planned results. Where planned results are not achieved, correction and corrective action is taken, as appropriate. The identification of the methods to be employed take into consideration the type and extent of monitoring and measurement appropriate to each Approved for use by:

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processes in relation to their impact on the conformity to product requirements and on the effectiveness of the quality management system. 8.2.3 Monitoring and Measurement of Products Production personnel monitor and measure the characteristics of the product to verify that product requirements have been met. This is carried out at appropriate stages of the product realization process in accordance with planned arrangements. Records to show evidence of conformity with the acceptance criteria are maintained. We maintain records for all orders showing the results of all monitoring, inspection and testing, including the responsibility authorizing product release. Product release does not normally proceed until the planned arrangements have been satisfactorily completed, unless otherwise approved by the customer or by a relevant authority.

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Control of Non-Conforming Product Products which do not conform to product requirements are identified and controlled to prevent its unintended use or delivery. A documented procedure defines the controls and related responsibilities and authorities for dealing with nonconforming products. The manner by which nonconforming products are dealt with may be done in any of the following manner: a)taking action to eliminate the detected nonconformity; b)authorizing its use, release or acceptance under concession by a relevant authority and, where applicable, by the customer; c) by taking action to preclude its original intended use or application; d)by taking action appropriate to the effects, or potential effects, of the nonconformity when nonconforming product is detected after delivery or use has started. When nonconforming products are corrected, it is subjected to reverification to demonstrate conformity to the requirements. Records of the nature of nonconformities and any subsequent actions taken, including concessions obtained, are maintained. 8.4

Analysis of Data To demonstrate the suitability and effectiveness of the quality management system and to evaluate where continual improvement of the effectiveness of the quality management system can be made, appropriate data will be determined, collected and analyzed. This includes data generated as a result of monitoring and measurement and from other relevant sources. Analysis of data provide information relating to a)customer satisfaction, b)conformity to product requirements,

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c) characteristics and trends of processes and products, including opportunities for preventive action, and d)suppliers. 8.5

Improvement 8.5.1 Continual Improvement The effectiveness of the quality management system is continually improved through the use of the quality policy, quality objectives, audit results, analysis of data, corrective and preventive actions and management review. 8.5.2 Corrective Action Actions are taken to eliminate the causes of nonconformities in order to prevent recurrence. Corrective actions are appropriate to the effects of the nonconformities encountered. A documented procedure defines the requirements for: a) reviewing nonconformities (including customer complaint); b) determining the cause of nonconformities c) evaluating the need for action to ensure nonconformities do not recur; d) determining and implementing action needed, e) records of the results taken, and f) reviewing the effectiveness of the corrective action taken. 8.5.3 Preventive Action Actions are taken to determine causes of potential nonconformities to prevent their occurrence. Preventive actions are appropriate to the effects of the potential problems. A documented procedure defines requirements for a) Determining potential nonconformities and their causes;

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b) Evaluating the need for action to prevent occurrence of nonconformities, c) Determining and implementing action needed, d) Records of results of action taken, and e) Reviewing the effectiveness of the preventive action taken.

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ANNEX 1 QUALITY PLAN Revision No.

PROCESS

RESPONSIBI

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WHAT

WHO

HOW

KEY FACTORS/CRITERIA

(RESOURCES NEEDED)

(COMPETENCE REQUIRED)

(PROCEDURES/ INSTRUCTIONS/ REFERENCE)

LITY

(PROCESS CRITERIA)

PERFORMANCE INDICATOR

(OUTPUT CRITERIA)

(MEASUREMENTS/ FINDINGS)

100% of information in the Master List of Controlled Document is updated 100% of information in the Master List of Records is updated Implemented as scheduled

QMS Processes

Control of QMS Documents

DCO

Office supplies equipment Work space

and Personnel trained on ISO 9001:2008

Control of QMS Practical and easy Documents, to implement QMS-01

Documents are relevant, updated and available

Control of Quality Records

DCC

Office supplies equipment Work space

and Personnel trained on ISO 9001:2008

Control Records, QMS-02

Management Review

QMR

Office supplies equipment Work space

and Personnel trained on ISO 9001:2008

Policy on Management Review

Timeliness Practical and easy to implement

Records are legible, readily identifiable and retrievable Complete and accurate information

Office supplies equipment

and Trained Personnel

Training, RM-01

Practical and easy to implement

Competent personnel with

of Practical and easy to implement

Resource Management Processes

Training

Manager

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Updated and complete

ANNEX 1 QUALITY PLAN Revision No.

PROCESS

RESPONSIBI

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WHAT

WHO

HOW

(RESOURCES NEEDED)

(COMPETENCE REQUIRED)

(PROCEDURES/ INSTRUCTIONS/ REFERENCE)

KEY FACTORS/CRITERIA

LITY

(PROCESS CRITERIA)

(OUTPUT CRITERIA)

PERFORMANCE INDICATOR (MEASUREMENTS/ FINDINGS)

appropriate education, training, skills and experience

Maintenance of Infrastructure and Work Environment

Manager

Office supplies equipment Work space

and Trained and Experienced Personnel

Policy on Infrastructure and Work Environment

Practical and easy to implement

Office supplies equipment

and Trained and Experienced

Policy on Planning of

Practical and easy to implement

Personnel Records Updated Training Plan Updated Personnel Evaluation Record Infrastructure Well-maintained and work infrastructure environment and work suitable for environment production and company operations

Product Realization Processes

Planning of Product Manager Realization

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Information in Resources Quality Plan provided for

ANNEX 1 QUALITY PLAN Revision No.

PROCESS

RESPONSIBI

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WHAT

WHO

HOW

(RESOURCES NEEDED)

(COMPETENCE REQUIRED)

(PROCEDURES/ INSTRUCTIONS/ REFERENCE) Product Realization

KEY FACTORS/CRITERIA

LITY

Maintenance tools and equipment Work space Customer Process

Purchasing

Personnel

(PROCESS CRITERIA)

Related Manager

Office supplies equipment Work space

and Trained and Experienced Personnel

Policy on Ease of Customer deployment and Related Process implementation

Manager

Office supplies equipment Work space

and Trained and Experienced Personnel

Policy on Ease of Purchasing deployment and implementation Supplier Evaluation, PR-01

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PERFORMANCE INDICATOR

(OUTPUT CRITERIA)

(MEASUREMENTS/ FINDINGS)

properly disseminated within the organization Information properly disseminated within the organization Purchased products conform to requirements: MAP:75% min purity Clean Extinguishing Agent: 99% minimum purity

when required

Customer Satisfaction On time deliveries

Updated Master List of Accredited Suppliers 100% of purchased products meet specifications

ANNEX 1 QUALITY PLAN Revision No.

RESPONSIBI

PROCESS

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WHAT

WHO

HOW

(RESOURCES NEEDED)

(COMPETENCE REQUIRED)

(PROCEDURES/ INSTRUCTIONS/ REFERENCE)

KEY FACTORS/CRITERIA

LITY

(PROCESS CRITERIA)

Production Process Control

Manager

Production Equipment Work space Materials Monitoring and Measuring Equipment

Trained and Policy on Ease of Experienced Production deployment and Personnel Process implementation Control

Control of Monitoring and Measuring Equipment

Technician

List of Calibration Service Providers Supplies and Materials Work and storage space

Trained and Policy on Control Experienced of Monitoring Personnel and Measuring Equipment

Ease of deployment and implementation

Work space Office Supplies and Materials

Trained and Experienced Personnel

Ease of deployment and implementation

Identification Traceability

and Technician

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Policy on Identification and Traceability,

(OUTPUT CRITERIA) Cylinder and Accessories: per PNS Products that meet the PNS requirements

Accurate and valid monitoring and measurement results Products are suitably identified

PERFORMANCE INDICATOR (MEASUREMENTS/ FINDINGS)

Updated Production Records Updated Process Control Documents All MME have updated calibration status

All products can be easily identified whether they have “passed”

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RESPONSIBI

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WHAT

WHO

HOW

(RESOURCES NEEDED)

(COMPETENCE REQUIRED)

(PROCEDURES/ INSTRUCTIONS/ REFERENCE)

KEY FACTORS/CRITERIA

LITY

Handling Property

Customer Technician

Preservation Product

of Technician

Production Equipment Work space Supplies and Materials

Trained and Experienced Personnel

Policy on Handling Customer Property

Production Equipment Work space Supplies and Materials

Trained and Experienced Personnel

Policy on Preservation of Product

Trained and Experienced Personnel

Internal Audits, QMS-06

(PROCESS CRITERIA)

(OUTPUT CRITERIA)

Ease of deployment and implementation

Customer property are properly identified, verified, protected and safeguarded. Ease of Products deployment and conform to implementation requirements throughout internal processing and delivery

PERFORMANCE INDICATOR (MEASUREMENTS/ FINDINGS) or “failed” testing. Updated Records

No customer complaints

Measurement, Analysis and Improvement Processes

Internal Audit

Internal Quality Audit

Production Equipment Work space

Approved for use by:

Timeliness Ease of deployment and

Complete and accurate reports

Activity implemented as scheduled

ANNEX 1 QUALITY PLAN Revision No.

PROCESS

RESPONSIBI

Page vi

Effective

WHAT

WHO

HOW

(RESOURCES NEEDED)

(COMPETENCE REQUIRED)

(PROCEDURES/ INSTRUCTIONS/ REFERENCE)

KEY FACTORS/CRITERIA

LITY

Officer

Monitoring and Measurement of QMS Processes

QMR

Monitoring and Measurement of Product

Technician

Control of Nonconforming Product

Technician

Supplies and Materials Standards Office Equipment Production Equipment Work space Supplies and Materials Standards Production Equipment Work space Supplies and Materials Standards Monitoring and Measuring Equipment Production Equipment Work space Supplies and Materials Standards

Approved for use by:

(PROCESS CRITERIA)

(OUTPUT CRITERIA)

PERFORMANCE INDICATOR (MEASUREMENTS/ FINDINGS)

implementation

Trained personnel

Trained and Experienced Personnel

Trained and Experienced Personnel

Policy on Monitoring and Measurement of QMS Processes Policy on Monitoring and Measurement of Product

Control of Nonconforming Product, QMS-03

Ease of deployment and implementation

Accuracy

100% Attainment of Objectives

Ease of deployment and implementation

Accuracy Reliability

Updated records on monitoring and measurement of products

Ease of deployment and implementation

Complete and Corrective Accurate Actions taken Reports on Nonconforming products

ANNEX 1 QUALITY PLAN Revision No.

PROCESS

RESPONSIBI

Page vii

Effective

WHAT

WHO

HOW

(RESOURCES NEEDED)

(COMPETENCE REQUIRED)

(PROCEDURES/ INSTRUCTIONS/ REFERENCE)

KEY FACTORS/CRITERIA

LITY

Corrective Action

QMR

Preventive Action

QMR

(PROCESS CRITERIA)

Monitoring and Measuring Equipment Work space Supplies and Materials Office Equipment

Trained and Experienced Personnel

Corrective Action, QMS-04

Ease of deployment and implementation

Work space Supplies and Materials Office Equipment

Trained and Experienced Personnel

Preventive Action, QMS-05

Ease of deployment and implementation

Approved for use by:

(OUTPUT CRITERIA)

PERFORMANCE INDICATOR (MEASUREMENTS/ FINDINGS)

Complete and Corrective Accurate Actions Reports promptly implemented Complete and At least one Accurate preventive Reports action implemented

ANNEX 3 MASTER LIST OF QUALITY RECORDS Revision No.

Description

Page i

Effective

Responsibility

Retention Period (yrs)

Location

Disposition

QMS Records Audit Program Corrective Action Report Management Review Master List of Controlled Documents Master List of Records Preventive Action and Continual Improvement Report Sales Records Charge Invoice Customer Order Logbook Customer Complaints Log Customer Satisfaction Report Delivery Receipt Pull-out Receipt Purchase Order Sales Invoice Service/Inspection Report

Secretary Secretary Secretary DCC

3 3 3 Indefinite

Admin Office Admin Office Admin Office Admin Office

Shredding Shredding Shredding Not applicable

DCC QMR

Indefinite 3

Admin Office Admin Office

Not applicable Shredding

Secretary Secretary Secretary Secretary

3 3 5 5

Admin Office Admin Office Admin Office Admin Office

Shredding Shredding Shredding Shredding

Secretary Secretary Secretary Secretary Secretary

3 3 3 3 5

Admin Office Admin Office Admin Office Admin Office Admin Office

Shredding Shredding Shredding Shredding Shredding

Indefinite Indefinite

Admin Office Admin Office

Not applicable Not applicable

Human Resource Development Records Annual Training Program Secretary Employee 201 File Secretary

Approved for use by:

ANNEX 3 MASTER LIST OF QUALITY RECORDS Revision No.

Description

Page ii

Effective

Responsibility

Retention Period (yrs)

Location

Disposition

Performance Evaluation

Secretary

Indefinite

Admin Office

Not applicable

Purchasing Records List of Accredited Suppliers Purchase Requisition Slip Supplier Evaluation Record

Secretary Secretary Secretary

5 5 5

Admin Office Admin Office Admin Office

Shredding Shredding Shredding

Secretary Technician

5 5

Admin Office Production Area

Shredding Shredding

Technician Secretary Technician Secretary Technician

5 5 5 5 5

Production Area Production Area Production Area Production Area Production Area

Shredding Shredding Shredding Shredding Shredding

Production Records Calibration Certificates Inspection and Test Records Incoming Refilling Record List of MME Maintenance Record PIPAC Test Result Production Logbook

Note: shredding may be done manually or by the use of a mechanical shredder.

Approved for use by: