QMS INITIAL ASSESSMENT

KAPCO Manufacturing, Inc.

Date: June 2, 2009

Program Objectives:

ISO 9001:2008 Certification, New application.

Enhance QMS to align with current organizational structure and business process
Work on possible application of management softwares

Program Commencement: June 2, 2009

Target Completion: Last Week of November 2009

Nature of Business: Surface treatment and plating process

Scope of Certification: Provision of Surface treatment and plating process

Previous Certification: June 2008 Validity under MOODY International

Number of Employees: 170

ISO 9001:2008 Assessment Result

ISO CLAUSE EXISTING SYSTEM CURRENT STATUS REQUIREMENTS REMARKS

4.0 Quality Management Business Process Map Not updated - Established, document, implement, Identify Business needs and organizational set-
System Quality Manual Not updated maintain and improve the QMS up.
4.1 General Requirements Procedures Updated effectiveness.
Work Instructions Not updated - Business Processes Description Design and Develop QMS based on the current
Quality Plans Updated - Control of Outsourced Process business process and organizational structure.
Records
Conduct Business Process Mapping Session.
4.2 Documentation Quality Manual based on Not updated - Documented Quality Policy and Needs updates and revision in compliance to
Requirements ISO 9001:2000 Objectives ISO 9001:2008
4.2.1 General - Quality Manual
4.2.2 Quality Manual - Procedures and records
- Extent of documentation depends on
the organization
4.2.3 Control of Documents Procedure: Control of Implementation on going, Documents and records required by the Alignment with current business operation and
Documents & Control of records are updated and QMS must be controlled. ISO 9001:2008.
Records maintained.
4.2.4 Control of Records
5.0 Management
Responsibility
5.1 Management
Commitment
5.2 Customer Focus
5.3 Quality Policy
5.4 Planning
5.4.1 Quality Objectives
5.4.2 QMS Planning
5.5 Responsibility, Authority
and Communication
5.5.1 Responsibility and
Authority
In-charge: 2 DCC Documented procedure is required for Try Implementation of Document Control
personnel Archive room maintained documents and records control. Software.
- Access & Filing System not
implemented in some Orientation of staff and employees on
departments document and records control is
recommended.
President: Mr. Y. Kurosaka President: Active Required evidence of commitment for Recommend system or process for top
VP: Mr. T. Kurosaka VP: Based in Japan QMS development, implementation and management involvement and participation.
GM: Mr. R. Naito GM: Based in Japan Improvement.
Check how this requirement is being met and
Ensure customer requirements are recommend a system or process in order to
determined and are met with the aim of comply
enhancing customer satisfaction.
Quality Policy The Same, currently used, Appropriate to the purpose of the A review of Quality Policy content is
documented and posted evidence of continuing review organization. recommended.
not available
Includes commitment to comply with Check if the Policy provides framework for
requirements & continually improve the establishing objectives, what does this really
QMS effectiveness. mean?
Provides a framework for establishing Check method of review and communication
objectives and how are these defined in the QMS
Is communicated and understood
Needs review for continuing suitability
Department Goals, Not established for the Top management must ensure quality Review and develop guidelines for setting and
targets, measurable previous years objectives including those needed to monitoring quality objectives.
objectives. meet requirements for the product are
established at relevant functions and
levels within the organization.
Must be measurable and consistent with
the quality policy
Must ensure planning of QMS is carried Develop guidelines for the Conduct of QMS and
QMS and Business Not performed since 2006 out. Ensure the integrity of QMS is Business Planning.
Planning maintained when changes are planned
and implemented.
Organizational Stucture - Updated Must ensure responsibilities and Review of Manpower job assignments and
Job Descriptions - Not updated, some not authorities are defined and departmental functions is recommended.
Authority & Approval available communicated
Matrix - Not updated Study the need for re-allocations of job, vs
Departmental/Functional hiring and transfer of employees.
Description - Not updated
Set appointment and schedule for organizing

5.5.2 Management
Representative
5.5.3 Internal Communication
5.6 Management Review
5.6.1 General
5.6.2 Review Input
5.6.3 Review Output
6 Resource Management
6.1 Provision of resources
6.2 Human resources
6.2.1 General
6.2.2 Competence, training
and awareness
activity.
Develop or revise documentation when
necessary.
Appointed QMR - Existing and employed MR must be appointed by top Review position and appointment of MR
- Records not updated management and must be a member of
the management.
Shall have responsibility and authority: Check how the MR should meet the
- Ensure that the QMS is established, responsibility and authority requirements. Set
implemented and maintained guidelines or incorporate in the system when
- Reporting the performance of the QMS necessary.
- Ensuring the promotion of awareness
of customer requirements
- Meetings - Existing and regularly Check the need for allocating bulletin boards
- Memos conducted and other internal communication processes.
- Bulletin Boards - Memos still circulated
- Bulletin Boards are used
Management Review Last Management Review Shall review the QMS at planned Review System for the conduct of management
Meeting at least twice a Year 2006 intervals to ensure its continuing review. Set guidelines when necessary.
year. suitability, adequacy and effectiveness.
Required Inputs
Required Outputs
Records shall be maintained (1)
PPC and Warehouse - Implemented and Shall determine and provide resources Review the existing system and align It with the
process 2 In charge maintained needed to: current organizational set-up and ISO
HR procedure 1 HR - Implemented and - Implement and maintain the QMS and 9001:2008 requirements.
personnel Maintained continually improve its effectiveness
Accounting procedure 2 - Implemented and - To enhance customer satisfaction by Identify available records to demonstrate
In charge maintained meeting customer requirements compliance.
Job Specifications - Existing not updated Personnel performing work affecting Review the existing system and align it with the
Competency Statement - Existing and not updated conformity to product requirements shall current business needs and requirements of
Training Procedure - Partially implemented mostly be competent. ISO 9001:2008.
general orientation
Training In-charge 1 HR Determine the necessary competence.
Officer
Where applicable provide training or
other actions to achieve the necessary
competence.
Evaluate the effectiveness of the action
taken.
Ensure personnel awareness

6.3 Infrastructure
6.4 Work environment
7.0 Product Realization
7.1 Planning of Product
realization
7.2 Customer-related
processes
7.2.1 Determination of
requirements related to the
product
7.2.2 Review of requirements
related to the product
7.2.3 Customer
Communication
7.4 Purchasing
7.4.1 Purchasing process
7.4.2 Purchasing Information
7.4.3 Verification of purchased
product
Facilities and maintenance
Procedure
1 Staff
Clean room procedure
Health and Safety
program
Product Planning and
realization.
Sales Marketing Flow
Test Run
Quality Plan
Sales and Marketing Flow
Purchasing procedure
1 Purchasing Staff
Inspection & Testing - Implemented but records are
receiving inspection.
- Warehouse staff
-Partially implemented, some
records not updated
-Some improvements in
facilities
-Implemented and
maintained
-Not established
-Not fully implemented.
-Not fully implemented
-Implemented, records not
available
- Sales and Marketing section
removed in current
organizational chart.
- Sales marketing are mostly
performed by mother
company or the Japanese
management
- Former System is currently
not implemented.
- System is partially
implemented
not maintained.
- Performed by purchasing
Records shall be maintained (2)
Shall determine, provide and maintain
the infrastructure needed to achieve
product conformity.
-Buildings, workplace and associated
utilities
-Process equipment (both hardware and
software)
-Supporting services (such as transport,
communication or information systems)
Determine and manage the work
environment needed to achieve
conformity to product requirements.
Review the existing system and align it with the
current business needs and requirements of
ISO 9001:2008.
Review the existing system and align it with the
current business needs and requirements of
ISO 9001:2008.
Review the existing system and align it with the
current business needs and requirements of
ISO 9001:2008.
Review the existing system and align it with the
current business needs and requirements of
ISO 9001:2008.
Review the existing system and align it with the
current business needs and requirements of
ISO 9001:2008.
7.5 Production and service
provision
7.5.1 Control of production
and service provision
7.5.2 Validation of processes
for production and service
provision
7.5.3 Identification and
traceability
7.5.4 Customer Property
7.5.5 Preservation of product
7.5.6 Control of monitoring
and measuring equipment
8.0 Measurement Analysis
and Improvement
8.1 General
8.2 Monitoring and
Measurement
8.2.1 Customer Satisfaction
8.2.2 Internal Audit
Production Schedule (PPC -Implemented but records are Clarify guidelines when should be a WIS be
Flow) not available. provided.
- 2 Staff Review the need for establishing SOP or
Operations Manual.
SOP not established -WIS Complete and posted
WIS available -Production Records
Production Reports maintenance Partially
implemented
QC-Engg Process - System not fully Review the existing system and align it with the
Test Run implemented current business needs and requirements of
Inspection and Testing - Records not available ISO 9001:2008.
- Performed under supervision
of Production Manager
Identification and - Not fully implemented, Review the existing system and align it with the
Traceability records not maintained. current business needs and requirements of
ISO 9001:2008.
Control of Customer - Not fully implemented and Review the existing system and align it with the
Property maintained. current business needs and requirements of
ISO 9001:2008.
Preservation of Product - Implemented but not in Review the existing system and align it with the
Inventory Management accordance with designated current business needs and requirements of
function. ISO 9001:2008.
- Under
Warehouse
Control of Monitoring and - Implemented but some Review the existing system and align it with the
Measuring device. lapses is assumed. current business needs and requirements of
ISO 9001:2008.
Performed under
maintenance section
Statistical Techniques - Not fully implemented Identify the need for the application of
statistical techniques and other measurement
analysis and improvement activities.
Identify training needs and provide the
training.
Sales & Marketing - Not fully implemented Review the existing system and align it with the
current business needs and requirements of
ISO 9001:2008.
Internal Audit Procedure - Not fully implemented Review the existing system and align it with the
current business needs and requirements of
ISO 9001:2008.

8.2.3 Monitoring and
measurement of processes
8.2.4 Monitoring and
measurement of product
8.3 Control of Nonconforming
Product
8.4 Analysis of Data
8.5 Improvement
8.5.1 Continual Improvement
8.5.2 Corrective Action
8.5.3 Preventive Action
Conducted by:
Norlito M. Suelo
MST Consulting & Training Services
Noted by:
Aprilyn Armintia
KAPCO Manufacturing Inc.
Inspection and Testing - Implemented and records
maintained.
Inspection and Testing - Implemented and records
maintained.
Control of Nonconformity - Not fully implemented
Quality Manual - Not fully implemented
Quality Manual - Not fully implemented
- More on facility
Continual Improvement Improvement
programs
Corrective Action - Only external concerns with
Procedure issued corrective action
records
Preventive Action - Preventive action not fully
Procedure implemented.
Identify training needs and provide the training
Review the existing system and align it with the
current business needs and requirements of
ISO 9001:2008.
Review the existing system and align it with the
current business needs and requirements of
ISO 9001:2008.
Review the existing system and align it with the
current business needs and requirements of
ISO 9001:2008.
Identify and Classify data needed for gathering
and analysis.
Identify continual improvement programs
suited for the company.
Review the existing system and align it with the
current business needs and requirements of
ISO 9001:2008.
Review the existing system and align it with the
current business needs and requirements of
ISO 9001:2008.