1. Process approach

1.1 The quality management system is designed as a system of interrelated processes. All main activities in the company are defined as Quality System Processes (QSPs) and are grouped into the following six categories (refer to the diagram at the top of this section):

· Customer Requirements,

· Product Realization,

· Measurement, Analysis and Improvement,

· Management Responsibility,

· Resource Management, and

· Continual Improvement,

And are organized into a Plan-Do-Check-Act loop.

1.2 The sequence and interrelation between the six groups and individual QSPs are illustrated in a diagram at the beginning of this section (Quality System Processes Diagram). Every QSP is further defined in process sheets at the end of this section (Quality System Processes Sheets).

1.3 QSPs and their sub-processes are documented in this quality manual and in associated operational procedures and work instructions. The documentation defines these quality system processes and their sequence and interaction, and instructs on how to implement and apply them throughout the organization.

1.4 Quality system documentation also defines criteria and methods needed to ensure that the operation and control of quality system processes are effective. This includes assignment of responsibilities and allocation of resources for the process, instructions on how to carry out (or operate) the process, and definition of methods for monitoring and/or measuring the effectiveness of the process.

1.5 Quality Manual Section 4.2 and the corresponding Operational Procedure QOP-04-01, Quality System Documentation, explain in more detail how quality system processes are defined and documented.

2. Resources and information

2.1 Quality Assurance manager is responsible for determining resource and information requirements necessary to support the operation and monitoring of quality system processes, and for communicating these requirements to the top management. The top management is responsible for ensuring the availability of necessary resources and information. Quality Manual Section 6.1, Provision of Resources, explains in more detail how resource requirements are identified and satisfied.

3. Monitoring and measurement

3.1 Performance of quality system processes is systematically monitored and measured. This is to ensure their effectiveness and identify opportunities for improvement.

3.2 Performance of quality system processes is monitored through internal quality audits (refer to Quality Manual Section 8.2 and Operational Procedure QOP-82-02, Internal Quality Audits). The overall performance of the quality system is monitored by measuring customer satisfaction (refer to Quality Manual Section 8.2 and Operational Procedure QOP-82-01, Customer Satisfaction).

3.3 Quality system processes are reviewed and analyzed by the management review of the quality system (refer to Quality Manual Section 5.6 and Operational Procedure QOP-56-01, Management Review).

4. Continual improvement

4.1 Quality management system processes are regularly reviewed by the top management to identify any possible failures or breakdowns, as well as opportunities for improvement. Actions necessary to address actual or potential problems and to improve the quality system are implemented through corrective and preventive actions and through quality objectives.

4.2 Quality Manual Section 8.5 and Operational Procedures QOP-56-01, Management Review, QOP-54-01, Quality objectives, and QOP-85-03, Corrective and Preventive Actions, define how the quality management system itself ensures its own compliance and continual improvement.

5. Outsourced processes

5.1 When processes that affect product conformity are outsourced, special controls are implemented to ensure that these processes meet specified requirements. Such controls may include, as appropriate:

· Evaluation and pre-qualification of suppliers;

· Assessment of supplier realization processes and quality system;

· Flow-down of customer (contract) requirements,

· Monitoring of supplier quality performance;

· Requirements for process control, inspection, testing or other records demonstrating product conformity; and

· Verification of the supplied product.

Quality Manual Section 7.4 and Operational Procedures QOP-74-01, Supplier Evaluation, QOP-74-02, Purchasing, and QOP-74-03, Verification of Purchased Product, define these purchasing control processes.

5.2 Ensuring control over outsourced processes does not absolve BIOSCULPTURE TECHNOLOGY, INC. Inc. of the responsibility of conformity to all customer requirements.

QUALITY SYSTEM PROCESSES (QSP) SHEETS

BIDS, QUOTATIONS, ORDERS AND CONTRACTS
Purpose		To determine customer requirements, prepare bids and quotations, submit tenders, and take orders from, or enter into contracts with, customers.
Owner		Marketing, Sales and Customer Service departments
Process Inputs		§ Statements of product requirements and customer requirements received from customers (requests for quotations, inquiries, orders, etc.) § Legal, statutory and regulatory requirements § Product information, and information regarding lead times, inventory levels, engineering capabilities, production capabilities and capacities, etc. § Customer profiles and previous orders
Sub- Processes		§ Determining product requirements – QOP-72-01, QOP-72-02 § Determining customer requirements – QOP-72-01, QOP-72-02 § Evaluating capability and capacity to meet requirements – QOP-72-01, QOP-72-02 § Preparing quotations, bids and tenders – QOP-72-01, QOP-72-02 § Entering orders (or signing contracts) – QOP-72-01, QOP-72-02 § Preparing pick lists, and internal design and/or production work orders – QOP-72-01, QOP-72-02 § Receiving, entering and processing change orders – QOP-72-01, QOP-72-02
Process Outputs		§ Order confirmations § Product design orders § Production work orders § Pick lists § Change orders (design and/or production) § Sales records
PRODUCT DESIGN
Purpose		To design products meeting the design input requirements.
Owner		Design Engineering
Process Inputs		§ Product requirements § Customer requirements § Legal, statutory and regulatory requirements § Experience from similar designs
Sub- Processes		§ Planning and scheduling design projects - QOP-73-01 § Reviewing and controlling design input - QOP-73-01 § Performing design activities - QOP-73-01 § Conducting design reviews - QOP-73-01 § Establishing design output documents - QOP-73-01, QOP-42-02 § Verifying and validating product designs - QOP-73-01 § Controlling design changes - QOP-73-01
Process Outputs		§ Product design record (specifications, drawings, mathematically based data, material and parts lists, etc.) § Product acceptance criteria § Design review records § Design verification and validation reports (records) § Records of design changes
PLANNING OF PRODUCT REALIZATION
Purpose		To plan and develop processes needed for product realization.
Owners		Process Engineering, Production and Quality Assurance
Process Inputs		§ Product design record (specifications, drawings, mathematically based data, material and parts lists, etc.) § Customer requirements § Legal, statutory and regulatory requirements § Experience from similar processes
Sub- Processes		§ Determining quality objectives and requirements for products – QOP-72-02 and QOP-73-01 § Developing, verifying and documenting production processes (process flowcharts, process sheets, equipment setup instructions, tooling specifications, operator instructions, etc.) – QM 7.1, QOP-75-01 and QOP-75-02 § Establishing product acceptance criteria and product verification requirements (measuring, inspections, tests, etc) - QOP-72-02, QOP-73-01, QOP-74-03, QOP-82-04 and QOP-82-05
Process Outputs		§ Process flowcharts, process sheets, equipment specifications, tooling requirements, etc. § Process operator instructions § Production process verification and validation records § Product acceptance criteria and product verification plans
PURCHASING AND RECEIVING
Purpose		To select qualified vendors and to purchase from them materials, components, and services necessary for the manufacture and delivery of the product (for full scope of application refer to QOP-74-02, Purchasing).
Owners		Purchasing and Quality Assurance
Process Inputs		§ Purchasing requisitions, to include product description and identification, specification, quantity, required date, etc. § Quality requirements (quality system, product testing requirements, etc.) § Legal, statutory and regulatory requirements § Other requirements (packaging, marking, delivery, etc.)
Sub- Processes		§ Evaluating and selecting suppliers and subcontractors - QOP-74-01 § Maintaining a list of approved suppliers - QOP-74-01 § Preparing, reviewing and issuing purchasing documents - QOP-74-02 § Receiving purchased products - QOP-74-03 § Inspecting or otherwise verifying conformity of purchased products - QOP-74-03 § Applying, maintaining and recording purchased product identification and traceability - QOP-75-03 § Monitoring quality performance of suppliers - QOP-74-01 § Communicating with suppliers regarding their quality performance (notifications, requests for corrective actions, etc.) - QOP-74-01
Process Outputs		§ Approved supplier list § Purchase orders § Purchased products § Purchased product verification records § Identification of purchased product and its status § Records of supplier quality performance history § Records of communication with suppliers (notifications, CARs, etc.)
PRODUCTION
Purpose		To manufacture products conforming to requirements.
Owners		Production Manager and Warehouse Manager
Process Inputs		§ Product design records (specifications, drawings, mathematically based data, material and parts lists, etc.) § Product acceptance criteria § Manufacturing process design record (specifications, drawings, equipment, tooling, parameters, etc.) § Process operator instructions § Production work orders § Purchased products (materials, components, etc.)
Sub- Processes		§ Training process operators (on-the-job) - QOP-62-01 § Carrying out manufacturing processes - QOP-75-01 § Maintaining and recording product identification and traceability - QOP-75-03 § Handling, moving, storing and preserving materials and products - QOP-75-04 § Managing and operating storage areas and warehouses - QOP-75-05 § Maintaining production equipment and tooling - QOP-63-01
Process Outputs		§ Finished products § Finished product identification, configuration and traceability records § Production records § Inventory records
SHIPPING AND DELIVERY
Purpose		To package and dispatch finished products and deliver them to customers.
Owners		Warehouse Manager and Shipping Manager
Process Inputs		§ Shipping orders § Finished product release records (authorization) § Packaging requirements and specifications § Shipment labeling and marking requirements
Sub- Processes		§ Packaging products - QOP-75-06 § Labeling and marking shipments - QOP-75-06 § Preparing shipping documents - QOP-75-06 § Dispatching shipments (loading, fastening, protecting, and/or transferring custody to shippers) - QOP-75-06
Process Outputs		§ Products delivered to customers on time and in good condition § Shipping records
MONITORING AND MEASUREMENT OF PRODUCTS
Purpose		To verify conformity of products (in-process and final).
Owners		Quality Assurance and Production
Process Inputs		§ Product design record and acceptance criteria § Monitoring and measuring devices § Inspection and testing procedures (instructions)
Sub- Processes		§ Monitoring, measuring, and testing products - QOP-74-01, QOP-82-04 and QOP-82-05 § Identifying and controlling nonconforming products - QOP-83-01 § Applying and maintaining inspection status identification - QOP-75-03 § Releasing products - QOP-82-05
Process Outputs		§ Product verification records § Identification of nonconforming products § Identification of product status (pass/fail) § Product release records
MONITORING AND MEASUREMENT OF QUALITY MANAGEMENT SYSTEM (QMS)
Purpose		To verify conformity of the quality management system, and to evaluate its effectiveness and efficiency
Owners		Quality Assurance
Process Inputs		§ QMS requirements (ISO 9001 standard) § Internal audit (QMS) plans § Internal audit (QMS) checklists § Results of previous QMS audits § Quality system performance records, to include corrective and preventive actions, customer feedback and complaints, and customer satisfaction data.
Sub- Processes		§ Conducting internal audits of the quality system - QOP-82-02 § Analyzing and evaluating results of internal, third-party and customer audits – QOP-56-01 § Analyzing and evaluating quality system performance and customer satisfaction data and trends – QOP-56-01
Process Outputs		§ Internal audit findings and associated corrective actions § Results of third-party and customer audits § Conclusions regarding the conformity, effectiveness and efficiency of the quality system.
MONITORING CUSTOMER SATISFACTION
Purpose		To process customer feedback and complaints and to measure customer satisfaction
Owners		Customer Service
Process Inputs		§ Customer feedback and complaints § Notifications, CARs and performance reports from customers § On-time delivery and quality performance records § Customer-returned product
Sub- Processes		§ Receiving and logging customer feedback and complaints - QOP-72-03 § Processing and responding to customer complaints - QOP-72-03 § Handling and evaluating customer-returned product - QOP-83-01, QOP-85-01 § Gathering of information and data about customer satisfaction - QOP-82-01 § Analyzing, reporting and presenting customer satisfaction information and data (preparing reports, plotting charts, holding meetings, etc) - QOP-82-01, QOP-56-01
Process Outputs		§ Response actions to customer complaints § Returned product identification, documentation and disposition § Customer satisfaction information and data
MANAGEMENT POLICIES, PLANNING AND COMMITMENTS
Purpose		To define the quality policy and quality objectives, to plan the quality management system (QMS), and to implement management commitments.
Owners		Top Management
Process Inputs		§ Customer satisfaction data and trends § Quality performance data and trends § Results of internal and external audits § Results of management reviews of the quality system
Sub- Processes		§ Establishing quality policy – QM 5.3 § Establishing and monitoring of quality objectives – QOP-54-01 and QOP-56-01 § Planning the quality management system – QM 5.4 and QOP-56-01 § Defining responsibilities and authorities (including the responsibility for quality) – QM 5.5 § Appointing Management Representative – QM 5.5
Process Outputs		§ Quality policy § Quality objectives § Quality management system § Organizational structure (responsibilities, authorities and interrelation)
MANAGEMENT REVIEW
Purpose		To review the suitability and effectiveness of the quality system; to consider changes to the quality system, quality policy and quality objectives, and to identify opportunities for improvement.
Owners		Top Management (coordinated by Quality Assurance)
Process Inputs		§ Follow-up actions from previous management reviews § Results of internal and external audits, § Customer feedback and complaints § Product conformity data § Status of preventive and corrective actions § Changes that could affect the quality system § Customer satisfaction § Awareness and training programs § Quality policy and quality objectives
Sub- Processes		§ Presentation, discussion and evaluation of review input information (outlined in Process Input above) - QOP-56-01 § Determining changes required (if any) for the quality policy, quality objectives and the quality management system - QOP-56-01 § Identifying opportunities for improvement and defining improvement objectives and goals - QOP-56-01
Process Outputs		§ Revised quality policy (if changed) § New quality objectives § Actions to change/improve the quality management system, quality performance, and products.
HUMAN RESOURCES
Purpose		To define competency requirements, provide training, and ensure awareness about quality-related issues.
Owners		All departments (coordinated by Human Resources)
Process Inputs		§ Job (position) descriptions § Quality performance and corrective action data and trends
Sub- Processes		§ Determining competency requirements for jobs/positions affecting product quality- QOP-62-01 § Providing training and/or taking other actions to satisfy competency requirements – QOP-62-01 § Evaluating the effectiveness of training - QOP-62-01 § Providing awareness programs to ensure employee motivation, empowerment, and knowledge of quality-related issues. – QOP-62-01
Process Outputs		§ Defined competency requirements § Personnel competency and training records
PLANT, FACILITY AND EQUIPMENT
Purpose		To ensure appropriate and adequate facilities, production equipment and supporting services.
Owners		Plant Manager
Process Inputs		§ Manufacturing process requirements (capacity, raw materials, equipment, power, water, waste, etc) § Equipment maintenance requirements § Work environment and safety requirements § Requirements for supporting services
Sub- Processes		§ Plant, facility and equipment planning - QM 6.3 § Maintaining plant, facilities and manufacturing process equipment - QOP-63-01
Process Outputs		§ Plant, facility and equipment plans (floorplans, flowcharts, etc.) § Maintenance plans and records
INFORMATION RESOURCES (DOCUMENT CONTROL)
Purpose		To control documents related to products, manufacturing processes and the quality system; and to control quality records.
Owners		All departments (coordinated by Quality Assurance)
Process Inputs		§ Document control requirements § Record control requirements
Sub- Processes		§ Establishing documents needed by the organization - QOP-42-01, QOP-42-02 § Reviewing and approving documents - QOP-42-02 § Controlling document revisions and distribution (availability) - QOP-42-02 § Managing retention, storage, and disposition of records – QOP-42-03
Process Outputs		§ Reviewed and approved documents. § Document review, approval and distribution records
	MEASURING AND MONITORING DEVICES
	Purpose		To identify, maintain and calibrate monitoring and measuring devices.
	Owners		Calibration Lab
	Process Inputs		§ Monitoring and measurement requirements
	Sub- Processes		§ Selecting monitoring and measuring equipment - QOP-76-01 § Calibrating monitoring and measuring equipment – QOP-76-01 § Controlling monitoring and measuring equipment – QOP-76-01
	Process Outputs		§ Verified and calibrated monitoring and measuring equipment § Records of monitoring and measuring equipment calibration status and accuracy
	CONTINUAL IMPROVEMENT
	Purpose		To continually improve the quality management system, processes and products.
	Owners		All departments (coordinated by Quality Assurance)
	Process Inputs		§ Quality policy § Quality objectives § Results of quality management system audits § Records of manufacturing process and product nonconformities § Quality performance data § Customer satisfaction data and trends § Results of management reviews
	Sub- Processes		§ Collecting and analyzing quality performance data – QM 8.4 § Handling and evaluating customer complaints - QOP-72-03 § Requesting and implementing corrective and preventive actions – QOP-85-01 § Establishing, reviewing and updating the quality policy - QOP-56-01 § Establishing, implementing and monitoring quality objectives - QOP-54-01
	Process Outputs		§ Improved quality performance § Improved customer satisfaction