Our Quality System has been planned and implemented to meet our quality objectives and the requirements of 4.1 of the ISO 9001 standard. Quality planning takes place as changes that affect the quality system are planned and implemented. 

PRODUCT REALIZATION
Planning of product realization

Quality planning is required before new products or processes are implemented. The quality planning may take place as a design project, or according to the Planning of Product Realization procedure. During this planning, management or assigned personnel identify:

1. The quality objectives and requirements for the product,
2. Processes, documentation and resources required
3. Verification, validation, monitoring, inspection and test requirements, and
4. Criteria for product acceptance

The output of quality planning includes documented quality plans, processes, procedures and design outputs.

CUSTOMER-RELATED PROCESSES
Determination of requirements related to the product

Synergetics determines customer requirements before acceptance of an order. Customer requirements include those:

• Requested by the customer
• Required for delivery and post-delivery activities
• Not stated by the customer but necessary for specified use or known and intended use
• Statutory and regulatory requirements applicable to the product
• Additional requirements determined by Synergetics

Customer requirements are determined according to the Customer Related Processes Procedure.

REVIEW OF REQUIREMENTS RELATED TO THE PRODUCT

Synergetics has a process in place for the review of requirements related to the product.  The review is conducted before the order is accepted. The process ensures that:

• Product requirements are defined
• Contract or order requirements differing from those previously expressed are resolved
• Synergetics has the ability to meet the defined requirements
• Records are maintained showing the results of the review and any actions arising from the review
• Where a customer does not provide a documented statement of requirement, the customer requirements are confirmed before acceptance
• When product requirements are changed, Synergetics communicates changes to relevant personnel and amends relevant documents

CUSTOMER COMMUNICATION

Synergetics has implemented an effective procedure for communicating with customers in relation to:

• Product Information
• Enquiries, contracts and order handling, including amendments
• Customer Feedback, including customer complaints

DESIGN AND DEVELOPMENT PLANNING

The design and development procedure outlines the process for controlling the design and development process. The R&D Department plans design and development according to this procedure. The design plan includes:

• Design and development stages
• Required design reviews
• Verification and validation methods appropriate to each design and development stage
• Responsibilities and authorities for design and development
• Identification of the technical interfaces required for the project
• Updating of the design plan as the project progresses