ABOUT the ISO Quality Management System
Today, more than ever, there is a worldwide trend towards increasingly stringent customer expectations regarding quality. A single worldwide standard was needed to simplify international standards.
The result: The International Organization for Standardization (ISO)
This gave rise to ISO. Located in Switzerland, ISO is the specialized international agency for standardization and the source of ISO 9000 (Quality Management System). Established in 1947, it is an association of approximately 149 National Standards Bodies which each represent their own country.
ISO 9000 has become synonymous with quality. ISO 9000 translates "quality management" into a continuously improving process designed to meet or exceed customer and regulatory requirements.
Sigma Hellas Limted has an ISO 9001:2008 Registered Quality Management System. We successfully achieved ISO 9001:2000 in December of 2002, and we are continuously improving and evolving our services, processes and procedures.
Overview of ISO as applied
1.1 - Management responsibility
This clause defines the responsibilities of senior management related to designing and implementing the quality system. It ensures that a quality policy is created, implemented, managed, followed up and understood by employees. Quality management review meetings are held annually at our company. Within these meetings, we review our entire quality system and adjust as necessary. We are constantly striving to achieve new goals to ensure complete customer satisfaction.
1.2 - Quality system
We are required to establish, document and maintain a quality system to ensure that our products conform to both customer requirements and our own. Within this clause is the need to document the quality system by creating a quality manual. The quality manual references applicable procedures within the quality system. This allows us to be consistent in all we do.
1.3 - Contract review
This clause encompasses how we review and change customer contracts to ensure accurate and timely delivery of our products to our customers.
1.4 - Document and data control
Included within this clause is the stipulation that all documentation and data must be controlled. Authorized personnel before release must approve documentation, and the revision status of all documentation is to be easily identified to eliminate the chance of using invalid or obsolete documentation. Any changes to documentation must be approved and reviewed by the person who authorized the original document. This ensures product is built right the first time, on time.
1.5 - Purchasing
Procedures are required to ensure purchased products conform to requirements. All suppliers are evaluated and approved prior to purchase. Suppliers must be able to meet all of our required specifications. All purchase orders are to be approved and all requirements are to be clearly stated. This provides the assurance that the correct parts arrive on time.
1.6 - Control of customer supplied product
This clause stipulates that any product supplied to Sigma Hellas Ltd is to be properly verified, stored and maintained. Any losses or damages are to be reported to the customer.
1.7 - Product identification and traceability
Product is to be easily identified from receipt and during all stages of production and delivery. If traceability is required, product is identified with batch or serial numbers, and all data is documented.
1.8 - Process control
All processes are carried out under controlled conditions. These conditions include documented procedures, suitable equipment, and compliance with applicable procedures, monitoring of parameters and characteristics, approval of processes and equipment, workmanship standards, and maintenance of equipment. This provides confidence in our production process and equipment.
1.9 - Inspection and testing
All product is inspected and tested (as applicable) before receipt, as the product is in process and before shipping. Records are kept as evidence that the product was properly inspected and tested.
1.10 - Control of inspection, measuring and test equipment
This ensures that all of our inspection, measuring and test equipment is controlled, calibrated and maintained at regular intervals. All of our equipment is clearly marked to enable us to determine the status at a glance. This enables us to produce accurate reading products.
1.11 - Inspection and test status
All product is easily identified to allow us to determine the status of the product. Product is easily identified to allow us to determine if it has been inspected and tested before release to our customers.
1.12 - Control of nonconforming product
Any product found nonconforming to requirements is identified and segregated to prevent usage. Appropriate personnel are notified of nonconforming product and results are documented for further evaluation. Results are evaluated and appropriate corrective actions are taken.
1.13 - Corrective and preventive action
Action is taken in the event of actual or potential nonconformities. Problems are documented with the appropriate solution and are implemented immediately to correct or prevent recurrence.
1.14 - Handling, storage, packaging, preservation and delivery
Procedures exist to ensure correct handling, storage, packaging, preservation and delivery of products. This enables us to use quality components to build quality products.
1.15 - Control of quality records
Quality records are identified, collected, accessed, filed, stored and maintained to demonstrate conformance to requirements.
1.16 - Internal quality audits
Sigma Hellas Ltd. performs internal audits on our quality system annually. These enable us to determine how to improve our procedures and quality system. All results are recorded and reviewed. Corrective action is taken on any discrepancies found, and a follow up is performed to ensure the effectiveness of the action taken. The results become a part of the annual management review.
1.17 - Training
Documented procedures exist for training of employees. Specific needs and skills are noted to ensure complete understanding of the job functions to be performed. This provides us with confidence in our employee's abilities.
1.18 - Servicing
We have procedures in place in the event a product fails to perform to your satisfaction. These procedures ensure timely evaluation, repair/replacement and return of your product.
1.19 - Statistical techniques
Statistical techniques are used for data collection, analysis and application. We use them for finding root causes of problems, nonconformity avoidance, problem analysis and risk determination.
Finally ISO 9001:2008 only introduces clarifications to the existing requirements of ISO 9001:2000 and some changes intended to improve consistency with ISO 14001:2004. There are no new requirements.