Overview

ISO 9000 is a set of quality management standards approved by the International Standards Organization (ISO) that defines a quality assurance program. It can be applied to all kinds of organizations in a variety of areas. Adherence is accomplished through an application process for ISO 9000 certification in company standards for inspecting production processes, updating records, maintaining equipment, training employees, and handling customer relations. The standards require that a basic quality system be in place to ensure that the company has the capabilities and systems to provide its customers with quality products and services. It is not a standard for ensuring a product or service is of quality; rather, it attests to the process of production, and how it will be managed and reviewed.

Benefits

Some of the perceived – and actual – benefits experienced by certified companies include:

• Well defined and documented procedures improve the consistency of output.
• Documented procedures are easier for new employees to follow.
• Reduction and variability resulting from both documentation and the use of statistical techniques to monitor the system.
• Using their registration to help develop and expand business, particularly those areas where registration is a prerequisite for doing business.
• Reduction or elimination of customer audits.
• Increased profitability/reduced costs.
• Improved communications, both internal and external.
• Greater awareness of quality by employees, accompanied by enhanced pride in their jobs and contribution to the company's quality system.
• Supplying training to all personnel.
• Ability to remain/become competitive in the markets.
• Realization that meeting the requirements is not rocket science but common sense.
• Elimination of redundancy.
• Quality is constantly measured.
• Customer satisfaction, and more importantly, customer loyalty, grows.
• Procedures ensure corrective action is taken whenever defects occur.
• Defect rates decrease.
• Defects are caught earlier and are corrected at a lower cost.
• Defining procedures identifies current practices that are obsolete or inefficient.
• Organizations retain or increase market share, increasing sales or revenues.

Back to top

The Challenge

The following issues may impact a company in its registration efforts:

• Limited resources ­ when asked, most companies will normally identify money, personnel, and time as their most problematic resources.
• Lack of analysis tools for managing the portfolio.
• Overlapping of responsibilities – each employee most likely wears a number of hats, thus limiting the amount of responsibility that can be placed on each person. The challenge for the company becomes finding ways not to overburden its employees.
• Difficulty in adoption and standardization of quality management initiatives across the organization.
• Time – the company may be pressured by customers to implement a quality management system within a certain time frame or potentially lose their business.
• Supporting cultural change throughout implementation.
• Unable to analyze interdependencies across different projects.
• Implementing an effective team structure with management support.
• And many others.

All of these are significant challenges. However, the implementation and registration of a management system helps an organization achieve continuous performance improvement.

To deal with all these challenges, an integrated and automated management system can certainly be of great help.

ISOSYSTEM is a web-based management system, designed to help you to meet ISO requirements easily and effortlessly.

ISOSYSTEM provides organizational efficiency, process control, and flexibility to help simplify the tasks involved in managing data and information. It will also help your organization make better decisions in managing the content and process that drive your business.

Back to top

ISOSYSTEM Compliance Mapping

Each ISOSYSTEM module addresses key compliance issues as shown below:

ISOSYSTEM Module	ISO 9000 Compliance and Requirements
Document	Manage the creation, review, approval, and distribution of documents. Document the Quality Management System. Prevent unintended use of incorrect documents. Automate document protection and retention rules. Enterprise-wide involvement in the process of document changes. Ensure only the latest document versions are used.
Action	Problem causes are identified and registered. Specific problems and their causes are corrected. Effectiveness of corrective actions assessed. Nonconforming products are controlled to prevent inadvertent use or installation. Review and disposition of nonconforming product is formalized. Ensure that appropriate corrective action is decided upon and implemented. Ensure that responsibility for corrective action is clearly defined. Keep records of all complaints and follow-up actions. Correct any deficiencies before they can cause defects in products or processes. Keep records of defects, the investigation of their cause, and the corrective actions.
Audit	Audits are planned and performed. Results of audits are communicated to management. All findings are corrected and registered. Manage any required corrective action. Ensure corrective actions are carried out on time.
Process	Ensure production (and installation) processes are defined, planned, and documented. Production shall be carried out under controlled conditions: documented instructions, in-process controls, approval of processes and equipment, and criteria for workmanship. Ensure processes are monitored and controlled.
Competence	Identify training needs. Keep records of all trainings. Ensure staff performance are regularly appraised and recorded. Ensure lack of skills of qualifications is found, staff need to attend internal or external training courses. Keep information up to date enabling staff to adequately operate equipment they are responsible for. Ensure qualified individuals are assigned to proper tasks.
Calibration	Identify measurements to be made. Identify affected instruments. Calibrate instruments (procedures and status indicators). Check calibration periodically. Ensure no unregistered or overdue equipment is used. Assess measurement validity if found out of calibration. Ensure measurement uncertainty and equipment capability are known. Identify equipment which does not need to be calibrated. Trace equipment measurements to national or international standards. Document calibration steps for each piece of equipment.
SPC	Verify acceptability of process capability and product characteristics. Ensure that required characteristics of processes and products are monitored and measured. Document procedures to implement and control the statistical techniques identified. Ensure action plans are taken when out-of-control signals are detected.
Inspection	Ensure incoming materials are inspected or verified before use. Keep records of inspections. Ensure final inspection is performed prior to release of finished product. Keep record of the results of supplier evaluations and follow-up actions.
Maintenance	Keep records of all maintenance work. Ensure unique identification of each piece of equipment. Keep records of equipment calibration and maintenance. Document equipment instructions – usually supplied by the manufacturer. Ensure that equipment operates within specifications. Provide maintenance schedule to ensure no equipment is overlooked.
Project	Ensure projects are initially planned then approved. Estimate initial project time, costs, and deliverables. Identify, document, review, and approve all project changes and modifications. Ensure critical path assessment. Provide WBS & Milestone plan. Keep record of all project meetings. Ensure project tasks are performed and verified.

Back to top

Industries

Automotive
Financial Services
Energy & Utilities
Food & Beverage
Manufacturing
Public Sector & Associations
High-tech
Healthcare
Pharmaceuticals & Biotechnology

Back to top