XYZ Organization Quality System

Table of Contents

Quality System establishment for a Manufacturing Organization

Quality refers to the delivery of projects and products that meet the expectations of all the stakeholders. A project that may meet all the specifications of the client, but may overrun the project or batch schedule hence can not be terminated as a quality project. Lack of quality system results in extra costs to the management by increasing the storage and inventory costs. In order to bring down such risks, manufacturing units need to adopt different Quality models. One among such quality models for Manufacturing nits is the ISO system. Adopting the quality models allows the organization to identify the risk areas and constantly work on controlling the risk areas. So the current report presents the feasibility and the requirements to implement the ISO quality system for XYZ organization.

Relevancy to the Standard

XYZ is a manufacturer of computer components, hardware kits & electronic assemblies of finished goods. The activities include a variety of mechanical tooling & designing supplier parts coordination, billing, and invoice, etc., So it is recommended that ISO 9000:2000 will be a relevant standard for such contract-based manufacturing units.

ISO 9001:2000 quality management standard specifying organizational requirement to:

  • Demonstrate the organizational ability to provide consistently a product that meets customer and applicable regulatory requirements.
  • Address customer satisfaction through the effective application of the system, developing processes for continual improvement, and the prevention of errors and mistakes.

Management Commitment

The perceived benefits of the ISO 9001:2000 for the XYZ manufacturing unit are as follows:

  • The organization can experience a profit across different activities of the unit by improving the efficiency of operations, Less wastage, and continuity of quality processes.
  • The management can experience constant control over the key process areas.
  • The close monitoring of the processes against the quality standards the organization can reduce the insurance premiums over the contracts.
  • Risk management is possible through the identification of quality gaps in eh system.
  • As internal employee safety is one of the company’s policies, adoption of quality standards in the workplace will ensure it.
  • Possible increase in market capture by meeting the industry standards.
  • Increased worldwide reorganization through the adoption of global standards.

However, the disadvantages of the ISO 9000:2000 management concerns can be addressed in the following way:

  • Costly to obtain and maintain: While observing the pre-certification process close to the ISO standards, it can be easy to obtain the certification. Also by conducting the internal quality audits and by closing the Nonconformities from time to time maintenance will be easy.
  • Lengthy time-scale to obtain certification: Strong commitment and quick adherence to the standards will shorten the time scale to obtain the certification.
  • Time-consuming development: When a separate department is established with assigned roles and responsibilities, it will not consume the time of the main course of activities.
  • Difficult to implement: By thorough training and awareness generation the organization will be ready for the quick and easy implementation of quality practices.
  • Organizational and staff resistance to change: Awareness generation and performance evaluations included in the quality implementations will eliminate the resistance to change.
  • More Documentation: A clear statement of processes, functionalities will establish the organizational quality norms once and forever. Revisions and updating of documentation are only of minimal effort for great organizational return.

Quality policy

As the management has decided to implement the ISO Quality system, it is imperative to develop the quality policy to make the entire quality system frame around the policy. As the company’s mission statement specifies Customer satisfaction as a prime motto and internal employee safety and corporate responsibility as the key concerns of its every activity, the same should reflect in the Quality policy.

Communications strategy

In order to communicate the Quality activities around the organization, it is proposed to establish a Quality project team within the organization, which acts as a coordinator between management, employees, and the outside parties like external auditors and other supplier partners. The management initiatives are communicated to the Quality project team which consists of a Management representative, Quality manager, Quality coordinator, and process representative from each process of the organization.

Appropriate documentation

Though at the beginning documentation is necessary to define each process’s activities, requirements and to establish procedures and metrics the documentation becomes less once the system learns to work according to the established quality norms and policies.

  • Quality Policy: This is the policy that directs every other activity or document of the Quality system.
  • Quality Manual: This is the principle manual for an organizational quality system with defined objectives and procedures in general terms.
  • Quality Procedures: These are the operational procedures that determine the size and complexity of the organizational process and the scope of the quality system.

It contains detailed procedures under different sections along with document circulations and the authorization of different roles and responsibilities.

  • Forms and Records: Records the stored activities with working sheets or forms allowing the staff to enter their day-to-day activity reports.
  • Staff Training: The staff training can be conducted through the consultancy trained outside or internal professional, can be the Management representative to reduce the cost and to facilitate the timings of the internal staff.
  • Internal audit procedures: Once the Quality Management System (QMS) is ready it can be audited by the external party before the certification to identify any Nonconformities and to close them and to make the system ready for the ISO 9000:2000 certification. MR will be coordinating the internal and external audits from here onwards.

Certification requirements

The system should be read with proper management responsibility by appointing a Management Representative and Quality staff. The initiation of the QMS can be identified with the quality policy definition and funds and resource allocation by the management. The QMS readiness is required for certification with all the documentation ready and the closed Nonconformities in the external and pre audits.

Timeline

The entire QMS is proposed to be implemented with a span of 2 years with various phases at different timelines.

The following chart will present the timeline to obtain the ISO 9000:2000 certifications for XYZ company:

Timeline in Months
Activity 3 3 3 3 3 3 3 3
Preparation of Action Plan
Obtaining Management Commitment
Budget allocation
Resource allocation
Meeting with staff on QMS PLAN
Initiation of Quality Documentation
Management Review on Documentation
Document Authorization
Staff training on QMS
QMS Implementation
Metrics collection
Internal Audit
Closing of Non-Conformities
Pre-audit by external agency
Closing of Non-Conformities
Organization Readiness
Certification Audit process

References

Richard C. Randall, Randall’s Practical Guide to Iso 9000: Implementation, Registration, and Beyond (Engineering Process Improvement), Prentice Hall, 1995. BSI, ISO 9000:2000 Achieving Registration.

Matt Seaver, Implementing Iso 9000, Gower Publication, 2001.

David Hoyle, ISO 9000 Quality System Assessment Handbook , Butterworth- Heinemann, 1996.

Quality Systems In The Small Or Medium Sized Enterprise, 2008. Web.