Quality Standards: ISO 9001: 2015
The Scope of ITI’s Quality Management System
M01 - Scope of Quality Management System
This scope has been produced in line with the requirements of the latest quality management system standard ISO9001:2015 Clause 4.3. We will ensure that it is made available to all interested parties.
The scope details the types of products and services covered and justification for any requirements not covered by the scope.
Scope of our Management System
Transom Scopes is a U.S. engineering-based firm with operations in Westfield, Massachusetts. The Quality Management System (QMS) documentation is written and implemented to meet the requirements of ISO 9001:2015 with a scope of registration for: The Design, Manufacture and Repair of Scopes for Industrial, Law Enforcement, Veterinary and Medial Applications. Customers are both domestic and international.
The scope of our management system includes the following:
- The manufacture of all products and provision of services as specified in the customer order and confirmed in the Order Acknowledgement
- The procurement of all material resources used in the manufacture of our products and service provision
- Supplier selection, evaluation and relations, material quality, service and delivery
- Business and manufacturing infrastructure maintenance and housekeeping
- Human resource management, safety, capabilities, development, performance
- Compliance with Federal, State and Local employment, health and safety and environmental regulations
- All clauses of ISO 9001:2015 are applicable to this QMS
M02 - Quality Policy
We have established this quality policy to be consistent with the purpose and context of our company. It provides a framework for the setting and review of objectives in addition to our commitment to satisfy applicable customer, regulatory and legislative requirements, as well as our commitment to continually improve our management system.
Customer focus: As an organization, we have made a commitment to understand our current and future customers’ needs; meet their requirements and strive to exceed their expectations.
Leadership: Our Top Management have committed to creating and maintaining a working environment in which people become fully involved in achieving our objectives.
Engagement of people: As an organization, we recognise that people are the essence of any good business and that their full involvement enables their abilities to be used for our benefit.
Process approach: As an organization, we understand that a desired result is achieved more efficiently when activities and related resources are managed as a process or series of interconnected processes.
Improvement: We have committed to achieving continual improvement across all aspects of our quality management system; it is one of our main annual objectives.
Evidence-based decision making: As an organization, we have committed to only make decisions relating to our QMS following an analysis of relevant data and information.
Relationship management: We recognise that an organization and the relationship it has with its external providers are interdependent and a mutually beneficial relationship enhances the ability of both to create value.
Our policy is also to meet the requirements of other interested parties and in meeting our social, environmental, regulatory and legislative responsibilities.
We have produced quality objectives which relate to this policy and they can be found in document R03 Quality Objectives.
This policy is available/communicated to all interested parties as well as being made available to the wider community through visual postings in work spaces and high traffic areas, company literature and publication on our Website.
At ITI, we live and breathe ISO quality standards. We never stop striving for continuous improvement in everything we do.
ITI was started in 1967 to develop custom remote viewing instruments for the then-expanding commercial and government nuclear power industry. The customers were predominately US government facilities. In this period ITI learned the basics and continuously improved our capabilities by taking on difficult projects. Many contracts required MIL-I-45208 quality standards. ITI has maintained a quality system for this requirement.
During the early 1990s world-wide quality renaissance, we had been involved with a plethora of quality programs including TQM, Continuous Improvement, Benchmarking, Malcolm Baldrige National Quality Award, etc. While all these programs have admirable goals, the implementation of them was rather overwhelming and did not provide the clear and concise message that ITI management desired.
In early 1995 we learned of ISO 9000 and chose to implement it solely to advance our business practices. ITI’s incentive was to create a more solid foundation to grow the company. It provided a very consistent message throughout the company, and it was an attainable goal, for our background had always been focused in quality assurance.
We had a unique opportunity to take advantage of world-class training in our own backyard. The University of Massachusetts at Amherst, School of Management (UMass) had developed a summer training course, in conjunction with the training arm of British Standards Institution Quality Assurance (BSI). BSI is the world’s largest certification body and one of the originators of the ISO 9000 system. Several professors created a summer-long training course that initiated several local businesses into the requirements of ISO 9000. They hired BSI professionals to participate in this training.
Our development history of ISO 9001 compliance:
The UMass/BSI program helped us to a very good beginning toward becoming ISO 9001 compliant. The finale of this program was a day-long audit of our quality system by one of the BSI professionals.
ITI was audited to ISO 9001 by Origin Medsystems, Inc. in February. Their audit report contained three findings. ITI addressed these issues with a corrective action plan in March, and our plan was accepted by the auditor in April.
In the summer of 1996, UMass and BSI worked with another group of companies. At the end of the program, UMass contacted ITI with an offer to have a BSI consultant return to our facility for a check-up audit. We gladly accepted. Another day-long audit was performed on October 1st. The auditor expressed to us that he was very impressed with our quality system and that ITI was ready for certification.
ITI was audited to ISO 9001 on April 1st by an aerospace industry customer, Chandler Evans. ITI received one Minor Nonconformity regarding its implementation of ISO 9001, a semantic preference with respect to the wording of our procedure. He found no fault with our practices.
ITI received an ISO 9001:2015 “gap analysis” audit by IMSA International accredited ISO audit company. The audit summary stated ITI was compliant with ISO 9001:2015. Continuous improvement opportunities included the requirement to 1) Strictly enforce our company QMS communication plan, 2) Demonstrate our efforts of continuous improvement in everyday activities, and 3) Demonstrate our company goals with top leadership owning the QMS.
ITI continues to aspire to even greater heights and better operations. One of the tools we use is the ISO 9000 required internal audit. ITI performs an audit each month on one of the 20 sections of the ISO 9000 standard. We also welcome customer audits; we feel they are wonderful learning experiences.
ITI has achieved the desired results it set out to obtain by implementing ISO 9001. We maintain that ITI is an ISO 9001 compliant company. However, with our recent change in ownership, our new owners recognize the market needs and new customer requirements that ITI not only be ISO 9001 compliant, but also ISO 9001:2015 certified. We are scheduled for an ISO 9001:2015 certification audit in November 2017. Following certification we will then strive for ISO 13485 Medical Device Standard.