Micro-Poise Measurement Systems (a business unit of Amatec, Inc.) provides a complete line of high performance production and laboratory equipment used by manufactures globally to meet their test, measurement and inspection requirements. This equipment allows customers in the Tire, Wheel, and Automotive industries to assess and correct the balance, uniformity and geometry of tires, wheels, tire & wheels assemblies, power train components, and other products.
Recognizing the value of a solid quality management system, Amatec Micro-Poise began working with simpleQuE consultant, Jen Briese in March 2018 to implement ISO 9001. By July they passed their certification audit with Smithers Quality Assessments with no findings. It’s evident this team works hard to provide exceptional craftsmanship with every machine they build. And by designing and manufacturing quality products, they will always strive to exceed their customers’ expectations.
Whether facing a surveillance audit from a certification body or preparing for an internal quality audit – knowing what you face and being prepared puts you a step ahead. Review this checklist which covers the majority of the QMS requirements.
Who or what are the:
What are the resources needed for the process?
Are these resources appropriate?
Are authorities and responsibilities for required resources defined, documented and known throughout the organization?
Are these persons competent?
Are competency criteria defined? What are these criteria? How is competency evaluated, approved and monitored, and by which method(s)?
Are these methods effective? – refer to outputs
Are the resources adequate? Which are they?
Are records available and appropriately maintained?
What are the inputs to this process?
Are these inputs documented and reviewed by competent persons?
Is a description of the processes available and documented?
Are these descriptions controlled? – Verify the effectiveness of the organization’s documented information control procedure.
Who are the “customers” (internal and external) of the processes? What are the requirements of these customers?
What are the characteristics of the intended results of the process?
What are the characteristics of the unintended results of the process?
Are correction and corrective action applied as appropriate?
What are the criteria for monitoring, measurement and analysis?
How are these criteria incorporated into the planning of the processes?
Are the business performance issues taken into proper account?
What methods are used for data gathering?
What records are kept and how these are maintained?
What are the communication channels?
How is external and internal information about the process provided? What are the outputs of the process? – Identify outputs.
Do these outputs provide evidence of effective implementation of the process?
How is process performance monitored?
Are appropriate controls defined?
What measurements are applied?
How is the gathered information analyzed?
How are the results of the analysis taken into account?
How is feedback obtained?
What data is collected?
Is the issue of improvement of the processes properly addressed? How? What are the results?
SimpleQuE offers free sample manufacturing process audit checklists for AS9100, ISO 9001 and IATF 16949 which can be used as an example to examine a company’s key manufacturing process and prepare your company for the highest internal quality auditing possible.
The ISO 9001 standard exists to provide organizations with the opportunity to develop baseline quality management systems, improve processes and meet the needs of customers. Achieving ISO 9001 certification is an important step for manufacturers and service providers, as it emphasizes performance while proving a dedication to quality and customers.
As ISO 9001 certification has been adopted across a wide range of industries, the standards have been altered to fit specific industry requirements. From the automotive and aerospace industries to telecommunications companies, laboratory settings, medical device manufacturers and more, each industry has adopted its own set of standards that all derive from the basic principles of the ISO 9000 series.
What are the Benefits of ISO 9001 Certification? There are a variety of advantages to having ISO 9001 certification. It creates a more efficient, effective operation for a company, if implemented properly, and also improves employee awareness and motivation, and increases customer satisfaction. Here are some additional reasons to get ISO 9001 certified:
Client Requirements – More and more customers are demanding that their vendors be certified. If your business doesn’t meet this criteria you could be losing out on sales.
Increased Revenue – Studies show that ISO 9001 certified organizations are paid 7% more on average, have better sales growth and an improved ROA. (source: iso.org)
Reduce Waste – By establishing the rigor of an ISO 9001 Quality Management System, you can reduce inefficiency and make the most of your business’ time and resources.
Brand Image – Maintaining quality in your organization minimizes the chance of a slip up or error that could hurt your reputation.
Manage Risk – ISO 9001:2015 is all about managing risk. By adopting these standards you will learn how to best identify and mitigate threats to your business model.
Most importantly, as your company grows, becoming certified is vital to fostering continued success in the future.
SimpleQuE – ISO 9001 Certification Experts
SimpleQuE (an ISO 9001 certified company) assists organizations with implementation, improvement or transition of the standards by providing customized ISO 9000 consulting, training and internal auditing services and solutions. Contact us for more information or to hire an ISO 9001 consultant.
Powder Processing & Technology, LLC has maintained ISO 9001 certification since 1998 and just transitioned to the latest version – ISO 9001:2015. PPT’s professionals have assisted the top materials technology companies around the world for over 30 years. The company performs process development and contract manufacturing on a wide range of powders, and has a fully equipped pilot plant as well as multiple production areas specializing in spray drying, calcining and firing
PPT uses the formulas and processing parameters provided by their customers and/or develops the formulations and processing parameters of the products produced for customers. Therefore precise process control is necessary to meet high quality standards. For that reason in 2012, PPT brought in simpleQuE to conduct its quarterly internal audits. Kenneth Bartelt, President, said, “PPT is a small technology company which places significant weight on its quality management system and which needs to ensure its valuable and limited technical resources are focused on customer requirements and our ability to deliver results.”
“We consider the quality system to be part of the fabric of our management system and simpleQuE has added a critical component to that system,” added Ken. “I think that simpleQuE has a practical approach to quality management that is effective and efficient.” In the case of PPT, the commitment to maintaining quality standards is evident and practiced from the highest level of management to their plant workers.
SimpleQuE matched PPT to auditor/consultant, Don Milinkovich, whose 34 years in the chemical manufacturing business made him the right fit. “Don is an experienced and personable consultant who has delivered meaningful audits and provided relevant expertise. Our audits have been at the right level of detail and have made a significant contribution to the business. The performance from simpleQuE has been such that the registrar’s representative and auditor has been very complimentary of the service they have performed,” stated Ken regarding the benefits of working with an experienced auditor. Don also worked with the PPT team to prepare them for a smooth transition to the new standard.
These internal audits have reinforced the objectives of PPT to maintain high levels of service and customer satisfaction while utilizing the principles of ISO 9001 to incorporate continual improvement into their business practices.
Twenty years ago small businesses focused on one thing: how to make profits. Today, environmental impact is turning out to be just as important as meeting the bottom line. Here’s how to manage it for growth:
Incorporate planning – the very first place to start with addressing environmental impact and risks is to include them in strategic planning at every level. Because ISO 14001 is the cornerstone of environmental standards for a business, planning is essential. If the matter isn’t addressed to begin with from the top down, one of two things occur: 1) no one internally treats the matter as a priority, and 2) responses that do occur end up being ad hoc and disparate, which often incurs more costs than expected.
Anticipate that not everyone will be happy at first – getting environmentally focused is still a politically-charged approach. Education is probably the best response, even though it may require a bit more effort. At the end of the day, however, socially-conscious businesses sometimes have to stake out a claim. Choose wisely and then stay the course.
Embrace leadership – businesses that really break out and become the major players using ISO 14001 as their environmental management system are not necessarily the biggest in their industry. Smart businesses are out ahead looking for these leadership opportunities to craft their own path and market niche before anyone else.
Use size to an advantage – Being a small business comes with a lot of advantages in terms of flexibility and speed for adjusting to changes. Rather than a big bureaucracy involved in shutting down an assembly line, small business can test the waters far more rapidly and frequently with new ideas in environmental impact and that’s a huge competitive advantage when used effectively.
Don’t throw out the baby with the bath water – Every new change should have a thorough cost-benefit analysis. There are plenty of existing quality management procedures that align with ISO 14001, including ISO 9001 and IATF 16949.
SimpleQuE offers customized consulting solutions for all sizes of Aerospace, Automotive, Laboratory, Manufacturing and Service organizations. When it comes to environmental impact and responsibility, ISO 14001 certification makes good business sense for businesses small and large, across all industries.
Not only is Accutech Mold and Machine (AMM) ISO 9001:2008 certified, but they also achieved their IATF 16949:2008 certification from Eagle Registrations. In January 2016, simpleQuE consultants, Larry Vance and Don Milinkovich began working with AMM to assess their existing processes and formulate an action plan that would address the gaps and fit their very tight timeline. That was followed up by an internal audit and training to prepare for the expansion to the automotive standard.
Why was this so important to AMM’s founders, Kelly and Darrin Geiger? As AMM’s website states, “International Standards are the backbone of our society, ensuring the safety and quality of products and services, facilitating international trade and improving the environment in which we live in. Conformity to International Standards helps reassure our customers that Accutech Mold and Machine’s products, systems and organizations are safe, reliable and good for the environment.”
Founded in 1996, AMM specializes in plastic injection mold manufacturing. In 2004 the company expanded with an injection molding press to sample molds that were built. Today, AMM continues to build high quality plastic injection molds and also produces plastic injection molded components with 25 presses running 24 hours a day.
Vice President, Darrin Geiger, had this to say, “It was easy to work with simpleQuE and they provided an action plan which our team utilized, working hard to reach our certification goal in just six months. The advantage to being IATF 16949 certified is that it has opened new doors for us in the automotive industry, and our non TS clients are happy because they also benefit from these additional business processes.”