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:
- Process Owner
- Personnel Interviewed
- Documentation Reviewed
- Records Sighted
- 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?
Source: Eagle Certification Group – 2017 Annual Bootcamp/Conference
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.
Links to Checklists:
IATF 16949 Sample Manufacturing Process Audit Checklist – FREE
AS9100 Sample Manufacturing Process Audit Checklist – FREE
ISO 9001 Sample Manufacturing Process Audit Checklist – FREE
Founded in 1970, Die Craft Machining and Engineering is a certified ISO 9001:2015 and ITAR Compliant corporation offering precision CNC machining fabrication, assembly and industrial repair services to support general industry in the greater Cincinnati area. A broad range of machinery, combined with their talented workforce, allows them to service a variety of clients in Aerospace, Chemical, Defense, General Contracting, Food Processing, Paper, Rail Transportation, Steel and Utilities Industries steel, paper and pulp, chemical and construction.
Die Craft’s partnership with simpleQuE began in 2013 with a gap analysis to determine the actions necessary to implement ISO 9001. It was followed with consulting, training and guidance to support their efforts for successful ISO 9001:2008 certification. SimpleQuE continued in the following years performing their internal audits. In 2016 Die Craft began the transition to ISO 9001:2015 with a gap assessment by simpleQuE consultant, Don Milinkovich. The quality team at Die Craft worked on the action plan and in October 2017 Don performed a validation audit to evaluate the quality management system against requirements for the new standard. Success! Die Craft passed their audit with Eagle Certifications Group to and transitioned to ISO 9001:2015.
What makes Die Craft stand out from the rest? A philosophy that is centered on a partnering culture, delivering the complete approach for an unparalleled commitment to their customers’ success. Die Craft can reverse engineer old parts as well as develop new solutions. Analyzing every part that comes in the door for improvements is a regular part of the service they provide. Whether it’s customized services/products or engineering support, Die Craft’s long-term focus, through industry and knowledge-based planning, allows them to deliver cost effective solutions, reduce manufacturing lead times and improve quality.
We did it! SimpleQuE has been recertified to ISO 9001:2015 by Eagle Certification Group through December 2020. Our initial ISO 9001:2015 certification was in November 2015 right after the standard was released and we were one of the first to be certified.
“The majority of companies have waited until the last possible year to upgrade to the new standards. This is consistent with the past, when changes to the standards occurred. The problem now is that all the key standards (ISO, automotive, aerospace, environmental) have the same expiration date of 9/15/18 and everyone is rushing to get it done at the last minute. The capacity constraints on registrars, consultants, and auditors is evident and organizations that have not begun the transition process are in serious jeopardy of losing their certification, especially if attempting to wing it with the registrar and not doing anything new to comply with the new standards.”
-Jim Lee, simpleQuE President.
The ISO 9001:2015 certification provides us many benefits and is a big differentiator over our competitors. This is especially critical since this standard and common structure are integrated into other management system standards like environmental, aerospace and automotive. It also provides simpleQuE with cost savings, an innovative service offering, market access, and a high level of customer confidence and satisfaction.
As an organization that is ISO certified, it proves to our clients that Quality Excellence can be made Simple. It’s what our company name means. For over 10 years, our simple approach has allowed us to have a quality manual that is only a few pages as we put our simple best practices to work in our own company. At simpleQuE, we don’t take a cookie cutter approach, therefore, we don’t implement our processes at our client sites. We look at what works for them and leave that alone, only focusing on those areas that don’t comply. Considering each company’s culture and unique situation results in different solutions for each client.
As the transition deadline of September 14th approaches, we encourage organizations that are still working on their implementation or transition certification to keep at it, ask questions, and ask for assistance. Demonstrating a commitment to maintaining the effectiveness of your system, continual improvement and customer satisfaction will put you in the lead. ISO 9001:2015 certification is an internationally recognized distinction that will benefit your organization for years to come.
Pilgrim Harp, located in Avon, Ohio, provides the global and domestic sourcing of components and assemblies, handling every aspect of the sourcing process from beginning to end and ensuring the highest quality levels at all times. Pilgrim Harp and its manufacturing partners all maintain TS, ISO and/or AS certifications.
As a manufacturing outsourcing company for the healthcare/medical, heavy industrial and aerospace industries Pilgrim Harp is a source for a wide range of products. For aerospace, their aircraft interior products include: airplane seat legs, seat spreaders, seat backs, seat frames, seat arms, seat arm assemblies, seat tray tables, seat tracks and more. For this customer base, Pilgrim Harp leadership recognized the need for AS9120B certification – which pertains to Quality Management System (QMS) requirements for Aviation, Space and Defense distributors. This standard includes ISO 9001:2015 QMS requirements.
SimpleQuE consultants, Jen Briese and Jim Lee began working with Pilgrim Harp in 2016 to assess where there were gaps between their current system and the new requirements. They then worked out a customized action plan and timetable to make implementation simple and sustainable. End result – certification was achieved in June 2017 with no findings from Eagle Certification Group! Congratulations to the team at Pilgrim Harp!