Manufacture Smarter Blog

Internal Audits Made Easy – And Practical

8/3/2018 By: Dale Wicker If your company is registered to one of the ISO Quality Management Systems (ISO 9001, AS9100, ISO 13485, IATF 16949), then you are required to perform internal audits at planned intervals to verify the conformance of your system. Since these ISO standards are process-based, these audits should be developed and scheduled around the company’s current processes to assure the organization can meet the intended results and satisfy its customers. What does this look like in practice? For example, prior to committing to a customer’s order, you must review their contract (or quote) for requirements to confirm your organization can meet their demands.


Achieving Competency in Quality - Manufacturing's Got Talent!

2/2/2018 By: Andy Nichols Competency is all around us. It pervades our lives. We see competency on television, for example, in “America’s Got Talent.” Talented people, regardless of their age, gender or social background, performing all manner of stage acts that wow the show’s judges and viewers. We often ask ourselves, “How did they do that?” We see competency in Quality as well. ISO 9001 includes a requirement for an organization’s people, specifically those involved in the Quality Management System, to be competent in their work responsibilities.


Quality Manuals – QMS “Quick-start” Guide?

11/3/2017 By: Andy Nichols One of the first things that comes to mind when describing Quality Management Systems and “ISO 9000” is documentation, which often includes a Quality Manual. The background to Quality Management Systems started with big procurement organizations such as government agencies and Fortune 500 companies making Quality Systems a contractual requirement. Frequently, these requirements included the need for a document, often referred to as a “Quality Manual,” a “Quality Plan” or similar.


10 Things to Ask Your Certification Body Auditor – Before Your ISO 9001:2015 Audit

9/29/2017 The latest version of ISO 9001 was published in September of 2015 and is considered to be a significant departure from the previous version because: There’s no reference to a Quality Manual No Documented Procedures are required The use of Work Instructions isn’t mentioned A Management Representative isn’t required The standard mentions “risk and opportunity” The terminology of controlled documents and records has been replaced by “documented information” A new requirement, the “Context of the Organization,” has been added.


A Year to Go...

9/15/2017 If your organization is certified to ISO 9001:2008 (or ISO/TS 16949 or AS9100C) you have approximately 365 days left to upgrade your Quality Management System (QMS) and have your Registrar audit it. In fact, you should aim to be done and have your certificate in hand by the end of August 2018 at the latest. Meeting the Deadline To be exact, ISO 9001:2008 expires at midnight on September 14, 2018. A question I am often asked is: What if an organization wasn’t able to prepare and successfully complete their audit? The simple answer is that the Registrar would request their certificate be returned, the organization would not be able to post their certificate on their website (for example) and they would not be able to use the Registrar’s logos, etc.


A Message for Management: Leverage Your QMS to Maximize Success

3/3/2017 By: David Bradley If executed properly, a business plan can help increase profits and the likelihood of your organization’s long-term success. Do you know that your Quality Management System (QMS) was designed to work in conjunction with your business plan? It’s true. ISO 9001 expects top management to take an active role throughout the entire process, otherwise the results will be less than stellar. Below are some helpful tips to enable your organization to reach its QMS goals: • Business plan: There are several areas where the ISO 9001 standard refers to “the purpose and strategic direction of the organization.


Think Strategically, Act Tactically With ISO 9001:2015

11/11/2016 You are in business for a reason. One of those reasons involves the successful setting and achieving of long-range goals. And, in order to achieve those goals, strategic plans were executed.  From a business standpoint, tactical day-to-day operations, which are short term, need to support the strategic plans of an organization. This includes items such as scheduling, training, lean programs and an effective Quality Management System (QMS). ISO 9001:2015 and Strategic Direction ISO 9001:2015 has several places where it refers to “…the strategic direction…” of the organization.


Small & Medium Sized Manufacturers: Take Advantage of Process Improvement Programs

10/28/2016 For small businesses in today’s global and technologically advanced market, it is crucial to maintain competitiveness and stay aligned with larger organizations. Generally speaking, small and medium sized manufacturers, those categorized with less than 250 employees, are as much in need of process improvement programs to enhance and develop their business as those of larger firms. In general, smaller organizations lose much more compared to larger firms when practices and operations are not constantly improved on.