Manufacture Smarter Blog

Making Management Reviews Beneficial - Are We There Yet?

9/28/2018 By: Andy Nichols If you are registered to ISO 9001:2015 or one of the quality management requirements built on the international standard, like IATF 16949 or AS9100D, your management must comply with the requirements of the “Management Review” clause 9.3. When complying with this requirement, commonly asked questions include how often and when to do the review. A quick look at the inputs and outputs of the review process doesn’t provide much of a clue to an organization since there is no clearly stated requirement to review those things at any specific time.


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isn’t required The standard mentions “risk and opportunity” The terminology of controlled documents and records has been replaced by “documented information” A new requirement, the “Context of the Organization,” has been added.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.


Drowning in ISO Paperwork?

7/14/2017 How to Stay Afloat By: David Bradley ISO 9001:2015 blends documents and records into a single concept called “Documented Information” and no longer requires any documented procedures. If you’re still in the ISO transition phase, you might be thinking that certain procedures for handling documents and records got a lot more complicated—but did they? If your procedures for documents and records served you well under the 2008 version, they will probably do the same for the 2015 version. Just because they are no longer mandated does not mean they should be discarded.


ISO 9001:2015 Internal Audits

6/30/2017 “Is the Process Approach to Audits Just a Myth?” By: Andy Nichols Since ISO 9001:2000, it’s become increasingly common to consider that an organization’s Internal Quality Audits be performed using the so-called “Process Approach.” At the time of publication, that particular version of the International Standard for Management Systems contained no description of what the process approach was. The recently introduced 2015 version makes the “Process Approach” a lot clearer by describing what is envisaged, in section 0.


Risk in ISO 9001:2015 Transition?

6/2/2017 By: Dale Wicker In the ISO 9001:2015 standard there are two basic terms encompassing risk: risk-based thinking and the compound term risk and opportunities. Risk-based thinking is intended to be the system or approach an organization takes when considering risks and opportunities. These risk and opportunities are only those that may affect the organization’s ability to enhance customer satisfaction and consistently meet customer requirements, and, as applicable, statutory and regulatory requirements.