Category Archives: ISO 9001 – Quality Management Systems

ISO Requirements or Good Documentation Practices?

  Question Are these standard for ISO or just good documentation practices? 1. All entries, except IPQA, should be made with blue ball pen in clear and legible handwriting. 2. IPQA entries shall be done in black ball pen. Answer … Continue reading

Posted in ISO 9001 - Quality Management Systems, Other | Tagged ,

ISO 9001: 2015 Clause 8.4.3

Question It’s not clear to me who an external provider may be. Could it be an electrical contractor, a lunch truck, a caterer, or other similar? That thinking is tremendously different than just the traditional “supplier” which is what this … Continue reading

Posted in ISO 9001 - Quality Management Systems, Other | Tagged , , | 2 Comments

ISO 9001: 2015 Clauses 4.1 and 4.2

Question Let’s start with clause 4.2. What level of detail is required here? Is “supplier” or “customer” sufficient, or is it required to drill down from there to specific suppliers or customers? We have hundreds of suppliers and many more … Continue reading

Posted in ISO 9001 - Quality Management Systems, Other | Tagged , , , ,

Relocation Requires Audit?

Question One of my contract manufacturers who is ISO 9001: 2008 certified, submitted a Supplier Change Notice to relocate their factory to a new site/location. This will trigger many activities including re-qualification, etc. My question is, for their ISO 9001 … Continue reading

Posted in Auditing, ISO 9001 - Quality Management Systems, Other | Tagged , , | 1 Comment

Quality Progress’ Standard Issues Column

ASQ Members: please find Quality Progress’ latest Standard Issues column here about ISO 9001: 2015 and top management. You must be logged in to view the column. And at this link, ASQ members may find additional articles published in Quality … Continue reading

Posted in ISO 9001 - Quality Management Systems, Other, Quality Progress | Tagged

Customer ISO Status In Jeopardy?

Question My customer wants to get ISO 9001:2015 certified. He refuses to create a first-article, in-process, and final-inspection report. He has a router sheet that has a tiny space for final inspection brief information and the operator’s initials; no inspection … Continue reading

Posted in ISO 9001 - Quality Management Systems, Other | Tagged , , , | 1 Comment

EHS Procedures and ISO 14001

Question Do EHS procedure have to be managed under ISO 9001:2008 if the company is not ISO 14001 certified? Answer It depends – are the EHS procedures part of the QMS of the organization. If so, yes. Otherwise no. Charles Cianfrani … Continue reading

Posted in ISO 14001 - Environmental Management Systems, ISO 9001 - Quality Management Systems, Other | Tagged , , ,

Special Process NCRs During Audit

Question Recently one of our business units had an ISO 9001: 2008 audit and during the audit they received a couple NCRs on welding as a special process. One of the NCRs was “Some welders are not qualified prior to … Continue reading

Posted in Auditing, ISO 9001 - Quality Management Systems, Other | Tagged , , ,

Work Instructions and Audits

Question Regarding ISO 9001: 2008 (or 2015) auditing, I have always been trained that a work instruction when implemented as supporting the QMS can be audited as it is supporting the effectiveness of the QMS. I was recently told by … Continue reading

Posted in Auditing, ISO 9001 - Quality Management Systems | Tagged ,

Document Revision Criteria

Question Is there any criteria available for the frequency of document revision in ISO 9001 or ISO 13485?  Some organization don’t revise the documents for a period of more than 2-3 years.  The reason provided by the organization is that … Continue reading

Posted in ISO 13485 - Medical Devices, ISO 9001 - Quality Management Systems, Other | Tagged ,