Product Planning

How to Advertize Your Registered Quality System

Thursday, 06 March 2014
ASR Editor
Advertising Your Registered Quality System
Does your organization's advertising material reflect the scope statement printed on your registration certificate?

Waste: How to increase margin from supplied parts or services?

Tuesday, 19 November 2013
Brad Bukowski, ASR Lead Auditor & Registration Manager
To help in the never ending quest for increased profitability, I believe it is a good thing to review what WASTE is:

Waste is defined as anything that does not add value to the customer. Overproduction – There are two types of overproduction:
  • Producing more parts than are necessary
  • Producing parts at a rate faster than is required
  • Example: Using up the rest of a material even though the correct ship quantity was produced.

Why are ISO audits so long?

Monday, 13 October 2014
ASR Editor

Think Your Auditor Will Never Go Home???


Ever have the feeling that your auditor has moved in with you? It may appear that way, especially if your auditor is on-site for multiple days or two auditors arrive and spend two or three days moving about the facility.

Defining Design and Design Responsible

Thursday, 17 April 2014
Rand E. Winters - ASR Senior Auditor
ASR technical personnel are periodically asked to define "Design" and what criterion determines "Design Responsible."

Changes In the New ISO 13485 Standard (DIS)

Thursday, 18 June 2015
ASR Editor
The draft standard to ISO 13485 (ISO TC 210 WG1) has added new requirements and clarifications in a number of areas.

This article covers a few areas

  • QMS
  • Management Responsibility
  • Human Resources
.

Process Metrics (Monitoring the Quality Management System Processes)

Thursday, 01 August 2013
Bart Solomon - Senior ASR Lead Auditor

Organizations sometimes struggle with setting up, maintaining and getting value from process metrics.

ISO 9001 does require that:

Clause 4.1
"The organization shall:
  • Determine criteria and methods needed to ensure that both the control and operation of these processes are effective
  • Monitor, measure where applicable, and analyze these processes and
  • Implement actions necessary to achieve planned results and continual improvement of these processes and Clause 8.2.3

Executive Management, are you Using the Quality Management System to Improve Your BUSINESS?

Saturday, 08 March 2014
ASR Editor
Organizations today cannot afford to maintain a quality management system without getting full value from it. So....How do we  get value from our quality management system?

BY using the management system to:

ISO 9001:2015 – On its Way

Wednesday, 08 October 2014
ASR Editor
A major rewrite draft of ISO 9001 is circulating through the voting stage. If the latest draft is approved, release is expected in the 4th quarter of 2015 following a final vote sometime mid 2015. Implementation deadline is three years from date of approval making it in a 2018 – 2019 timeframe.

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Automotive

  • IATF 16949
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Medical Devices

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