How Much Do Certification Bodies Charge for ISO?

March 20th, 2013

How Much do Certification Bodies Charge?

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Tangible Benefits of ISO 9001 – (done right)

March 07th, 2013

It is important to remember that if ISO is not implemented correctly then it is likely that you won’t get any benefits. The probability is that it will do harm to your organization — increasing bureaucracy, creating duplication of effort, pointless maintenance efforts, and higher ISO costs. Worse still, frustration and avoidance of important controls could affect your quality.

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In Scope or Out(sourced)! Is your supplier’s ISO certificate applicable?

January 21st, 2013

ISO certificates describe the scope of the certified management system. Typically this includes physical location of the organization but it also includes a description of the products and services covered – those that a customer might be buying. Technically if the organization outsources main processes, design is a good example, then it cannot be included on the certificate. To be included the certification body must see what controls they have over those outsourced activities and then...

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The Changing Nature of ISO Special Processes

June 25th, 2012

“Some processes are no longer special and you can relax your controls over these vendors of outsourced special processes.”

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What’s the best for ISO: Flowcharts or procedures?

November 03rd, 2011

Procedures!

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I have 13485 — Do I need “harmonized standards”?

November 03rd, 2011

The term harmonized standards is officially used in European law. To meet European product laws such as the Medical Device Directive (or Active MDD or In-vitro MDD) an organization must meet the requirements laid down in the directive itself. In order to make that easier (legislation is written in legalize and not technical language) the European Union officially recognizes international and National standards that specifically meet legislative requirements. These standards are then termed...

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ISO Lead Auditor Training — Is it really not required?

September 12th, 2011

There is a lot of confusion over lead auditor training.

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Testimonial from an Auditing Client of Ours

September 08th, 2011

We enjoyed working with you and want to thank you for your professional and congenial nature as you conducted our audit. All the employees had very positive things to say and enjoyed visiting with you both about what they do. We appreciate your knowledge and expertise of ISO and look forward to implementing your suggestions in order to improve and streamline our quality system. Since we did not know what to expect from an ISO audit, we were very pleased with the audit method and look forward...

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I am going to be involved in getting ISO. What is the best training course for me?

August 03rd, 2011

There are obviously many training classes out there but there are commonly three or four types.

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Upgrading to ISO 13485 from ISO 9001. Differences and Considerations.

June 03rd, 2010

Kerri Williams of Platinum Registration was recently asked to make a presentation about upgrading an existing ISO 9001 management System to ISO 13485.

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