Quality Assurance Auditing, Training and Consultancy...

Quality Assurance Auditing, Training and Consultancy

Articles tagged under Quality Management

Quality in a changing world

Posted by: Tony Wilkinson

Managing change in a volatile world

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Filed Under: Quality Management

Sustainability

Posted by: Tony Wilkinson

Corporate social responsibility is under the spotlight. Are Self assessment questionnaires a valid approach?

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Filed Under: Quality Management

The Quality Management principles

Posted by: Tony Wilkinson

The 7 Quality Management principles - The back bone of any management system.

Customer focused organisation

Leadership

Engagement of people

Process approach

Improvement

Evidence based decision making

Relationship management

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Filed Under: Quality Management

What does it take to make a quality system work?

Posted by: Tony Wilkinson

Strong governance

Robust Systems of assurance

Culture of improvements to keep getting better.      (CQI)

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Filed Under: Quality Management

Quality is...

Posted by: Tony Wilkinson

'Quality is, doing the right thing when no one is looking.' Henry Ford

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Filed Under: Quality Management

The Quality Management principles

Posted by: Tony Wilkinson

The 7 Management principles are still relevent many years after they were originally defined. Although a systematic approach was dropped for being a pre-requisite the others remain useful. :-

Customer focused organisation, Leadership, Engagement of people, Process approach, Improvement, Evidence based decision making, Relationship management

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Filed Under: Quality Management

Black box thinking

Posted by: Tony Wilkinson

How often do you hear the phrase 'These things happen'? If only people would ask themselves why?

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Filed Under: Quality Management / Process Improvement

Medical devices auditor training

Posted by: Tony Wilkinson

I recently had the pleasure of participating in a ISO13495 auditor training course presented by an old friend

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Filed Under: Quality Management

Effective corrective action

Posted by: Tony Wilkinson

Effective corrective action requires black box thinking!

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Filed Under: Quality Management

Real auditing returns

Posted by: Tony Wilkinson

Real auditing face to face is a delight.

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Filed Under: Quality Management

The 7 Quality Management principles

Posted by: Tony Wilkinson

The 7 Quality Management principles

Customer focused organisation

Leadership

Engagement of people

Process approach

Improvement

Evidence based decision making

Relationship management 

For further details please read on.

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Filed Under: Quality Management

Light at the end of the tunnel

Posted by: Tony Wilkinson

After 3 vaccines have been approved by the MHRA in double quick time there is now light at the end of the tunnel.

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Filed Under: Quality Management

Remote auditing - revisited

Posted by: Tony Wilkinson

Just when you thought there might be a return to real auditing. The widely predicted 2nd wave has put paid to that. Remote auditing via Zoom, Teams  or Webex will be with us for some time to come.

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Filed Under: Quality Management

The new normal

Posted by: Tony Wilkinson

Progressive and creative businesses have adapted well to the new situation and brought in more efficient contactless processes. Home working for some of the week is going to be the new normal and why not if this works and results in no loss of efficiency.

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Filed Under: Quality Management

Major NCR's to clean sheet in 12 months

Posted by: Tony Wilkinson

I was involved with a remote re-certification audit with one of my clients who needed rescue after 3 major NCR's last year.

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Filed Under: Quality Management

Remote auditing revisited

Posted by: Tony Wilkinson

Remote auditing is possible and works reasonably well but I am still looking forward to real socially distanced auditing in the future.

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Filed Under: Quality Management

Homeworking and remote auditing

Posted by: Tony Wilkinson

The COVID 19 disaster has made homeworking a reality for many and put internal auditing on the back burner.

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Filed Under: Quality Management

Organisational Knowledge

Posted by: Tony Wilkinson

Organisational Knowledge Clause 7.1.6

This is a new and interesting clause in ISO9001, it balances the lack of prescriptive requirements in the standard, although not very convincingly at this stage. I am sure this section will be developed in future revisions.

It is intended to safeguard organisations from loss of knowledge and to encourage the acquisition of knowledge. 

 

 

 

 

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Filed Under: Quality Management

Documented information

Posted by: Tony Wilkinson

Documented information in ISO9001:2015 refers to both documents and records in whatever format, hard copy or electronic. Previously this was termed documents, documented procedures, quality manual or quality plan

Due to pressure from UKAS, certification bodies are targeting documented information references in the standard. Although this approach is missing the point of the standard somewhat it is quite easy to audit and prepare for. A management system was never intended to be a collection of documents it needs to have a structure.

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Filed Under: Quality Management

Lazy audit techniques

Posted by: Tony Wilkinson

Poor audit technique

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Filed Under: Quality Management

100% conversion to ISO9001:2015

Posted by: Tony Wilkinson

The business management system approach pays dividends!

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Filed Under: Quality Management

Are you there yet! ISO9001:2015

Posted by: Tony Wilkinson

The expiry of ISO9001:2008 is fast approching. September 15th 2018 is the deadline.

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Filed Under: Quality Management

13 months to go! deadline draws near.

Posted by: Tony Wilkinson

ISO9001:2008 is being withdrawn at the end of September 2018.

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Filed Under: Quality Management

ISO9001:2015 transition underway

Posted by: Tony Wilkinson

3 Year transition underway

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Filed Under: Quality Management

ISO9001:2015 is Out!

Posted by: Tony Wilkinson

The new 10 clause ISO9001:2015 has been issued with much fanfare.

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Filed Under: Quality Management

ISO9001:2015 FDIS

Posted by: Tony Wilkinson

New standard focuses on leadership and Quality Risk assessment.

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Filed Under: Quality Management / All Categories

PS9001:2011

Posted by: Tony Wilkinson

PS9001 to follow annex SL

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Filed Under: Quality Management

The ISO9001:2015 draft is out for comment

Posted by: Tony Wilkinson

As promised the standard follows the Annex SL common standard structure with 10 clauses.

 

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Filed Under: Quality Management

And now there are seven!

Posted by: Tony Wilkinson

The Quality Management Principles upon which ISO9001 as based have been reduced from 8 to 7.

in the planned annex to ISO9001:2015. "A systematic approach to management" effectively goes without saying and has therefore been removed.

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Filed Under: Quality Management