The latest news and updates from cognidox

ISO 9001 vs ISO 13485. What’s the difference?

ISO 9001 is the internationally recognised standard for quality management used in many sectors from construct...

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Implementing Medical Device Design Controls for ISO 13485 and FDA 21 CFR 820

30 years ago the FDA introduced robust new requirements for medical device design control following a string o...

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QMS documentation requirements in ISO 13485

  How should you structure your documentation to meet the requirements of ISO 13485?

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8 Reasons To Document Your Standard Operating Procedures (SOP)

Documenting your SOP (standard operating procedures) can be a drag. It can feel unnecessary for a relatively s...

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Will ISO certification give you a competitive edge?

The expense and effort of achieving ISO certification is sometimes regarded as excessive and onerous by SMEs -...

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ISO 9001:2015 – How to apply Risk-based Thinking to Quality Processes [Part X]

There are twelve posts in this series. To read Part IX, please click here. In this and the following two posts...

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ISO 9001:2015 – How to apply Risk-based Thinking to Quality Processes [Part IX]

How to apply Risk-based Thinking to Quality Processes - a Summary There are twelve posts in this series. To re...

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ISO 9001:2015 - How to apply Risk-based Thinking to Quality Processes [Part VIII]

RISK MANAGEMENT METHODOLOGY FOR QUALITY MANAGEMENT Steps 4-6 in the method There are twelve posts in this seri...

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ISO 9001:2015 - How to apply Risk-based Thinking to Quality Processes [Part VII]

There are twelve posts in this series. To read Part VI, please click here.  Steps 1-3 in the method If you hav...

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ISO 9001:2015 - How to apply Risk-based Thinking to Quality Processes [Part VI]

  There are twelve posts in this series. To read Part V, please click here. Risk based thinking is the new 'pr...

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ISO 9001:2015 - How to apply Risk-based Thinking to Quality Processes [Part V]

SO 31000 Risk management techniques - continued Attributes of a selection of risk assessment tools   There are...

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ISO 9001:2015 - How to apply Risk-based Thinking to Quality Processes [Part IV]

ISO 31000 Risk management techniques - continued There are twelve posts in this series. To read Part III, plea...

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ISO 9001:2015 - How to apply Risk-based Thinking to Quality Processes [Part III]

ISO 31000 Risk management techniques Attributes of a selection of risk assessment tools If you haven't yet rea...

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ISO 9001:2015 - How to apply Risk-based Thinking to Quality Processes [Part II]

ISO 31000 Risk management techniques: A selection of risk assessment tools you might like to consider Part 1 i...

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ISO 9001:2015 - How to apply Risk-based Thinking to Quality Processes [Part I]

Why taking a risk-based approach is a requirement of ISO 9001 Risk-based thinking is a sore point among many Q...

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ISO 9001:2015 - The likely impact (Part II)

There are twelve posts in this series. To read Part I, please click here. Risk-based thinking and the resultin...

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