Latest News & Updates

Insightful content from our thought leaders

Join our subscribers

Receive instant blog updates, straight to your inbox

How to structure your QMS documentation for ISO 13485 compliance

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

4 min read

Medical Device Technical File requirements: what you need to know

What is the medical device technical file? What should it contain and how should it be structured? And is it e...

6 min read

Understanding the Differences: ISO 9001 vs ISO 13485

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

4 min read

Streamlining Medical Device Design Controls for FDA and ISO Compliance

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

5 min read

The Competitive Edge of ISO Certification: A Path to Success

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

5 min read

Apply Risk-Based Thinking in ISO 9001:2015 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...

5 min read

Apply Risk-Based Thinking in ISO 9001:2015 Quality Processes - Part IX

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

10 min read

Risk-Based Thinking in ISO 9001:2015 Quality Processes - Part VIII

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

9 min read

Risk-Based Thinking in ISO 9001:2015 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 have...

9 min read

Apply Risk-Based Thinking in ISO 9001:2015 Quality Processes - Part VI

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

9 min read

Apply Risk-Based Thinking in ISO 9001:2015 Quality Processes - Part V

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

5 min read

Apply Risk-Based Thinking in ISO 9001:2015 Quality Processes - Part IV

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

10 min read

Risk-Based Thinking in ISO 9001:2015 Quality Processes - Part III

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

5 min read

Apply Risk-Based Thinking in ISO 9001:2015 Quality Processes - Part II

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

7 min read

Apply Risk-Based Thinking in ISO 9001:2015 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...

5 min read

Impact of ISO 9001:2015: What You Need to Know (Part II)

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

8 min read