Search results for "iso17025 vs gmp"

Expert perspective on ISO 9001:2026 transition – Sanity check on Gap Analysis and strategic shift

Thank you for the questions. My reading is a little more cautious.Some months ago I wrote:  ISO 9001:2015 vs. ISO DIS 9001:2025 – Main differences.

First, I would not say that ISO 9001:2026 will necessarily push for “less paperwork.” In the draft analysis I wrote, clause 7.5 on documented information appears mainly as a small/editorial change. The more relevant point is not less documentation, but better evidence: documented information that supports process control, risk evaluation, change management, customer communication, external provider control, and improvement. Digital evidence can certainly help, but I would treat that as a good implementation approach, not as a new requirement imposed by the revision.

Second, I agree more with the idea of a shift toward a more resilient QMS. The draft strengthens the treatment of risks and opportunities by separating them and requiring more analysis and evaluation, and it expands the requirements for planning changes. That does move the system beyond a narrow “preventive action” mindset toward a more disciplined ability to anticipate, adapt, communicate, and learn.

Third, a transition until 2029 looks realistic if the final standard is published in 2026 and a three-year transition period is confirmed. For complex global supply chains, however, the challenge will not be rewriting procedures; it will be aligning risk evaluation, change management, external provider communication, customer disruption communication, and management review across different sites and suppliers.

One important warning: ISO 9001:2025 / ISO 9001:2026 is not yet an approved International Standard. The FDIS stage is still part of the approval process, and the final text may still be subject to formal voting and final adjustments before publication. So my advice to clients would be: prepare now, but do not over-engineer changes until the final version is published. The right approach is proactive, but proportionate.

Data Processing

Hello,

Sadly, we cannot offer legal assistance or legal advice, because in California GDPR doesn't apply. We can help you though with guidance related to GDPR versus CCPA - please consult this article: https://advisera.com/articles/gdpr-vs-ccpa-what-are-the-main-differences/ 

Best regards,

Tudor

Identifying gaps between ISO 13485 and ISO 9001

We do not have as part of our documentation toolkit any GAP analysis template. But you can look at this article for details:

• Similarities and differences between ISO 9001:2015 and ISO 13485:2016 https://advisera.com/9001academy/blog/2015/01/21/iso-9001-vs-iso-13485/

Also, you can check the Annexes in ISO 13485:2016, where you have a cross-reference table between ISO 9001:2015 and ISO 13485:2016.

Regulatory Compliance QMS Program

... You can download the complete list of documents on the following link: https://advisera.com/13485academy/iso-13485-eu-mdr-documentation-toolkit/

More details regarding the differences and similarities between the US and EU markets are discussed in this article:

• FDA vs. EU MDR Technical Documentation Matrix https://info.advisera.com/13485academy/free-download/fda-vs-eu-mdr-technical-documentation-matrix

How to write a separate strategic risk assessment?

... assign rankings based on the specific criteria for each category. Strategic risks may receive rankings based on their potential impact on long-term goals, while operational risks are ranked according to their daily impact and likelihood.
 
You can find more information in:

• ISO 14001 risks and opportunities vs. environmental aspects
• The role of risk management in the ISO 14001:2015 standard

Can a company be certified by someone who works for them?

Please note that companies can only be certified by certification bodies (independent organizations that employ their own certification auditors for the process).

For further information, check out the differences in accreditation, certification, and registration in the ISO world.

Asset and Risk Owners - can it be a role and also a name of an employee

... ss administrative effort. 

For more information, check out how to handle an asset register/asset inventory.

Read this article to find out the difference between risk owners and asset owners.

Design exclusion

... ification-vs-design-validation/" rel="nofollow ugc">ISO 9001 Design Verification vs. Design Validation

Risk Management Requirements

... >... p;

ISO 27001 2013 vs. 2022 revision

A company is going for its first year ISO 27001 surveillance audit based on ISO 27001:2013. I have been appointed to perform its internal audit. Kindly advise if we should cater for the 2022 revision during my audit. If yes, in which section and how.