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Integration of ISO 9001:2015 with TS 16949 certification

1. If an Organization doesnt have ISO 9001:2015 certification, can it directly get TS 16949 certification alone?

If you manufacture parts for the automotive industry and the part you produce is assembled on an OEM or OES vehicle, you can apply for IATF 16949 certification. Your Quality Management System must be ready before the audit according to the IATF rules.

2. Do we need to maintain different set of Documents for ISO 9001:2015 and TS 16949 if we go for both the certifications? cant we have single process documents and Quality manual for both?

ISO 9001: 2015 and IATF 16949: 2016 should be managed with the same documentation structure, separating them from each other is not appropriate according to the rules.

3. Can the Audits (external/internal) audit be conducted together with the same ISO 9001:2015 qualified Auditor or do we need to train the Auditors and get qualified seperately for 9001:2015 and TS 16949?

All IATF 16949: 2016 3rd party auditors are also qualified within ISO 9001: 2015.

Verification and validation

You asked

if i done have traceability or stander to calibrate any device can i used ane method created by my lab employee???

Unless the client  or regulations require you to use a standard method, the laboratory is free to use any suitable method. “Suitable” means that the method measures what it is supposed to, in the matrix of interest; accurately, and reliably and meets the parameters required by the client; for example for limit of detection and precision. An inhouse method, however, requires a more extensive validation experiments than a standard method.

You also asked 

I need ti ask you about calibration based on iso 17025 if should be done by third party on we can do as internal party then records"

Certain calibrations can be performed inhouse, justified based on the assurance risk and the type of measuring equipment. You need to use an external accredited calibration laboratory if you need to meet legal requirements, those of your accrediation program, or do not have the expertise or suitable equipment /  calibrators that can provide results with unbroken metrological traceability to international measurement units.  Have look at the answer provided for a similar question. “Calibration of laboratory equipment” at https://community.advisera.com/topic/calibration-of-laboratory-equipment/
 

For further information see the following:
The article What does ISO 17025:2017 require for laboratory measurement equipment and related procedures? at https://advisera.com/17025academy/blog/2019/07/25/iso-17025-measurement-requirements-of-the-standard/
The ISO 17025 document template: Equipment and Calibration Procedure at https://advisera.com/17025academy/documentation/equipment-and-calibration-procedure//

Implementation difficulties

Raise awareness of people involved with the Information Security Management System and get their engagement are often the most difficult to implement, due to the tendency of employees to resist change.

These articles will provide you additional information:

• The 3 key challenges of ISO 27001 implementation for SMEs https://advisera.com/27001academy/blog/2017/04/17/the-3-key-challenges-of-iso-27001-implementation-for-smes/
• How to perform training & awareness for ISO 27001 and ISO 22301 https://advisera.com/27001academy/blog/2014/05/19/how-to-perform-training-awareness-for-iso-27001-and-iso-22301/

These materials will also help you regarding ISO 27001 implementation:

• Book Secure & Simple: A Small-Business Guide to Implementing ISO 27001 On Your Own https://advisera.com/books/secure-and-simple-a-small-business-guide-to-implementing-iso-27001-on-your-own/
• ISO 27001 Foundations Course https://advisera.com/training/iso-27001-foundations-course/

IVD Smartphone glucometers

Hope you are doing safe, recently I joined an IVD startup manufacturing company, the product is Smartphone glucometers there is no predicate device in the market, now we are planning for ISO 13485, could you suggest to me what strategy should be followed for implementation & technical documentation.
Thanks.

PIMS

Please note that ISO 27701 is based on ISO 27001, adding specific requirements related to the protection of private information, so ISO 27701 would be the best approach for a PIMS.
 
Regarding ISO 27018, you need to consider this supporting standard only if you have specific requirements regarding the protection of information in the cloud (ISO 27701, like ISO 27001, which has enough controls for overall protection of information in cloud environments).
 
These articles will provide you a further explanation about ISO 27001, ISO 27018, and ISO 27701:  

• Relationship between ISO 27701, ISO 27001, and ISO 27002 https://advisera.com/27001academy/blog/2019/12/10/relationship-between-iso-27701-iso-27001-and-iso-27002/
• ISO 27001 vs. ISO 27018 – Standard for protecting privacy in the cloud https://advisera.com/27001academy/blog/2015/11/16/iso-27001-vs-iso-27018-standard-for-protecting-privacy-in-the-cloud/