ISO 9001 - Expert Advice Community

La importancia de la norma ISO 9001

La importancia de la norma ISO 9001:2015.

Auditing regulatory offices

How to audit an ISO 9001-2015 regulatory office?

ISO 9001 update on the requirements

Would you please advise, if there are any updates to requirements on ISO 9001:2015?

Quality Management System

All departments of our company start to create their procedures. All prepared procedures review by department heads and then approved by the company director. For the ready procedure, they give a number, rev. and an effective date. Finally, they submit to the QA department to establishing on master document register.
My question that, what is QA/QC role in this process?
Is it required to re-approved by the Quality manager for conformity of procedure to standard requirements? if required how to proceed?
If not, how the Quality team be ensuring that procedure suitable for ISO 9001 standard requirements.

ISO 9001 KPIs for the documentation department in the pharmaceutical industry

How can I determine ISO 9001 KPIs for the documentation department in the pharmaceutical industry?

Prioridades en la implementación

Tackling clause 8.5.1

Hi, I am a production manager at a soap manufacturing company. How do I tackle clause 8.5 production and service provision 8.5.1 F which says [the validation, and periodic revalidation, of the ability to achieve planned results of the processes for production and service provision, where the resulting output cannot be verified by subsequent monitoring or measurement?

Framing Standard Process Conditions (SPC) and specifications

We are manufacturing color concentrates for plastic industry. Daily we are adding new products in terms of new colors required by our customers, hence daily we are developing 10-15 new colors based on almost identical recipes and ingredients (RMs) by simply changing % of RMs. 
How to frame Standard Process Conditions (SPC) and specifications and for individual product in such a scenario for reference and adhering to ISO requirements as it is highly impossible to frame new specifications and process parameters on daily basis. Please guide us how to address this issue. 

Mandatory roles in ISO 9001

In ISO 9001, which roles are mandatory? Quality Manager I guess, something else?

ISO 9001 Implementation timeline and costs

Hello, I'm just starting to evaluate the cost efficiency for obtaining an ISO 9001 certification.  I would like to know more about the process involved for a small electronics assembly contract manufacturing.  I would like to speak with someone about the timeline and costs involved.