Control de la producción y la provisión del servicio
En la versión ISO 9001: 2008 se hablaba acerca de la validación del producto, hay entidades que se exoneraban de ese apéndice (creo que era el 7.5.2 de esa versión); mi consulta es a qué se aplicaba realmente ese concepto y cómo se enfoca actualmente con la versión 2015?
GDPR Documentation Requirements
Answer:
If you are under time pressure you could of course start with the mandatory documents that would be covering most of the outstanding amount issues in terms of the compliance. Also consider to implement the mandatory documents in the order from the Toolkit https://advisera.com/eugdpracademy/eu-gdpr-documentation-toolkit/ since they are interlinked. This will make your implementation effort more streamlined.
However, I strongly recommend that you consider all the documents in the Toolkit after implementing the mandatory ones.
Internal audits and checklists
Where is a good place to find audit questions to use for auditing these areas? Is it ok to use the internal QMS audit checklist that provides questions pertaining to each section? Also for each section who is the best person to audit? We are a company with just a Plant Manager, HR, Controller, Salesman, Quality Manager, and Production Manager.”
Answer:
You should audit your QMS, that means to check if:
* it is conforming with all 7 areas of ISO 9001:2015;
* it is conforming with your own requirements; and
* it is effectively implemented and maintained.
The auditors can read the standard and the internal documentation and list topics about what they want to ask, what they want to see, what they want to read, in order to be able to conclude if the QMS is being applied and it is effective . Those collected topics can become your internal QMS audit checklist, that can be collected and improved audit after audit.
Your organization must have defined what are the competence requirements for your internal auditors. For example, what kind of training on audits and ISO 9001:2015 they must have. So, your internal auditors must be competent, according to your own requirements and, very important, they must not audit their own work. That means that, for example, your Quality Manager even if competent should not audit the Quality Department activities.
The following material will provide you information about audits and checklists:
- Your company is offering goods or services to individuals in the Union. It refers to both free and paid goods and services; and
- Your company is monitoring the behavior of individuals in the EU/EEA. This refers to more intrusive activities such as tracking individuals across multiple sites or using Apps to track an individual’s location.
Answer: Holding an ISO 27001 certification is not necessary if your partners can evidence you by other means they can effectively manage information security. A common situation is by fulfilling security clauses established on a partnership agreement (you can include in the agreement clauses related to the practices you want them to follow, and how these clauses will be verified).
Answer: ISO 27001 does not prescribe specific infrastructure and system requirements to support an Information Security Management System. These should be identified based on the organizational context, ISMS purpose and results of risk assessment.
4.1. Objectives and measurement :
· [Job title] will measure the fulfillment of all the objectives.
· [Job title] is responsible for setting the method for measuring the achievement of the objectives.
4.5. Responsibilities
· [job title] will define which information related to information security will be communicated to which interested party (both internal and external), by whom and when.
· [job title] is responsible for adopting and implementing the Training and Awareness Plan, which applies to all persons who have a role in information security management
Answer: Regarding the responsibilities you mentioned related to section 4.1, and the first one on section 4.5, they are generally assigned to a role created specifically for that purpose (e.g., the CISO), bu t you also can assign them to an existing role in the organizational chart, provided that this person has the necessary skills to carry out the activities (a good choice would be the Management Representative or Quality Manager if you have this role).
For the second responsibility you mentioned in section 4.5, this one can be assigned either to HR Manager or to the roles above mentioned.
Answer:
The main additions to AS9100 Rev D come under context of the organisation where the new standard asks that you consider the internal and external issues that affect your QMS as well as identifying the interested parties of your QMS and their requirements. Other additions include requirements around product safety and control of counterfeit products. One small change that can also have repercussions is the phrase "products and services" which is used throughout the standard and now requires you to consider all oft he products and services you provide to the customer as part of your business.