ISO Audit and the Company Image
The Company must have a true picture of itself. It is not enough to possess the required information related to legislation, internal and external issues and interested parties, all this data should be properly documented, this information has to be available to the relevant project team members, who have to ensure the right policies are implemented, monitored and updated.
One of the very first questions that an external auditor would ask is the context of the organization.
The context of the organization has to include some relevant issues, like:
What is the company doing exactly (for example research, software development, chopstick production, etc. )
Determining all the relevant factors such as
- governmental legislations,
- special regulatory requirements, etc. that makes any impact on the company’s work and structure
- what kind of training the company has to organize,
- what kind of permissions the company has to obtain, etc.
- Concrete examples are: fire protection, safety standards, sales permissions, etc.
The company should also consider the so-called internal and external factors that could have a relevant impact on the quality processes.
- the internal issues can be the employees’ motivation, skills, professional competence, the quality of equipment that is used, inappropriate work conditions – the system is slow, ineffective document management, bad communication, etc.
- external factors might be the: taxes are rising, political, regulatory, governmental decisions, updated statutory requirements, new competition in the market, a new technology appeared on the market that has a significant impact on the product future, etc.
Finally, the company must be aware of its interested parties such as customers, suppliers, regulatory agencies, manufacturers, any third-party company involved, consultants, external experts, testing laboratories, certification bodies, etc.
If the company is not aware of its context, then that could lead to some real pitfalls since that means there is no real picture.
Various reasons can cause this: committing to look after and determine all the governmental, regulatory expectations and legislation related to the activities of the company. This could infer penalties and restrictions. Companies may easily have a distorted image of themselves if the above-listed issues are not monitored.
That would inevitably lead to a significant impact on the company’s work, on the quality they produce, and as well on the competitiveness of their products.
ISO 13485 implementation: Mandatory documents and records
Gap analysis in QMS