1.
The organization shall plan:
2.
Who is responsible for ensuring the quality policy is applicable to the purpose of the organization
3.
In ISO 13485: 2016 records and documents are now called documented information.
4.
Risk-based thinking enables an organization
5.
Understanding internal context can be facilitated by considering issues arising from social and economic environments.
6.
When planning how to achieve objectives, the organization shall determine:
7.
Which of the below is not one of the seven quality management principles?
8.
Within ISO 13485, what does the term shall refer to??
9.
Whilst ISO 13485 is a stand-alone standard, which standard is it based upon??
10.
Which standard provides details of the application of risk management to medical devices?
11.
Top Management of Goodwill Services shall demonstrate leadership and commitment by promoting improvement..
12.
What does clause 4.2 of ISO 13485 provide details of?
13.
Scope of MDMS of Goodwill Services shall be available and be maintained as documented information.
14.
Which products are covered by the Medical Device Directives and CE marking
15.
Top Management of Goodwill Services shall assign the responsibility and authority for ensuring the promotion of employee focus throughout the organization.
