Professional Documents
Culture Documents
ISO 9001 2015 Documented Information List
ISO 9001 2015 Documented Information List
2020
Clause Nos Activity 16 Understanding QMS documented information
Documented information to be
4 Context of the Organization maitained/ retained Relevant Records
4.1 Understanding the organization and its context
6.2 Quality objectives and planning to achieve them 6.2.1 documented quality objectives QMS manual
6.3 Planning of changes
7 Support
9.2 Internal audit 9.2 internal audit should be documented Internal audit report
9.3 Management Review 9.3.3 documented MRMs MRM records
10 Improvement
10.1 General
10.2 Nonconformity and corrective action 10.2.2 Record of NCs Corrective Action Record
10.3 Continual improvement
Internal
Vision
Mission
strategic objectives and direction- road map
Organisation makeup- quality of people
SOPs- obtaining accrediation
Resources required in a rural area
Organisational Culture
External
Legal
social
political
Regulatory x
Economic x
Financial- overall performance x
Market trends- marketing
Security
internal and external and intrested parties are addressed and risk is mitigated in 6.1
look for evidence in MRM document
S.M.A.R.T specific measurable
identify issues that can be seen
determine what can be determined which cannot be seen too