EDWARD DANISH A dt 22.04.

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

4.2 Understanding the needs and expectations of interested parties

4.3 Scope of the QMS maintained as
4.3 Determining the scope of the quality management system documented information
4.4 Quality management system and its processes
4.4.2 Operational process information
documented information to support operational process chart Process monitoring record
5 Leadership

5.1 Leadership and commitment: General and customer focus

5.2 Policy: Establishing and communicating
documented quality policy 5.2.2 Quality Policy QMS manual
5.3 Organizational roles, responsibilities and authorities
6 Planning
6.1 Actions to address risks and opportunities

6.2 Quality objectives and planning to achieve them 6.2.1 documented quality objectives QMS manual
6.3 Planning of changes
7 Support

7.1.5.1 documented information on the

fitness of monitoring and measurement
7.1 Resources resources Preventive maintainence records
7.1.5.2 basis for calibration should be
documented information Calibration Records
7.2 Evidence of Competence shall be
7.2 Competence documented Educational and Training records
7.3 Awareness
7.4 Communication

7.5.1 docuemnted information as

required by the standard, necessary for
the effectiveness of QMS as deemed by
7.5 Documented information the organisation Validated process/ published records

7.5.2 proper identification of

documented information for creating
and updating Amendment records
7.5.3.1 documented information shall be
controlled Control policy QMS manual

7.5.3.2 acessess, distribution, storage

retention and dispostion shall be
controlled Documents Control records
8 Operation

8.1 Plan implement and control the

processes maintain docuemnted
8.1 Operational planning and control information to the extent necessary Process manual
8.2.3.2 maintain review of results /or
8.2 Requirements for products and services any new requirements Change records

8.2.4. relevant persons are made aware

while documented information is
changed. Change notifiction
8.3 Design -excluded

8.4.1 Control of externally provided

process, product of service- Approved
supplier programme process
8.4 Control of externally provided processes, products and services documentation
8.5.1 Characterstics of products and
8.5 Production and service provision services will be documented
8.5.2 Documented information on
identification and tracebility
Supplier Evaluation records
Production process measuement record-
log
Record of production Lot no/ batch no/
unique id / barcodes/ tags etc
 8.5.3 documented information on
incidents occurred Incident record

8.5.6 documented information for

control of changes to confim to
conformity with the requirements Change records

records of analysis / measurements as

8.6 document information on release of evidence of confirming to the
8.6 Release of products and services products and services acepetance criteria
8.7.2 Documented information on non Non conforming product / services
8.7 Control of nonconforming outputs confirming products record
9 Performance evaluation

Records of analysis / measurements as

9.1.1 Document the performance ad evidence of confirming to the
9.1 Monitoring, measuring, analysis and evaluation effectiveness of the QMS acepetance criteria

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

achievable realistic time bound