Context of the organization

1. Understanding the organization and its context

-Determine external and internal issues that are relevant to purpose and strategic direction
-Monitor and review information related to internal and external issues
-External-legal,market,technological,cultural, -
social,economic,international,national,regional,local
-Internal-values,culture,knowledge,performance of the business organization
-SWOT Analysis
2. Understanding the needs and expectations of interested parties
-Statutory and regulatory requirements
-Interested parties-stakeholders (customers,suppliers,investors,employees)
3. Determing the scope of the qms
-boundaries and applicability of the scope
-identify what is applicable
4. Qms and its processes
-design and develop right processes
4.1 Define the context of the organization
4.2 Identify internal and external needs
4.3 Determine needs and expectations of interested parties
4.4 Design and develop processes

5.1 Leadership and Commitment

Compliance with legal and other requirements

Conduct management reviews

Provision of resources

5.2 Quality Policy

Over-all direction of the organization

Framework of the organization

5.3 Organizational Roles

Well defined accountability and responsibility

10 point scorecard (expectations)

1. Qms being measured

2. Quality policy & targets are set
3. QMS is part of over-all business
4. Resources are planned and provided
5. Continual improvement is promoted
6. Legal and other compliance is monitored (customer statutory and regulatory requirements are
met)
7. Constant emphasis on customer-focus
 8. Defined roles, responsibilities, authorities
9. Management reviews are conducted
10. Processes are managed and improved

Determine the persons who will conduct the steps

Who will do what

6.1 Planning

6.1 Actions to address risk and opportunities

Preventive Action – no longer separate requirement

Risk based thinking (RBT) – applied at various stages (planning,design,development,release

Health and safety, property, financial and reputation

Risk v Opportunities

Customer and regulatory requirements Identify then accept,avoid,mitigate

6.2 Quality objectives and planning to achieve

The organization shall… anyone may formulate objectives

Strategy, quality policy, quality objectives

SMART-Specific,Measurable,Achievable,Relevant(to product and customer),time-bound

6.3 Planning of Changes

7 Support

Determine Resources, provide resources

7.1.2 People

-effectively operate and control processes

7.1.3 Infrastructure

Equipments, Utilities, Technology, for effective QMS

7.1.4 Environment for operation processes Social, Psychological, Physical needed for QMS effectivity

7.1.6 Organizational Knowledge

What knowledge is difficult to replace?

What would happen if it gets lost?

Is knowledge becoming obsolete?

7.2 competence

-being able to apply knowledge and skill to achieve intended results

-qualified to do the job

-determine necessary competence

-train or hire

-evaluate effectiveness

-keep training records

7.3 Awareness

-quality policy

-quality objectives

-qms processes

7.4 Communication

-internal and external communication

-needed for QMS processes to be effective

What,when,with whom, how

7.5 Documented information

GDP-good documentation process

Unique Identification includes date,history of changes,protection for evidence of conformity,review and

approval,access control (intellectual property)

8.1 Operational Planning and control

Requirements

Production processes

Acceptance and output

Controls (controls of changes)

Records

8.2 Requirements for products and services

8.2.1 Customer communication

Requires elements of customer communication

Marketing, sales, inquiries, customer feedback and complaints, handling of customer property

8.2.2 determining the requirements for products and services

8.2.3 review of the requirements for products and services

8.2.4 changes to requirements

8.3. Design and development planning of products and services

8.4 control of externally provided processes, products and services

8.4.1 General

Relevant

Evaluate, select, monitor

8.4.2 Type and extent of control

Consistently deliver conforming products and services resk based thinking

8.4.3 information for external providers

Requirements and expectations

8.5 Production and service provision (operation)

8.5.1 Control

Controlled conditions (doc reqs)

Verified at planned control points (any part of the process)

Process validation

Risk-based thinking

Documented information: processes and evidences

8.5.2 identification and traceability

8.5.3 Property belonging to customers or external providers

8.5.4 Preservation

8.5.5 Post-delivery activities

8.5.6 control of changes

Change request form (HR)

8.6 Release of products and services

Other notes: