4.
Systemic requirements and guidelines
4.1
Organizational requirements and guidelines
4.2
Documentation requirements and guidelines
4.2.1 Prepare
quality documents.
4.2.2 Develop
a quality
manual.
4.2.3 Control
quality documents.
4.2.4 Maintain
quality records.
4.2.4.1
Show that requirements are being met.
4.2.4.2
Demonstrate that your QMS
is effective.
4.2.4.3
Control record retention and disposition.
5.
Management requirements and guidelines
5.1 Commitment
requirements and guidelines
5.2 Customer
requirements and guidelines
5.3 Policy
requirements and guidelines
5.4 Planning
requirements and guidelines
5.4.1
Establish quality
objectives.
5.4.2 Carry
out quality
planning.
5.5 Managerial
requirements and guidelines
5.5.1 Clarify
responsibility and authority.
5.5.2 Appoint
management representative.
5.5.3
Establish internal communications.
5.6 Review
requirements and guidelines
5.6.1 Perform
reviews
at planned intervals.
5.6.2 Examine
management review inputs.
5.6.3 Generate
management review outputs.
6.
Resource requirements and guidelines
6.1 Allocation
requirements and guidelines
6.2 Personnel
requirements and guidelines
6.2.1 Provide
competent
personnel.
6.2.2 Meet
competence requirements.
6.3 Infrastructure
requirements and guidelines
6.4
Environmental requirements and guidelines
7.
Realization requirements and guidelines
7.1 Planning
requirements and guidelines
7.1.1 Use life cycle
models to plan work.
7.1.2 Carry
out software quality
planning.
7.2 Customer
requirements and guidelines
7.2.1
Determine requirements related to products.
7.2.1.1
Determine customer-related requirements.
7.2.2.2
Determine additional product requirements.
7.2.2 Consider
your product-oriented requirements.
7.2.2.1
Review contractual issues and concerns.
7.2.2.2
Evaluate risk before agreeing to supply software.
7.2.2.3
Appoint someone to represent the customer.
7.2.3
Establish effective customer communications.
7.2.3.1
Consider the type and extent of your contractual obligations.
7.2.3.2
Schedule joint reviews during software development projects.
7.2.3.3
Communicate with customers during operations and maintenance.
7.3
Development requirements and guidelines
7.3.1 Plan
product design and development activities.
7.3.1.1
Plan the design
and development of software products.
7.3.1.2
Plan your review,
verification,
and validation
activities.
7.3.1.3
Plan your design and development work assignments.
7.3.1.4
Plan design and development boundaries and interfaces.
7.3.2 Define
product design and development inputs.
7.3.3 Generate
product design and development outputs.
7.3.4 Perform
product design
and development reviews.
7.3.5 Conduct
product design
and development verifications.
7.3.6 Carry
out product design
and development validations.
7.3.6.1
Carry out planned software validation activities.
7.3.6.2
Carry out planned software testing activities.
7.3.7 Control
product design and development changes.
7.4 Purchasing
requirements and guidelines
7.4.1 Manage
purchasing process.
7.4.1.1
Control purchased products and services.
7.4.1.2
Control the use of external resources.
7.4.2 Clarify
purchasing information.
7.4.3 Verify
purchased products.
7.5 Production
requirements and guidelines
7.5.1 Control
production and service provision.
7.5.1.1
Control software production and service activities.
7.5.1.2
Control software build and release activities.
7.5.1.3
Control software replication activities.
7.5.1.4
Control software product delivery activities.
7.5.1.5
Control software product installation activities.
7.5.1.6
Control software operation and support activities.
7.5.1.7
Control software product maintenance activities.
7.5.2 Validate
processes if outputs cannot be verified.
7.5.3 Identify
your products and establish traceability.
7.5.3.1
Use configuration
management to identify and track software.
7.5.3.2
Clarify scope of software configuration management process.
7.5.3.3
Establish a process to trace your software components.
7.5.4 Protect
customer property supplied for products.
7.5.5 Preserve
software products and components.
7.6
Measurement requirements and guidelines.
8. Remedial requirements and guidelines
8.1 Planning
requirements and guidelines
8.2 Research
requirements and guidelines
8.2.1 Monitor
and measure customer satisfaction.
8.2.2 Perform
internal
audits at planned intervals.
8.2.3 Find out
if processes achieve planned results.
8.2.4 Verify
that quality requirements are being met.
8.3 Control
requirements and guidelines
8.4 Analytical
requirements and guidelines
8.5
Implementation requirements and guidelines
8.5.1 Improve
quality management system.
8.5.2 Correct
actual nonconformities.
8.5.2 Prevent
potential nonconformities.
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