Chapter of Standard: 5.

Management Responsibility
5.1 Management Commitment
Requirement / Subject Docu- E Documents Reviewed Audit Notes
mentation
Evidence of commitment to o Management review
the development and
implementation of QMS and o Written quality policy
continually improving its o Training schedules/evidence
effectiveness by:
- Communicating to the o Employee information (notices,
organization the impt. Of agenda of informative events)
meeting customer as well o Manpower development plans
as statutory and legal
requirements o Quality plans
- Defining the Quality
policy and Quality
o Records of defined objectives
objectives o Project plans
- Conduct of management
reviews
o Investment plans
- Steps taken to ensure o Plant agreements
availability of resources
Legal requirements
- How does the
organization identifies
applicable statutory or
legal requirements for
processes and/or
products

5.2 Customer focus

Ensure determination and o Evaluation of customer surveys
fulfillment of customer
requirements with the aim o Market analysis
of enhancing customer o Complaint documentation /
satisfaction.
analysis
o Product validation records
o Standards
o Customer satisfaction analysis
5.3 Quality policy
What is the use/purpose of o Quality Manual
the Quality policy.
Top management o Vision, mission, other policies &
Involvement & strategic objectives
considerations in o Corporate guidelines and
developing the Quality
policy. principles
o Written quality policy
Top management
responsibility to ensure that
o Training schedules / evidence
the Quality policy: o Employee information (notices,
- Is appropriate to the etc.)
purpose of the
organization
o Management review
- Includes commitment to o Internal audits
comply with requirements
&continual improvement
o Measurement results of Quality
of QMS effectiveness policy attainment
- Provides framework for o Action Plans if QP is not
establishing & reviewing
 quality objectives achieved
- Is communicated &
understood within the
organization
- Is reviewed for continuing
suitability

Chapter of Standard: 5. Management Responsibility

5.4 Planning
5.4.1 Quality objectives
Requirement / Subject Docu- E Documents Reviewed Audit Notes
mentation
What is the use/purpose of o Quality manual
the Quality objectives.
o Internal/external target
Top management agreements (business plans,
involvement and project plans, quality assurance
consideration in agreements)
establishing Quality o Company related
objectives (consistent with
the quality policy, and o Product related
established at relevant
function & levels)
o Customer related
o General employee information
How are these objectives
translated into measurable
o Records of employee interview
targets. o Records of defined objectives

Quality objectives are o Management review

achieved thru: o Orientation / training records
- Communicating to the
organization on how the o Customer specification /
people can contribute. requirements
- Defining responsibility for o Meeting minutes
its deployment
- Systematically review
and revised as necessary

Top management ensure

that those needed to meet
requirements for product
are established at relevant
functions and levels within
the organization
5.4.2 Quality system planning by top management
- Steps taken to ensure o Quality manual
that quality objectives
and requirements o Documented procedures
outlined in 4.1 are o Input data for planning
satisfied (planning
process defined) o Output data for planning
- Inputs for effective and o Investment plans
efficient planning
- Outputs of planning o Business plans
defining the product
realization and support
o Strategic plans
processes needed o Project plans
- Steps taken to
ensure that changes do
o Production plans
not impair QMS integrity
- Documentation o Resources plans / records
and records
o Process descriptions / work
instructions
o Test plans
5.5 Responsibility authority and communication
5.5.1 responsibility and authority
Top management ensure: o Quality Manual
- Definition and
communication of o Documented procedures
responsibilities and o Job function / profiles
authorities and their
interrelation within the o Org-chart / authority matrix
organization o Requirement profiles
o Memo / circulars

Chapter of Standard: 5. Management Responsibility

5.5 Responsibility authority and communication (cont’n)
5.5.2 Management Representative
Requirement / Subject Docu- E Documents Reviewed Audit Notes
mentation
Appointment and o Quality manual
announcement of an
independent member of the o Organizational chart and
management responsible organizational structure
for this task: o QMR appointment letter
- Processes of QMS
establishment, o QMR function profile
implementation and o QMR job profile
maintenance
- Reporting to top o Status report / Q analysis
management on QMS
performance and any
o Internal audit reports
need for improvement o Reports re: quality situation
- Promotion of awareness
of customer requirements
o Statistical situation
throughout the o Management review
organization
- Liaison with external o Orientation / training records
parties on QMS matters o Meeting minutes

5.5.3 Internal communication

- Establishment of suitable o Minutes and reports of meetings
communication
processes / channels o Team trainings and other
within the organization meetings
(about: quality policy, o Notice boards, internal
requirements, objectives,
& accomplishments) magazines/journals
- Communication o Audio visuals and electronic
regarding the QMS media (i.e. email, websites)
effectiveness o Agenda of company events
- Feedback and
communication from o Circular letters
people as a means of
encouraging involvement
o Statistics postings
 o Reports on quality system
effectiveness
o Employee surveys and
suggestion scheme

5.5 Management Review

5.6.1 General
Top management ensure: o Quality Manual
- Review of QMS at
planned intervals o Management review Agenda
- Review includes o Management review reports
assessment of
opportunities for
improvement & the need
for changes in the QMS,
quality policy and quality
objectives
- Records of management
reviews maintained

Chapter of Standard: 5. Management Responsibility

5.6 Management review (cont’n)
5.6.2 Review input
Requirement / Subject
mentation
Management review input
must include:
- Audit results
- Customer feedback
- Process performance
and product conformity
- Status of preventive and
corrective actions
- Follow-up actions on
previous management
reviews
- Planned changes that
could affect the QMS
- Recommendations for
improvement
Docu- E Documents Reviewed Audit Notes
o Management Review agenda
o Management review report
o Customer satisfaction analysis
o Evidence of corrective and
preventive action
o Resource deployment and
application planning
o Benchmarking results
o Quality analysis
o Risk analysis (technical /
economic)
o Internal audit reports
o Process audits
o Product audit reports
o Action reports
o Investment planning
5.6.3 Review output
Decisions and actions o Management review reports
relating to:
- improvement of the o Business plans
effectiveness of the QMS o Strategic plans
and its processes
- improvement of products o Investment plans
related to customer o Human resource plans
requirements
- resource needs