1.2

Exclusions

Exclusion or Scope of the QMS needs to be stated.  Some examples of exclusions could be;  IS0 9002 Organisation's exclude Design, Calibration or Purchasing where limited to stationery or not affecting product/service quality.

4.1

Outsourcing

Verification required over and above supplier controls, including verifiable procedures  e.g. an outsourced Organisation should have a Quality Management System (QMS)

4.2

Documentation

Six obligatory procedures addressed in the original QMS; using flow charts, procedures, plans, etc. 

See Quality Management Books including section on Process mapping and QM&T's flow charting software

4.2

Records

Records need to be readily available

Records - See QM&T's ISO 9001 software specifically design for maintaining ISO records

5.1/ 5.3

Policy

Needs to:
Incorporate meeting customer and regulatory requirements.
Commitment to meeting requirements and continual improvement.
Communicating to the Organisation the importance of above.

Quality Policy - See Quality Management Books including section Quality Policy
Communication - See QM&T e-learning awareness training download example.

5.4.1

Quality objectives

Measurable objectives to be defined at the most senior level reflecting in continual improvement.

Quality Objectives - See Quality Management Books including section Quality Objectives

5.5.2

Management

Promote awareness of customer representative requirements throughout the Organisation.

Communication - See QM&T e-learning awareness training download example.

5.5.3

Internal communication

Communications take place at all levels addressing the QMS and its effectiveness.

Communication - See QM&T e-learning awareness training download example.

6.2

Human Resources

Need to determine individuals competence.  Possibly through appraisals, tests, training matrix or job profiles.

See QM&T's Human Resources records - part of the Quality Database package

6.4

Work Environment

Review the infrastructure and working environment possibly as part of the Health & Safety Management System, including risk assessment.

See QM&T's Risk Assessment part of the Quality Database package

7.1

Planning of product

Quality Plan equates to the QMS introduction programme, including process realisation; procedures, work instructions & records.
Specific quality plans only need to be  produced for customer requirement or specific controls necessary e.g. project

7.2.1/ 7.2.2

Contract/Order

All incoming order (customer orders) need to be reviewed (record) irrespective of how received.  If there is no formal written order then order confirmation note may be necessary. Review should also address regulatory and legal requirements.

8.1

Performance monitors

Measuring & monitoring activities needed to assure conformity & achieve improvement (defined & implemented).

See QM&T's Non-conformance part of the Quality Database package

8.2.1

Customer satisfaction

Customer satisfaction ensuring that the customer perception of quality performance is known by the organisation.

See Measuring Customer Satisfaction Service offered by QM&T
and
See QM&T's Non-conformance part of the Quality Database package

 8.2.3

Measurable objective

Audit process addresses the relevance and effectiveness of procedures

See 
Audit training via Distance Learning or Via ISO9000:2000 Course for Auditors - Registered Course
and software
 QM&T's Audit records part of the Quality Database package

8.4

Analysis of data

Collect & analyse data; customer satisfaction/dissatisfaction, conformance to customer requirements, characteristics of processes, products & trends, suppliers.

Quality Objectives - See Quality Management Books including section TQM and RCA