Implementation of
ISO 9001 standard
Steps to implement ISO 9001
1. Assemble a Quality Management Team
2. Skill Gap analysis to determine training
requirements
3. Status survey of existing quality system
4. Choose a certification body
5. Conduct pre-assessment audits
Quality Management Team
• Commitment from top management to ensure success
of quality initiative .
• A management representative to act as an interface.
• Implementation team comprising all functions of the
organization.
• The members of the implementation team should be
trained on the ISO 9001 Quality Management Systems
requirements by a professional training organization.
• If required, some members of the team should undergo
Internal Auditor training.
Quality System requirements
• An initial status survey of the existing quality system
should be conducted to avoid redundancy.
• Conformance to ISO 9001 documentation requirements
such as :
 Company Quality manual
 Quality policy
 Working quality objectives
 Work procedures
 Records
 ISO 9001 required procedures
Quality System requirements
• The required procedures are :
 Control of documents
 Control of records
 Internal audit
 Control of non conforming products
 Corrective action
 Preventive action
continued
Pre-assessment Quality Audit
• During the implementation process, quality audits
should be conducted to check and monitor the system.
• The audits should take into consideration the
conformance to the requirements of the ISO 9001
standards and the quality system requirements
established by the organization.
Conducting a Quality Audit
• An audit schedule should be generated based on the
importance and complexity of the functions involved.
• The audit team selected should be comprised of trained
auditors who are impartial to the function audited.
However knowledge on the function would be
beneficial.
Planning a Quality Audit
• Review the function or the process to be audited.
• Identify the interfaces with the standard requirements.
• Documentation review to ensure compliance to the
standards.
• Identify process interfaces
• Develop audit questions
• A checklist should be used to ensure all aspects of the
ISO 9001 standard requirements as well as the function
procedures are covered.
Quality Audit results
• Results of the quality audits are to be compiled and
presented in a report to the functions audited.
• Any nonconformities raised during the audit are to be
addressed.
• Corrective and preventive actions for the
nonconformities are to be conducted by the function
involved.
• The results of the corrective and preventive actions are
to be verified by the auditors.
• A complete report of the audit is to be presented
during the management review