Implementing ISO 9001

"Before you start some work, always ask yourself three questions - Why am I doing it? What the results might be? And Will I be successful? Only when you think deeply and find satisfactory answers to these questions, go ahead."

Chanakya (Indian politician, strategist and writer, 350 BC-275 BC)

Follow the 10 step approach to certification given below:

• Step 1: Top Management Decision and Formation of Task Force
  Decide to go for ISO 9000 certification. Share the commitment to seeking ISO certification with all levels of management, choose Management Representative (MR), and decide whether to use a consultant or not. Train the Management Representative and some key team members on ISO at a higher level.
  Check Things you should do / not do to get ISO 9000 certificate
• Step 2: Training to Top Management and Task force
  The top management and the members of task force including management representative must be trained for the requirements of ISO 9000 standard, if they are already not qualified for. Arranging an in-house training will be most economical or attending a two day workshop or an online education programme will also do the intended.
• Step 3: Gap Analysis and Implementation planning
  Review the existing management System; determine the gap in the existing system and the requirements of ISO 9000 standards. Prepare report on what procedures are to be generated or modified, what needs to be implemented, what training needs to be provided, and decide on how to format and structure the documented quality management system required by the standard. Prepare a time based implementation plan (Pert Chart) to achieve certification. This should be preferably done by the task force, though a consultants help can ease the job.
  Check Implementing Process approach
• Step 4: Generating (Preparing) Quality System Documents (Manuals)
  Use the findings of the gap analysis (report) to have the appropriate resources (persons, departments, consultant) work on the procedures required to have a complying documented quality management system.
  Try ISOhelpline Documentation Kit.
• Step 5: Quality System Review and update
  Review and update the documented quality management system in order to achieve completeness, cohesion and compliance with the ISO standard. Generate a process map to illustrate the interrelation of all the procedures.
  Evaluate potential nonconformities and take preventive action.
• Step 6: Training for all
  Give appropriate training to all levels of the organization on the policies, procedures, processes and the quality concepts of ISO 9000. Provide internal auditor training.
  Try ISOhelpline Training Kit
  Try ISOhelpline Examination to certify internal auditors. You can use your computer system and conduct the exam. Keep a record of examination result, either save it in electronic media or print and store properly.
  You can also print the examination paper and take examination in conventional manner ad examine the results as per answer sheet.
• Step 7: Internal Quality Audit and Corrective Action
  Conduct Internal Quality Audit(s) to verify compliance with procedures. Initiate corrective actions on deviations or findings (if any). Conduct follow-up audit to verify the effectiveness of corrective action. Repeat follow-ups if required to ensure that established procedures are being followed.
• Step 8: Management Review Meeting
  Conduct Management Review Meeting to review the performance of the quality system. Review the Internal Quality Audit, Corrective actions, Preventive actions, Quality Policy and continual improvement plan. The frequency of such reviews depends on size and type of organization and the business needs.
• Step 9: Pre-assessment Audit / Document Review
  Decide on the certification body (registrar). Call certification body to conduct a preliminary audit. The certification body auditors will review the documentation and conduct a preliminary assessment of the system. This will help you in finding the potential non compliances or over sight omissions in the system. Though pre-assessment is optional, it is recommended for a first hand experience of final (certification) audit. Check Common finding during ISO 9001 certification audits.
• Step 10: Registration or Compliance Audit and surveillance audits
  Call certification body to conduct the certification audit. Follow the surveillance audit plan of the certification body to maintain your certification. Check Common finding during ISO 9001 certification audits.