subject: ISO 9001 standard certificate implementation steps and requirements for successful iso certification [print this page] ISO 9001 standard certificate implementation steps and requirements for successful iso certification
Success of an ISO 9001 quality management system depends on how the entire implementation was carried out.
Implementation methodology from Lakshy Management consultant's experience of more than 2000 successful ISO 9001 implementation consultancy is given below.
(1) Start with a well defined awareness training programme. You need to have separate awareness training programmes for top management, middle management and lower management. You need to discuss about quality management, iso 9001 requirements and how quality management will make a difference to your organization. You can hire an external consultant/trainer for doing the awareness in a professional manner.
(2) Next step is to conduct a gap analysis. Gap analysis is a detailed and complete study of the current business processes of your organization vs. requirement of ISO 9001 standard. This is the most important and crucial stage during entire ISO 9001 implementation process. Whether you a manufacturing company or an service organization, you need to benchmark your current business processes with ISO 9001 requirements. Outcome of gap analysis study should be generation of a gap analysis report that you need to circulate with all the process owners and departmental heads. It is always advisable that you appoint a well renowned and experienced consultant for carrying out gap analysis of your organization as external consultant like Lakshy Management Consultant Pvt. Ltd. comes with a lot of functional and domain specific experience and expertise.
(3) After gap analysis, you need to carry out work shop for deriving quality policy and process wise quality objectives. These objectives will be the driving force in the organization for performance improvement and measurement.
(4) On the basis of gap analysis and process wise quality objectives, you need to develop various documents like quality manual, functional procedures (SOP), Formats, work instructions, system procedures and check lists.
(5) After documentation is developed should be approved by respective process owner and issued formally by a Management Representative. You need to provide training to the employees of your organization about documentation and it's effective implementation.
(6) Process owners along with departmental heads and management representatives are required to monitor effective implementation of the ISO 9001 system in the organization and their respective processes / departments. Provide help/assistance to users about the new system and ISO 9001 requirement if required to facilitate proper implementation of ISO 9001 in the organization.
(7) Select a team of employees to be trained as internal auditors. Consult your consultant or trainer to carry out an exhaustive quality internal auditor training. This training will enable your employees learn auditing skills understand process approach to carry out audit as per ISO 9001 clauses and it's requirements.
(8) Schedule an internal audit and ensure that ISO 9001 internal audit is conducted as per schedule. If required, you can rope in an external consultant to facilitate you first round of internal audit. MR and auditor should co-ordinate with the auditee to ensure that the Non-Conformities observed during the audit are closed and the corrective actions taken are effective in nature.
(9) Organize management review meeting to discuss various points like quality policy and objectives, results of audit, supplier performance, customer complaints and their redressal, customer feedback and it's analysis, customer enquiries and their status, training and it's effectiveness, change in process or QMS etc. Agenda and minutes of MRM is to be prepared with an action plan.
(10) Select a certification body depending on your budget and your specific requirements. You an use experience of your consultant in selection of the most suitable certification agency.
(11) It is advisable to get one pre-assessment audit done before the final certification audit. After taking care of the findings of the pre-assessment audit, schedule the final audit and communicate to everybody in the organization.
(12) Get the final certification audit done and ensure that you close all the non-conformities (if any) within the stipulated time.
(13) You get recommendation for ISO 9001 quality management system and you receive a certificate as ISO 9001 certified organization.
Note:- Time required for ISO 9001 quality management consultancy and certification varies from 2 months to 6 months depending on size and nature of complexity of an organization. Total cost involved in ISO 9001 consultancy varies from US $ 1,000 to US $ 10,000 or more as per size and business of an organization.
Lakshy Management Consultant Pvt. Ltd. can help you implement ISO 9001 in your organization in the most effective, economical and result oriented manner. With Lakshy, your ISO 9001 certification is 100% assured with resultant improvements in your business processes and performance.
