ISO certification is considered by most of the organizations as a tool to add credibility to their business. It helps an organization with augmentation of products or services / process and higher customer satisfaction. How to get ISO 9001 certification? A company should know the answer, before actually applying for certification or starting the process of implementation to make sure you execute the process in correct manner which adds value to your organization and saves time and valuable resources. Let’s take a look at ISO 9001:2015 implementation requiremetns step-by-step.
(1) Awareness Training
(2) Business process review & gap analysis
(3) Process design
(4) Documentation design and implementation covering the below mentioned guidelines. Kindly note that the below list covers mandatory and non-mandatory but good to have compliances.
Compliance Requirement |
|---|
Identification of internal issues, external issues and needs - expectations of interested parties. Identification of risks for each of the three if not properly addressed |
Scope finalization and identification of requirements which cannot be applied. |
Identification of risks and opportunities from context, processes, services / products / projects and changes. |
Top management involvement and active participation in the QMS implementation process. |
Identification of ISO representative(s) / ISO in charge and core team and issuance of appointment letter with responsibilities. |
Quality policy displayed and known to everybody. If required, translated in local language. |
Quality objectives established with achievement plan prepared and last 2/3 months’ performance tracking done. |
Identification of processes in the organization. |
Process effectiveness parameters / KPIs for various critical processes in the company with process input, output and description. |
Availability and compliance to all the functional SOPs / flow charts - at least for the critical and important processes / departments) |
Organization chart updated and available. |
Roles, responsibility & authority defined and communicated to all the employees. |
Competence evaluation carried out with identification of ideal competence and mapping with existing competence of all the employees. |
Training calendar prepared and 2 / 3 trainings completed with training records available. |
Effectiveness of the trainings carried out available with training attendance records |
Purchase orders available for all the purchases made |
Supplier registration carried covering all the suppliers whose product / service affect quality. |
List of approved suppliers available. |
Supplier evaluation carried out for all the suppliers and analysis is done. |
Third party inspection certificate for first purchase from a particular supplier/ supplier test report for the products to be obtained from all the suppliers where incoming inspection is not possible. |
Daily / weekly / monthly production / work / project execution plan and report |
All the enquiries received in last 2 / 3 months documented in enquiry log |
Documentation of client complaints with correction, root cause and corrective actions along with its analysis |
Customer feedback collection and its analysis |
List of applicable legal & statutory & regulatory requirements |
List of items requiring calibration and calibration records with availability of calibration certificate. |
Calibration tag on the instruments / equipment. |
Incoming inspection quality plan and records |
In process & final inspection quality plan and records. |
List of outsourced processes and identification of control parameters for outsourced processes. |
Records to prove that outsourced partner's work is as per our requirement and meeting product / service conformity requirements. |
List of processes that needs to be validation and validation records. |
List of customer property / supplier property if damaged / compromised with while being in possession of the organization. |
Master list of documents and records covering all the documents with information like document name, number, revision no, effective date, issued to, location, retention period, disposal mechanism, disposal authority etc. |
List of documents of external origin |
Document change request for any documents changed. |
Document issuances records |
Internal audit yearly schedule. |
Internal audit plan |
internal audit summary report |
internal audit non conformity report |
Management Review agenda |
Management Review minutes |
Management Review action plan |
Documentation of any process non conformity with correction, root cause analysis and corrective action. |
Quality Manual if required by the organization with scope of QMS, any exclusions with justification, SOPs or reference to them and process interaction. |
Procedures on documented information, internal audit, non-conformity management, corrective actions, management reviews if required by the organization. |
Making sure right kind of knowledge is made available to employees. |
Change management and ensuring change is a controlled change with risks identification if any. |
Statistical analysis of process performance / objectives / KPIs / supplier performance / customer perception / complaints / non conformities etc. |
Identification of improvements / continual improvements projects in the organization. |
(5) Internal audit
(6) Management Review
(7) Documentation Review
This is the primary step which checks whether the quality management system given by you, matches the standards of ISO or not. Auditor will match the QMS with requirements of ISO standard and will highlight the key areas where the company needs improvement. Such reviews are usually done on-site, but also possible on off-site.
(8) Pre-assessment
A company may prefer to have pre-assessment before actual audit, as it will help them to identify and address the concerns. But yes, this process is completely optional.
(9) Actual ISO 9001 certification audit
It is the day when the auditors will visit your company for monitoring business procedures and the quality standard your company is following. They may find some non-conformity if any and prepare the report accordingly. Company needs to prepare a report declaring the corrective actions which will be taken for improvement. Severity of errors will decide your ISO certification. ISO 9001 cost depends on the size and number of employees present in your company.
It is true that ISO publishes standards, but they are not involved in giving certification. However CASCO i.e. ISO's Committee on Conformity Assessment has introduced many standards which are followed by ISO 9001 certification body. Make sure that you have selected certification body which uses CASCO standard and has IAF membership with a valid accreditation like UKAS, NABCB, DAR, JAS ANZ, DAC etc.
Many companies are looking for ISO 9001 standard for bringing consistency, quality and compliance in the procedure. Although this standard requires regular maintenance post certification and in the absence of it, organizations may face problems during surveillance audit / recertification audit.
Effivity is a cloud based software which takes care of business strategies; products or services by following ISO standards and remains compliant. It also helps in risk management, so that your business can achieve its goals. Effivity is one of the leading software which allows company to implement ISO standard exactly in a way it is supposed to be implemented.
The idea of this concept came because of booming demand of ISO certification. Companies are very much interested in getting certification, but maintaining the standard becomes tedious for them. This has made Effivity Technologies to introduce Effivity, software dedicated to make business process simple, effective and compliant. Another advantage of this software is it keeps the organization audit ready - always. Usually, when it comes to audit, company needs to spend time in updating documents for fulfilling ISO 9001:2015 requirements. The way to avoid this situation is to bring automation in your business through Effivity. It will ensure your meet compliance in real time, documented information is updated and complete with all documents and forms, thus making audits hassle-free.
So, stop being at loss through inappropriate implementation, take it easy with Effivity as it adds value to your ISO 9001 compliance for compliance, maintenance and certification.
