ISO Certification

ISO certification is considered by most organisations to be a tool which adds credibility to their business. Certification helps organisations with augmentation of products, services and processes as well as increased customer satisfaction. How do organisations obtain ISO 9001 certification? A company should know the answer before applying for certification or starting the implementation process to make sure they execute the process in the correct manner to add value to the organisation. They will save time and valuable resources by being prepared. Let’s look at ISO 9001:2015 implementation requirements step-by-step.

  1. Awareness training
  2. Business process review and 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.

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Compliance Requirements

Identification of internal and external issues and needs and expectations of interested parties. Identification of risks for each if not properly addressed.
Scope finalisation and identification of requirements which don’t apply.
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 policy displayed and known to everybody. If required, translated in local language.
Quality objectives established with achievement plan prepared and last two to three months’ performance tracking done.
Identification of organisational processes.
Process effectiveness parameters and KPIs for various critical processes in the company with process input, output and description.
Availability of and compliance with functional SOPs and flow charts - at least for the critical and important processes / departments)
Organisational chart updated and available.
Roles, responsibility and 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 2/3rd of training completed with training records available.
Effectiveness of training carried out available with training attendance records.
Purchase orders available for all purchases.
Supplier registration covering all suppliers whose products or services affect quality.
List of approved suppliers available.
Supplier evaluation for all suppliers with analysis is done.
Third party inspection certificate for first purchase from a supplier or 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 enquiries received in last two to three months documented in enquiry log.
Documentation of client complaints with correction, root cause and corrective actions along with analysis.
Customer feedback collection and analysis.
List of applicable legal, statutory, and regulatory requirements.
List of items requiring calibration and calibration records with availability of calibration certificate.
Calibration tag on instruments and equipment.
Incoming inspection quality plan and records.
In process and 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 and service conformity requirements.
List of processes for validation and validation records.
List of customers and supplier property if damaged or compromised while being in possession of the organisation.
Master list of documents and records covering all 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 organisation with scope of QMS and any exclusions with justification, SOPs or reference to them and process interaction.
Procedures on documented information, internal audits, non-conformity management, corrective actions, management reviews if required by the organisation.
Ensure the right kind of knowledge is made available to employees.
Ensure the right kind of knowledge is made available to employees.
Statistical analysis of process performance, objectives, KPIs, supplier performance, customer perception / complaints / non-conformities, etc.
Identification of improvements and continual improvements projects in the organisation.

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