ISO 9001 Quality Assurance Certification Process QA

This article provides information on the various steps an organisation would typically take to achieve ISO 9001  Quality Assurance certification.

Stage 1: Information Gathering

An ISO 9001 Quality Management System requires both management commitment, and an undertaking to review the operation of the business with a view to improvement. The first stage involves a staff information session to provide an overview of the certification process, so that all members of staff are aware of what is involved. It is imperative that the Management System is developed with input from staff who will be using the system, imparting ownership and engaging them in the compliance process.

Following the information session the consultant will undertake an in-depth review of the operational procedures identifying (but not limited to):

  • key processes that the company utilises in day to day business activities,
  • software and business systems utilised,
  • staff roles and responsibilities, and
  • any procedures, forms or other documentation already in place.

Once all relevant information has been obtained, the consultant will then perform a “Gap Analysis”, to identify areas of the business that need to be addressed to comply with the requirements of the ISO 9001 Standard.

Stage 2: Draft Documentation Development

The consultant will then use the information obtained in the ‘Information Gathering and Review’ stage to produce draft Quality Management System manual and associated documentation including policies and procedures, forms, templates and registers (as required to meet the Standards and current Acts, Regulations and Codes of Practice).

Stage 3: Final Documentation Development

A final documentation review is conducted prior to QMS implementation. Any required amendments are made to the documentation, and forwarded to management for approval.

Stage 4: QMS Implementation (Rollout)

When management approval has been received the QAS consultant would normally have a meeting with Senior Management to conduct a final joint review and explain how the management system needs to be implemented, as well as provide specific training for the designated Quality Manager and other key staff as required. The QAS International consultant will also conduct a staff briefing session/PowerPoint presentation on the Quality Management System. This session is designed to share the rollout/implementation plan and provide information for the implementation of the QMS. The briefing session for key staff will take about an hour and would normally cover such things as:

  1. Quality Management System requirements,
  2. any changes/additions to staff responsibilities,
  3. details of where compliance with the Quality Standards has required changes to, or the adoption of new operating procedures and/or additional record keeping,
  4. sharing of internal and external audit plans,
  5. explaining what internal and external auditors will be looking for, and
  6. provision for question time.

Stage 5: Internal Audit

The internal audit is a requirement of the ISO 9001 and is conducted by the QAS consultant. The purpose of the Internal Audit is to cover and confirm effective implementation and compliance within all parts of the Quality Management System, with a focus on areas that the external auditors are likely to check. It is recommended that internal audits be performed once the Quality Management System has had sufficient time to mature (ie, be fully adopted by all staff and when appropriate auditable records have accumulated). All audit observations will recorded by QAS International on an Internal Audit Report, with any problems recorded as either “non-compliances” or “improvements needed” – all of which should be redressed prior to the external audit.

Stage 6a: External Audit (Stage 1)

The External Audit consists of two stages and is conducted by an independent external third party Certifying organisation. There are a number of companies that provide third party auditing and Certification services and it is the Clients responsibility to engage and pay for the cost of this service. The first part of the External Audit process consists of a review of the System Policy and Procedures Manual and associated documentation (forms, registers etc). The external auditor will check that the Manual and documentation meets the required standard. Any “non-compliances” or “improvements needed” need to be addressed prior to Stage 2 of the External Audit.

Stage 6b: External Audit (Stage 2)

Stage 2 of the External Audit process is an onsite check or verification that the organisation is operating as detailed in the System documentation. The external auditor will check the processes in use, confirm that records are being kept in accordance with System Manual and verify staff awareness and compliance with the System. Any “non-compliances” or “improvements needed” are identified on the External Audit Report and need to be redressed prior to Certification is issued.