ISO9001:2015 - Certification
The 5 Step Process to ISO9001:2015 Certification
Regardless of industry or company size, the process to certification remains the same.
Review the Standard
- The BSI website is also a good source of free supporting information such as checklists and guidance if you wanted to go through the process on your own and have a company like BSI come in for the audits; https://www.bsigroup.com/en-GB/iso-9001-quality-management/Resources-for-ISO-9001/.
- Standards are available from multiple sources, but we would recommend obtaining from a primary source such as ISO or BSI. The ISO9001:2015 standard should cost circa £115.
- Review the requirements set out within the standard and identify areas that require additional support / resource in order to interpret, apply and implement.
- Set objectives for the QMS and identify responsible and interested parties for implementation.
- Successful implementation will only come if the QMS is adopted, driven and supported by senior management.
- The QMS should not be imposed upon staff: they should be actively encouraged to be part of its delivery and take responsibility for their processes.
- Set out realistic, high level timescales for implementation and provide capacity so that people can plan and prepare alongside their day to day work without seeing the QMS as an inconvenience.
- Champion the benefits!
Establish the Baseline
- Undertake a review of current business processes and practices against the standard, identifying areas of both strength and weakness.
- Identify the critical aspects of the process.
- Identify training / awareness requirements of existing staff.
- Consider utilising a consultant to ensure the assessment is unbiased. At this stage it is essential that the assessment is an open and honest evaluation of the current processes.
Develop the QMS
- Create a high-level vision of the QMS, including the platform you will utilise (SharePoint, ERP system, process maps etc), how it will be structured, define responsibilities and confirm that the identified implementation resources remain sufficient.
- Produce an implementation plan identifying new process requirements, modifications to existing processes and any new aspects required to address the gaps identified.
- Assign realistic target dates to each action.
- Establish new processes.
- ‘Walk the walk’ – a certification body will not just assess the system on paper. You will be required to show it working over a given time period (typically 3–6 months).
- Collect records (performance statistics, calibration records, maintenance records etc)
- Conduct internal audits
- Conduct management meetings / review
- Stage 1 audit.
SELECT A CERTIFICATION BODY
- Shop around – ensure you understand the total costs including any regular visits the certifying body (CB) requires. The standard requires an annual review, whereas some CBs dictate more regular reviews, or may require minimum 3-year contracts. It is important this is established as part of the initial reviews, as well as including travel costs / expenses that may be charged.
- Accreditation – ensure any industry-specific requirements are understood and the chosen CB is an accredited body. UKAS-accredited ISO 9001 certification is frequently a condition of being a supplier to large companies, local government departments or Government-funded bodies (e.g. NHS, MOD).
- Familiarity – check to see who your customers and competitors have used. Using CBs with experience of your industry can significantly ease the process.
- Note: it is not possible for the chosen CB to provide consultancy / assist with documentation as part of the process, as they must remain impartial.
STAGE 1 AUDIT
- Your chosen CB will review your documentation to verify that, on paper, you have addressed all the necessary requirements of the ISO 9001 standard. The auditors will issue an initial assessment report identifying any non-conformances to the standard.
- This initial assessment can take place during the ‘walk the walk’ period of implementation.
- You will be provided a timescale to implement any actions / improvements and the CB will identify an appropriate timescale to return for final assessment.
STAGE 2 AUDIT
- This is the main assessment audit when the CB auditors will review the records you have accumulated by operating your QMS processes, including your records of internal audits, management review and corrective actions.
- Depending on the size of your organisation, the in-depth audit can take 2–3 days.
- A final report will be issued, identifying good practice observed, opportunities for improvement and any non-conformances that require addressing.
- The auditors will make a recommendation for certification if you meet all requirements. If you have any major non-conformances, then you will need to take corrective action on these problems before certification can be recommended.
Executive Compass Services
If you are taking your first steps on the ISO9001 journey, looking to adapt your system to a growing business or ready to transition to the latest ISO9001:2015 standard, our team of experienced Quality professionals can work with you to ensure the transition is as straightforward and as stress free as possible.
ISO9001:2015 Quality Management Systems
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