This document has been prepared to explain the main stages of the Arrowhead Certification Services (ACS) Quality Management System Assessment process for certification to a recognised quality standard. (Usually ISO 9001)
Following application review, two visits to the customer’s site are usually required for approval to be recommended:
- Stage 1 Initial Certification Audit – document review and stage 2 planning
- Stage 2 Initial Certification Audit – certification audit
Once certification is confirmed, the approval is maintained by means of routine surveillance visits. Certification lasts for 3 years – a full recertification assessment is required at least 3 months prior to certification expiry.
Audit teams, dates and itineraries will be discussed and agreed with you before the assessment visits take place. Occasionally observers and trainee auditors may accompany the audit team as part of the ACS accreditation process – details will be discussed and agreed with you.
At the start and end of every day that the Auditor is on your site, there will be review meetings to discuss any issues that arise during that day. At these daily review meetings, our customers may invite appropriate members of their staff relevant to the areas being discussed. Any findings remain provisional until the formal report is issued following Head Office review.
STAGE 1 INITIAL CERTIFICATION AUDIT
For each new contract, ACS will usually arrange an on-site Stage 1 audit review of your Quality Management System (QMS) to establish that the QMS is soundly based and sufficient to permit a meaningful assessment of the QMS. This will be achieved by means of a review of documents in English and a tour of the site. The visit will also be used to plan the Stage 2 Audit.
Whilst the main focus is on the planning elements of the certification process, the Stage 1 audit will identify any weaknesses in the QMS that may require corrective action to be taken.
The visit starts with an opening meeting with your management team during which the Auditor will explain the ACS assessment process and agree a programme for the visit.
The programme will include:
- A review of the design and structure of the system against the assessment standard and scope of certification.
- A site tour.
- A report describing any issues requiring attention before the Stage 2 Audit.
- The preparation of a detailed programme for the Stage 2 Audit.
Documents and arrangements that the Assessor will expect to see include:
- Quality Policy.
- QMS Documentation as required by the relevant Standard.
- Organisational structure, roles and responsibilities.
- Site activities to be included in the scope of approval – confirmation of the processes and products covered by the QMS.
- Product and statutory requirements – this may include performance or compliance claims made in your product literature and how you address legal or regulatory requirements, applicable to your product or service, within the QMS.
- Operational arrangements including monitoring and measurement.
- Internal Audits and Management Review records. A complete audit cycle and at least 1 management review must be completed prior to the Stage 2 Audit.
- Continual improvement – a review of quality objectives relative to the Quality Policy.
At the end of the visit, the Auditor will prepare the Stage 1 Audit report and will present this to the Management Representative. The arrangements for the Stage 2 Audit Certification Assessment visit will be confirmed.
The documentation reviewed as part of this visit will be used as the basis for the stage 2 Audit. If you need to make changes between the Stage 1 and Stage 2 audits, these changes will be reviewed at the next visit.
At each visit, the Auditor will review any changes made to the QMS and documents issued under it.
NOTE: Under certain conditions, the Stage 1 audit may not require an on-site visit.
STAGE 2 INITIAL CERTIFICATION AUDIT
The aims of this visit are to confirm:
- The effective management of significant processes within the management system.
- Conformance of the management system with the assessment standard.
- The effective implementation of the policy, objectives and procedures.
In order to achieve these aims, the auditor will focus on the implementation of your planned arrangements and will follow the programme agreed at the Stage 1 Audit. At a suitable stage during the Stage 2 Audit, the Auditor will wish to meet with the senior management representative for the Company – e.g. MD, CEO or equivalent.
Elements of the QMS that the Assessor will report on:
- Review and follow-up of findings resulting from the Stage 1 Audit
- Effectiveness of the QMS with regard to the Policy and objectives.
- Implementation of the planned arrangements with respect to activities, products and services covered by the scope of the certification – including a review of records associated with such elements.
- Progress in achieving objectives, including those for quality improvement and customer satisfaction – provisions for monitoring and measurement.
- Management involvement and commitment including internal communications.
- Internal reviews of the QMS – internal audits, corrective and preventive actions and management reviews.
At the end of the visit the Auditor will hold a closing meeting to present a formal report of the Stage 2 Audit and recommendation.
Note: The Auditor does not award certification; this can only be granted by the ACS Technical Manager based on the information and recommendations provided by the Auditor in his Visit Report.
Any findings, based on objective evidence noted during the audit will be classified as:
Major Nonconformity (Major NCN) The absence of, or failure to implement and maintain, one or more of the QMS requirements, or a situation which would, on the basis of objective evidence, raise significant doubt as to the quality of what the organisation is supplying.
Minor Nonconformity (Minor NCN) These are raised where there is a perceived weakness in the system, procedure or area of the QMS that if left without corrective action may raise doubt on the capability of the QMS to achieve the company’s stated Policy and objectives.
Observation (OBS) These are findings noted by the Auditor that do not necessarily require action but should be reviewed by the company to ensure that they do not lead to potential deficiencies within the QMS – they will provide a prompt for Auditors during future surveillance and assessment visits with regard to any QMS changes that may have been implemented.
If no Major NCNs are raised then the Auditor will recommend to ACS Technical Manager that certification to the assessment standard be awarded. Minor NCNs will not prevent certification but will require remedial action to be taken. If one or more major NCNs are raised, certification will not be awarded – a follow-up assessment visit will normally be required to confirm the effective implementation of remedial action. This visit may be arranged with the Auditor during the closing meeting.
When certification has been achieved, ACS will monitor the maintenance of the QMS through a series of routine surveillance visits, the frequency and duration will be determined by the scope and scale of your QMS. The objective is to verify that you are continuing to maintain your QMS by means of effective implementation and the achievement of continual improvements of the system. The visits will provide the opportunity for ACS to review ongoing changes that you will make to the QMS to ensure that the QMS continues to comply with the assessment standard. Surveillance visits shall be scheduled during the Stage 2 Audit and shall ensure that, together with mandatory surveillance activities, all elements of the system are covered within the 3-year certification validity period.
Surveillance activities include:
- Review of progress made with regard to outstanding minor nonconformities and observations – such findings reported during a visit will usually be followed-up during the next visit.
- Internal audits and management reviews. ACS will expect that the maximum interval between audits of QMS Elements will be 12 months and, similarly, there shall be at least one full management review of your QMS every year.
- Quality objectives and how well these are being met.
- System / key personnel changes including the management of such changes.
- Review of corrective and preventive action systems (including customer complaints and customer satisfaction).
- Use of ACS and UKAS accreditation marks.
If a Major NCN is raised during the surveillance visit, remedial action shall be required within a 3-month period of the report being made. It will usually be necessary for the Auditor to arrange a follow-up visit within the 3-month period to confirm effective implementation of appropriate remedial action. Major NCNs raised during surveillance are the first stage of ACS’s suspension and withdrawal of certification.
CERTIFICATE RENEWAL (RECERTIFICATION)
Part of the last surveillance visit of the 3-year certification validity period shall be allocated to a review of internal audit, corrective & preventive action and management review records; ACS assessment reports and changes to the QMS during the 3-year period. You should, therefore, maintain appropriate records to assist this activity. The purpose of this review is to establish the extent of re-assessment necessary for the Recertification visit.
The Recertification audit is scheduled prior to the current certification expiry date. This allows time for any Major NCNs identified to be closed out as a new certificate cannot be issued with outstanding nonconformities and a break in certification may result.
A client application to expand the scope of certification already granted to a client shall be reviewed to determine and plan the necessary audit activities which may be conducted with a surveillance audit.
ACS shall undertake a short-notice or unannounced audit to investigate complaints, or in response to changes, or as a follow up on suspended clients.
At all stages of the assessment process, Auditors can only sample the elements of the QMS and therefore the absence of Major or Minor Nonconformities does not imply the absence of system deficiencies.
ACS assessment reports follow the same format at all stages of the assessment process. In addition to Major and Minor NCNs and observations they will also report on any Opportunity for Improvements noted during the audit as well as points of interpretation and clarification.
The Auditor may record observations and comments to be used as an “aide memoir” for review during the next assessment visit. You should retain a copy of all ACS assessment reports for the duration of the 3-year certification validity period as the Auditor may require you to produce copies of earlier reports.
ACS is accredited by the United Kingdom Accreditation Service (UKAS) in the UK.
Companies certified by ACS will receive up to 5 copies of their certificate free of charge. For quantities exceeding 5, a nominal charge will be made.
ACS is required to make publicly accessible information about certifications granted, suspended or withdrawn and on request provide confirmation of the validity of a given certification.
For further information regarding ACS products and services, please contact us.