FG Media's blog : Understanding the Audit Process for ISO 9001 Certification

In today's competitive marketplace, ISO 9001 certification can go a long way toward enhancing business credibility, efficiency, and customer satisfaction. Undoubtedly, ISO 9001 sets the globally accepted requirements for a QMS to ensure that organisations constantly meet customer and regulatory requirements. However, acquisition of such certification takes one through an auditor, the process of which businesses that are new to such procedures may experience as either complex or a source of intimidation.

The article describes the audit process of gaining ISO 9001 certification and hence is very incisive on just what firms should expect and how they can better prepare to ensure certification success.

Why ISO 9001 certification is important

Far more than a feather in one's cap, ISO 9001 certification can be a urge toward quality and improvement on an ongoing basis. Many businesses that get this certification do, in fact, find an increase in activity efficiency, better quality in their customers, and an improved position in the market. Oftentimes, certification, per se, is a prime opportunity for embracing inefficiency and putting best practices in place.

How does the ISO 9001 audit process take place?

In ISO 9001 certification, the audit process occurs on a systematic appraisal of the quality management system implemented within any given establishment. An audit involves a process or sequence of activities aimed at ascertaining whether the implemented processes and systems within a given organization conform to what has been required by the ISO 9001 standard. Fundamentally, it comprises two crucial stages: the Stage 1 audit, which is also known as the documentation review, and the Stage 2 audit, which is also known as the main audit.

Stage 1 Audit: Documentation Review

The first part of an ISO 9001 audit is usually a document review to see whether the documentation drawn up by the organization meets the requirements of the standard. This stage forms the basis for the whole audit process.

Key Points from the Document Review

Quality Manual: The quality manual will be examined by the auditor to ensure that it does provide adequate description for the quality management system and the processes undertaken. There shall be stated the scope of the QMS, the quality policy by the organization mandated to the employees and the responsibilities of those people working to endorse the QMS.
Procedures and Work Instructions: Procedures and work instructions should be documented, and the auditor should ensure there is relevance of the tools for the accomplishment of the ISO 9001 requirements. These documents should clearly translate how given processes are done and how those activities support the mutual realization of quality objectives.
Records: There shall be documented evidence made available that demonstrates conformity to the QMS. In the Stage 1 Audit, the auditor will establish that records are made available, maintained, and retrievable when needed.

The auditor may also use gap analysis to determine areas in the organizational documentation that are not entirely representative of the principles of ISO 9001. Gap analysis helps the organization understand what needs to be acted upon prior to dealing with the follow-up audit.

Primary Audit: Stage 2 Audit

Once documentation review is through and all necessary corrective actions have been taken on basis of the review, then the organization can go ahead and conduct the Stage 2 audit. The audit at this stage is far more detailed since it requires an on-site assessment of the quality management system put in place by the organization.

What is entailed by the Stage 2 audit?

Opening Meeting: The audit will start with an opening meeting during which the auditor will communicate an outline of the audit, audit plan, and major objectives. This offers an opportunity to allow the organization to raise questions and be completely clear on any concern before the audit commences.
On-Site Assessment: Involves a visit by the auditor to the auditee's premises to assert the effectiveness of the QMS in practice, interviewing employees, observing processes, inspecting records, and verify whether procedures documented are actually performed by the organization.
Process Audits: This aspect will be audited through the use of a process audit that determines the compliance of ISO 9001–based processes with the standard. Typically, such audits focus on production, customer service, and internal audits. The auditor must examine their consistency, effectiveness, and compliance with the approach presented in the standard.
Nonconformities: During the audit process, an auditor comes across two types of nonconformities—all those elements in which an organization is deficient with respect to the requirements of ISO 9001. Based on the level of seriousness, both forms of nonconformities are categorized as major and minor. It is necessary for an organization to completely work out these nonconformities and take corrective measures in both cases before award of certification is given.
Audit Report: Upon completion of the assessment exercise, the auditor shall prepare an audit report in which he shall record his findings in respect of nonconformities, observations, and opportunities for improvements. The report shall be shared with the concerned organization, and the same should be rectified before further step.
Closing Meeting: An audit is completed with a closing meeting, during which an auditor provides information on the findings and discusses next steps. It is the opportunity for the organization under audit to ask questions as well as bring clarification to any points made during the audit process.

Preparing for an ISO 9001 Audit

Proper preparation is basically the need of every activity, more so on auditing an ISO 9001. It must, therefore, be taken as a serious commitment for businesses to enable them to have a base fit for pulling through with minimal trouble within the audit session. The following are steps an organization may decide to take up as fit ones in preparing itself for the audit process.

Internal Audit: Conduct an Internal Audit. Internal audit is an important preparatory step for the ISO 9001 audit. The self-assessment step of the organization's QMS should be verified by one system audit, which, in general, should effectively cover documentation of processes and records in all aspects of the QMS.
Handle Nonconformities: With any nonconformities identified in the internal audit, the organization has to address them right away. It can be updating the documentation, processing improvements, or giving more training to employees. Compliance with all nonconformities prior to the external audit could avoid delaying the certification process.
Check Documentation: It is important for a company to ensure that, before an audit, all documentation concerning the quality management system is reviewed for its suitability and that it properly demonstrates the ISO 9001 requirements. These types of documents can take the form of a quality manual, processes or procedures, work instructions, and records. Systematic documentation is suitable for the auditor and is easily accessible during the audit.
Train the workforce: Employees have the major role in the audit process, as they had to execute the defined processes and procedures in the QMS. This implies that the organization should train to the employees so that they understand the roles and responsibilities and be ready if any questions are asked by the auditor.
Carry out a Pre-audit Meeting: Such an audit objective could be facilitated with a pre-audit meeting, which generally would address audit plan review and the handling of salient areas of focus as well as other audit-related concerns. Those who need to be involved in this pre-audit meeting would normally include management principals, perhaps process owners and quality professionals of the organization.

Post-Audit: General Anticipations after an ISO 9001 Audit

The organization receives the audit report of findings. After a successful audit, the organization will be given ISO 9001 certification where conformation has been achieved after correction of any nonconformity. The certification takes three years whereby they must conduct surveillance audits to ensure they remain harmonized with the standard throughout the three years.

Watching in the Aisles: ISO 9001 follows

Surveillance audits would be conducted annually to make sure that the organization remains compliant with the requirements of ISO 9001. Again, as intense as the certification audit, the level of review would still necessitate the QMS and its key processes' review.

What happens during a surveillance audit

Review of documentation: The auditor will verify that the organization's documents are current and in compliance with the ISO 9001 standard.
On-Site Assessment: Similar to Stage 2 audit, the auditor will undertake now an on-site assessment to the evaluation of effective QMS performance. It might include interviews of personnel, observations of processes, and examination of records.
Non-conformities: These will be raised in the same way as the audit conclusion, and therefore the organization must take immediate action to eliminate such non-conformities for certification to be retained. If not, the certification must be suspended or removed.

Some of the generic problems that occur during the audit process are:

Whilst the process of auditing with ISO 9001 is inimical, what an organization might be able to face is the challenge that approaches. These issues can assist businesses in being well prepared, rather than being caught unaware of the customary pitfalls.

Unpreparedness: Most prevalent continually will be unpreparedness; those organizations which are unprepared for an audit may well find it close to impossible to provide the necessary documentation, deal with any nonconformities that arise, or answer any questions which may be posed by the auditor.
Employee Disengagement: Success of the ISO 9001 audit would largely depend on the extent to which employees commit to it. In the case where the employees are not fully part of the agenda or do not understand their part within the QMS, then the organization will have brought issues on itself during the audit.
Complex Processes: Organizations with complex or unclearly defined processes might find it difficult to easily demonstrate ISO 9001 compliance at first. Documentation processes should be simplified and clearly articulated to minimize these hardships.
Resistance to change: Implementation work by some means aimed at obtaining ISO 4001 can also be formidable on occasions as a bit of natural resistance sometimes occurs from inside the organizations. Management support and effective communication take care of this resistance to successfully implement the required changes.

Here are some great benefits attached to gaining ISO 9001

Despite the many difficulties, getting ISO 9001 certified has got a number of benefits for organizations. Some of the benefits are as follows:

More Credibility: ISO 9001 certification is an international mark of acceptance. It serves as positive evidence to customers, suppliers, or other stakeholders of an organization that it is holding high-class standards.
Improved Efficiency: Through a closer look at the company's operations, the auditing process will prompt companies to rationalize their processes and eliminate non-productive elements, thus realizing better results.
Increased customer satisfaction: An organization having abided by ISO 9001 standards is certain to meet customer requirements more consistently and, as a result, satisfy more customers.
Competitive Advantage: The most salient advantage of ISO 9001 is its provision of competitive edge in facilitating the contracts and obtaining new market opportunities for the organizations.

FAQs

What does ISO 9001 audit process involve?

The audit in the ISO 9001 process is a systematic determination of extent and fact conformance to criteria based on an organization. Generally, it involves two major stages: Stage 1 Audit is the documentation review, while Stage 2 Audit is the on-site assessment.

How long does the ISO 9001 audit process take?

The duration of the process of auditing ISO 9001 depends on the size and complexity of the organization. Usually, Stage 1 audit will take place between one and two days, and Stage 2 audit will take the space of some days.

What if there is a finding of nonconformity during the audit?

In cases where non-conformities are found, the identified non-conformities shall be corrected; in such a case, the corrective action shall be checked or evaluated by the certification body before the certificate is granted.

How often are surveillance audits conducted under the ISO 9001 Certification program?

Then the surveillance audits are carried out at least annually after the certification for another stringent check on compliance with the measures of the ISO 9001 standard; they are relatively less extensive than the certification audit.

Conclusion

Receiving the certification for ISO 9001 means a huge leap for an organization and a big undertaking with regard to commitment to quality and continuous improvement. Proper understanding of the process of the audit and the actions required in preparation for the same will make businesses ready for the pursuit that is certification. An audit process that runs from the review of initial documentation to the final on-the-ground assessment captures the many stages at which an organization can be certain of meeting high ISO 9001 standards. Proper preparation, including involvement of the staff, and concentrating on continuous improvement can lead organizations to seek such a certification not just for the sake of the achievement but for the value gained in the use of a quality management system over quite a long time.

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