What is ISO 9001 Compliance?

TOPICS COVERED IN ISO 9001 STANDARD

ISO 9001 incorporates principles of the Plan-Do-Check-Act (PDCA) cycle and provides a process-oriented approach for establishing an effective quality management system (QMS). The current ISO 9001 revision places greater emphasis on risk management and involvement of an organization’s leadership team.

Key areas covered in the ISO 9001 standard include:

• Requirements of a QMS, including documentation and planning
• Roles and responsibilities of the management team
• Management of resources, including employees and work environment
• Product realization—planning, design, development, production, and delivery
• Measurement, analysis, and improvement of the QMS through activities such as internal audits and corrective and preventive actions (CAPAs)

ISO 9001 CERTIFICATION STEPS

ISO 9001 is the only standard in the ISO 9000 series that companies can apply for certification. The certification process lasts an average of six months; however, the duration really depends on the size and complexity of the business.

The path to a successful certification and achieving ISO 9001 compliance hinges on the following steps:

1. Preparation

The first key step in the certification process is setting clear business goals and objectives. What do you want to accomplish (e.g., operational efficiency, customer satisfaction, improved quality)? This will help you define the scope of the certification and determine how it should be applied across the organization.

Also identify the person(s) responsible for overseeing and maintaining the certification. This could include a quality assurance manager or an executive.

Once you’ve established goals and objectives and identified key stakeholders, it’s important to conduct companywide trainings to ensure employees clearly understand the ISO requirements and how they impact the day-to-day operation.

Lastly, perform a gap assessment to gauge where your company is at in meeting the ISO 9001 requirements. Based on the analysis, you can identify deficiencies and prioritize areas that need the greatest attention.

2. QMS Implementation

A QMS serves as the roadmap to help your organization carry out processes in a systematic manner and achieve ISO 9001 compliance.

Develop documentation to support your QMS and reflect what your business does. As part of the QMS, a robust document management system should be in place to ensure proper revision control.

Required QMS documentation includes:
• Quality policy
• Quality objectives
• Scope of the QMS
• Procedures
• Work instructions
• Forms
• Process maps/flowcharts
• Training records

Today many companies are moving away from traditional paper-based systems and embracing an enterprise quality management system (eQMS) solution to simplify ISO compliance and gain greater control and traceability over product and quality records.

3. Internal Audit

To verify the effectiveness of your QMS, perform an internal audit. The role of an auditor is to thoroughly review specific processes or issues. Auditors can be trained company employees or an external consultant.

Results of the internal audit should be presented during a management review to ensure that the proper corrective actions are put in place.

4. Certification Audit

Certification audits are conducted by accredited third-party organizations. The assessment is typically divided into two phases. A stage 1 audit is conducted remotely and involves the review of QMS documentation. The stage 2 audit is conducted on-site and entails the review of work processes.

Most audits will uncover minor issues that can be corrected prior to receiving the certification. If severe nonconformities are detected, a follow-up audit will be conducted to determine if the company can be certified.

Upon passing an audit, the ISO 9001 registrar will issue a certificate, which will remain valid for up to three years.