To earn ISO 9001 certification, you will need to implement the standard and successfully complete a two-visit Initial Certification Audit. After earning the initial certification, you will need to complete yearly surveillance audits and re-certification audits every three years to maintain your certification.

The audits must be completed by an accredited third-party certification body like Keyn Certification. In addition, you must be able to prove that your QMS has been operational for at least three months and has undergone a management review and a full cycle of internal audits before you can earn ISO 9001 certification.

Quality Manager’s common roles in ISO 9001:

• Ensure customer, internal, ISO 9001 and regulatory requirements are conformed
• Manage and organize Management Review meetings
• As the team lead for second or third-party audit inspections
• Review company Quality Policy, Quality Manual and relevant documented information
• Responsible for accuracy and calibration of infrastructure
• Provide suggestions and consultation to management on non-conformance closure and corrective actions
• Conduct periodic internal audits
• Define outgoing Quality Plan

Quality Executive common roles in ISO 9001:

• Control, maintain and update documented information periodically
• Work with suppliers, outsourcing firms to meet customer requirements
• Conduct periodic internal audits
• Review and oversee product or service quality
• Track quality performance and initiate quality improvement plans.

In these times of tight budgets and cost-saving measures, an ISO 9000 Consultant is a luxury that many companies have decided to do without. But how can a Project Manager be responsible for implementing ISO 9001, if they have not done it before?

• Make use of the resources and training available online today:
• Take an online implementation course
• Purchase an ISO 9001 Documentation Package
• Customize the documentation
• Train your employees

1. Prepare your organization
2. Gap Analysis
3. Planning
4. Training
5. Documentation
6. Use and Improve QMS
7. Internal Audits
8. ISO Registration

Are you ready and competent in ISO 9001? Test and evaluate your readiness here.

Depending on the readiness and progress made prior to Stage 2 (Certification Audit), a company with well-prepared documentation and knowledge will be able to easily achieve readiness upon commencing Stage 1 (Initial Documentation Review).

Ideally, this will take up to 3 months minimum from preparation to the compilation of documentation ready for audit.

Once readiness has been achieved, the company can proceed to Certification Audit smoothly and acquire their certification.

You may expect 1-2 months of time taken for scheduling and audit to take place.

We’ve prepared a sample Gantt Chart to help you visualize the overall time length of ISO 9001 implementation to certification. Click here.

1. Be well trained with ISO or ISO 9001 knowledge
2. Involve company’s participation in implementation
3. Be open for critiques and suggestions
4. Practise discipline and consistently update to logs, records and documents

Here’s a brief summary of what to expect prior to an audit:
Planning:

• Confirmation of contract details
• Audit schedule
• Audit Plan (Auditor Information, Audit Site, Sampling etc.)

Audit Entry Meeting

• Clarification of information (Audit Scope)

Audit

• Auditor collects evidence
• Auditor generate findings

Audit Exit Meeting

• Discuss audit findings
• Breakdown of potential non-conformances
• Highlights areas for improvement
• Provide possible solutions to as corrective action

Audit Report & Summary

• Detailed breakdown of audit findings

1. Understand which part of the activity/operation was issued an NC
2. Trace back to specific requirements that did not conform
3. Raise the NC during a management review meeting
4. Find out the root cause of non-conformance issued
5. Discuss potential solutions to resolve NC
6. Select and execute the decided solution
7. Record and submit to Auditor for approval
8. Closure of NC

• ISO 9001:2015 is the latest version under the ISO 9000 series.
• ISO 9000 refers to ISO’s Quality Management System Fundamental and Vocabulary.
• ISO 9001 is the standard requirements derived for Quality Management System.
• ISO 9004:2009 are the Guidelines for Performance Improvements.

In general, these listed documents are the best evidence to support the conformance to ISO 9001 requirements. However, not all are mandatory for a successful certification.

• Quality Manual
• Quality Policy
• Quality Plan
• Records of Operation

It’s great that your company can demonstrate these certifications. Above all, suppliers and buyers have some preferences your company may not yet have.

This is where ISO 9001 certification, as an international-recognized certification can improve your chances of success. Certified in quality indirectly tells how quality matters to your business and to fulfill their requirements.

Having FSSC / ISO 22001 / HACCP / ISO 45001 / OSHA 18001 certified is the best choice of certification acquired for food manufacturing industry. It also simplifies your requirements for ISO 9001, ISO 9001 as the basis of most ISO standards can be the missing piece to fit your business to other industries.

ISO 9001 can be a bonus certification you acquire as you integrate ISO 45001 with ISO 9001, with just a single price. There’s no hassle to perform audit twice!

A small investment for a big return.

With a management system such as ISO 9001 certification in place, your business is set up the perform at the most efficient and effective yet economical way. Certification for small businesses are definitely recommended as your processes are not as complex yet, while having certification price charged at the minimum!

A systematic business has all the actions transparent and reported, while simplifying your way to acquire new business opportunities. Start your business with quality guaranteed to customers today!

You can purchase and refer to the requirements here:

Malaysia

International