Frequently Asked Questions

ISO 9001 sets out the criteria for a quality management system and is the only standard in the family that can be certified to (although this is not a requirement). It can be used by any organization, large or small, regardless of its field of activity. This standard is based on several quality management principles including a strong customer focus, the motivation and implication of top management, the process approach and continual improvement

This certification is intended for organizations that design, develop, or provide aviation, space, and defense products and services; and by organizations providing post-delivery activities, including the provision of maintenance, spare parts, or materials for their own products and services.

The AS9100 standard includes ISO 9001:2015 quality management system requirements and specifies additional aviation, space, and defense industry requirements, definitions, and notes.

All new clients must complete a Stage 1 and Stage 2 audit. Kalos may conduct the Stage 1 and Stage 2 back-to-back. Most clients choose to put 2-4 weeks in between the Stage 1 and Stage 2 audits. The purpose of Stage 1 is to assess your organization's readiness for ISO 9001:2015 certification. 

The basic objectives will be:

• to review your management system documented information (i.e., quality manual or equivalent, quality policy, scope, objectives, process interactions, etc.)
• processes and equipment used
• evaluate the site-specific conditions / discuss preparedness for stage 2
• review your understanding regarding the requirements of the standard with respect to identification of key performance indicators
• evaluate if the internal audits and management reviews are being planned and performed
• assess the level of implementation of your Quality Management System (QMS)
• Identify areas of concern that may lead to nonconformance in Stage 2

There are risks and benefits to completing your stage 1 and stage 2 back-to-back. 

Risks

• The Stage 1 report will identify any "areas of concern" the auditor has related to your QMS. If areas of concerns are identified, your team may not have time to complete the necessary corrective actions before the Stage 2 audit. These concerns may turn into nonconformances at stage 2.
• If your site is not prepared for certification, your Stage 2 will be rescheduled for a later date. Your organization is responsible for expenses incurred for travel, etc. per the Kalos Contract.

 Benefits

• Your organization may save money on auditor travel cost.

No. You may have nonconformances and still achieve certification. All nonconformances must be closed and verified before a certificate is issued.

Yes. Kalos must conduct an audit each calendar year for your organization to maintain its certification.

A Kalos Pre-Assessment is an option available to new clients. A Kalos auditor will visit your facility and assess a sample of your processes, like a surveillance audit. They will provide an FM-03-05 Audit Report with any opportunities for improvement or nonconformances identified in Section 6 of the report. The responses to pre- assessment findings are not required to be submitted to Kalos.

• The auditor may not offer any consulting or solutions for the issues found.
• The pre-assessment visit does not fulfill the requirements of ISO 9001:2015 section 9.2 or a stage 1 audit.
• The organization must still complete an internal audit through their preferred method (incumbent team members or consultant).
• The organization must also complete a full stage 1 and stage 2 activity to achieve certification.

A Consultant Internal Audit is an option available to all clients. A list of consultants that have helped clients achieve their certification goals is available upon request. The use of any consultant does not mean that the certification process will be simpler, easier, faster or less expensive. Kalos' process does not change based on the use of any consultant.

• The deliverables of a consultant internal audit are determined by the client and consultant.
• Consultants may offer suggested solutions to issues found during the internal audit.
• The consultant internal audit may be used to fulfill the requirements of ISO 9001: 2015 section 9.2.
• The organization must also complete a full stage 1 and stage 2 activity to achieve certification.

No. The expectation for clients is that they understand the requirements of the standard and apply them effectively. This could be accomplished in several ways based on the learning style and experience of the client.

Examples of learning:

• knowledge gained from experience
• lessons learned from failures and successful project
• the results of improvements in processes, products, and services
• gathering knowledge from external providers – trainers or consultants
  

Kalos offers opportunities to gain knowledge of the standards and other relevant topics. We host AZ Quality Network meetings 2-3 times per year. The topics range from current regulations, ISO/AS standard topics, changes to standards/expectations, etc. This is a free, public seminar- so bring a colleague and share with friends! All persons open to learning are welcome.

It’s also a great opportunity to meet other quality professionals, suppliers, auditors, and consultants. Past topics can be viewed here: https://kaloscertifications.com/az-quality-network
We’re always open to suggestions for topics or speakers!

ISO 9001 Auditing Practice Group
https://committee.iso.org/sites/tc176sc2/home/page/iso-9001-auditing-practices-grou.html

ISO 9001 Standard
https://www.iso.org/standard/62085.html

AS9100 Standard
https://www.sae.org/standards/content/as9100d/

IAQG OASIS Supply Chain Management Handbook (SCMH)
https://iaqg.org/tools/scmh/

To best serve you and select an appropriate audit team, we assign an Accreditation Technical Cluster number to your organization. To maintain consistency, these technical clusters are based on the statistical nomenclature for economic activities NACE rev. 2 published by the Commission of European Communities (Official Journal L 393/1, 30.12.2006).

Often the financial department of your organization will have the NACE code established since most business tax forms require it. They can be very helpful in determining what NACE code and technical cluster best fit your organization.

More information on NACE codes here: https://ec.europa.eu/eurostat/web/nace-rev2/correspondence- tables/publications

A comparison of IAF Technical Clusters and NACE codes is available upon request.

IAF ID 1: Informative Document for QMS and EMS Scopes of Accreditation