Many companies aren’t sure where to start when it comes to implementing ISO 9001 or a new quality management system, so ISO 9001 resources and tools are useful. SimpleQuE has been around since 2005 and over the years, we’ve developed some tools for organizations to utilize to “make quality excellence simple”. After all, that’s what our name stands for. So see if one or more of the options below is just what you need to be on the right path.
Understanding what you need – A short video providing guidelines for choosing an ISO 9001 consultant.
Customized consulting services – ISO 9001 Gap assessment is one of the many tools we use to support and improve an organization’s overall processes. A thorough ISO 9001 Gap Analysis identifies what needs to be implemented or changed based on the extent to which a company already complies with their current systems. The gap assessment results in an action plan that functions as a road map for each task that needs to be accomplished and is a great project management tool, as it assesses their own timing expectations based on the resources available. Additionally, using our gap analysis as a pre-assessment tool or readiness audit rather than a certification body’s allows our ISO 9001 consultants to coach and consult when problems are found.
Download our free ISO 9001 Sample Manufacturing Process Audit Checklist – This example is used to examine a company’s key manufacturing process and prepare for the highest quality internal auditing possible.
Customized on-site training – From ISO 9001 Implementation and Requirements Training to ISO 9001 Internal Audit Training, simpleQuE courses are designed to meet the specific needs of an organization. The course – ISO 9001 Internal Auditor with the Process Audit Approach fulfills the requirements for competent, knowledgeable, and well trained internal auditors, including hands-on practice auditing.
Whether you have a mature system and an experienced quality team or are new to the quality arena, simpleQuE has the resources and expertise to help you achieve your objectives and ISO 9001 standard certification. Contact us to learn more.
For more information on the simpleQuE Quality Connection, check out this blog post!
The International Automotive Task Force just released Revision 5 of the IATF 16949 Transition Strategy and Requirements. This revision of the Transition Strategy document incorporates a new FAQ no. 20 that clarifies questions for those situations where a previously certified IATF 16949 organization has to start over with an initial certification audit to IATF 16949.
Download the IATF 16949 Transition Strategy and Requirements document
For automotive suppliers who are having a difficult time meeting the requirements of the new IATF 16949 quality standard, Minimum Automotive Quality Management System Requirements for Sub-Tier Suppliers (MAQMSR) may be an option you want to consider in conjunction with ISO 9001 certification. With initial audit results coming in from certification bodies, it is evident that companies are failing to comply and in some cases IATF certification can’t be achieved.
IAOB released the top IATF 16949 findings based on 3,172 audits conducted as of August 2017 – the top 5 non-conformances overall were written against:
- 5.1.5 Total productive maintenance
- 5.1.1 Control plan
- 1.2.3 Contingency plans
- 5.1 Control of production and service provision
- 2.3 Internal auditor competency
As an option for suppliers, the Minimum Automotive Quality Management System Requirements for Sub-Tier Suppliers (MAQMSR) was released in September 2017 as a possible intermediate step for a supplier’s Quality Management System (QMS) under the authorization of IATF 16949, Section 184.108.40.206.c and Sanctioned Interpretation, SI #8.
Conformance to MAQMSR helps a lower tiered supplier transition to IATF 16949 by allowing many of the key Automotive Requirements to be met while developing the remainder of the QMS. The ultimate goal of the supplier development process is to achieve 3rd party registration to IATF 16949. It is important to note that the customer determines the path and steps, so approval must first be obtained before proceeding. The suggested steps of supplier development referencing 220.127.116.11 are as follows:
- Certification to ISO 9001 through 3rd party audits
- Certification to ISO 9001 + compliance to MAQMSR through 2nd party audits* (suppliers who did not achieve upgrade transition may consider this)
- Certification to ISO 9001 + compliance to IATF 16949 through 2nd party audits*
- Then finally certification to IATF 16949 through third party audits
MAQMSR aligns the Automotive QMS Requirements with the corresponding IATF 16949:2016 section(s); however, it is not certifiable or a third party auditable standard, though the guideline may be referenced during a second party audit *(by customer or with a qualified 2nd party like simpleQuE).
SimpleQuE consultants have been assisting companies to understand their options and make the change to drop IATF 16949 and prepare for ISO 9001:2015 certification. Upon receiving customer approval to use 2nd party audits to be compliant with MAQMSR, our consultants can provide guidance for that process and perform the audits. For more information on MAQMSR, contact us.
The automotive quality standard has come a long way since its first inception in 1994. With the new standard and more than 200 changes, simpleQuE recognized the need for an IATF Gap Audit Checklist to assist companies with the transition. The checklist includes the new automotive requirements (IATF 16949:2016 and ISO 9001:2015) and is intended to be used as a tool to identify both compliance with the new requirements and the differences between IATF 16949:2009 and the new requirements.
The utilization of this checklist, when populated with objective evidence of compliance and non-compliance, will satisfactorily demonstrate you have audited the differences between IATF 16949 standard and the new requirements. It should be used with your certification body as evidence of internal audits to the new IATF 16949 and ISO 9001:2015 requirements. It’s one of the methods simpleQuE auditors and consultants use with our own clients.
A free half hour of phone or email consulting with a simpleQuE expert is included with the checklist for the purchase price of $300.
The simpleQuE team wishes you a smooth and simple transition!
Certified companies to AS9100C will need to upgrade to AS9100D from when their certification body can begin issuing certificates (sometime late in 2016) through June 14, 2018. This should typically coincide with a scheduled surveillance or recertification audit. A special audit can also be scheduled and paid for. You should plan your upgrade based on this transition timing window and when your audit cycle falls.