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Do you need some help in preparing your required QMS documentation? No worries I have made it easy and affordable for you. I will be adding more documentation in the coming week.

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The value of metrics. If you don't know where are you, you don't know where your going.
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The Auditor is not the Grim Reaper!
If I had a dollar for every time I saw stress, worry and concern on the face of the auditee’s employees, I would more money than Bill Gates. This post is written and directed towards the terrified auditees of the world. Contrary to popular we auditors are on your side, yes I know that’s hard to believe but we are. We don’t want to write pages of findings and observations. But sometimes you leave us no choice. As an auditor our main task is to evaluate the overall effectiveness of your QMS “Quality Management Systems” based on the ground rules (audit standard) provided to us. We are trained to be partial and unbiased, just like the jurors in the OJ Simpson trial (oops bad example).
All kidding aside when the auditor asks you an open ended question like “Can you explain the process of how Certificates of Conformance are generated”? Do exactly that in your own words and don’t add anything else to your response, just answer the question without giving him or her more reasons to question your further. The auditor is attempting to gage your understanding of the process in question and if you can effectively articulate this to the auditor you have answered the question successfully. If the auditor has concerns with your response, but your response reflects the actual documented process then his/her concerns with be referenced in the final audit report.
Audits are based on sampling of documents, records, procedures and forms and observing actual processes. The auditor may sample 7 certificates of conformances, 7 nonconformance reports, and 8 inspection records and based on the result of that sampling he/she will make an inference as to whether the documents are being completed correctly. Therefore, if employees have been completing the aforementioned documents correctly the sample will pass the auditors evaluation.
Keep in mind that audits whether internal or external (customer driven) only make you stronger and reveal areas where improvement is needed. Just like no city is without crime, no company has a perfect QMS in place, if they did there would be no need for auditors and I would be unemployed. Take your time and review all procedures and processes that apply to you weeks before the audit and make sure that you understand those procedures and processes and most importantly make sure that you are in compliance. If so, then you don’t need to fear the Grim Reaper.

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10 Reasons your organization should pursue and achieve ISO certification

1. Develop a Professional Culture
2. Improve the Consistency of Your Operations
3. Increase Customer Satisfaction with your Products
4. Improvement of your credibility and image
5. Promote continual improvement
6. Raise quality awareness among employees
7. Quality is constantly measured
8. Customer request
9. Improved internal communication
10. Integration and alignment of internal processes which will lead to increased productivity and results

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ISO 9001:2015 Gap Analysis

Adams Quality Services can support you by performing an on-site Gap Analysis to help you and your organization plan for the transition to ISO 9001:2015.

We can help you plan for a smooth transition by confirming your understanding of the changes introduced by ISO 9001:2015 and examining how you have introduced the changes into your Quality Management System.

The Gap Analysis will typically take 16 hours (2 days) onsite to complete.

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Don’t Let Your Audit Process Slide

The internal audit process is a vital element of the Quality Management System for both small and large manufacturing organizations. As a veteran auditor I conduct audits at organizations all over the U.S. and it never ceases to amaze me when I see organizations not performing internal and/or external audits. I always ask upper management at these companies “How do you know if your QMS is in compliance with your stated requirements?”. The answer I get most of the time is “We don’t get a lot of customer complaints and returns”. The first thing that comes to my mind is “Your Very Lucky”.

This is so far from the truth to base compliance to your internal QMS upon lack of customer returns and complaints. To improve upon your QMS you must perform internal and external assessments (audits) on a regularly schedules basis and generate corrective actions based on the audit results. In other words, “If you don’t know where you are, you don’t know where you are going”. Audit results will provide your organization with objective evidence of QMS compliance and provide your organization with a list of areas for improvement.

For organizations certified to ISO 9001:2008 and those preparing for the ISO 9001:2015 transition the audit program is a must. ISO 9001:2015 clause 9.2.1 states;
The organization shall conduct internal audits at planned intervals to provide information on whether the quality management system:
Conforms to the organization’s own requirements for its quality management system, the requirements of this standard and is effectively implemented and maintained.

Many smaller companies make the decision to outsource the audit function due to manpower and resources constraints. This is total acceptable per the ISO standards. Just remember however you choose to implement the audit function within your organization you must make certain that the audit program is effective, maintained and continuous.

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