3 Tips to Ensure a Successful ISO 9001:2015 Audit

Posted by Courtney Underwood

Sep 8, 2017 6:26:27 PM

Read Time: 3 Minutes

ISO 9001:2015 is a widely used standard for quality certification and also one of the most stringent. This standard ensures that every aspect of a contract manufacturer’s business is well-run and continually improving, including key processes, management roles and responsibilities, documentation, customer satisfaction, employee training, vendor performance and internal audits.

Certification audits are used to evaluate the effectiveness of and assess conformity to documented Procedures and Work Instructions, and identify opportunities for improvement. During an audit, a manufacturer’s quality system is measured against the requirements of the standard. More than just a method of checking practice against procedure, audits are a powerful tool in manufacturing improvement processes. Below please find 3 tips to ensure a successful audit:

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Topics: iso

5 Things to Expect in an ISO Stage 1 Audit

Posted by Courtney Underwood

Aug 11, 2017 6:00:00 PM

Read Time: 3 Minutes

ISO 9001:2015 is a widely used standard for quality certification and also one of the most stringent. This standard ensures that every aspect of a business is well-run and continually improving, including key processes, management roles and responsibilities, documentation, customer satisfaction, employee training, vendor performance and internal audits.

The last step in obtaining certification is the Certification Audit, which usually happens in two stages: Stage 1 and 2. Stage 1, the preliminary audit, is used to gain knowledge of a company’s policies, objectives, risks, and processes. This top level review is usually done on-site and determines whether a manufacturer’s quality system has met the requirements of the standard. Below please find common activities performed during a Stage 1 Audit:

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Topics: iso

3 Ways You Can Benefit from Customer Surveys

Posted by Craig Zoberis

Dec 9, 2016 5:42:37 PM

Read Time: 4 Minutes, 30 Seconds

As an ISO 9001: 2015 certified contract manufacturer (CM), Fusion OEM is required to conduct customer satisfaction surveys. Results from these surveys are used to drive improvements in our business, strengthen our client relationships, and identify opportunities for improvement.

Our surveys, conducted annually, provide an opportunity for our customers to share their opinion of our services. We ask questions in several different areas, including customer service, product quality and the policies and procedures of our business. Our survey is designed to make Fusion a better contract manufacturer. Here are several ways that we benefit:

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Topics: oem, iso, customer intimacy

Fusion OEM Achieves ISO 9001:2015 Certification

Posted by Craig Zoberis

Sep 9, 2016 6:51:27 PM

Fusion OEM, a local contract manufacturer specializing in assembly of industrial products for OEMs, announced that it has been awarded ISO 9001:2015 certification from Eagle Certification Group for the design, manufacture, distribution and service of their client’s products.

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Topics: iso

Qualifying New Business with ISO 9001:2015

Posted by Craig Zoberis

Jul 22, 2016 6:43:31 PM

Read Time: 2 Minutes

As discussed in our previous posts, the challenges faced by manufacturing companies today are
different from a few decades ago and ISO 9001 has been updated to take this new environment into account. ISO 9001:2015 adopts a risk-based approach to various requirements throughout the standard, including new business development. When evaluating potential opportunities with both prospects and existing customers, the ISO standard requires companies to establish processes for identifying customer requirements and communicating those requirements throughout their business. At Fusion OEM, we have implemented the Optimum Maximizer Scorecard to fulfill this requirement.

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Topics: iso

Breaking Down the Changes in the ISO Standards – Part 2

Posted by Craig Zoberis

Jul 15, 2016 6:24:33 PM

Read Time: 2 Minutes

Last week’s blog discussed the changes in the new ISO 9001 standard. The challenges faced by manufacturing companies today are very different from a few decades ago and ISO 9001 has been updated to take this new environment into account. By upgrading our current ISO 9001:2008 certification, Fusion OEM is ensuring that we are optimized, competitive, and delivering the highest quality and value to our customers. Below find some of the benefits enjoyed by manufacturing companies who opt to adopt the new ISO 9001:2015 standard early:

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Topics: iso

Breaking Down the Changes in the ISO 9001 Standards - Part 1

Posted by Craig Zoberis

Jul 8, 2016 6:00:00 PM

Read Time: 4 Minutes

ISO 9001 is the international standard that specifies requirements for a Quality Management System (QMS). It is the most widely used quality certification and also one of the most stringent. This standard ensures that every aspect of a contract manufacturer’s business is well-run and continually improving, including key processes, management roles and responsibilities, documentation, customer satisfaction, employee training, service and internal audits. Organizations use the standard to demonstrate the ability to consistently provide products and services that meet customer requirements.

The challenges faced by manufacturing companies today are very different from a few decades ago and ISO 9001 has been updated to take this new environment into account. For example, there are increased expectations from customers and other interested parties and, with more access to information, today’s society has a stronger voice than ever before. To remain relevant, ISO 9001: 2015 reflects these changes:

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Topics: iso

Assessing Risk in Manufacturing

Posted by Craig Zoberis

Jun 10, 2016 6:00:00 PM

Read Time: 2 Minutes

Manufacturing companies are constantly searching for solutions that can improve business performance and enhance their operations. In today’s highly competitive market, success for manufacturers hinges on developing a business strategy that will minimize costs and create a
culture of continuous improvement. A key component of that strategy involves carefully calculating risks.

As an ISO 9001 certified contract manufacturer, risk management is woven into our business. The following five steps are used when completing our risk assessment:

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Topics: iso, risk management

4 Tips for a Successful ISO 9001 Management Review Meeting

Posted by Ken Chess

Nov 20, 2015 7:55:58 PM

As an ISO certified contract manufacturer, Fusion OEM is required to hold Management Review meetings, where we discuss our strategies for improvement, policies, goals, objectives, needed changes and resources, and financial performance. These meetings are a cornerstone of a thorough Quality Management System (QMS), but many companies do not seize the opportunity to maximize their effectiveness. Instead, businesses treat their Management Review meetings as a required formality to generate meeting minutes to demonstrate compliance to an auditor. How do leaders change the perception and get the most out of their QMS? Below find four successful strategies Fusion used to make these meetings meaningful.

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Topics: iso

3 Qualities of Fusion's Supply Chain

Posted by Keith Gansberg

Nov 6, 2015 6:33:13 PM

As an ISO 9001: 2008 certified contract manufacturer (CM), Fusion OEM is required to conduct annual supplier reviews. Having a formal system in place to track and evaluate supplier performance is essential to the smooth operation and profitability of our business.  The ISO 9001:2008 standard states that suppliers should be evaluated and selected based on their ability to meet our requirements. In order to accomplish this, we first had to define what those requirements are. Next, we created specific performance criteria for tracking and assessing our suppliers. After taking several factors into consideration, we arrived at the following three qualities that make a supplier successful (it may not be what you think):

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Topics: iso, supply chain management

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