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During the process of being ISO 9001 certified requires that an organization develops a Quality Management System (QMS). This system and the resulting certification benefits an organization in two areas:

  1. to your organization
  2. for your customers

Ideas for ISO 9001:2015 Internal Auditing

As ISO 9001 organizations adjust their systems to meet 2015 requirements, it opens an opportunity to add two new processes to the internal auditing requirements to capture effective implementation.

Audit program managers might want to consider Context of the Organization and Strategic Direction as separate audits inside of the organization’s audit program.  Adding these topics to the internal audit process based format requires inputs/outputs to these processes as well as measurement activities to demonstrate effective implementation.

FMEA (Failure Modes Effects Analysis) can be a successful risk reduction tool to assist in meeting the risk planning (design and manufacturing process) requirements mandated by ISO 9001:2015.

As an analytical tool, ISO 9001 organizations can use the FMEA to review steps in a process to determine how much risk there is in each specific process step.

ISO 9001 is a set of basic business principles written in a standard for quality management systems that is accepted around the world. ASR is an accredited ISO 9001 Registrar.

Currently more than 100 countries have adopted ISO 9001 as a national standard. The standard is intended for quality management system assessments and registrations to ISO 9001. The standards apply uniformly to organizations of any size or type of business.

Competency as described in the 2015 revised ISO 9001 standard changed slightly from the 2008 version.

In 2008, training addressed product conformity. The 2015 revision relabeled training as competency with the focus aimed at Quality Management System effectiveness.

ISO certified golden labelThe final step in your quest for registration is the third party audit by a Certification Body (CB) or registrar.

where do you find a registrar? 

How do you choose the right ISO 9001 registrar? 

Request a quote for a review or an ISO standards auditThe short answer is - it depends

There are 2 types of costs:
  • costs for the certification itself - American System Registrar is ready go give you ISO 9001 Certification Audit Quote
  • costs associated with preparing for ISO 9001 certification
To prepare for certification, your organization must consider these factors: Time & Cost

ISO 9001:2015 Documentation - What is Really Necessary?

Organizations are beginning to transition their QMS to the 2015 version of ISO 9001 prompting some clients to ask how much documentation is necessary. The answer is your choice as 2015 is very open regarding documentation.

ASR continues its update of common nonconformance's being experienced by ASR's ISO 9001 clients as they transition to the 2015 version of this international standard.

Following is a highlight of the common issues recently written by ASR's ISO 9001 auditors in the following sections:

Section 4 – clients are not addressing the new requirement to identify and define interested parties. Also, monitoring and measuring of processes is an issue. This is another new requirement.
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