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What is ISO 9001:2015?

ISO 9001 is a globally recognized Quality Management System (QMS) standard published and maintained by the International Standards Organization (ISO). The ISO 9001 QMS is the most commonly known standard within the manufacturing industry and represents the global standard when evaluating a QMS. It is also a foundational framework that forms the basis for many other QMS standards, such as ISO 13485 and IATF 16949.

An organization can be compared to team sports; most do not rely on one player’s skills, but rather on those of the entire team to achieve a consistent, collaborate approach that leads to success. For an organization, ISO 9001:2015 provides the playbook for companies to achieve that consistent, collaborate approach which ultimately leads to success. It provides a framework of guiding principles and objectives for organizations to strive towards, regardless of their size.

When an organization considers playing to or having their suppliers play to the ISO 9001:2015 standard, they may engage an external coach or evaluator to guide them. This is where Pro QC gets involved. Regardless of industry, we provide the analysis, coaching and corrective action planning required to ensure an organization is achieving that consistent, collaborative approach and is ultimately ISO 9001:2015 compliant.

ISO 9001:2015 for the service industry

vendor compliance

While earlier versions of ISO 9001 were created for application in the manufacturing sector, the later versions of the ISO 9001 have sought to generalize the requirements to broaden the application to all business types and sizes including the service industry. Pro QC is a service company and a good example of applicability to the service industry. Many of our regional branches are ISO 9001 certified and committed to ensuring a consistent global standard is followed to deliver quality services to our clients.

Many of the quality disciplines, principles and best practices covered in ISO 9001 can often be implemented in an organization even if it does not have a production line. Whether technology, software, finance, NGO or government, virtually every business organization can benefit from implementing ISO 9001 quality management system.

How does Pro QC assist organizations to achieve ISO 9001 audit certification?

The first step in achieving ISO 9001 certification is to establish an organization’s place along the journey. From our years of experience working with all types of organizations, there are six key milestones to be passed. Pro QC’s team of lead auditors and factory consultants facilitate clients through any or all these steps to ensure ISO 9001 implementation or certification is achieved:

1. Understanding ISO

  • Orientation training on the principles of ISO 9001
  • Initial desk audit and documentation review

There are many organizations providing classroom training on the standard and ISO 9001 implementation. In Pro QC we advocate learning by doing. We arrange an on-site visit to provide more effective training tailored to your organization and using your processes.

2. Internal Audit & Gap Analysis

  • Pro QC internal audit and completion of on-site gap analysis
  • Findings analysis and suggested action plan

Based on the ISO 9001 audit requirements, Pro QC performs a detailed and objective gap analysis which will identify the maturity of your Quality Management System and provide the necessary details and corrective actions to begin filling those gaps.

3. Preparing Documentation

  • Desk audit and documentation review
  • Pro QC establishes ISO 9001 documentation package

Based on the findings from the internal audit and gap analysis, Pro QC establishes the necessary ISO 9001 documentation by working closely with the broader organization. We can work together with the team step by step or remain on the side-line in a review and advise capacity.

4. ISO 9001 Implementation

  • On-Site facilitation of QMS implementation
  • Corrective action follow up visit
  • Corrective action validation

Documents form the basis of a quality management system, but the quality management system only becomes truly effective when the whole organization commits to the implementation, i.e. from top management & middle managers, down to the production floor staff and field service operators. Pro QC consultants ensure effective ISO 9001 implementation through regular follow ups with the management team as well as operators.

5. ISO 9001 Internal Audit

  • ISO 9001 audit or internal audit
  • Corrective action validation

As part of the ISO 9001 audit requirements, it is necessary for organizations to perform an internal audit at least once a year in order to achieve/maintain certification. This ensures organizations demonstrate the effectiveness and continuity of their quality management system. Pro QC will act as a third-party auditing company to provide internal audit reports and any subsequent corrective action plan required to maintain the required standard.

6. ISO Registration & Formal Audit

  • Assist with closure of any non-conformity from the formal audit
  • Corrective action validation

An organization can only apply for formal ISO certification and the corresponding audit by a certification body if the QMS standard has been consistent for six months and the necessary records and evidence have been maintained. In case the certification body finds any non- conformities (NC) or Opportunities For Improvement (OFI), Pro QC provides the required support to improve the QMS and close those items.

If suppliers or sub-suppliers require certification or simply an objective verification of ISO 9001 or any other global standard, Pro QC can support with a tailored supplier program to meet those needs.

Other Standards?

Most other Quality Management System standards follow a similar structure with similar milestones. Our team can provide the same services described above or a bespoke approach to meet any validation or certification requirements. Visit our Factory and Supplier Audit page to explore our wide range of supplier management services.

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