ISO 9001:2008 to 2015 Transition Solutions

Is Your Company Prepared for ISO 9001:2015?

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What You Need To Know About ISO 9001:2015

How Implementing ISO 9001:2015 Benefits Your Bottom Line

Stay Viable by Meeting Your Customer Requirements
Increasingly customers are requiring ISO 9001:2015 Certification and many will only do business with suppliers that are compliant. Implementing ISO 9001:2015 now ensures long-term customer retention, and, in many cases, puts you ahead of your competition.

 

Increase Your Market Share
Being ISO 9001:2015 compliant is a great marketing tool. By advertising that your firm is ISO 9001:2015 certified, you increase the size of your market due to the increase in customers that require ISO 9001:2015 compliant suppliers.

 

Command Higher Prices for Your Products and Services
Often a customer is willing to pay more for ISO 9001:2015 compliant services and products than those not. This increases your competitive advantage over companies who have not implemented ISO 9001:2015 standards.

 

When Should You Begin Transitioning to ISO 9001:2015?

The short answer is now. There are over one million companies and organizations in over 170 countries certified to ISO 9001:2015. The closer the September 2018 deadline approaches, the more more backlogged consultants and registrars are likely to be.

Download our free gap analysis checklist here.

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Get Started Now With a Gap Analysis

What Steps are Involved With A Gap Analysis?

Pro QC assists clients with the transition process by providing a comprehensive gap analysis and follow-up corrective action consulting. During the initial consultative evaluation, auditors specially trained in the 2008-2015 transition process identify opportunities for improvement. Within the evaluation, the auditor assesses the following and recommends corrective action for areas identified as requiring improvement for 2015 certification.

  • Understanding of the organization and its context
  • Understanding of the needs and expectations of interested parties
  • Determining the scope of the quality management system
  • Evaluating the quality management system and its core processes
  • Evaluating leadership and commitment
  • Confirming and evaluating existing of a quality policy
  • Review of organizational roles, responsibilities and authorities
  • Identification of actions that address risks and opportunities
  • Evaluation of support and resources
  • Evaluation of competence, awareness and communication
  • Evaluation of documentation, including creation, updating and control
  • Evaluation of the design and development inputs, controls and outputs
  • Evaluation of the control of nonconforming outputs

Download the complete gap analysis checklist by filling in your contact information in the form to the right.

 

In addition to a gap analysis, our trained auditors can assist with step-by-step guidance on implementing or transitioning to the new ISO 9001:2015 QMS structure. We can also assist in training your personnel as necessary.

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Gap Analysis Checklist

Frequently Asked Questions

How do you schedule an audit with Pro QC?

We make scheduling easy. Contact us at +1-813-252-4770 or info@proqc.com for additional information.

When are detailed audit reports provided?

Pro QC uses standard audit checklists and report forms but can accommodate to use your company-specific forms as well. Audit reports are uploaded to an online database. An email notification is sent to the client when posted.

Each report outlines the audit scope and includes recommendations, strength’s of the quality system and manufacturing process, and opportunities for improvement (weaknesses). An audit result based on the percent of conformances vs. non-conformances is provided.

Review example reports here. http://proqc.com/services/sample-reports

What is risk-based thinking and why has it been introduced into the standard?

The phrase risk-based thinking is used to describe the way in which ISO 9001:2015 addresses the question of risk. The concept of risk has always been implicit in ISO 9001, by requiring the organization to plan its processes and manage its business to avoid undesirable results. Organizations have typically done this by putting greater emphasis on planning and controlling processes that have the biggest impact on the quality of the products and services they provide. The way in which organizations manage risk varies depending on their business context (e.g. the criticality of the products and services being provided, complexity of the processes, and the potential consequences of failure). Use of the phrase risk-based thinking is intended to make it clear that while an awareness of risk is important, formal risk-management methodologies and risk assessment are not necessarily appropriate for all business situations and organizations. For further information about risk-based thinking see the papers on this topic available on www.iso.org/tc176/sc02/public .

Contact us at +1-813-252-4770 or info@proqc.com for additional information.

What are the benefits of the new version of ISO 9001?

  • Less prescriptive, but with greater focus on achieving conforming products and services
  • More user friendly for service and knowledge-based organizations
  • Greater leadership engagement
  • More structured planning for setting objectives
  • Management review is aligned to organizational results
  • The opportunity for more flexible documented information
  • Addresses organizational risks and opportunities in a structured manner
  • Addresses supply chain management more effectively
  • Opportunity for an integrated management system that addresses other elements such as environment, health & safety, business continuity, etc.

(Source: http://isotc.iso.org/livelink/livelink/open/tc176SC2public)

What are the main differences in content between the old and new version?

  • The adoption of the high level structure as set out in Annex SL of ISO Directives Part 1
  • An explicit requirement for risk-based thinking to support and improve the understanding and application of the process approach
  • Fewer prescriptive requirements
  • More flexibility regarding documentation
  • Improved applicability for services
  • A requirement to define the boundaries of the QMS
  • Increased emphasis on organizational context
  • Increased leadership requirements
  • Greater emphasis on achieving desired process results to improve customer satisfaction

(Source: http://isotc.iso.org/livelink/livelink/open/tc176SC2public)

Want To Know More?

We’ve answered many of our clients’ most commonly asked questions regarding audits in the articles and videos below. Let us know if you have any additional questions and/or comments!

Why You Should Consider Pro QC as Your Partner in Quality

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Stability

Pro QC is an established and reliable organization, providing quality assurance, engineering and consulting services since 1984.

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Global Presence

Pro QC offers services in 38 countries and growing. When services are required in an area where coverage is currently not available, we are able to secure local engineers or arrange travel for our engineers in order to accommodate the request.

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Experienced, Degreed Engineers

Pro QC’s professional and knowledgeable staff represents your interests on-site. Our inspectors and supervisors are degreed engineers. Our staff offers experience in a variety of industries from toys to aerospace, including consumer retail, textiles/fabrics, electrical/electronics, housewares, medical, and many more.

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Scheduling Flexibility

Pro QC understands the unpredictable nature of sourcing and the importance of meeting critical deadlines. We schedule accordingly, which often means accommodating last minute requests.

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Timely Feedback

Pro QC offers online reporting, with detailed reports provided within 24 hours of completion. Our web resident database provides scheduling information and report access anytime, from anywhere.

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Dedicated Account Managers

Pro QC employs regional account managers who are available to assist clients 24/7.

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Scalability

Pro QC maintains an advanced HR system that enables a high degree of scalability worldwide. We routinely manage project demand fluctuations within and across countries. We are able to train and deploy engineers within days, for projects of all sizes, so that bookings are completed in the time required.

Deadline for ISO 9001:2015 Transition.
Are you ready?

 

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Smart IT

Smart IT offers various products relating to personal computing, electronic entertainment and much more. Pro QC partnered with Smart IT in 2004 and has since provided product inspections and supplier audits in China and Taiwan.

For additional insight into our involvement in their quality assurance program, we spoke with Jakob Ludvigsen, Smart IT’s CEO.

Jakob explained that they started out their business in China with an in-house inspector that turned out to be an “inefficient and expensive solution.” He went on to say that having someone on staff was inefficient when more than one inspection was required per day and expensive when travel outside of the local area was required. Pro QC was recommended to Jakob by a business contact and he has utilized our services ever since.

Understanding The Supplier Audit Process

Pro QC International

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In North America Call: (813) 252-4770

info@proqc.com

Schedule a consultation with one of our expert auditors.


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