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SERVICES


Internal Auditing

Supplier Auditing

QMS Training

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ISO, FDA and EU regulations require that companies conduct Internal Audits to ensure that the appropriate regulations are being followed. Unless there are company dedicated Internal Auditors, there may be a risk of conflict of interest if internal auditors are conducted by company employees. PQS Auditors are highly experienced and will provide an internal audit experience that is guaranteed to improve and optimize your processes. We conduct Internal audits to the following standards:

  • ISO 9001:2008, and ISO 9001:2015
  • ISO 13485: 2003, and ISO 13485:2016
  • 21 CFR 820
  • Other regulatory standards.  

The regulatory bodies expect that the critical suppliers are audited periodically to prevent supply chain issues. PQS can perform your supplier audits and ensure that your critical suppliers are compliant to the applicable regulations and/or quality agreements. We provide supplier audits to the following standards:

  • ISO 9001:2008 and ISO 9001: 2015
  • ISO 13485:2003 and ISO 13485:2016
  • cGMP 21 CFR 820, 21 CFR 210 &211
  • Other regualtory standards

PQS provides QMS training to companies that are desirous of implementing or optimizing an ISO 9001 or ISO 13485 Quality Management Systems. Our highly experienced trainers will go the extra mile to ensure trainees' goals are met. We offer training to the following standards:


  •  ISO 9001:2008 and ISO 9001: 2015
  • ISO 13485:2003 and ISO 13485:2016
  • cGMP 21 CFR 820, 21 CFR 210 &211
  • Other regualtory standards

Internal Auditing

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ISO, FDA and EU regulations require that companies conduct Internal Audits to ensure that the appropriate regulations are being followed. Unless there are company dedicated Internal Auditors, there may be a risk of conflict of interest if internal auditors are conducted by company employees. PQS Auditors are highly experienced and will provide an internal audit experience that is guaranteed to improve and optimize your processes. We conduct Internal audits to the following standards:

  • ISO 9001:2008, and ISO 9001:2015
  • ISO 13485: 2003, and ISO 13485:2016
  • 21 CFR 820
  • Other regulatory standards.  

Supplier Auditing

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The regulatory bodies expect that the critical suppliers are audited periodically to prevent supply chain issues. PQS can perform your supplier audits and ensure that your critical suppliers are compliant to the applicable regulations and/or quality agreements. We provide supplier audits to the following standards:

  • ISO 9001:2008 and ISO 9001: 2015
  • ISO 13485:2003 and ISO 13485:2016
  • cGMP 21 CFR 820, 21 CFR 210 &211
  • Other regualtory standards

QMS Training

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PQS provides QMS training to companies that are desirous of implementing or optimizing an ISO 9001 or ISO 13485 Quality Management Systems. Our highly experienced trainers will go the extra mile to ensure trainees' goals are met. We offer training to the following standards:


  •  ISO 9001:2008 and ISO 9001: 2015
  • ISO 13485:2003 and ISO 13485:2016
  • cGMP 21 CFR 820, 21 CFR 210 &211
  • Other regualtory standards

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Quality Consulting

PQS provides Quality Systems and Quality Assurance and Compliance consulting services. Our consulting services are as follows:

  • QMS Implementation
  • QMS Optimization
  • Quality remediation and Compliance

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Audit Specialization and Commonly Serviced Locations

 

  • ISO 9001 San Francisco Bay Area, ISO 9001 San Jose, ISO 9001 Mountain View, ISO 9001 Menlo Park, ISO 9001 California   
  • ISO 13485 San Francisco Bay Area, ISO 13485 San Jose, ISO 13485 Mountain View, ISO 13485 Menlo Park, ISO 13485 California
  • cGMP San Francisco Bay Area, cGMP San Jose, cGMP Mountain View, cGMP Menlo Park, cGMP California