Our Expertise
Shirley® Auditors offer a pragmatic approach to conformity assessment to ensure our clients understand both their responsibilities as Manufacturers, and the applicability of the requirements to their own products and processes.
One-Stop Shop
Shirley® are an INAB accredited Notified Body. In addition, in conjunction with our sister company BTTG®, a UK Approved Body, we can also offer UKCA Marking conformity assessment and certification simultaneously with INAB activity, meaning one visit combining all of the client’s certification needs, as detailed by our Accreditation Schedule.
Integrated Audits for Streamlined Certification
Our auditors conduct combined assessments for all accredited schemes, enabling you to achieve Quality Management Systems approval while efficiently meeting your regulatory obligations. With BTTG® as a Certification Body offering UKAS accredited ISO 9001 certification, we can combine ISO 9001 audits with Notified Body audits under relevant EU legislation, such as PPE Module D.
Audits we offer
PPE Module D
- We are an accredited Notified Body (2895) and can provide the conformity assessment Module D certification for manufacturers of Cat III PPE with an approved quality-control system, such as ISO 9001 or similar systems. The conformity assessments are performed through various evaluation procedures that apply to the products.
- On successfully completing of the assessment, Module D certification is granted by Shirley®. You will be issued with a Module D certificate, with Validity for 3 years. The Module D certification is maintained through a programme of annual surveillance audits and re-certification audit in the 3rd year before the certificate expires.
MED Module D & E
- We are an accredited Notified Body (2895) and can provide the conformity assessment Module D (Production Quality Assurance) & Module E (Product Quality Assurance) certification for manufacturers with an approved quality-control system, such as ISO 9001 or similar systems. The conformity assessments are performed through various evaluation procedures that apply to the products.
- On successfully completing of the assessment, Module D or Module E certification as chosen by the manufacturer is granted by Shirley®. You will be issued with a Module D or Module E certificate, with Validity for 5 years. The Module D & Module E certification is maintained through a programme of annual surveillance audits and re-certification audit in the 5th year before the certificate expires.
MED Module F
- This Module is suitable for manufactures who produces small quantities of products and do not have an approved quality system.
- The Manufacturers must present their products manufactured in Batches or Lots. The Notified Body selects samples from the Batches/Lots at random based on statistical sampling plan and caries out tests to demonstrate conformity to the Type tested under Module B.
- On successfully completing of the testing on the selected samples, a Module F certification is issued for the batch/Lot produced.
CPR Certification Process
- The Certificate is issued without an expiry date, and is valid for as long as the system continues to comply and the manufacturer produces the product. Shirley®, as a Notified Body, would continue to monitor the FPC system by carrying out annual surveillance audits.
- Certificates for additional products can be issued, covered by the same FPC approval, with suitable additional testing (if required) and a declaration of performance.
CPR FPC Process
- The manufacturer shall provide Shirley® with its factory production control documentation. Our qualified auditors inspect the production sites and where required by the product type, laboratories, design offices etc.
- For System 1, our auditors will take samples of the product, and will arrange for the initial type-testing in our sister company BTTG®'s laboratories.
- Once the manufacturer has demonstrated, through this sampling exercise, that the system can produce products which conforms with the declared essential characteristics of the original model, Shirley® can then issue a Certificate of "Conformity of Factory Production Control" (System 2+) or ‘Certificate of Constancy of Performance’ (System 1) for the product family or products.
ISO 9001
- Our sister company, BTTG®, is a UKAS accredited Certification Body offering ISO 9001 certification.
- Our auditors can conduct combined assessments for ISO 9001 from BTTG®, alongside Notified Body audits for PPE, MED and CPR.
- BTTG®’s ISO 9001 scope includes:
- IAF 4 Textiles and textile products (full scope)
- IAF 5 Leather and leather products (tanning, dressing and dyeing of leather and fur)
- IAF 12 Chemicals, chemical products and fibres (Man-made fibres)
- IAF 14 Rubber and plastic products (Plastic Products)
- IAF 29 Wholesale and retail trade and repair (Wholesaling, retail sales and clothing repair)
- IAF 23 Manufacturing not elsewhere classified (NACE 32.99 - fire assessment and protective safety clothing, hard hats, other plastics personal safety equipment and fire fighting suits)
Please contact our auditing team today if you would like to find out more about any of the services we offer.
