Q
QMSvigilanti
Hello all,
ISO 13485 indicates (paraphrasing) that top management is responsible for ensuring that the quality management system is in place, and establishing the quality policy and quality objectives, etc. I was told today that the quality manual is a 'policy' and therefore, top management needed to approve this document, which is in our company under change control. However, after reading section 5.0, I believe they need to sign the 'Quality Policy', which may be included in the Quality Manual, but is a separate document, different from the Manual. In our case, we've had managers and directors of different disciplines approve the Quality Manual on an ECO, but have not included top management. My question is, is it a requirement that both the Quality Manual and Quality Policy be approved by top management? Thanks for your help clarifying this.
ISO 13485 indicates (paraphrasing) that top management is responsible for ensuring that the quality management system is in place, and establishing the quality policy and quality objectives, etc. I was told today that the quality manual is a 'policy' and therefore, top management needed to approve this document, which is in our company under change control. However, after reading section 5.0, I believe they need to sign the 'Quality Policy', which may be included in the Quality Manual, but is a separate document, different from the Manual. In our case, we've had managers and directors of different disciplines approve the Quality Manual on an ECO, but have not included top management. My question is, is it a requirement that both the Quality Manual and Quality Policy be approved by top management? Thanks for your help clarifying this.