Accreditation

PASCB (Program for Accreditation of Standardization & Conformity Bodies) is committed to ensuring that Conformity Assessment Bodies (CABs) operate with competence, impartiality, and consistency. We evaluate the systems and personnel of CABs to verify their compliance with international standards and requirements.

Accreditation Process

General Requirements for Conformity Assessment Bodies (CABs). PASCB ensures that every CAB seeking accreditation meets the following key requirements:

Personnel Competence

CABs must ensure all certification staff are competent and define a clear process with expected outcomes PASCB reviews criteria documents outcomes and personnel evaluations

Certification Functions

CABs must define and apply competence criteria for all certification activities including audits and decisions

Management Oversight

Competence is also required for management impartiality committees internal auditors and evaluators

Effectiveness and Records

Results must show consistent achievement as proof of effective processes PASCB checks documentation to verify this

About ISO 15378:2011 & ISO 15378:2006

ISO 15378 specifies requirements for a Quality Management System (QMS) for manufacturers of primary packaging materials for medicinal products. It incorporates Good Manufacturing Practice (GMP) and ISO 9001 standards to ensure compliance with regulatory and customer requirements.

Scope & Application

This standard applies to manufacturers of:

  • Glass
  • Plastic
  • Rubber
  • Aluminum
  • Other materials that come into direct contact with medicinal products.

It is used for:

  • Design and production
  • Quality control
  • Regulatory compliance
  • Certification of packaging operations

Benefits of ISO 15378 Certification

Partnering with PASCB for ISO 15378 certification offers key advantages:

  • Improved operational efficiency and process control
  • Reduced contamination, mix-ups, and manufacturing errors
  • Enhanced compliance with legal and regulatory requirements
  • Greater customer confidence in product quality
  • Clear demonstration of organizational competence
  • Cost savings and risk reduction
  • Competitive market advantage

Why Choose PASCB?

Expert Support

Our experienced support team is ready to handle diverse technical and operational inquiries with accuracy and professionalism.

Transparent & Objective Process

We uphold integrity and clarity at every stage of the accreditation process, from application to decision.

Collaborative Approach

We don’t just assess—we guide and support certification bodies in understanding and improving their management systems.

Quality and Timeliness Commitment

PASCB is dedicated to delivering accurate accreditation results without delay, maintaining the highest standards of quality.

Professional Solutions for Reliable and Accredited Certification Bodies.