《KE01-05和ISO13485QSR820要求的对比和检查要点》讲述.pptVIP

PG KEY与QSR820、ISO13485要求对比解析 Kevin Tang 2009-07-02 PG KEY 01 Leadership Leadership ensures that the organization is designed, staffed and capable of delivering intended quality products, data and results. Leadership is accountable for quality results and quality assurance systems. PG KEY 01 Leadership Leadership uses a written statement to establish a commitment to quality and continuous improvement (e.g. mission and vision). They define, in measurable terms, the quality objectives, together with the means and methods to achieve these goals. PG KEY 01 Leadership Systems, sponsored by leaders