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Regulatory Compliance - Documenation - Apex Manual Status 28 Aug 2019 - g2 Consulting
Regulatory Compliance - Documenation - Apex Manual Status 28 Aug 2019 - g2 Consulting
APEX MANUAL
Section 0: Introduction
This section introduces the purpose, principles and key concepts of the standard,
including risk-based thinking and the process approach.
STATUS: DONE
PENDING: INTERNAL AUDIT
Section 1: Scope
This section defines the scope of the 9001:2015 standard. In summary, the scope
includes specifying requirements for a QMS of any organization.
STATUS: DONE
PENDING: INTERNAL AUDIT
India: C 905 Krishna Appra Saphire, Vaibhav Khand, Indirapuram. Ghaziabad. UP. India
1 .No. 16, First Floor, 70 HK Bld, Y M Road, Masjid Bunder, West Mumbai, India
UAE: Spark International FZE, PO Box 16111, RAK FTZ, RAK-UAE.
Algeria: No: 2 Etage Batimet Billayat, Cite Eyalarsa, SETIF, ALGERIA.
G2 Consulting
STATUS: DONE
PENDING: INTERNAL AUDIT
Section 4: Context of the Organization
When you are implementing your Quality Manual System (QMS), the first step for ISO
9001 requirements is to thoughtfully align your business objectives and intent with the
QMS. Determine external and internal issues, the needs and expectations of
interested parties, quality management system scope and its processes.
STATUS: DONE
PENDING: INTERNAL AUDIT
Section 5: Leadership
Section 5 of the ISO 9001:2015 requirements covers leadership responsibility. Top
management must demonstrate leadership and commitment, establish and
communicate a quality policy, and ensure responsibilities and authorities are
assigned, communicated and understood.
STATUS: DONE
PENDING: INTERNAL AUDIT
Clause 7 of the ISO 9001:2015 requirements covers the resources needed for the
QMS this covers: providing resources, ensures employees are competent and aware,
India: C 905 Krishna Appra Saphire, Vaibhav Khand, Indirapuram. Ghaziabad. UP. India
2 .No. 16, First Floor, 70 HK Bld, Y M Road, Masjid Bunder, West Mumbai, India
UAE: Spark International FZE, PO Box 16111, RAK FTZ, RAK-UAE.
Algeria: No: 2 Etage Batimet Billayat, Cite Eyalarsa, SETIF, ALGERIA.
G2 Consulting
Clause 8 covers the plan and control processes needed to meet the requirements for
products and services (design and development, external providers, production and
service provision, release of products and services, nonconforming outputs). Learn
More:
STATUS: DONE
PENDING: INTERNAL AUDIT
Section 9: Performance Evaluation (DEPARTMENTS HAVE STARTED THIS IN
DETAIL)
ISO 9001 requires your organization’s QMS to monitor, measure, analyze, and
evaluate your quality management system.
STATUS: DONE
PENDING: INTERNAL AUDIT
Section 10: Improvement (DEPARTMENTS HAVE STARTED THIS IN DETAIL)
ISO 9001:2015 requirements for clause 10 are based around continual improvement.
Select opportunities for improvement, take action against nonconformities, implement
corrective actions as necessary, and continually improve your quality management
system.
STATUS: DONE
PENDING: INTERNAL AUDIT
India: C 905 Krishna Appra Saphire, Vaibhav Khand, Indirapuram. Ghaziabad. UP. India
3 .No. 16, First Floor, 70 HK Bld, Y M Road, Masjid Bunder, West Mumbai, India
UAE: Spark International FZE, PO Box 16111, RAK FTZ, RAK-UAE.
Algeria: No: 2 Etage Batimet Billayat, Cite Eyalarsa, SETIF, ALGERIA.