SBS - The best value in QMS software

Documented procedures requirements for AS9100C requirement 7.5.1 a)

L

littleRoot

#1
#1
Section 7.5.1 'Control of Production and Service Provision'

a) the availability of information that describes the characteristics of the product
NOTE: this information can include drawings, parts lists, materials, and process spec.

My question is would I have to document in procedures how we control raw material specs and external specs? We have a process in place but it is not documented in QMS documents.
 
QMS for Medical Device Companies
Elsmar Forum Sponsor
D

dbaca0903

#2
#2
Chantalw,
The only time you must have a "documented procedure" is when the standars says to (eg. Control of records, control of documented etc.). I wouldn't write a new procedure if I already had a process in place. Look at the standard as questions. How would you answer an auditor if he asked "how do you control production and service provisions?" What would your answer be? I would reference the current process in place, and so long as you address the requirements in the standard, your good.
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
JoCam NADCAP AC7120 Rev A to B Documented Procedures Requirements Changes AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
M Quality System Processes without Documented Procedures Document Control Systems, Procedures, Forms and Templates 39
R How to Control Videos as part of the QMS Documented Procedures and Instructions Document Control Systems, Procedures, Forms and Templates 2
N Must Bioburden Sampling Procedures be Documented? Other Medical Device Related Standards 5
T Notification of affected parties of Updated Documented Procedures ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
J Can the mandatory procedures of ISO 9001-2008 be documented within one procedure? Document Control Systems, Procedures, Forms and Templates 5
S Number of Documented / Controlled Procedures Required by TS 16949 IATF 16949 - Automotive Quality Systems Standard 6
B ISO9001 Mandatory Documented Procedures help ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
S Must *All* Procedures Be Documented for ISO 9001 Internal Audit? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 19
J Minor Corrections to Documented Procedures ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
Z How to understand Processes, Procedures and Documented Procedures Misc. Quality Assurance and Business Systems Related Topics 7
T Matrix for Documented Procedures (US FDA Part 820, ISO 13485 and ISO 9001) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
V Definition Documented versus Defined Procedures Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 5
A Which should be documented first? The six mandatory procedures or other processes? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
A Sample Documented Procedures that satisfy 4.4.6 Operational Control wanted ISO 14001:2015 Specific Discussions 2
B Mandatory Documented Procedures in OHSAS 18001? Occupational Health & Safety Management Standards 18
B Should Documented Procedures be accessible to all people/employee? Document Control Systems, Procedures, Forms and Templates 20
I Is there a need to reference Documented Procedures - 4.2.2 b) ISO 13485:2016 - Medical Device Quality Management Systems 4
M The 6 documented procedures required by ISO 9001:2008 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 30
L Unconditional Documented Procedures vs. Recommended Procedures in 17025 ISO 17025 related Discussions 2
Y Mandatory Documented Procedures - What processes do mandatory procedures belong to? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
D Requirement for specific reference to documented procedures IATF 16949 - Automotive Quality Systems Standard 22
K The Six Activities in ISO 9001 that must have Documented Procedures ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 20
C Documented procedures per ISO 17025 ISO 17025 related Discussions 8
A Why does ISO 9001:2000 require 6 Documented Procedures? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 23
T Sarbanes Oxley Act (SOX) linkage to a documented QMS - Detailed Procedures Required? Document Control Systems, Procedures, Forms and Templates 21
G Documented Procedures for the Issue of Advisory Notices and the FDA (Medical Devices) ISO 13485:2016 - Medical Device Quality Management Systems 2
D AS9100 Para 7.5.1.3 Maintained according to documented procedures... AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 7
A Minimum Number of Documented Procedures for TS 16949 IATF 16949 - Automotive Quality Systems Standard 0
R Procedure Request for the six 'must have' documented procedures ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
A Downsizing the number of documented procedures Document Control Systems, Procedures, Forms and Templates 4
S Detail Required in Documented Procedures Document Control Systems, Procedures, Forms and Templates 7
Sidney Vianna Release of ISO 10013:2021, Quality management systems – Guidance for documented information Other ISO and International Standards and European Regulations 0
L Documented Information in Internal Audits Process (9.2) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
eule del ayre Documented Information - Periodic Review of Documents? IATF 16949:2016 / ISO 9001:2015 IATF 16949 - Automotive Quality Systems Standard 34
T Controlled Forms or documented requirements for records? ISO 13485:2016 - Medical Device Quality Management Systems 2
qualprod Documented actions and changes in the QMS by COVID 19 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
C Missing routers/documented information Nonconformance and Corrective Action 5
K AS9100D Clause 7.5.2.a) - What is considered to be "documented information"? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
Q AS9120 7.5.3.2 Control of Documented Information - Audit Nonconformance AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 20
J ISO 17025 Documented Procedure for 6.2.5 - Determining competency ISO 17025 related Discussions 4
L VDA 1 Documented Information and Retention (new revision 4, August 2018) VDA Standards - Germany's Automotive Standards 0
C Significant Organizational Changes - Documented Responsibilities Document Control Systems, Procedures, Forms and Templates 4
B Documented process for type and extent of control IATF 16949 - Automotive Quality Systems Standard 6
K Documented problem solving and documented error-proofing - IATF 16949 10.2.3 & 10.2.4 Internal Auditing 7
Q Stage 1 audit observations - documented report? General Auditing Discussions 5
H Documented processes required by IATF 16949 section 4.4.1 IATF 16949 - Automotive Quality Systems Standard 1
H New IATF 16949 required Documented Processes IATF 16949 - Automotive Quality Systems Standard 5
P Retained Documented Information for Management Reviews ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
S ISO 13485 Cl. 5.4.2 - Is Documented Quality Planning required? ISO 13485:2016 - Medical Device Quality Management Systems 2

Similar threads

Top Bottom